Final Report (all chapters)

Beyond Bioethics:
A Proposal for Modernizing
the Regulation of Human Biotechnologies
Francis Fukuyama & Franco Furger
Paul H. Nitze School Advanced International Studies
Washington, DC

Executive Summary
1 Overview
This report presents a proposal for a new approach to regulating reproductive medicine and
biomedical research in the United States. It is the product of more than three years of research,
and of a study group convened in Washington, D.C., dedicated to this subject. The members of
the study group, numbering 42 people, were chosen to be representative of the different
stakeholders in reproductive medicine and biomedical research, including the American Society
for Reproductive Medicine (ASRM), the Federation of American Societies for Experimental
Biology (FASEB), the American Association for the Advancement of Science (AAAS), the
Council of Scientific Society Presidents (CSSP), the President’s Council on Bioethics, the
Biotechnology Industry Organization (BIO), the National Osteoporosis Foundation (NOF), and
the Food and Drug Administration (FDA). While they have intensively discussed various issues
raised in this report, these organizations have not been asked to endorse this report or its final
conclusions, which the report’s primary authors take full responsibility for.
It is our belief that the existing system for regulating reproductive medicine and biomedical
research in the United States, while unrivaled in many respects by that of any other country,
contains certain gaps or omissions that will render it increasingly inadequate to meet the
challenges posed by new biotechnologies and medical procedures in the coming years. Other
developed countries have put new regulatory institutions in place already, or are in the process of
doing so in anticipation of new developments, and the United States must follow suit.
In putting forth the proposals laid out in this report, we fully understand the downsides of
regulation. If you regulate something, you get less of it, and many people fear that excessive
regulation of biomedicine will stifle innovation and progress in many areas critical to human
health and well-being. While this fear is often well-founded, we believe that properly designed
regulation can have the exact opposite effect: It can promote research and scientific advances by
establishing a clear framework under which innovation can take place, a framework that
reassures the broader society that the research is being conducted safely and ethically.
1.1 Domain of Inquiry
In this report, we intend to focus on technologies and medical practices related to human
reproduction and on research activities focused on reproductive tissues. Our reasons for choosing
these areas are that they encompass most of those technologies, existing, over the horizon, and
possible in the more distant future, that bioethicists have pointed to as raising significant moral
and ethical issues. Within this domain lie – among other things – human cloning, prenatal
genetic diagnosis, genetic testing, germ-line modifications, embryonic stem cell research, the
creation of human-animal chimeras and hybrids, and novel forms of reproduction (such as the
creation of embryos from the genetic material from one, three, four, or more parents). It includes
medical and clinical practices involving both old and new assisted reproductive technologies
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(ARTs) as well as laboratory research involving embryos, both as an object to be manipulated
and as a source of biological tissues like stem cells, and other reproductive tissues.
It should be noted at the outset that to say that these technologies are related to human
reproduction does not necessarily mean that they are intended to produce children. This is
particularly true of embryonic stem cell research, whose end is, of course, the development of
treatments for diseases affecting already-living human beings. Nonetheless, the fact that such
stem cells are derived from embryos and may in the future be capable of producing embryos
means that it is impossible to regulate the broader field of human reproduction without regulating
them. Indeed, the manipulation of stem cells may become the primary technological gateway
through which many of the other reproductive technologies noted above become possible.
To say that these practices should be regulated is not to say that they should be banned or
unduly restricted. As we explain in greater detail below, it is our view that stem cell research
would greatly benefit from being placed within a regulatory framework. But precisely because
embryonic stem cell research today requires the use of embryos and may at some point in the
future lead to the creation of embryos, it is not possible to separate this kind of work from
research and medical practices that aim directly at creating children.
1.2 Embryo Politics
It is safe to say that in the United States, all legislation in the general area of reproductive
medicine and biomedical research is made vastly more complicated by the underlying societal
controversy over the moral status of the embryo. Other developed countries that have passed
legislation in this area have reached consensus either to permit (as in the case of Britain) or to
prohibit (as in the cases of Germany and Canada) certain forms of embryo research. In the
United States, there are passionate proponents of both the pro-life and pro-choice positions.
We do not begin from a pro-life position. We believe that human embryos have an
intermediate moral status. They are, on the one hand, not the moral equivalents of newborns;
destruction of an embryo, for us, is not tantamount to murder. On the other hand, we do not
believe that embryos are just clumps of cells like any other tissue specimen; because they are
potential human life, they deserve some degree of respect. We believe that a regulatory system
that keeps track of such embryos, permitting them to be used for select scientific purposes but
prohibiting their casual creation or destruction, is an appropriate way of recognizing this
intermediate status. Our ethical concerns in this area relate not to embryo destruction per se as
much as to other technological possibilities that are either emerging now or will appear in the
coming years.
We raise this issue not to persuade others of our case, but rather to point out that there are
several deeply held alternative views on this issue, over which it is not likely that there will be
consensus any time in the near future. These large moral questions cannot possibly be delegated
to a regulatory agency. They must rather be adjudicated at higher levels of the political system,
in Congress and the state legislatures or, less optimally, through the court system (as has actually
happened in the case of the legalization of abortion). Indeed, if any kind of regulatory system
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involving human embryos is to succeed, it is critical to fence off the realm of delegated authority
from the issues of abortion and embryos’ moral status.
We believe that embryonic stem cell research should proceed with federal funding, and that
a new regulatory system will actually promote that end. We note that Britain, with its Human
Fertilisation and Embryology Authority (HFEA), has one of the world’s strictest regulatory
environments in this area, and yet is a leader in stem cell research.
1.3 Regulation: General Considerations
Most Americans rightly regard regulation as a necessary evil; with the rapid growth of the
state sector in developed countries in the twentieth century, it became clear by the 1970s to many
people that many parts of the American economy were over-regulated. Much of the thrust of
policy in the United States since then has been to cut back on regulation in areas ranging from
airlines to trucking to electricity to telecommunications. In some cases, like telecom
deregulation, this has led to great success; in others, less so. The dangers of over-regulation
remain, however, and the burden of proof ought to lie with anyone who argues that new
regulatory bodies are necessary.
A useful prudential rule in public administration is not to multiply regulatory agencies
unnecessarily when the new functions required can be performed just as easily by existing ones.
On the other hand, certain historical precedents suggest that it is at times wiser to create a new
institution to deal with a new problem. Take the case of transportation, for example. The former
Interstate Commerce Commission (ICC) was created in 1887 to regulate the new railroad
industry. At the beginning of the twentieth century, the rise of interstate trucking posed the
question of who should regulate this new industry. The Hepburn Act of 1906 gave regulatory
authority to the ICC on the grounds that trucking and railroads were similar, both being means of
moving goods across state borders. Most experts in administrative law believe now, in retrospect,
that this was a mistake: The economics of the rail and trucking industries were very different, the
interest groups involved differed substantially, and the technical expertise require to regulate rail
service did not spill over into trucks.
When commercial aviation emerged in the 1920s, regulation of this sector could have been
given to the ICC on the grounds that airplanes are simply another means of interstate commerce.
Instead, the Air Commerce Act of 1926 created a new independent Aeronautics Branch within
the Commerce Department to promote and ensure the safety of civil aviation. With the advent of
commercial jet aircraft after World War II, this branch eventually evolved into two independent
agencies – the Federal Aviation Administration and the Civil Aeronautics Board. It is doubtful
that anyone today regrets this choice to create new agencies to regulate aviation rather than
building on the authority of the ICC.
The question to consider here, then, is not the broad one of whether or not to regulate
reproductive medicine and biomedical research, as a positive choice was made in this area long
ago. The question, rather, is whether we are currently at a juncture somewhat like the mid-1920s,
when civil aviation first emerged as a new but highly promising industry. Do we regard the
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issues raised by new biotechnologies as cases of problems with which we are already familiar, or
are they sufficiently different in kind as to merit new regulatory powers? Surely, no one in a
liberal society wants to multiply regulatory agencies unnecessarily or add more layers of
bureaucracy. On the other hand, it is sometimes more efficient to begin afresh rather than trying
to change bureaucratic cultures to handle problems they were never designed to handle.
2 Sources of Concern
2.1 General Ethical Principles
We believe that human reproduction is a particularly important and morally meaningful part
of human life, and that society has an inherent interest in protecting the human values associated
with it. We will begin by laying out a general set of ethical principles that we believe should
guide regulation in the domain we have defined above – namely, medical practices related to
human reproduction and research activities involving reproductive tissues. We believe that these
general principles are ones that the American public will broadly support, and we have
considerable polling data to back this up. The following is a set of principles that we believe any
regulatory system touching on this domain should promote.
The well-being and health of children. Since reproduction aims at the creation of children,
their welfare ought to be placed first and foremost as an objective of regulation. We believe that
this means, in the first instance, better and more systematic monitoring of health outcomes.
Compared to other developed countries, public oversight of assisted reproductive technologies in
the United States is limited, and funds to carry out studies have thus far also been very limited.
It may seem obvious that the well-being and health of children ought to have priority over
the interests of other stakeholders in reproductive medicine, including parents, doctors, clinics,
and biomedical researchers. Many discussions of new reproductive technologies, however, often
put the wishes and desires of potential parents foremost. Clearly, parents who want children also
want the best for their children, and so the law generally allows them generous discretion in
following their own instincts, under the assumption that this will also lead to good outcomes for
their children. But it is not always necessarily the case that what parents want will correspond to
the best interest of their children.
We interpret “well-being and health” broadly to mean not just physical health, but
psychological and social well-being as well. We believe that this means that every child has the
right to be genetically related to a mother and a father, even though they may be brought up in a
variety of households in which the genetic mother and father may be absent. We believe that this
right overrides the interest of parents in creating biological offspring through novel medical
techniques like cloning or the harvesting of fetal eggs (see the following section on prohibited
activities).
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Equal access to ARTs on the part of infertile couples. At this point, more than one
million children have been born worldwide through ARTs. The benefits of these technologies to
infertile parents have been enormous, and equal access to them ought to be a priority. In the
United States, however, treatment for infertility is often not regarded as an insurable medical
condition, but rather as a health option. Insurance coverage varies by state, and many Americans
do not have access to ARTs because of their cost. Expanding the availability of safe ARTs and
equalizing their costs ought to be a policy priority.
The well-being and health of women. ARTs frequently involve special risks to women,
particularly due to the need to take fertility drugs that stimulate ovulation. Most ARTs involve
invasive medical procedures; new techniques that may become available in the future could lead
to pregnancy complications that do not exist now. We place the priority of women’s well-being
and health somewhat lower than that of children and of infertile couples, only because the
women who take these risks generally do so voluntarily and in full knowledge of possible
adverse consequences.
Informed consent. It is important to recognize that a great deal of what happens in ART
clinics constitutes a form of experimental medicine. It is very important, therefore, that parents
be fully informed ahead of time as to existing risks, and in cases where procedures are genuinely
novel, that they be informed of this as well. This, in turn, generates requirements for better data
collection on actual risks.
Limits to commercialization. While the practice of medicine using assisted reproductive
technologies constitutes a business for the doctors and clinics participating in it, we believe that
there should be limits to the commercialization of many aspects of reproduction. This involves
limits on production and sale of eggs and sperm, and particularly on the production and sale of
embryos.
Therapeutic over enhancement uses of ARTs. We believe that the priority in biomedical
research and clinical practice ought to be given to therapeutic ends – that is, healing the sick and
relieving the pain and suffering of those suffering from pathological conditions.
These general principles, then, need to be translated into specific rules that would be used to
guide regulators. The rules are divided into two categories: (1) activities that we believe ought to
be banned outright, and (2) activities that should be permitted, but regulated.
2.2 Targets of Prohibition
On the list of banned activities are:
Reproductive cloning. All versions of the cloning legislation that have been introduced in
Congress since 2001 have included bans on reproductive cloning. Human reproductive cloning is
not today something that can be done safely, and for that reason alone should be banned on the
basis of the principle of prioritizing the health and well-being of children.
Creation of chimeras and hybrids. We believe that the creation of human-animal chimeric
and hybrid embryos for the purposes of reproduction should be banned. Other situations in which
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human and animals cells, tissues, and organs are mixed for purposes of biomedical research are
less problematic and should not be subject to significant restrictions. Animal-derived organs are
now routinely implanted in humans, and animal-derived genes may be available in the future for
treating human diseases; all of these are by and large legitimate activities. There may be complex
cases where the degree of human and animal mixing may become ethically problematic; we
believe that determining this boundary is something that can be left to the regulatory authority, at
least initially.
Germ-line modification. Germ-line modification of human beings, of the sort that is now
done routinely with plants and animals, cannot now be done safely, and should therefore be
banned. It necessarily involves a kind of experimentation on human beings who will clearly not
be able to give their informed consent, and therefore violates the first and fourth ethical
principles laid out above.
New reproductive possibilities that alter the genetic relationship of parents and
children. There are a number of technologies emerging that will make possible the creation of
children who are not the offspring of one man and one woman, as every human child has been up
to now in the history of our species. We believe that the first ethical principle enunciated, placing
priority on the well-being of children, gives all children a right to be born out of the union of a
man and a woman, and that technologies that alter this fundamental relationship ought to be
banned.
Patenting of human embryos. We believe that property rights in a human embryo should
be banned. Property rights are usually granted to stimulate research and innovation; there will be
plenty of other incentives to conduct necessary embryo research in the absence of ownership
rights in specific embryos.
2.3 Targets of Regulation
Other activities we believe are ethically legitimate, but ought to be carried out under
carefully controlled circumstances, include:
Research cloning. We believe that research cloning should be permitted but tightly
regulated. We see why many people who are not troubled by the use of excess embryos in stem
cell research may yet oppose the deliberate creation of cloned embryos for research purposes.
We believe, however, that whatever extra instrumentalization this act may imply does not
outweigh the gains potentially to be derived from this kind of research. It is, however,
particularly important for the regulatory authority to monitor and control this kind of research
very carefully – not just because of what we call the intermediate moral status of embryos, but
also because it is the only way to enforce a ban on reproductive cloning.
Pre-implantation genetic diagnosis. Pre-implantation genetic diagnosis (PGD) is a service
performed by many fertility clinics. We believe it is an important way for couples with heritable
genetic disorders to ensure that those conditions are not passed down to their children. On the
other hand, PGD involves certain kinds of risks and creates incentives (for example, for the
production of large numbers of eggs and embryos) that could pose serious health problems for
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the women involved. Using PGD for non-therapeutic purposes raises a host of ethical issues, and
should be strongly discouraged by the regulatory system.
Biomedical research involving early-stage embryos or blastocysts. We believe that
medical research on embryos or blastocysts is important and legitimate, but that it ought to be
done under carefully controlled circumstances, given the intermediate moral status of embryos.
This means that the regulatory authority ought to monitor and control the creation and transfer of
all embryos used for these purposes, much as the British HFEA does currently. This kind of
regulatory capacity will also be necessary in order to enforce any reproductive cloning ban.
Commercialization of elements of human reproduction. We believe that the buying and
selling of human embryos should be strictly regulated, again, given their intermediate moral
status. We believe that embryos can be used for research purposes and that a limited market
should be allowed to develop to facilitate their transfer (for example, excess embryos from ART
clinics), but that all such transfers should be carefully tracked by the regulatory authority.
3 The Current Legislative and Regulatory Framework
3.1 Federal Regulators
Human biomedicine is and has for a long time been one of the most heavily regulated areas
of endeavor in the United States. The FDA’s “gold standard” of costly, double-blind clinical
trials for pharmaceuticals is unmatched anywhere the world. On the other hand, the FDA
regulates only drugs, medical devices, and biological products (or “biologics”), and can regulate
them only on the basis of safety and efficacy. It does not directly regulate the practice of
medicine, which means that the large area of medicine involving assisted reproductive
technologies receives virtually no direct federal government oversight. While the FDA strictly
enforces testing procedures for new drugs, it does not control their off-label uses, meaning that
doctors are free to innovate and in effect experiment on their patients in such cases.
The other big regulatory institution in the United States is the National Institutes of Health
(NIH), which through its control over federal funding exerts enormous control over the nature,
scope, and direction of scientific research in biomedicine. It is the NIH that now oversees bodies
like the Recombinant DNA Advisory Committee (RAC), and requires institutional review boards
(IRBs) to monitor research involving human subjects. The NIH is not limited to considerations
of safety and efficacy like the FDA; it can and has introduced moral and ethical concerns into its
decision-making. President Bush’s August 2001 decision limiting federally funded stem cell
research to existing stem cell lines reflected his concerns over protecting embryos, and was
implemented by the NIH. Here, the limits of regulatory authority are different than in the case of
the FDA. The NIH can influence science only through its control of funding; it cannot prohibit
privately funded research, and it has no say over what happens in the private biotech industry.
In addition to the statutes governing the FDA and the NIH, there are other federal statutes
relevant to assisted reproduction, including the Clinical Laboratory Improvement Amendments
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(CLIA) of 1988 and, more importantly, the Fertility Clinic Success Rate and Certification Act
(FCSRCA) of 1992. CLIA was designed to ensure that clinical laboratories meet a range of
quality and safety standards, but it does not provide regulatory guidance for ethically problematic
reproductive choices. FCSRCA did establish a model program for the certification of embryo
labs that could play a central role in facilitating monitoring practices of reproductive medicine
and compliance assurance. This program, however, has not been implemented by any state, and
would in any event lack credible sanctions.
Publicly funded research on human subjects (by the NIH or any other federal agency) is
governed in large measure by institutional review boards, as required by what is known as the
“Common Rule.” Privately funded research involving human subjects also is subject to IRB
review, but in these cases, IRB review rules and procedures drafted by the FDA apply.
Neither the Common Rule nor the FDA’s own set of regulations governing IRBs and
privately funded research on human subjects establish clear jurisdiction and authority over
potentially controversial research involving reproductive technologies. IRBs are designed to
protect human research subjects, and not to make judgments about the ethical appropriateness of
the research protocols.
There are, of course, any number of other agencies that have regulatory authority over
various aspects of human biomedicine, including the U.S. Patent Office and the Drug
Enforcement Agency. This agencies’ main mission, however, is not to regulate reproductive
medicine or biomedical research; their impact is not insignificant, but is indirect.
3.2 Direct Legislative Intervention
Since 2001, Congress has attempted more than 40 times to pass legislation related to cloning
and stem cell research. None of these initiatives has become law. These legislative proposals fall
essentially in two distinct categories – prohibitions of any kind of cloning research, and bills that
explicitly ban, and often criminalize, cloning for reproductive purposes, but legalize cloning for
research purposes.
An example of the latter is Senate Bill 303, referred to the Senate Judiciary Committee in
2003, where it has languished ever since. This bill establishes a legal framework for conducting
research cloning, requiring that nuclear transplantation research be scrutinized by an institutional
review board, and that informed consent must be obtained from the human subjects involved in
the research. As indicated above, the ability of IRBs to make complex ethical determinations is
very limited, and thus the oversight provided by this framework is inadequate. The British
HFEA, which seeks to facilitate stem cell and embryo research, subjects researchers to much
stricter scrutiny than is laid out in Senate Bill 303.
3.3 Regulation by States
States, and not the federal government, are the primary regulators of the practice of
medicine. The rules they establish in this area may or may not be specific to assisted
reproduction. State regulation includes the licensure of physicians, facility licensure, hospital
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credentialing, requirements for DEA registration on the part of doctors and hospitals,
enforcement of informed consent rules, establishment of requirements for malpractice insurance
coverage, and other requirements. In theory, states could use these powers to revoke the licenses
of physicians that practice unsafe procedures like reproductive cloning, though it is not clear how
well any state agencies are set up to make rules in this area and to enforce them.
Several states have enacted legislation in the area of reproductive medicine, but state-level
legislations are generally limited to very specific aspects of reproductive medicine. Recent state
laws either attempt to ban any kind of cloning or limit the ban to reproductive human cloning.
Among the states that have banned both reproductive and research cloning are Arkansas, Iowa,
North Dakota, South Dakota, and Michigan. New Jersey and California, both home to large
biotech sectors, have passed legislation banning reproductive cloning but legalizing research
cloning. In our view, these state measures have failed to provide sufficient regulatory oversight.
California is notable insofar as it drafted model legislation in 2003 to provide for state regulatory
oversight of embryo research, legislation that was then superseded by Proposition 71. The latter,
which passed in November of 2004, removed most prior institutional safeguards, and is in our
view totally inadequate as a regulatory model.
3.4 Self-Regulation
Both foes and advocates of regulation often see industry self-regulation as quite distinct
from government oversight, but in fact the line between the two is often blurred. The government
often relies on private sector groups to achieve public goals (for example, the Underwriters
Laboratories’ role in consumer safety), or else backs up private enforcement through an implicit
threat of formal sanctions (for example, the Securities and Exchange Commission).
Over the last 25 years, the American Society for Reproductive Medicine has developed most
of the currently existing medical and ethical guidelines in the area of reproductive medicine. The
Society for Assisted Reproductive Technologies (SART), which comprises most of the nation’s
ART programs, has a well-established though narrow history of self-regulation that gathers data
about ART success rates.
In our view, these programs rarely meet the standards of legal precision expected by legal
scholars and policy-makers. Often, they come dangerously close to being simple exhortatory.
Nevertheless, this admittedly incomplete system of private governance provides an important
basis for incrementally and selectively strengthening the oversight of the ART industry.
4 Recent Regulatory Initiatives in Other Countries
4.1 The British HFEA
The British Human Fertilisation and Embryology Authority (HFEA) was established in 1990
on the basis of the Human Fertilisation and Embryology Act, which in turn sprang out of the
earlier Warnock Commission. The act established the HFEA as a new regulatory body to oversee
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the activities of both private and public clinics and laboratories dealing with ARTs, providing a
licensing scheme for treatment services, the storage of gametes and embryos, and embryo
research. The HFEA monitors and tracks all embryos in the United Kingdom. Violation of the
act is considered a criminal offense under British law. The HFEA’s statute creates a governance
mechanism consisting of a 17-member board, appointed for three-year terms that are renewable
once. The board must consist of both men and women, and the number of “lay” members must
exceed the number of those connected with the clinical or scientific research communities.
Positions on the board are advertised, and the selection is made by officials in the UK Health
Ministry. The HFEA is ultimately accountable to Parliament through the minister of health.
Both stem cell research and research cloning are legal in the United Kingdom. While some
decisions by the HFEA have been criticized for being excessively restrictive of the reproductive
rights of potential parents, the organization has by and large facilitated Britain’s emergence as a
leader in reproductive medicine and stem cell research.
4.2 The Assisted Human Reproduction Agency of Canada
The Assisted Human Reproduction Act (AHRA) of 2004 established the Assisted Human
Reproduction Agency of Canada (AHRAC), which as of early 2006 is still in the process of
implementation. This agency was created after a decade-long process of public consultation in
Canada, and it reflects consensus views of Canadian society. The AHRA established a set of
guiding principles from which is derived a list of proscribed and regulated activities. It bans both
reproductive and research cloning; it permits stem cell research, but only that involving excess
embryos. Treatment, storage, and research on human embryos are regulated through licensing.
Both public and private research are covered by the AHRA, which also regulates the sale of
gametes, embryos, and surrogacy.
The AHRAC is an administrative agency modeled on the British HFEA. It is different,
though, in what it regulates, as in Canada, neither research cloning nor stem cell research not
derived from excess embryos is legal. This underlines the fact that similar regulatory powers and
institutional designs can serve societies that make different decisions on the question of the
moral status of the embryo.
4.3 Other Legislative Initiatives
In addition to Britain and Canada, many other countries have enacted legislation to deal with
new reproductive technologies in recent years. Often, the scope of these legislative initiatives is
quite broad. In our report, we have identified 10 issues that these legislations tend to address.
They are embryo research broadly defined, reproductive cloning, research cloning, stem cell
research, pre-implantation genetic diagnosis, chimera and hybrid creation, germ-line genetic
engineering, reproductive services, and the trade and sale of gametes. The table below
summarizes the situation for a subset of these issues, namely reproductive cloning, research
cloning, and PGD. The first column indicates whether a country, as part of its recent legislative
efforts, has established a new regulatory entity.
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New Regulatory Reproductive Cloning Research Cloning PGD
Authority
Canada Yes Prohibited Prohibited Legislated
Australia Yes Prohibited Three-year moratorium Prohibited
Germany No Prohibited Prohibited Prohibited
UK Yes Prohibited Regulated Legislated/regulated
France Yes Prohibited Prohibited Legislated/regulated
Italy No Prohibited Prohibited Prohibited
Spain No Prohibited Prohibited Legislated/regulated
Sweden No Prohibited Legal Legislated
Japan No Prohibited Legal No action
China No Prohibited Legal Legislated
Singapore No Prohibited Legal No action
South Korea No Prohibited Legal Legislated/regulated
US No Prohibited (de facto) No action No action
Limited space prevents us from including the entire table here, but the essential point is clear
enough: With regard to most of the 10 issues identified above, the United States is an outlier. See
Appendix G for additional information.
5 Pros and Cons of Alternative Approaches
5.1 Maintaining the Status Quo
Pros. Maintaining the status quo, in the eyes of the proponents of this strategy, has one
distinct benefit: It doesn’t cost anything, either to the taxpayer or in terms of opportunity costs. It
is not so much a strategy as the expression of the belief that no government action is needed at
this time. Should the need for governmental intervention arise, it may be possible to simply use
existing statutory and regulatory tools. The FDA de facto prohibition of reproductive cloning is a
case in point. In 2001, the FDA restricted reproductive cloning by requiring that anyone seeking
to provide cloning services receive IRB approval and submit an investigational new drug (IND)
application, conditions that no practitioner of reproductive medicine is likely to fulfill. Until this
administrative decision is successfully challenged in court, reproductive cloning in the United
States is effectively banned.
Cons. The failure to anticipate the need for new regulatory powers invites societal
overreaction when the inevitable scandal, abuse, or disaster happens. Agricultural biotechnology
provides a vivid example. During the early 1990s, the agricultural biotech firm Monsanto, which
had initially favored certain forms of regulation like the labeling of genetically modified foods,
changed policy and argued before the Bush administration that no new regulations were needed.
After the company began marketing its Bt corn and roundup-ready soybeans in Europe, the BSE
scandal broke in the United Kingdom, convincing many European consumers that food safety
regulators were not doing their job. Much of the opposition to genetically modified foods in
Europe was irrational, but some was based on a view that consumers had a right to decide for
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themselves whether or not to eat foods that had been genetically modified. By not supporting
relatively modest forms of regulation like labeling, U.S. biotech firms like Monsanto found
themselves shut out of European markets as the EU imposed its own extremely strict safety rules
on genetically modified products.
The argument that existing statutory powers can be used to deal with new technologies is
very limited. While it is true that the existing FDA regulatory authority has been interpreted as
giving the agency power to regulate reproductive cloning, the legal grounds for this decision are
weak. Human embryos do indeed consist of “cellular products,” but it is doubtful that the courts
would consider them just another biological material. And there are clear limits to what the FDA
could do. The FDA’s enabling statutes establish that the agency is to regulate on the basis of
safety and efficacy only, and that it does not have authority over the practice of medicine. Apart
from the legal question of whether the statute can be stretched to in effect sneak in new powers,
there is also a legitimate question of whether the FDA has the right kind of bureaucratic culture
and expertise to exercise this kind of authority. Specialists in public administration point out that
agencies are often built around a traditional goal, and that when they are given new goals, they
often have a hard time adapting.
5.2 Incrementally Expanding Statutory and Regulatory Authority
Pros. A regulatory strategy designed to incrementally and selectively expand existing
statutory and regulatory authority has several distinct benefits. From a pragmatic standpoint, it
may be considerably easier to accomplish most if not all of the intended policy goals. Small,
incremental changes may attract broader political support. Congressional representatives may
conclude that the benefits of implementing this strategy compare favorably to the costs. It may
also be easier to generate sufficient support among stakeholders who are likely to bear some of
the costs associated with new regulations. In addition, selective interventions, by their nature, are
likely to produce fewer unintended consequences. For example, one could envisage modifying
the regulations that govern IRBs so as to make IRBs a more credible institution of ethical
scrutiny. One could also envisage making implementation of the FCSRCA model program
mandatory, and bolstering its implementation by including credible sanctions.
Cons. Nothing speaks against selectively expanding statutory and regulatory powers, per se.
It could make eminent sense, for example, to update the regulations governing IRB review or to
strengthen the FCSRCA. At the same time, minimalist interventions alone are very unlikely to
provide an adequate response to the challenges raised by new reproductive treatments and
medical research. Nor it is necessarily true that it would be easier to have Congress pass them. It
is quite possible that proposals for the incremental expansion of statutory and regulatory
authority would be ignored by the Congress until an egregious case of abuse receives extensive
media coverage.
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5.3 Direct Legislative Intervention
Pros. Congress can obviously speak the most authoritatively on important moral questions,
and we assume that large ethical issues will have to be decided in this fashion. Proposed
legislation in the area – like Senate Bill 303, which would ban reproductive cloning but permit
research cloning – has some provisions for regulatory oversight, as do similar bills proposed or
adopted at the state level.
Cons. Typically, legislative interventions are narrowly focused on a single, idiosyncratic
problem; the intervention may be effective, but its cost rarely justifies its benefits. Legislation,
by its nature, tends to be rigid and difficult to amend. In addition, Congress does not have either
the administrative resources or the technical expertise to debate and discuss the large number of
issues that will emerge as new technologies are developed. For example, specific legislation like
Senate Bill 303 that was introduced into the Senate to permit research cloning does not contain
adequate provisions for regulatory oversight of embryo research, relying as it does on IRB
review alone. Nor does it require that the production and use of embryos be tracked.
5.4 Self-Regulation
Pros. The practice of reproductive medicine already has an elaborate system of selfregulation
in place. Some measure of self-regulation is indeed a necessary requirement for any
effective regulatory system. Designing a credible and effective rule often requires information
and expertise available only to the regulated community. Perhaps surprisingly, self-regulation
can have a significant impact on the practice of reproductive medicine and on medical research,
even in the absence of formal mechanisms of monitoring and enforcement. In some cases,
informal mechanisms of sanction can be quite effective. The case of the Recombinant DNA
Advisory Commission is a case in point.
Cons. Trade associations and professional societies are almost always likely to favor selfregulation
over more formal regulatory approaches; how effective this is depends on the nature
of the sector and the incentives facing the actors in it. Prior to the collapse of Enron, the
American accounting industry believed that its system of self-regulation was adequate to counter
possible abuses; the fact that it was not led directly to passage of the Sarbanes-Oxley bill, which
created a host of new formal accounting rules.
The record of self-regulation in reproductive medicine raises questions as to whether the
procedures currently in place will be sufficient to guard against potential future abuses. There is
considerable evidence that trade associations, absent powerful selective incentives, are reluctant
to take measures that could be interpreted by their members as policing activities. And the RAC
remains an effective tool of self-regulation only as long as the risk of a major public health
disaster is perceived by the scientific community as a real possibility.
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5.5 Creating a New Regulatory Institution
Pros. There are important reasons why ARTs should be singled out as an area deserving
special legislative scrutiny. Assisted reproduction is not just another branch of medicine
dedicated to restoring a patient’s health; it makes children. The ART field is structured to meet
the needs and desires of potential parents; it is less well-organized to protect the long-term
interests of the children it produces. It is also the area in which new technological possibilities
for reproduction will be developed. Overall, a new regulatory system would more effectively
protect the safety and well-being of children. It would also forcefully protect new areas of
promising but controversial medical research. Last but not least, it would endow the United
States with an infrastructure of government geared toward addressing genuine public questions
in a public way, rather than de facto delegating these societal choices to business and scientific
interests.
Cons. Most arguments against a new regulatory system in the area of human reproduction
stem from considerations germane to government regulation, per se. If the government regulates
an activity, there is less of it, and there is a prima facie reason to support the most rapid possible
advance of scientific research into human biomedicine. Regulation always produces
unanticipated consequences as private agents seek to avoid them; one consequence here could be
the moving abroad of both researchers and biotech companies seeking a more favorable
regulatory climate. The United States is the world leader in biomedical research, and would be
hobbling its own competitive advantages by over-regulating itself, not to mention denying
patients the advantages of the latest technologies.
A new regulatory system is costly. These costs include not just the direct cost to researchers
and businesses of complying with new regulations, and the costs to the U.S. government of
running regulatory agencies, but also the opportunity costs of the new research, services, and
products that do not come into being as a result of regulation. That is, a new regulatory
institution risks slowing down the pace of technological advancement and innovation, imposes
opportunity costs, and risks unintended consequences. In addition, new federal regulatory powers
over ARTs will set a precedent for the federal regulation of the practice of medicine.
6 A New Regulatory Institution
6.1 General Design Considerations
In this report, we are proposing that the United States consider creating an entirely new
regulatory institution to deal with human reproduction. We believe that rather than trying to
reinterpret or augment the statutory powers of current regulators like the FDA or the NIH, or
passing new targeted legislation, it is much better to start afresh with a federal agency designed
de novo to deal with the problems and challenges that will be posed by new reproductive
technologies. To pick up an analogy used earlier, rather than trying to add airlines to the ICC’s
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egulatory portfolio of railroads and trucks, we want to create the equivalent of a new Federal
Aviation Administration.
We begin with several general institutional design considerations. Highest among our
priorities is the need to design a regulatory institution that cannot be manipulated by any political
constituency. Much of the discomfort among scientists with federal legislation originates with
the fear that the scientific enterprise will fall victim to ideological manipulations. On the other
end, opponents of unencumbered scientific and medical research believe that science and
medicine are on their way to becoming “rogue” societal institutions accountable only to
themselves. A credible regulatory institution effectively must dispel these widespread
perceptions; it cannot be perceived as pandering to powerful interest groups. It must operate in
an independent manner.
Ensuring independence in this context is similar but not identical to preventing regulatory
capture. All good regulatory institutions, if they are to do their jobs, must avoid being “captured”
by the sector or interests they are meant to regulate. On the other hand, the regulators need to
work closely with those they regulate, because the agency will be dependent on the latter for
information, implementation, and other matters. Just as institutions should avoid capture, they
should also avoid falling into a highly adversarial relationship with those they regulate.
The second, seemingly contradictory design consideration pertains to accountability. A
“rogue” regulatory agency that operates in an arbitrary and capricious way is bound to quickly
loose its credibility and to invite intervention by the Congress and the president, not to mention
judicial review. In certain circumstances, technical decisions provide an effective check against
unaccountable behavior. Agencies such as the Federal Aviation Administration (responsible for
aviation safety) and the Nuclear Regulatory Commission (responsible for the safety of nuclear
power plants) are certainly no example of “bureaucratic drift,” even though they do enjoy a
measure of formal independence. The situation in the case of reproductive medicine and
biomedical research bears only limited similarity to these cases. Ensuring the health and safety of
future generations would require our agency to make choices largely based on scientific and
medical evidence. In other cases, however, the agency would have to resolve difficult ethical
dilemmas for which no independent or scientific guidance is likely to exist. Under these
circumstances, independence may be perceived as “bureaucratic drift.”
A third, related design consideration is avoiding political gridlock. The practice of medicine
involving assisted reproduction as well as the scientific research community doing work in the
area of reproductive medicine, stem cells, and developmental biology would strongly prefer to
work without regulatory constraints, and indeed with substantial government funding for
research in this area. There are, on the other hand, pro-life groups that strongly oppose any
research that involves the destruction of embryos, including stem cell research and research
cloning. Both groups are just politically strong enough to block the other from achieving its
agenda.
Our report shows that these polarized interest groups actually do not represent the views of
the general American public, which in many ways is more flexible and centrist on issues
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egarding reproductive biomedicine than the current debate would suggest. Looking over 120
survey questions asked from 1993 to 2004, three consistent tendencies emerge. First, large
majorities of Americans oppose reproductive cloning outright. Second, there is considerable
ambivalence about research cloning: It is opposed by a two-to-one margin if the question is
posed in a “neutral” fashion; opposition rises to 80 percent if the question mentions only embryo
destruction, and falls to approximately 50 percent if only the benefits of cloning are mentioned.
Third, there is fairly strong support for embryonic stem cell research; a recent Harris poll, for
example, shows 72 percent of respondents favoring human embryonic stem cell research if
excess embryos are used, compared to only 13 percent opposed. The public, in other words,
favors policies that lie somewhere between the libertarian scientific community and the
restrictive pro-life community, and would be favorable to proceeding, as we suggest, with
embryo research that was closely regulated.
The governance structure for this new agency would be built on three levels. Congress
would delegate regulatory authority to a newly established administrative agency, just as is done
currently in the British, Canadian and Australian cases. The agency could be either an
independent or an executive agency. Our report explores design options for both. The main
benefit of establishing an independent agency lies obviously in its independence from the White
House. An executive agency may not enjoy the same independence from the office of the
president, but would have other benefits, chief among them being efficiency in decision-making.
In either case, a regulatory agency should be sufficiently insulated from undue political
influences and regarded by all affected parties as a credible and trustworthy regulatory
institution.
The second level of this new regulatory structure is a permanent advisory board. The
advisory board would have two main goals: to carefully explore all relevant ethical
considerations pertaining to complex ethical dilemmas, and to provide medical and scientific
advice to the regulatory institution. The board would operate in accordance with rules established
in the enabling legislation designed to protect the appointment process against political
manipulations. In particular, the statute would ensure that the board is broadly representative of
the three main constituencies in this field – reproductive medicine, biomedical research, and the
public at large. The statute also would establish the relative weight of each constituency on this
board.
The third level encompasses a variety of novel mechanisms of public consultation in
combination with a more structured rule-making process. Broad public consultation should
protect the agency not only against undue political influence, but also against agency drift. It is,
in other words, a quintessential accountability mechanism. These institutions of public
consultation would have to meet several requirements: Participants need to be well-informed
about the scientific and medical aspects of the controversy, the consultation process must be
deliberative, and the participating sample should be representative of the public at large. Clearly,
not all of these requirements can be met equally well and at the same time. We do, however,
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elieve that it is possible to design institutions of public consultation that are far superior to both
current administrative practices and recent proposals designed to democratize science policy.
6.2 The Independent Commission
We believe the organizational format in the best position to meet a Congressional mandate is
an independent commission. The newly established regulatory agency often will be called upon
to adjudicate among competing ethical claims in the light of fairly generic statutory provisions.
Resolving these controversies is not too dissimilar from issuing a judicial opinion. To be
regarded as authoritative by all affected constituencies, these decisions must be based on a
careful examination of all ethical aspects. The “finding of fact” would benefit from a deliberative
approach to resolving ethical dilemmas. Deliberation also would contribute to produce consensus
policies rather than simply majority positions. On the other end, decision-making would be
relatively slow. In this case, however, a slow pace of decision-making must be regarded as a
benefit rather than as a drawback. In areas as controversial as reproductive medicine and
biomedical research, producing policies widely regarded as legitimate by all affected parties is
more important than efficient decision-making. An independent commission is well-positioned
to meet these requirements.
When it comes to the creation of an independent commission, many precedents exist,
beginning with the Interstate Commerce Commission in 1887. Appointment rules are specified
by statute to produce some combination of political balance, expertise, and independence. The
commissioners are appointed by the president for a fixed term and have to be approved by the
Senate; they do not serve “at the pleasure” of the president, and can be removed only “for
cause.” Furthermore, commissioners on the new agency would serve for fixed terms. The terms
of office could be set so as not to coincide with the presidential term. Appointments could be
limited to one term only, and neither political party should hold a clear majority on the
commission. These are uncontroversial rules that have often been adopted throughout the history
of the administrative state.
6.3 The Permanent Advisory Board
Regulatory interventions in reproductive decisions and scientific research are so sensitive
and controversial as to warrant consulting all parties that are directly and negatively affected by
these interventions. In addition, the commission would not embody the broad range of ethical,
medical, and scientific expertise necessary to craft authoritative policies. A suitably designed
permanent advisory board would fill this gap. The board should include specific positions for
representatives of the ART sector, patients groups, the scientific community, and the biotech
industry.
The permanent advisory body is not too dissimilar from a board of directors. To prevent this
board from being dominated by the regulated interests, appointing independent board members
might be a wise approach. Over the last 15 years, the private sector has recognized that there is
considerable wisdom in appointing independent board members. These individuals are selected
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to represent constituencies that are crucial to the financial well-being and the public image of the
firm. In our report, we follow the spirit of this approach by recommending that the enabling
statute explicitly require appointing a number of independent board members equal to or greater
than the total number of board members representing specific constituencies.
The criteria for selecting and appointing independent board members, also included in the
enabling legislation, must ensure that the selected individuals are regarded by all constituencies
as genuinely independent. Thus, viable candidates for the position of independent board member
should not have strong ties to the ART and biotech industries or to the scientific community.
They should not have close relatives with medical conditions that could be cured by promoting
certain types of research, nor should they have financial interests in companies that may be
affected by the commission’s policies. They should also bring with them the analytical skills and
life experience required to navigate complex questions at the intersection of ethics, science, and
medicine in a charged political environment. Importantly, they should not be advocates
representing scientific, trade, professional, or religious groups.
Unlike the independent commission, the advisory board would make recommendations by
majority vote, and would include minority positions in its recommendations as deemed
appropriate. The advisory board task is not to develop consensual recommendations that would,
by their nature, restrict the range of ethical considerations, but rather to provide the
commissioner with a broad ethical and scientific analysis of the issue under consideration. The
board would also serve as an institutionalized link between the commission and the regulated
communities. In this role, it would also make negotiations between regulators and those
regulated more transparent, and reduce the room for regulatory capture.
6.4 Traditional Mechanisms of Public Consultation
One of the most often recurring and most important themes in public administration is
agency accountability. It is fair to say that no consensus exists among commentators on the
proper balance between agency discretion and agency accountability, or on the appropriate
mechanisms to ensure accountability. Our report suggests that this debate has placed too much
attention on traditional mechanisms of accountability, such as Congressional oversight, executive
scrutiny, notice-and-comment, and judicial review, and has ignored some relatively
straightforward alternatives.
It has long been a common legislative and administrative practice to ensure some measure of
accountability by requiring public participation in the regulatory process. Traditionally, this has
often meant that agencies have resorted to public hearings, and in some cases to notice-andcomment
(mandated by the Administrative Procedure Act) as their main vehicle to engage the
general public.
Both approaches are ill-suited to engage a broader audience. By the time a proposed new
rule is published in the Federal Register, it has already been extensively vetted by the agency in
consultation with leading interest groups. Comments usually produce only marginal changes, and
the process is used by the agency to build its record in the case of judicial review, and not as a
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tool of public participation. Public hearings, for their part, are used most effectively by wellorganized
interest groups to express their views on controversial agency decisions. As a result,
they tend to reflect only the views of established interest groups, and thus tend to distort the
process of public consultation rather than broaden it. Agencies, for their part, can use public
hearings in strategic ways so as to minimize interference with their decision-making processes.
In sum, public hearings are ineffective at best and have a distorting impact at worst on the
administrative decision-making process.
The call for the democratization of decision-making in the area of science and technology
policy has produced a few institutional innovations, such as citizens’ juries, citizens’ advisory
panels, and consensus conferences. The Environmental Protection Agency and the Department
of Energy, in particular, have frequently relied on citizens’ panels to implement highly
controversial policies at the local level. In this role, these approaches generally have been
beneficial. Their role in decision-making at the federal level is much more problematic, however,
mainly because the relationship between citizens and regulators has never been specified, and
because it is often unclear to what extent the views expressed by these small groups of citizens
may be regarded in any way as indicative of broader public sentiments. Against this background,
it is not immediately clear why a regulatory agency should take the recommendations adopted by
such a small group seriously. In sum, neither traditional tools of public consultation nor more
recent approaches for engaging the public provide sufficient safeguards against arbitrary and
capricious agency behavior.
6.5 New Approaches to Public Consultation
We believe that formal rule-making authority should lie with the agency, but that the latter
should be required to gauge public opinion through certain structured mechanisms for public
consultation. As mentioned earlier, one of the main goals of this process is to reach out to the
public beyond established interest groups; the credibility of the process should rest on two main
elements: The consulted sample should be representative of the general public, and the
participating individuals should be reasonably well-informed about underlying scientific facts. In
addition, the consultation process should be deliberative – that is, it should seek to mold
preferences through debate and discussion rather than simply to record preferences. More
specifically, deliberation, if properly designed, may help expand the “argument pool,” may
facilitate finding common ground on controversial issues, and may generally push participants
toward more nuanced positions. We suggest that the new agency make use of either one of the
following mechanisms for public participation.
6.5.1 Deliberative Panels
Our first proposal expands and refines the concepts of consensus conferences and citizens’
panels. As pointed out earlier, the modest size of the panels means that recommendations
developed at consensus conferences are not representative and lack legitimacy. A simple and
straightforward way to increase the legitimacy of these panels is to assemble several of them.
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“Deliberative panels,” the term we use in our report to identify this approach, could be organized
around the country, both in urban and rural areas. Each panel would consist of up to a dozen
participants; this size ensures that deliberation remains feasible, yet makes assembling the panels
a manageable task. Recruitment would reflect key socio-demographic variables such as sex, age,
and education. Locations would be selected to account for important cultural and regional
differences. At each location, deliberative panels should be conducted more than once and with
different participants.
This approach has existed in the form of town hall meetings, which are familiar means of
engaging the public on matters of national importance. In the present case, however, we envision
the agency conducting more than half a dozen deliberative panels, while reducing dramatically
the number of participants. Clearly, the more deliberative panels the agency convenes, the more
representative the results. Just how many panels can and should be convened is not as important
as the observation that the upper bound is likely to be much higher than one might anticipate.
The decentralized nature of this process and the need to query scientific experts representing
various positions (biotech industry specialists, academic scientists, regulatory scientists, and so
on) call for making extensive use of new information technologies in the form of a centralized
information and consultation clearinghouse. An Internet-based clearinghouse could greatly
facilitate learning and information exchange among all lay panelists. In addition to providing
basic scientific information, the clearinghouse would serve as a central repository for any
question submitted by panelists to experts and for the answers provided by these experts. The
clearinghouse would also serve as a repository for the conclusions reached by each deliberative
panel.
At the present time, there are only few examples of Web-based resources designed as both
informational and deliberative resources. Our own Human Biotechnology Governance Forum
was intended to serve exactly these two goals, but constraints on our resources have prevented us
from fully implementing it. 1 The Center for Genetics and Society Web site is probably the single
best source of information available in this area, but it does not include an interactive
component. 2 The Geneforum, a non-profit initiative launched in Oregon in 1998, pursues similar
goals, but it is still under development. 3 None of these Web resources fully implements the
concept of information clearinghouse as envisioned here, but taken together, they suggest that
implementation is within reaching distance. They also demonstrate that implementing our
approach is both a financially and organizationally feasible proposition that an average federal
agency could easily accomplish.
Consultative panels are clearly superior to both traditional surveys and one-shot, smallgroup
consultations such as consensus conferences and citizens’ panels, and should be preferable
and far more credible than traditional methods of public consultation such as hearings and
1
2
3
See http://www.biotechgov.org.
See http://genetics-and-society.org/.
See http://www.geneforum.org/.
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notice-and-comment. As such, it would be difficult for well-established interest groups and for
elected representatives to dismiss the recommendations emerging from deliberative panels as
unreliable or not representative.
6.5.2 Consultative College
The second option we examine in our report is what we call the consultative college. The
consultative college is reminiscent of but not identical to James Fishkin’s deliberative polling. A
consultative college consists of a randomly selected, representative sample of the general
population. Key to this institution of public consultation is the Internet. The members of the
consultative college are not required to physically meet in one location for a limited period of
time. Instead, the consultative process takes place over an extended period of time. For example,
college members could meet online on a regular basis, say once or twice a week, for two months.
To facilitate the discussion, participants would be assigned to smaller groups of approximately a
dozen individuals. This is the approach that the Genetics and Public Policy Center took in the
summer of 2004 to study public attitudes toward new reproductive technologies.
The consultative process follows a familiar plot: College members would first familiarize
themselves with the scientific underpinnings of the issues at stake. This could be accomplished
in the same way as discussed for deliberative panels. Participants will be given an opportunity to
engage a panel of experts. Questions (and answers) posed by one group would be made available
online to all members of the consultative college. The convening agency would then put several
questions to the online groups, including questions designed to elicit ethical reasons for and
against a new medical or reproductive procedure, and questions aimed at evaluating policy
options. In the final step, the agency would summarize and evaluate the range of expressed
concerns and attitudes toward various policy options.
Polling organizations for years have assembled permanent or semi-permanent representative
panels. These panels are being polled on a regular basis on any number of current topics, mainly
by telephone. In recent years, organizations such as Knowledge Networks have begun using the
Internet to enable online discussions among the panel members. And, as mentioned above, over
the summer of 2004, the Genetics and Public Policy Center conducted an Internet-based
deliberative poll similar to what we are proposing here. The logistics of online deliberation are
not trivial, nor are its costs. At the same time, the Genetics and Public Policy Center’s experience
with online deliberation clearly demonstrates that it is both possible and perfectly sensible to
envision mechanisms of public consultation above and beyond either traditional surveys or focus
groups.
Compared to other forms of public consultation, the consultative college has several
benefits. It is more cost-effective, although perhaps not as much so as one might think. The entry
barriers for average citizens are lower, since joining a consultative college does not encroach on
the participants’ daily routines. In addition, online discussion may have desirable attributes not
shared by traditional, face-to-face communication. For example, in an anonymous setting, the
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participants may be able to engage each other in a way much less encumbered by individual
status and prestige.
Having emphasized the benefits of the consultative college, we should point out some
difficulties. The quality of online deliberation may not be comparable to traditional, face-to-face
deliberation. This may indeed be the price for ensuring representativeness. Just how much the
quality of the dialogue would suffer from a shift to online deliberation is an important and stillopen
question. Heavy reliance on information technologies could prove a barrier for some,
especially among the poor and the uneducated. Access to information technologies is less and
less of a problem, however, as most public libraries, even in remote locations, provide free
access to the Internet. A more important hurdle is literacy. Being required to read and write
messages may constitute a serious problem for people with little education. Conceivably, the
convening agency could recruit volunteers willing to help these individuals overcome what may
be a significant barrier. There may well be other ways to address these concerns. We recognize
that convening a consultative college may raise a host of issues and concerns that we haven’t
discussed or addressed. Our aim here is not to develop a full-blown proposal for reforming
modern institutions of representative democracy. Rather, we want to make a sufficiently specific
case for experimenting with new forms of public consultation. We hope our readers will find our
discussion compelling enough to explore our proposals in more depth and offer suggestions as to
how to develop them more fully.
6.5.3 Semi-Traditional Survey Techniques
Expanding the number of deliberative panels is a straightforward way to ensure
representativeness. Similarly, assembling a large consultative college would all but ensure that
the recommendations emerging from the consultation process would be quite reliable.
Realistically, it may not always or even often be possible to fully implement this vision.
Depending on the availability of time and resources, an agency may have to limit itself to
assembling a sample that is not large enough to be considered representative of the whole U.S.
population. To address this limitation, one could consider exploring the panoply of instruments
nowadays available to survey researchers. Resorting to survey techniques would allow
administrators and politicians systematically to assess the relative importance of ethical
arguments in the general population. The agency responsible for the consultative process could
compile a list of the highest-ranking ethical arguments in favor of and the against a controversial
ART procedure or research field. It would then use this information to conduct a representative
survey of the general population. The agency should control for several key variables, including
a priori views and levels of expertise. Participants in this case would simply be asked to weigh
on a scale the extent of their agreement or disagreement with the ethical arguments uncovered by
the deliberative panels. A similar approach could be used to evaluate alternative policy options.
While purists may find this suggestion distasteful, we believe that in combination with novel
institutions of public consultation, survey techniques would provide regulators and
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Congressional representatives with a picture of public attitudes unmatched by current
approaches.
6.6 Final Remarks
Some commentators might criticize the institutions of public consultation proposed in this
report as not being “open and transparent.” We freely acknowledge that public consultation as
envisaged here, perhaps paradoxically, would not appear to be as open or transparent as
traditional mechanisms like public hearings. The legitimacy and credibility of the outcomes
produced by our institutions of public consultation depend crucially on the convening agency
maintaining tight control over the process itself. “Opening” the consultation process to anyone
and everyone would obviously undermine any claim to representativeness and make the
deliberative stage unmanageable, not to mention expose the entire consultative process to blatant
manipulations by organized interests. The proper place for the general public and interest groups
to provide their feedback is the notice-and-comment phase afforded to all citizens by the
Administrative Procedure Act. To facilitate public feedback, the agency would be required not
only to publish the proposed rule in the Federal Register, but also to take steps to make the
consultation process and all related materials broadly available.
7 Constitutional Constraints
Deciding whether restrictions on the use of new reproductive technologies may be
unconstitutional is a question fraught with difficulties. For starters, the label “new reproductive
technologies” includes several and very diverse technologies that would have to be examined
individually. The particular use of a given reproductive technology and the circumstances of its
use do of course matter a great deal. Yet the Supreme Court, as a matter of general practice,
renders its opinions on narrow grounds, and is very reluctant to generalize its rulings above and
beyond the case under consideration. In addition, there are only a few judicial precedents
relevant to this field of medicine, and there certainly are no well-established societal traditions
that the Court could invoke absent relevant case law.
There is considerable agreement among legal commentators that the Constitution does not
explicitly recognize a fundamental reproductive right, i.e., a positive right to reproduce. The
same commentators also agree that the Supreme Court is likely to recognize this right under
limited circumstances. A variety of precedents related to establishing a right to privacy and to
family, intimate relationships, and reproduction support the view that the Court would probably
recognize this right, at least in those cases that involve intimate relationships and traditional
forms of procreation.
Whether the Court would be inclined to expand a fundamental but limited right to
procreation to protect the use of any and every new reproductive technology designed not just to
facilitate procreation but also to exercise an increasingly tight control over it is doubtful. The
Court, more often than not, has ruled on negative reproductive rights, and has never defined the
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outer limits of the right to privacy. The Court could invoke unenumerated rights, but it would
also have to show that these rights are consistent with enumerated rights. We believe that
technologies of reproductive control are not simply a natural extension of more traditional forms
of assisted reproduction, but that they represent a radical departure from well-established assisted
reproductive technologies. The Court should not grant them fundamental status before society
and Congress have had an opportunity to properly debate their pros and cons.
8 International Considerations
There has been a great deal of legislative experimentation at the domestic level in many
OECD countries. The scope of adopted legislative and regulatory measures varies significantly
from country to country, and seems to reflect both cultural sensitivities and political realities.
Our report has scrutinized numerous legislative approaches ranging from Europe to Asia,
Australia, and Canada. The only consistent finding emerging from this review is that apart from
a ban on reproductive cloning, there is very little agreement across nations on the nature and
scope of legislative and regulatory interventions. Certainly, there is no agreement on whether to
ban or regulate research cloning. Other less visible but just as controversial issues, such as the
use of PGD for non-therapeutic uses, research on human embryos broadly defined, and the
production of hybrids and chimeras, often do attract the attention of domestic legislators, but no
coherent pattern has yet to emerge from this flurry of domestic legislative activities. They are
documented in some detail in our report.
The divergence of national priorities and the widely different scope of these approaches
suggest that it is far too early to envisage crafting broad international treaties. The repeated and
failed attempts by the United States and Costa Rica to ban both reproductive and research
cloning at the international level clearly illustrate this fact. Against this background, it would
also be unwise to call for the criminalization of any or all of these technologies, as some
commentators have suggested. Resorting to the International Court of Justice to render verdicts
on matters that have just barely begun to be debated at domestic levels strikes us as ill-advised.
For the time being, the least damaging course of action seems indeed to be simply allowing
nations to develop their legislative responses, and addressing international disputes in this area
on a case-by-case basis.
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Acknowledgements
Although this is the work of two individuals, its contents reflect the contributions of many
people. We would like first to thank all members of our study group. Their interest in this topic
and their probing comments have greatly improved the quality of this report. A special thank
goes to Leon Kass. His work as Chairman of the President’s Council on Bioethics and his
participation in our study group have been a precious source of inspiration. We owe special
gratitude to Rebecca Dresser, Gail Javitt, O. Carter Snead, Mary Ann Glendon, Steven Goldberg,
Erika Lietzan, Lorie Knowles and Steven Croley for their help in matters concerning the
administrative law and constitutional aspects of our projects. A special thank goes to Michele
Garfinkel, Dan Sarewitz and Richard Hayes for their encouragement and detailed feedback on
various parts of our report. Kathy Hudson and Joan Scott have been an invaluable source of
information on reprogenetics and participatory methods. We would also like to thank Sean
Tipton for his helping us better understand the reproductive sector and Marty Apple for his
critical comments. Jennifer J. Kurinczuk has been very patient in guiding us through the maze of
epidemiological studies on the safety of reproductive procedures. We also owe a debt of
gratitude to Jon Tucker, Christopher T. Hill, and Roberto Mazzoleni, with whom over the years
we had numerous and invaluable conversations. We would like to thank Cynthia Paddock
Doroghazi, Robin Washington, and our research assistants Wayne Mei and Antje Uhlig for their
assistance in helping to produce the current report.
We are very grateful to the Smith Richardson Foundation, the Lynde and Harry Bradley
Foundation, and the Richard Lounsbery Foundation for their generous support of this project.
25

About the Authors
Francis Fukuyama is Bernard L. Schwartz Professor of International Political Economy at
the Paul H. Nitze School of Advanced International Studies in Washington, DC. He is the author
of, among other books, The End of History and the Last Man, and Our Posthuman Future. He
was a member of the President's Council on Bioethics from 2001-2005.
Franco Furger is currently an independent consultant based in Lucerne, Switzerland. Until
2005 he was head of the Science and Society research group at the Institute of Communication
and Culture of the University of Lucerne, Switzerland. Before joining Lucerne University he was
Research Professor at the School of Advanced International Studies (SAIS) in Washington DC.
Prior to joining SAIS he was Research Associate Professor at the Institute of Public Policy,
George Mason University. He was also Senior Fellow at the Institute of Social Research in
Frankfurt am Main. Dr. Furger holds a B.A. in Electrical Engineering from the Swiss Federal
Institute of Technology and a Ph.D. in Environmental Sciences from the same institution. His
research interests include environmental and science policy and economic sociology. He has
published numerous papers and two books.
27

Table of Contents
EXECUTIVE SUMMARY....................................................................................................................................... 1
1 OVERVIEW ........................................................................................................................................................ 1
1.1 Domain of Inquiry ................................................................................................................................... 1
1.2 Embryo Politics ....................................................................................................................................... 2
1.3 Regulation: General Considerations ..................................................................................................... 3
2 SOURCES OF CONCERN..................................................................................................................................... 4
2.1 General Ethical Principles ..................................................................................................................... 4
2.2 Targets of Prohibition ............................................................................................................................. 5
2.3 Targets of Regulation .............................................................................................................................. 6
3 THE CURRENT LEGISLATIVE AND REGULATORY FRAMEWORK..................................................................... 7
3.1 Federal Regulators.................................................................................................................................. 7
3.2 Direct Legislative Intervention ............................................................................................................... 8
3.3 Regulation by States ................................................................................................................................ 8
3.4 Self-Regulation ........................................................................................................................................ 9
4 RECENT REGULATORY INITIATIVES IN OTHER COUNTRIES ........................................................................... 9
4.1 The British HFEA .................................................................................................................................... 9
4.2 The Assisted Human Reproduction Agency of Canada....................................................................... 10
4.3 Other Legislative Initiatives.................................................................................................................. 10
5 PROS AND CONS OF ALTERNATIVE APPROACHES......................................................................................... 11
5.1 Maintaining the Status Quo .................................................................................................................. 11
5.2 Incrementally Expanding Statutory and Regulatory Authority .......................................................... 12
5.3 Direct Legislative Intervention ............................................................................................................. 13
5.4 Self-Regulation ...................................................................................................................................... 13
5.5 Creating a New Regulatory Institution ................................................................................................ 14
6 A NEW REGULATORY INSTITUTION .............................................................................................................. 14
6.1 General Design Considerations ........................................................................................................... 14
6.2 The Independent Commission............................................................................................................... 17
6.3 The Permanent Advisory Board ........................................................................................................... 17
6.4 Traditional Mechanisms of Public Consultation................................................................................. 18
6.5 New Approaches to Public Consultation ............................................................................................. 19
6.6 Final Remarks........................................................................................................................................ 23
7 CONSTITUTIONAL CONSTRAINTS................................................................................................................... 23
8 INTERNATIONAL CONSIDERATIONS............................................................................................................... 24
ACKNOWLEDGEMENTS ................................................................................................................................... 25
ABOUT THE AUTHORS ...................................................................................................................................... 27
1 INTRODUCTION ............................................................................................................................................. 37
29

1.1 THE CHALLENGE OF NEW BIOTECHNOLOGIES ............................................................................................ 37
1.2 TO REGULATE OR NOT TO REGULATE ......................................................................................................... 38
1.3 THE DOMAIN OF INQUIRY OF THIS REPORT ................................................................................................. 40
1.4 SCIENCE, POLITICS, AND DEMOCRACY: SOME GENERAL CONSIDERATIONS ............................................ 41
1.5 ABORTION POLITICS AND THE MORAL STATUS OF THE EMBRYO .............................................................. 44
1.6 BIBLIOGRAPHY.............................................................................................................................................. 47
2 HUMAN GROWTH HORMONES FOR CHILDREN OF IDIOPATHIC SHORT STATURE:
MEDICAL TREATMENT OR ENHANCING THERAPY?..................................................................... 49
2.1 INTRODUCTION.............................................................................................................................................. 49
2.2 IS THERE A NEED FOR LEGAL GUIDANCE?.................................................................................................. 51
2.3 DISCUSSION................................................................................................................................................... 54
2.4 BROADENING THE ETHICAL DEBATE........................................................................................................... 57
2.5 BIBLIOGRAPHY.............................................................................................................................................. 61
3 ETHICAL PRINCIPLES ................................................................................................................................. 63
3.1 GENERAL ETHICAL PRINCIPLES GUIDING THE REGULATION OF TECHNOLOGIES AND MEDICAL
PRACTICES RELATED TO HUMAN REPRODUCTION...................................................................................... 63
3.2 TRANSLATING PRINCIPLES INTO RULES ...................................................................................................... 67
3.3 ACTIVITIES TO BE PROHIBITED .................................................................................................................... 67
3.4 ACTIVITIES TO BE REGULATED.................................................................................................................... 69
3.5 NEXT STEPS................................................................................................................................................... 70
3.6 BIBLIOGRAPHY.............................................................................................................................................. 73
4 NEW FRONTIERS OF REPRODUCTIVE SCIENCE AND MEDICINE ............................................. 75
4.1 AREAS OF INQUIRY ....................................................................................................................................... 75
4.2 STANDARD REPRODUCTIVE TECHNIQUES ................................................................................................... 77
4.3 INNOVATIVE REPRODUCTIVE TREATMENTS................................................................................................ 80
4.3.1 Tinkering with Biological Parenthood.............................................................................................. 81
4.3.2 Oocyte Cryopreservation (Freezing of Human Eggs) ..................................................................... 83
4.3.3 Co-Culture .......................................................................................................................................... 85
4.3.4 Other Experiments.............................................................................................................................. 86
4.4 REPRODUCTIVE CUSTOMIZATION TECHNOLOGIES...................................................................................... 88
4.4.1 Technologies of Sex-Selection: MicroSort........................................................................................ 90
4.4.2 Pre-Implantation Genetic Diagnosis for Therapeutic Uses ............................................................ 93
4.5 BIOMEDICAL RESEARCH INVOLVING REPRODUCTIVE TISSUES.................................................................. 95
4.5.1 Cloning Technologies......................................................................................................................... 97
4.5.2 Making Sperm...................................................................................................................................100
4.5.3 Making Eggs .....................................................................................................................................103
4.5.4 Remaking the Machinery of Gestation............................................................................................104
4.5.5 Hybrids and Chimeras .....................................................................................................................105
30

4.6 BIBLIOGRAPHY............................................................................................................................................109
5 THE CURRENT LEGAL AND REGULATORY FRAMEWORK........................................................117
5.1 FEDERAL LEGISLATION ..............................................................................................................................117
5.1.1 The Fertility Clinic Success Rate and Certification Act of 1992...................................................117
5.1.2 Public Health Service Act ................................................................................................................120
5.1.3 The Clinical and Laboratory Amendments of 1988 .......................................................................122
5.1.4 Institutional Review Boards and Human Subject Protection ........................................................123
5.1.5 Federal Funding of Embryo Research............................................................................................126
5.1.6 The National Organ Transplantation Act.......................................................................................126
5.1.7 Regulation by Tort............................................................................................................................127
5.1.8 Regulation by the Market.................................................................................................................127
5.2 RECENT LEGISLATIVE INITIATIVES............................................................................................................128
5.2.1 Congressional Initiatives .................................................................................................................128
5.2.2 Senate Bill 303..................................................................................................................................129
5.2.3 Legislative Initiatives at the State Level .........................................................................................131
5.3 SELF-REGULATORY INITIATIVES................................................................................................................133
5.3.1 Introduction ......................................................................................................................................133
5.3.2 Self-Regulation in the ART Industry................................................................................................135
5.3.3 Self-Regulation of Medical Research..............................................................................................141
5.4 BIBLIOGRAPHY............................................................................................................................................145
6 INTERNATIONAL LEGISLATIVE AND REGULATORY APPROACHES ....................................149
6.1 ITALY – FROM THE “WILD WEST” TO “POLITBURO”? ..............................................................................150
6.2 AUSTRALIA – REGULATED SELF-REGULATION.........................................................................................153
6.2.1 Regulatory Precedents .....................................................................................................................153
6.2.2 The Prohibition of Human Cloning Act of 2002 ............................................................................154
6.2.3 The Research Involving Human Embryos Act of 2002 ..................................................................156
6.3 CANADA: GROPING TOWARD A NEW REGULATORY STRUCTURE............................................................160
6.3.1 The Assisted Human Reproduction Act of 2004 .............................................................................160
6.4 THE HUMAN FERTILISATION AND EMBRYOLOGY ACT – BLUEPRINT FOR ACTION OR A CASE OF BRITISH
PECULIARITY?.............................................................................................................................................168
6.4.1 Introduction ......................................................................................................................................168
6.4.2 The HFE Act .....................................................................................................................................170
6.4.3 The Human Fertilisation and Embryology Authority ....................................................................171
6.4.4 Licensing ...........................................................................................................................................174
6.4.5 The Code of Practice........................................................................................................................177
6.5 SUMMARY AND CONCLUSIONS...................................................................................................................178
6.6 BIBLIOGRAPHY............................................................................................................................................181
7 CONSTITUTIONAL CONSTRAINTS? .....................................................................................................183
31

7.1 TRADITIONAL REPRODUCTIVE TECHNOLOGIES VERSUS TECHNOLOGIES OF REPRODUCTIVE CONTROL183
7.2 QUESTIONS OF CONSTITUTIONAL INTERPRETATION .................................................................................186
7.2.1 Selecting a Level of Generality........................................................................................................186
7.2.2 From Levels of Generality to Principled Interpretation................................................................190
7.2.3 An Idiosyncratic Approach to Constitutional Interpretation.........................................................190
7.2.4 Robertson’s Concept of “Presumptive Procreative Liberty”........................................................192
7.3 A DIFFERENT PERSPECTIVE .......................................................................................................................194
7.4 PROCREATIVE DRIVE OR FAMILIAL DESIRES?...........................................................................................199
7.5 BIBLIOGRAPHY............................................................................................................................................205
8 PUBLIC SENTIMENTS TOWARD NEW REPRODUCTIVE TECHNOLOGIES AND
BIOMEDICAL RESEARCH.........................................................................................................................207
8.1 INTRODUCTION............................................................................................................................................207
8.2 GENERAL ATTITUDES TOWARD SCIENCE AND TECHNOLOGY..................................................................208
8.3 REPRODUCTIVE CLONING...........................................................................................................................209
8.4 RESEARCH CLONING...................................................................................................................................212
8.5 STEM CELL RESEARCH ...............................................................................................................................214
8.6 GENETIC ENGINEERING ..............................................................................................................................218
8.7 AWARENESS AND FAMILIARITY .................................................................................................................219
8.8 THE CULTURE WARS: A MYTH? ...............................................................................................................222
8.9 BIBLIOGRAPHY............................................................................................................................................227
9 POSSIBLE SOCIETAL RESPONSES ........................................................................................................229
9.1 MAINTAINING THE STATUS QUO................................................................................................................229
9.2 TARGETED LEGISLATIVE INTERVENTION ..................................................................................................234
9.3 SELF-REGULATION .....................................................................................................................................236
9.4 REGULATORY RESPONSES..........................................................................................................................238
9.5 BIBLIOGRAPHY............................................................................................................................................243
10 CORRECTING POLITICAL AND REGULATORY DISTORTIONS ................................................245
10.1 REPRODUCTIVE TECHNOLOGIES: A CASE OF POLITICAL FAILURE............................................................245
10.2 A PROBLEMATIC START: THE PROFESSIONALIZATION OF ETHICAL DILEMMAS.....................................251
10.3 ELEMENTS OF A SOLUTION: NOTICE-AND-COMMENT ..............................................................................253
10.4 WHY CONSULT WITH THE PUBLIC?............................................................................................................256
10.5 WHO SHOULD BE CONSULTED?.................................................................................................................259
10.6 SCIENTIFIC LITERACY AND PUBLIC PARTICIPATION .................................................................................262
10.7 KEY FEATURES OF INSTITUTIONS OF PUBLIC CONSULTATION .................................................................264
10.7.1 Deliberation: Vehicle of Consensus or Catalyst of Conflict? .....................................................264
10.7.2 Other Features................................................................................................................................268
10.8 INSTITUTIONAL OPTIONS............................................................................................................................270
10.8.1 Public Hearings..............................................................................................................................271
32

10.8.2 Consensus Conferences .................................................................................................................272
10.9 PUBLIC PARTICIPATION AT THE FEDERAL LEVEL .....................................................................................277
10.9.1 The National Environmental Policy Act of 1969..........................................................................278
10.9.2 The Comprehensive Environmental Response, Compensation, and Liability Act of 1980........281
10.10 BIBLIOGRAPHY ..........................................................................................................................................287
11 INDEPENDENT AGENCIES .......................................................................................................................293
11.1 WHY AN INDEPENDENT AGENCY? .............................................................................................................293
11.2 DESIGN CONSIDERATIONS..........................................................................................................................300
11.2.1 The Advisory Board........................................................................................................................305
11.2.2 The Advisory Board as a Board of Directors?.............................................................................308
11.2.3 Appointment Rules..........................................................................................................................309
11.3 BIBLIOGRAPHY............................................................................................................................................313
12 DESIGNING MECHANISMS OF PUBLIC CONSULTATION ............................................................315
12.1 DELIBERATIVE PANELS ..............................................................................................................................316
12.1.1 Questions of Implementation .........................................................................................................317
12.1.2 Considerations of Feasibility.........................................................................................................318
12.2 CONSULTATIVE COLLEGE...........................................................................................................................319
12.3 PUBLIC CONSULTATION AND RULE-MAKING............................................................................................324
12.4 BIBLIOGRAPHY............................................................................................................................................327
13 IMPLEMENTATION ISSUES .....................................................................................................................329
13.1 MONITORING AND INFORMATION GATHERING .........................................................................................329
13.1.1 Embryos ..........................................................................................................................................331
13.1.2 Oocytes............................................................................................................................................332
13.1.3 Sperm...............................................................................................................................................333
13.2 STANDARD REPRODUCTIVE PROCEDURES.................................................................................................334
13.3 INNOVATIVE REPRODUCTIVE TREATMENTS..............................................................................................335
13.4 TECHNOLOGIES OF REPRODUCTIVE CUSTOMIZATION...............................................................................342
13.5 BIOMEDICAL RESEARCH.............................................................................................................................342
13.6 DESIGNING A SYSTEM OF COMPLIANCE ASSURANCE ...............................................................................345
13.7 OPERATING COSTS......................................................................................................................................348
13.8 BIBLIOGRAPHY............................................................................................................................................353
APPENDIX A – STUDY GROUP MEMBERS ................................................................................................357
APPENDIX B – THE SYNTHETIC HUMAN GROWTH HORMONE (HGH)........................................361
MEDICAL INDICATIONS .......................................................................................................................................361
SAFETY AND EFFICACY .......................................................................................................................................362
SOCIAL-PSYCHOLOGICAL PATHOLOGIES ...........................................................................................................363
Tallness – a Requisite for Success?..............................................................................................................364
33

Shortness as a Psychological and Social Impairment?...............................................................................365
PATTERNS OF USE ...............................................................................................................................................367
THE MARKET FOR HUMAN GROWTH HORMONE ...............................................................................................368
BIBLIOGRAPHY ....................................................................................................................................................371
APPENDIX C – IVF HEALTH AND SAFETY RISKS: SOME ILLUSTRATIONS................................373
MAJOR BIRTH DEFECTS ......................................................................................................................................373
LOW BIRTH WEIGHT ...........................................................................................................................................374
NEUROLOGICAL DISORDERS ...............................................................................................................................375
ECTOPIC PREGNANCIES.......................................................................................................................................375
CRANIOSYNOSTOSIS ............................................................................................................................................376
BECKWITH-WIEDEMANN SYNDROME ................................................................................................................377
ANGELMAN SYNDROME......................................................................................................................................378
THE CLOACAL-BLADDER EXSTROPHY-EPISPADIAS COMPLEX.........................................................................378
BIBLIOGRAPHY ....................................................................................................................................................381
APPENDIX D – CONGRESSIONAL LEGISLATIVE ACTIVITIES 2001-2004......................................383
APPENDIX E – COMMITTEE OPINIONS.....................................................................................................389
GUIDELINES .........................................................................................................................................................389
TECHNICAL BULLETINS.......................................................................................................................................390
EDUCATIONAL BULLETINS..................................................................................................................................391
GUIDELINES AND MINIMUM STANDARDS ..........................................................................................................392
JOINT REPORTS....................................................................................................................................................392
APPENDIX F – ASRM ETHICS COMMITTEE REPORTS AND STATEMENTS ................................393
APPENDIX G – STATE-LEVEL LEGISLATIVE INITIATIVES ..............................................................395
ENACTED LEGISLATION ......................................................................................................................................395
Reproductive cloning.....................................................................................................................................395
Research (Therapeutic) Cloning...................................................................................................................395
Stem Cell Research (explicitly).....................................................................................................................395
Embryonic Research (in general).................................................................................................................396
PENDING LEGISLATION .......................................................................................................................................397
LEGISLATION THAT HAS DIED OR WAS WITHDRAWN.......................................................................................398
APPENDIX H – LEGISLATIVE INITIATIVES AT THE INTERNATIONAL LEVEL ........................401
STATUTES ............................................................................................................................................................401
KEY PROVISIONS .................................................................................................................................................403
APPENDIX I – SELECT SUPREME COURT CASES..................................................................................407
MEYER V. NEBRASKA (1923) .............................................................................................................................407
PIERCE V. SOCIETY OF SISTERS (1925) ..............................................................................................................407
34

SKINNER V. OKLAHOMA (1942) .........................................................................................................................407
GRISWOLD V. CONNECTICUT (1965) ..................................................................................................................408
EISENSTADT V. BAIRD (1972).............................................................................................................................409
STANLEY V. ILLINOIS (1972) ..............................................................................................................................410
ROE V. WADE (1973) ..........................................................................................................................................410
CLEVELAND BOARD OF EDUCATION V. LAFLEUR (1974).................................................................................411
CAREY V. POPULATION SERVICES INTERNATIONAL (1977)..............................................................................412
APPENDIX J – ATTITUDES TOWARD SCIENCE AND MEDICAL RESEARCH ..............................413
APPENDIX K – REPRODUCTIVE CLONING..............................................................................................419
APPENDIX L – RESEARCH CLONING.........................................................................................................431
APPENDIX M – STEM CELL RESEARCH....................................................................................................439
APPENDIX N – GENETIC ENGINEERING ..................................................................................................451
APPENDIX O – AWARENESS AND KNOWLEDGEABILITY .................................................................457
APPENDIX P – ATTITUDES TOWARD STEM CELL RESEARCH BY INDIVIDUALS OF
RELIGIOUS AND OTHER ORIENTATIONS .........................................................................................463
APPENDIX Q – ACRONYMS ............................................................................................................................469
ORGANIZATIONS..................................................................................................................................................469
LEGISLATION .......................................................................................................................................................470
TERMS..................................................................................................................................................................471
35

1 Introduction
This report presents a proposal for a new approach to regulating human biomedicine in the
United States. It is the product of more than three years of research, and of a study group
convened in Washington, D.C., dedicated to this subject. The members of the study group (listed
in Appendix A) were chosen to be representative of the different stakeholders in human
biomedicine; while they have intensively discussed various issues raised in this report, they have
not been asked to endorse the report or its final conclusions. Those remain the responsibility of
the report’s primary authors.
It is our belief that the existing system for regulating human biomedicine in the United
States, while unrivaled in many respects by that of any other country, contains certain gaps or
omissions that will render it increasingly inadequate to meet the challenges posed by new
biotechnologies and medical procedures in the coming years. Other developed countries have put
new regulatory institutions in place already or are in the process of doing so in anticipation of
new developments, and the United States needs to follow suit.
In putting forth this proposal, the authors of this report fully understand the downsides of
regulation. If you regulate something, you get less of it, and many people fear that excessive
regulation of biomedicine will stifle innovation and progress in many areas critical to human
health and well-being.
While this fear is often well-founded, we believe that properly designed regulation can have
the exact opposite effect: It can promote research and scientific advance by establishing a clear
framework under which innovation can take place, a framework that reassures the broader
society that the research is being conducted safely and ethically. Clinical trials for new drugs are
facilitated, for example, by having clear rules established for human subject research by the
National Institutes of Health (NIH) and the Food and Drug Administration (FDA). As we will
demonstrate below, the benefits of a properly designed regulatory environment would be felt in
one particular area of acute concern – embryonic stem cell research.
1.1 The Challenge of New Biotechnologies
It has been clear for more than a generation that advances in biomedical technology pose
ethical challenges deeper and more abiding than those raised in other areas of scientific research.
Biotechnology from the start spawned a whole new field of bioethics; information technology,
by contrast, has not led universities to train professionals in “information ethics.” Recombinant
DNA (or rDNA), cloning, psychotropic drugs, and behavioral genetics have generated moral and
political controversies due to the ways that they could potentially affect human well-being, both
for good and ill.
37

When societal concerns about biotechnology first appeared in the 1970s, the scientific
research community and the biomedical industry reacted responsibly, putting in place new
institutions to reassure the public that biotechnological advance was not coming at the expense of
human safety or dignity. The scientific community, for example, organized the Recombinant
DNA Advisory Committee (RAC) under NIH auspices to vet new research projects in this area
and guard against the emergence of “superbugs.” There was also a major push to fund advisory
committees on bioethics at major research and medical institutions, and a whole series of
governmental boards, commissions, and councils were established to provide ethical guidance to
the U.S. government. The Human Genome Project has regularly devoted 3 percent of its research
budget to studying the ethical, legal, and social implications of genetic research.
The various communities involved in human biomedical research in the United States have
thus developed a model of self-policing in which bioethics plays a role, but only in an advisory
capacity. This model has by and large worked over the past generation. However, as John Evans
has pointed out, 4 this model was also put in place deliberately as a means of fending off more
overt regulation. All of the different bioethics advisory boards around the country have
effectively served as a cover for the scientific community, allowing it to argue that it was paying
attention to ethical issues while not giving those bodies any real authority to limit or sanction
research. The professional bioethics community, moreover, has tended to adopt a rather “thin”
view of ethical concerns centered on principles like autonomy, fairness, beneficence, and justice,
as opposed to the “thicker” moral views held by many Americans.
Bioethical discussion and debate remains critical; there are many ethical concerns that do
not have black-and-white answers and cannot be addressed through laws or regulation. But it is
our view that the time has come to move beyond bioethics and to begin considering a different
kind of regulatory system for human biomedicine that goes beyond current considerations of
safety and efficacy and takes ethical and normative concerns into account. How to
institutionalize a system that is representative of the interests of the different stakeholders and of
the general public, one capable of fostering rational deliberation and likely to promote necessary
and beneficial research and innovation, is the subject of this report.
1.2 To Regulate or Not to Regulate
Having just argued that the scientific community has held off overt regulation of many
forms of research and of biotechnology, it may seem contradictory to assert in the same breath
that human biomedicine is and has for a long time been one of the most heavily regulated areas
of endeavor in the United States. But both statements are true: The regulatory scene is a
contradictory patchwork of both under- and over-regulation. The FDA’s “gold standard” of
costly double-blind clinical trials for pharmaceuticals is unmatched in any other country in the
world. On the other hand, the FDA regulates only drugs and medical products, and can regulate
4
John H. Evans, Playing God? Human Genetic Engineering and the Rationalization of Public Bioethical Debate
(Chicago, IL: University of Chicago Press, 2002).
38

them only on the basis of safety and efficacy. It does not regulate the practice of medicine, which
means that the large area of medicine involving assisted reproductive technologies (ARTs)
receives virtually no government oversight. In Europe, things are typically rather different:
Drugs are given less careful scrutiny, while ARTs are closely monitored by governments. While
the FDA strictly enforces testing rules for new drugs, it does not control their off-label uses,
meaning that doctors are free to innovate, and in effect experiment on their patients in such
cases.
The other major regulatory institution in the United States is the National Institutes of
Health, which through its control over federal funding exerts enormous influence over the nature,
scope, and direction of scientific research in biomedicine. 5 It is the NIH that now oversees bodies
like the RAC, and establishes requirements for institutional review boards (IRBs) to monitor
research involving human subjects. The NIH is not limited to considerations of safety and
efficacy like the FDA; it can and has introduced moral and ethical concerns into its decisionmaking.
President George W. Bush’s August 2001 decision limiting federally funded stem cell
research to existing stem cell lines reflected his concerns over protecting embryos, and was
implemented by the NIH. Here, the limits of regulatory authority are different than in the FDA’s
case. The NIH can influence science only through its control of funding; it cannot prohibit
privately funded research and has no say over what happens in the private biotech industry.
No one designed this overall regulatory system. It was put together piecemeal in response to
scandals like those over sulfanilamide elixir and thalidomide, or those in response to the
Tuskegee or Willowbrook abuses. The fact that the United States regulates some things very
strictly and other things not at all is largely a path-dependent and contingent product of its
history. The question that confronts us is whether this system is adequate to meet the challenges
of twenty-first century biomedicine.
What some of those challenges are and why the present system may not be adequate to cope
with them is the subject of the growth hormone case study given in chapter 2. In light of these
challenges, we face a problem of institutional design: Do we stick with the existing regulatory
framework, or do we seek to introduce new regulatory powers or different kinds of institutions?
Most Americans rightly regard regulation as a necessary evil; with the growth of state
sectors in the twentieth century, it became clear to many people by the 1970s that many sectors
of the American economy were over-regulated. Much of the thrust of policy in the United States
since then has been to cut back on regulation in areas ranging from airlines to trucking to
electricity to telecommunications. In some cases, this has been met with great success; in others,
less so. The dangers of over-regulation remain, however, and the burden of proof should lie with
anyone who argues that new regulatory bodies are necessary. A useful prudential rule in public
administration is not to multiply regulatory agencies unnecessarily when the new functions
required can be performed just as easily by existing bodies.
5
There are, of course, any number of other agencies that have regulatory authority over various aspects of human
biomedicine, including the Centers for Disease Control and Prevention (CDC), the U.S. Patent Office, the Drug
Enforcement Agency, and state licensing boards.
39

On the other hand, certain historical precedents suggest that it is at times wiser to create a
new institution to deal with a new problem. Take the case of transportation, for example. The
Interstate Commerce Commission (ICC) was created in 1887 to regulate the new railroad
industry. 6
The Interstate Commerce Act that established it was a milestone in American
administrative law, extending for the first time the writ of the federal government into areas that
had previously been reserved for states.
At the beginning of the twentieth century, the rise of interstate trucking posed the question
of who should regulate this new industry. The Hepburn Act of 1906 gave regulatory authority to
the ICC on the grounds that trucking and railroads were similar, both being means of moving
goods across state borders. Most experts in administrative law believe now, in retrospect, that
this was a mistake: The economics of the rail and trucking industries were very different, the
interest groups involved differed substantially, and the technical expertise require to regulate rail
service did not spill over into trucking.
When commercial aviation emerged in the 1920s, the ICC could have been charged with
regulating this sector on the grounds that airplanes are simply another means of interstate
commerce. Instead, the Air Commerce Act of 1926 created a new, independent Aeronautics
Branch within the Commerce Department to promote and ensure the safety of civil aviation.
With the advent of commercial jet aircraft after World War II, this branch eventually evolved
into two independent agencies – the Federal Aviation Administration and the Civil Aeronautics
Board. It is doubtful that anyone today regrets this choice to create new agencies to regulate
aviation rather than building on the authority of the ICC.
The question to consider here, then, is not the broad one of whether or not to regulate human
biomedicine and biotechnology, as a positive choice was made in that area long ago. The
question, rather, is whether we are currently at a juncture similar to the mid-1920s, when civil
aviation first emerged as a new and highly promising industry. Do we regard the issues raised by
new biotechnologies as problems we are already familiar with, or are they sufficiently different
as to merit new regulatory powers? Surely, no one in a liberal society wants to multiply
regulatory agencies or add more layers of bureaucracy unnecessarily. On the other hand, it is
sometimes more efficient to begin afresh rather than trying to change bureaucratic cultures to
handle problems they were never designed to handle. The idea that a democracy may want to
create a new statutory authority to deal with new technologies cannot be totally outlandish, as a
number of other developed countries have decided to do precisely that.
1.3 The Domain of Inquiry of this Report
Human biomedicine is a huge field, and it is necessary at the outset to define the realm of
technologies and practices that we believe need to be regulated. There are many existing and
potential targets of regulation, including drugs and medical devices, various types of scientific
6
The ICC was disbanded in 1995 and its powers were given to the National Surface Transportation Board.
40

esearch, and clinical and medical practices. Many critics of the FDA have argued that the
agency over-regulates many drugs, preventing patients from having timely access to important
pharmaceuticals. This could well be true; a complete overhaul of the American regulatory system
may require deregulation of some areas as well as new regulation of others at the same time.
In this report, we intend to focus more narrowly – on the one end on technologies and
medical practices related to human reproduction, and on the other on biomedical research
involving embryos and other reproductive tissues. Our reason for choosing these areas is that
they encompass most of those technologies – existing, on the horizon, and possible in the more
distant future – that bioethicists have pointed to as raising significant moral and ethical issues.
Within this domain lie not only traditional ARTs, the most important of which remains in vitro
fertilization (IVF), but also novel forms of reproduction (the creation of embryos from genetic
material from one, three, four, or more parents, for example) and new reproductive services like
pre-implantation genetic diagnosis (PGD) and sex-selection technologies and, possibly, germline
genetic modifications (see chapter 3). This domain also includes laboratory research
involving embryos. Embryonic stem cell research is a well-known example; less familiar but just
as relevant is the creation of human-animal chimeras and hybrids.
It should be emphasized at the outset that to say that these technologies are related to human
reproduction does not necessarily mean that they are intended to produce children. This is
particularly true of embryonic stem cell research, whose end is of course the development of
treatments for diseases affecting already-living human beings. Nonetheless, the fact that such
stem cells are derived from embryos and may in the future be capable of producing embryos
means that it is impossible to regulate the broader field of human reproduction without regulating
them. Indeed, the manipulation of stem cells may become one of the means through which other
reproductive technologies become possible.
To say that these practices should be regulated is not to say that they should be banned or
unduly restricted. As we explain at greater length below, it is our view that stem cell research
would benefit greatly from being placed within a regulatory framework. But precisely because
embryonic stem cell research today requires the use of embryos and may at some point in the
future lead to the creation of embryos, it is not possible to separate this kind of work from
research and medical practices that aim directly at the creation of children.
In defining the domain of inquiry in this fashion, we are excluding a great many other issues
that may deserve greater or lesser degrees of regulation. Psychopharmacology is an area of
pharmaceutical development that is exploding, one that is regulated already and may deserve a
fresh look in light of new drugs coming on the market in the near future. These are issues,
however, that lie beyond the scope of the current report.
1.4 Science, Politics, and Democracy: Some General Considerations
Many people, including some members of our own study group, are strongly opposed to any
regulation of scientific research, and believe that science is a self-contained, self-justifying
41

enterprise that should be shielded from politics. To many people, the idea of Congress
intervening in this area evokes images of Galileo being prosecuted by the medieval Catholic
Church. As Congressman Ted Strickland of Ohio said during the House debate on cloning
legislation in 2001, “We should not allow theology, philosophy, or politics to interfere with the
decision we make on this issue.” It is therefore worth stepping back and raising the more general
question of who, legitimately, gets to make rules in this area.
This issue was settled in principle long ago: All scientific research is ultimately subject to
rules set not by scientists, but by the broader political community. In a liberal democracy, that
community consists of the sovereign people speaking through their elected representatives – that
is, Congress (and, in the case of presidential systems like that of the United States, the president).
Indeed, in a democracy, the people are sovereign not only over science, but over every other
field of activity. 7
The reasons for this are straightforward. Scientists qua scientists have no special authority to
make ethical or political judgments about the ends of their scientific research. Data is data: Even
if obtained by deliberately infecting experimental subjects with deadly disease agents in doubleblind
clinical trials, as was done by Nazi scientists, the results are still scientifically meaningful.
The fact that we do not allow this kind of research to be carried out in the United States reflects
an ethical judgment that it is wrong, based in part on the crimes of the Nazis. Virtually all
American scientists strongly support existing rules protecting human subjects of research. They
do so, however, not in their capacity as scientists, but as citizens, moral agents, religious
believers, or simply as human beings. It is precisely “theology, philosophy, and politics” that
provides guidance on this kind of issue.
While it is clear in principle that Congress and the president ultimately have legitimate
authority to set rules and boundaries for science and scientists, in practice science operates in a
much more autonomous fashion. There is a general political consensus that science and scientific
progress are good things that should be encouraged, and also a recognition on the part of elected
officials that they do not have the knowledge to intervene in most scientific issues. This has led
to a certain degree of self-restraint on the part of political authorities when it comes to scientific
rule-making, and a willingness to delegate considerable rule-making power to the epistemic
communities directly involved in scientific research and technology research and development.
Congressman Strickland’s comments about theology, philosophy, and politics interfering in
science reflect a default condition in which scientists regulate themselves, subject to broad
political guidelines set by Congress. While most Americans would accept the right of politicians
to regulate science, most also hope – rightly – that this does not happen too often.
7
Strictly speaking, in a liberal democracy like the United States, popular sovereignty is limited by a pre-existing
set of individual rights, which in the American case are said to come from nature rather than the people’s will.
Practically speaking, the definition of what constitutes these “natural” rights is a matter of popular choice (i.e.,
through ratification of the Bill of Rights and its subsequent interpretation through the courts), but one based on
supermajorities rather than simple majorities.
42

Congress’ powers over scientific research and technology research and development come
in many different forms. In some cases, the government has statutory powers to set rules, like the
FDA’s power to regulate drugs and medical devices. In other cases, political influence is
exercised through funding decisions made by agencies like the NIH or the National Institute of
Mental Health (NIMH). The fact that the United States chooses to wage a “war on cancer” rather
than sponsor research on tropical diseases like malaria reflects political judgments about U.S.
national priorities. Activities like embryonic stem cell research that are not banned but also not
federally funded reflect either political compromises or complex judgments as to their moral
acceptability. In light of these decisions, no one should pretend that the types and levels of
research carried out in the United States do not embed a host of normative judgments made by
the broader political community.
The issue we seek to address in this report is the proper modality of political intervention. In
doing so, we hope to avoid several pitfalls. The first is routine intervention by Congress to ban or
limit certain practices, technologies, or medical procedures. In 2001, legislation was introduced
into Congress to ban, in one version, reproductive cloning, and in another, both reproductive and
research cloning. While the latter bill passed the House of Representatives, neither made it
through the Senate due to a failure to agree on the legitimacy of research cloning. While one of
the present authors is on record in support of the broad cloning ban, neither of us believes that
this bill represents a good general model for future Congressional intervention in biomedicine.
While human cloning constitutes an important symbolic threshold meriting Congressional
action, 8 many future innovations emerging over the coming decades will not. We do not believe
that Congress has the time, energy, or expertise necessary to pass specific new laws in response
to the many future innovations that will emerge.
On the other hand, we also do not believe that the current model under which authority is
de-facto delegated to the epistemic communities and their stakeholders is adequate to meet future
challenges. The regulatory authority of the FDA and NIH is not only limited by statute in the
ways described above; it is administered almost exclusively by the epistemic communities
involved, with little opportunity for participation by other societal actors with an interest in
biomedicine. (Institutional review boards, with their statutory requirement that they include
members drawn from outside the scientific community, are the one exception). On the adequacy
of this arrangement, see chapter 5 below.) In designing new regulatory institutions, the issue then
is not only whether they should be given statutory authority to go beyond safety and efficacy as
criteria for regulatory decisions, but also whether those making the decisions on an agency level
should include people from outside the scientific research communities and the biotech and
reproductive industries.
We do not by any means mean to suggest that existing epistemic communities should be
deprived of their traditional self-regulatory powers. Rather, the question is whether participants
8
The recent report of the President’s Council on Bioethics Reproduction and Responsibility: The Regulation of
New Biotechnologies outlines a possible legislative agenda that would in effect ban reproductive cloning as well
as a number of other procedures, like the production of human-animal hybrids.
43

in the standard-setting process can be broadened to include other stakeholders more
representative of the broader society. There are a number of reasons for wanting to do this. While
the scientific community, ART professionals and the biotech and pharmaceutical industries are
the primary sources of knowledge about human reproductive medicine and biomedical research,
they are also self-interested actors whose goals and ethical orientations do not necessarily
coincide with those of the larger society. And even though scientists generally aspire to the
disinterested search for truth as an ideal, many also have financial relationships with biotech or
pharmaceutical companies that affect their personal incentives. These communities will continue
to play an important role in this field, if for no other reason than their possession of critical
scientific and medical information. The purpose of broadening participation in the resolution of
contemporary moral and ethical dilemmas is not to dilute this expertise, but to make the
regulatory body more representative of the society around it.
The final pitfall to avoid is the under- or over-delegation of authority to a new regulatory
authority. Regulatory agencies exist in the first place because Congress lacks the time or
knowledge to make the myriad complex decisions required by the statutes it enacts. Legislators
do not want to have to decide how many parts per million constitutes a dangerous level of
contamination for a particular chemical, or whether the results of a clinical trial are statistically
significant. On the other hand, there are certain issues that are much too large and controversial
to be delegated to a regulatory agency, and that ultimately must be debated and decided by the
broader political community. The key issue for the design of a new regulatory authority,
therefore, is what authority Congress should delegate and what issues it has responsibility for
deciding directly. Nowhere is this more true than in the area of stem cell and cloning research.
1.5 Abortion Politics and the Moral Status of the Embryo
It is safe to say that in the United States, all legislation in the general area of reproductive
medicine and embryo research is made vastly more complicated by the underlying societal
controversy over the moral status of the embryo. Other developed countries that have passed
legislation in this area have reached consensus either to permit (as in the case of Britain) or to
prohibit (as in the cases of Germany and Canada) certain forms of cloning research. In the
United States, there are passionate proponents of both the pro-life and pro-choice positions. One
reason that cloning legislation has remained stalled in the Senate since 2001 is that neither side
can muster more than about 40 votes for its preferred version of a cloning ban.
For what it is worth, we do not begin from a pro-life position. We believe that human
embryos have an intermediate moral status. 9 They are, on the one hand, not the moral equivalents
9
Some people have argued that human moral status is an “on” or “off” condition, and that the concept of an
intermediate moral status is incoherent. There are, however, other entities that have such intermediate status.
Dead human bodies are one example: We permit them to be used instrumentally for research and training
purposes, on the one hand, but we do not allow them to be used for less dignified ends, or to be disposed of
casually.
44

of newborns; destruction of an embryo for us is not tantamount to murder. On the other hand, we
do not believe that embryos are just clumps of cells like any other tissue specimen; because they
are potential human lives, they deserve some degree of respect. We believe that a regulatory
system that keeps track of such embryos, permitting their use for select scientific purposes of
scientific research but prohibiting their casual creation or destruction, is an appropriate way of
recognizing this intermediate status. Our ethical concerns in this area relate not to embryo
destruction per se as much as to other technological possibilities that are either emerging now or
will appear in the coming years (see chapter 4 below).
We raise this issue not to persuade others of our case, but rather to point out that there are
several deeply held alternative views on this issue, among which there is unlikely to be
consensus any time in the near future. This kind of large moral question cannot possibly be
delegated to a regulatory agency. They must rather be adjudicated at higher levels of the political
system, in Congress and the state legislatures or, less optimally, through the court system (as has
happened in the case of the legalization of abortion). Indeed, if any kind of regulatory system
involving human embryos is to succeed, it is critical to fence off the realm of delegated authority
from the issues of abortion and the moral status of embryos.
It is important to understand that a system to monitor and regulate biomedical research,
artificial reproductive technologies, and related areas does not necessarily presuppose a
particular position on the moral status of embryos. That is, such a system can be used to monitor
and enforce a ban on research cloning, stem cell research, and the like, or it can be used to
promote some or all of these activities. 10 The Germans and Canadians have constructed systems
to do the former, while the British have constructed a system to do the latter. The institutional
design of the regulatory system is in some sense independent of one’s stand on the underlying
moral question.
If we are to proceed with the construction of a new regulatory system, then, the political
system has to make a decision on the underlying legitimacy of embryo research and the broad
realms of what will be permitted and restricted in this area. These are not regulatory issues but
political ones. Only when the society has made a decision on the prior question will it be possible
to proceed to construct an institution capable of enforcing the agreed-upon rules.
As noted at the outset, we believe that embryonic stem cell research should proceed with
federal funding, and that a new regulatory system will actually promote that end. To those
opposed to any form of embryo research, we would point out that achieving their goals would
require a similar type of regulatory system. The current system, in which federally funded
research is restricted but private research is virtually unregulated, serves the interests of neither
camp.
If at a future point the American political system decides to drop existing limits on federal
funding of stem cell research, a solid regulatory system will become all the more necessary.
10
Indeed, a regulatory system with good enforcement powers is particularly essential if the government seeks to
permit some activities and restrict others.
45

Many people (ourselves included) are not concerned with the destruction of embryos per se, but
rather with potential slippery-slope consequences of using embryos in this fashion (for example,
setting a precedent for the harvesting of tissues and organs from cloned fetuses). Such concerns
could be largely put to rest if embryonic stem cell research were conducted under a
comprehensive regulatory framework that among other things kept track of cloned embryos to
prevent them from being implanted or grown into fetuses. The minority position taken by
supporters of stem cell research on the President’s Council on Bioethics argued in favor of
precisely such a regulatory environment. 11 While most stem cell research proponents make at
least a nod to the need for a regulatory framework for embryo research, relatively few have
thought seriously about the institutional design that would make this possible. It is noteworthy
that Britain, with its Human Fertilisation and Embryology Authority (HFEA), has one of the
world’s strictest regulatory environments in this area, and yet is a leader in stem cell research.
We do not have any illusions that the American political system will produce a clear
consensus one way or another on the issue of the legitimacy of embryo research, and we
therefore anticipate that the kinds of regulatory changes we propose in this report will face an
uphill struggle to be enacted. As in the case of other regulatory initiatives, it may take a major
scandal or controversy on the order of Thalidomide or the Enron collapse to persuade the
American people and Congress to act. We do believe, however, that we need to initiate a debate
over the adequacy of the current regulatory system, and to begin a broad discussion of the types
of institutions that will be sufficient to carry us into the twenty-first century.
11
See President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies
(Washington, D.C.: 2004).
46

1.6 Bibliography
Evans, John H. Playing God? Human Genetic Engineering and the Rationalization of Public
Bioethical Debate. Chicago, IL: University of Chicago Press, 2002.
President's Council on Bioethics. Reproduction and Responsibility: The Regulation of New
Biotechnologies. Washington, D.C., 2004.
47

2 Human Growth Hormones for Children of Idiopathic Short Stature:
Medical Treatment or Enhancing Therapy?
2.1 Introduction
Before turning our attention to new bioethical dilemmas, let us examine in some detail the
recent decision by the FDA to approve the use of human growth hormone (hGH) for the
treatment of children of idiopathic short stature (ISS). The case of the hGH is representative of
the many challenges regulators are likely to face in the not-too-distant future. Like many
reproductive treatments, synthetic hGH originally was developed to treat a narrowly defined
medical condition, chronic growth hormone deficiency in children. As for many other drugs, the
use of hGH has expanded over time to include indications initially not envisaged by the company
that developed it.
In this chapter, we examine the role the FDA played in sanctioning the shift from purely
therapeutic uses to what many have described as the cosmetic use of hGH. “Cosmetic use” is the
term the FDA uses to identify treatments or drugs that are not designed to cure a medical
condition, or that are intended to treat a condition that affects only the physical appearance of an
individual. In the following discussion, we prefer to use the term “enhancing.” “Cosmetic” and
“enhancing” are not always or necessarily synonymous terms. In the present case, however,
“enhancing treatment” better captures the nature of the underlying ethical dilemma. The FDA
decision to approve what may be described as an enhancing treatment then provides considerable
insight into how existing regulatory agencies are likely to resolve controversies surrounding the
use of medical technologies that are neither clearly therapeutic nor uniquely enhancing.
Until the mid-1980s, children with severe growth hormone deficiency could only be treated
with growth hormone obtained from cadavers. The amount of hGH so obtained was minuscule
compared to the number of children in need of treatment; the cure was extremely expensive and
not entirely safe, and some children treated with natural hGH contracted Creutzfeldt-Jakob
Disease. 1
Recombinant DNA technology changed all this, making it possible for biotech
companies to produce a once-scarce biological resource in large quantities of very high and
consistent quality. Human growth hormone was one of the very first drugs to be produced
through recombinant DNA technology, the use of which use was approved by the FDA in 1985
for the treatment of severe growth deficiency.
In subsequent years, the availability of synthetic hGH quickly increased, though the
treatment has remained very expensive. Since its introduction in 1985, human growth hormone
has been prescribed for a variety of approved and unapproved indications, including inadequate
1
American Academy of Pediatrics and Committee on Drugs and Committee on Bioethics, "Considerations
Related to the Use of Recombinant Human Growth Hormone in Children," Pediatrics 99, no. 1 (1997).
49

endogenous growth hormone secretion, chronic renal insufficiency, and Turner Syndrome,
among others. 2 With the fall 2003 approval of the use of synthetic hGH for the treatment of
idiopathic short stature, the FDA sanctioned a medical treatment that is neither obviously
therapeutic nor clearly enhancing.
Its obscure name notwithstanding, this condition can easily be explained: ISS children are
considerably below the mean stature for their sex and age group, yet their short stature cannot be
attributed to any physiological deficiency; their growth hormone levels are well within the norm,
and their parents’ stature is not generally below average. By all accounts, these are short but
otherwise healthy, normal children. In this and similar cases, the medical profession simply
assumes that the phenomenon under consideration is a condition whose origins are unknown;
hence the term “idiopathic.”
It should be pointed out that the FDA decision certainly cannot be described as an egregious
case of regulatory failure. The FDA did not endorse the prescription of hGHs for every case of
idiopathic shortness. The FDA approved this treatment only for extremely short children – that
is, for children two standard deviations below the mean for sex and age group. In addition, the
regulators were well aware of some of the broader societal implications of their decision. If this
was indeed a case of a regulatory agency sanctioning an enhancing therapy, it was neither a
spectacular nor an obviously outrageous decision. Paradoxically, it is precisely the ordinary
nature of the hGH case that makes it relevant to our discussion. Enhancing medical treatments,
as a rule, are unlikely to achieve dramatic improvements. Their effectiveness is often modest or
even controversial. In addition, they may raise considerable safety concerns. In sum, enhancing
treatments are likely to deliver only incremental benefits – benefits that regulators may not
consider important enough to warrant limiting their accessibility on the basis of considerations
other than safety and efficacy.
In each of these cases, patient groups and pharmaceutical and biotechnology companies,
with the more-or-less active support of the medical profession, are likely to portray a so-called
cosmetic treatment as an instance of the therapeutic use of a medical technology. Opponents, for
their part, will undermine the enhancing aspects of the treatment in question, or even dispute that
the proposed treatment constitutes a medical therapy. This is precisely why the case of the hGH
is so insightful: It is a very realistic test of the ability of existing regulatory agencies to recognize
the ambivalent nature of new, so-called medical treatments, and to address the ethical dilemmas
raised by medical treatments and technologies that are neither purely therapeutic not entirely
enhancing.
2
These are all approved indications. For a more detailed discussion of the approval history of hGH indications,
see Minnesota Department of Health Health Technology Advisory Committee, The Use of Growth Hormone for
Children with Idiopathic Short Stature (Minnesota Department of Health, 2000 [cited April 24, 2006]); available
from http://www.health.state.mn.us/htac/hgh.htm.
50

2.2 Is There a Need for Legal Guidance?
The FDA approved the cosmetic use of synthetic hGH based on a favorable
recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, one of its
many scientific advisory boards. The committee made the recommendation at its June 10, 2003,
meeting, the transcripts of which shed considerable light on the committee’s rationale for
approving the drug’s cosmetic use. The transcripts also provide a detailed insight into the
workings of scientific advisory boards more generally.
At issue at this committee meeting was the application by Eli Lilly and Company to approve
Humatrope, a popular hGH, for the treatment of ISS children. The Eli Lilly application was
certainly not the first of its kind. The FDA often has been called upon to approve cosmetic
treatments. Therapies to treat baldness, to eliminate wrinkles, to reduce weight, and to treat many
other conditions can all be described as cosmetic treatments, or as treatments that can be
prescribed for other-than-therapeutic indications. In all these cases, the FDA position has been
quite clear: The agency, in evaluating applications, focuses exclusively on its twin statutory
mandates of safety and efficacy – whether the drug (or medical device or biologic) in question
was designed for therapeutic or cosmetic uses or both. It tends to exclude other considerations,
such as whether a specific drug use may or may not be appropriate, acceptable, or desirable.
In the case of hGH, the FDA had no intention to take a different stance. From its point of
view, the question of whether treating ISS children with hGH constitutes a cosmetic use was not
part of the committee charges. At the same time, the FDA was well aware that the committee
might have been tempted to deviate from the prescribed course. As noted by David Orloff,
director of the Division of Metabolic and Endocrine Drug Products at the Center for Drug
Evaluation and Research (CDER):
[…] I just want to raise one other issue that has not actually been raised here explicitly, but may be
in the back of some people’s minds, and in the minds of those perhaps listening from the audience.
And that is, to some extent, it’s kind of the flip side of the clinical significance question that’s
been asked and will be asked again, and that is whether the use of growth hormone in non-growth
hormone deficient short stature represents “cosmetic” use of growth hormone, and […] might be
construed somehow as setting a broad precedent for cosmetic use of drugs.
The first point I’d like to say is that any decision that’s made with regard to growth hormone in
this instance will be based upon a judgment of a favorable balance of risk versus benefit for the
proposed indication, and that would not, in our minds, be setting a broad policy with regard,
generally, to the use of drugs for cosmetic purposes.
I’d also propose that it is not the purpose of this meeting to debate the merits of approvals of other
drugs for what some – usually those unaffected by the target condition – might construe as
cosmetic purposes. And I think it’s safe to say that we should concede that once demonstrated to
be safe and effective, the choice of whether to attempt therapy for, for example, baldness, or mild
acne, or even overweight is up to doctors, patients, and their families, as they weigh the potential
benefits of the therapy against the potential risks.
And, I guess I said it before, but I’ll just point it out one more time: that we don’t see a regulatory
stance favoring approval for the use of growth hormone putting this division or the agency on a
51

slippery slope toward blanket uses of – cosmetic uses of – growth hormone, as well as for other
drugs. 3
As this quote demonstrates, the FDA tried very hard to avoid getting involved in what it
probably regarded as a sterile controversy over its role in sanctioning the cosmetic use of hGH.
In this, it largely succeeded. The Endocrinologic and Metabolic Drugs Advisory Committee,
despite some hesitations, ultimately focused its attention on safety, efficacy, and what medical
practitioners label “clinical significance.” This is an interesting concept that refines and expands
the meaning of effectiveness. A drug or a medical treatment may be effective, in the sense that it
may produce the intended medical outcomes, yet it may not be “clinically significant” in the
sense that it may be unable to cure the core concerns associated with a condition. In the present
case, addressing clinical significance meant that the committee was called upon to determine (1)
whether idiopathic shortness should be considered a condition, (2) in what sense this medical
condition affects the health and well-being of ISS children, and (3) whether the treatment in
question not only raises the final height of affected children but also contributes significantly to
mitigating the associated psychological impairment and provides other benefits beyond merely
height.
In their presentation to the committee, Eli Lilly and its advisers identified several possible
benefits of treating short children with Humatrope, ranging from reaching the minimal height
required by some jobs to being able to buy normal clothes and being able to sit at least 10 inches
away from a steering wheel, as air bag safety regulations require. A senior Eli Lilly adviser
offered considerable evidence about the negative psychological impact of short stature. His
presentation was complemented by the testimony of short children describing in considerable
detail patterns of bullying and teasing by their peers.
Despite Eli Lilly’s considerable efforts to demonstrate not only efficacy but also clinical
significance, a large fraction of the committee members was not convinced. Of nine
commissioners, five expressed serious doubts about the benefits of hGH treatment, three were
unconcerned, and one was agnostic. It is worth quoting some of the dissenting voices at some
length:
[…] Just to summarize what was just said, I think that we’ve been shown that treatment with
growth hormone can improve height, but that the effect is, I think, fairly small; on the average,
about one-and-a-half inches; and that there’s been no demonstration of the impact of this on
quality of life. 4
I think the testimony we’ve heard, and probably from everybody’s own experience, we know the
enormous hurt and pain of the stigma of extreme shortness. And I think the kind of changes we’ve
seen here don’t address that. So I’m leaning on the side of thinking that we’ve heard that,
clinically, this much change in height is not enough. 5
3
4
5
Food and Drug Administration Center for Drug Evaluation and Research, "Endocrinologic and Metabolic Drugs
Advisory Committee Meeting," ed. Food and Drug Administration Department of Health and Human Services
(October 7, 2003), p.248-49.
Commissioner Grady, Ibid., p.257 emphasis added.
Commissioner Worcester, Ibid., p.267 emphasis added.
52

[…] I really think there should be additional data on some type of benefit besides simply the
height. Now, I agree that if the height was dramatic – six inches – you probably wouldn’t have to
show anything else. But because the height benefit is much smaller than that, I am concerned that
here is a very expensive treatment, in which the benefits are not clearly shown. 6
Not every committee member subscribed to these views. The committee chair remarked:
[…] In regards to the clinical importance, I think this is the crux of the problem that many of us
are having with this. Dr. Grady nicely brought out that there’s no really good evidence that oneand-a-half
inches or so is going to improve quality of life. I’m also concerned about the resource
allocation issues, about who’s going to pay for this, and the potential worsening of the drag on
health care dollars over time. Nevertheless, I don’t think that’s really the charge of the committee.
The charge of the committee is really to determine whether this is safe and efficacious, and
clinically important. 7
The committee chair went on to explain that in his view, clinical relevance is really a
question that must be decided by parents and children in cooperation with their doctors. In other
words, clinical relevance, in his view, is really a matter of informed consent. His take on this
matter was predicated on the assumption that hGH treatment was indeed effective. This
assumption was by no means shared by all committee members.
Several committee members noted that from a statistical standpoint, the treatment seemed
moderately effective (with, on average, a gain in final height of one to one-and-a-half inches),
but questioned whether such a modest gain would actually have any significant positive impact
on the life and well-being of the children. This question was raised several times, but no
convincing answer was provided. In addition, it was noted that, based on the data presented by
Eli Lilly, individual participants in the clinical trials had responded very differently to the
treatment, with some participants not responding at all and others responding very well. In other
words, the treatment did not seem to have a sufficiently predictable impact on the final height of
the participating children. The only critic invited to give a presentation at the meeting, an
internationally renowned endocrinologist, pointed out that in the study presented by Eli Lilly, the
final height reached by children in the control group (that is, in the group that had received a
placebo) and the final height reached by the children who had received the treatment were in fact
quite similar. (This problem is not confined to this particular type of hGH; other hGHs suffer
from the same limitation.) 8
In sum, the committee members seemed to disagree not only on what might constitute
efficacy in a narrow technical sense (Is a one-and-a-half inch gain in final height sufficient to
demonstrate efficacy?), but also on what the benefits of the treatment might be. These
reservations notwithstanding, the committee recommended by an eight-to-two vote and with
minimal qualifications that the FDA approve Humatrope for the treatment of ISS children as
6
7
8
Commissioner Schade, Ibid., p.263 emphasis added.
Commissioner Brunstein, Ibid., p.258.
Harvey J. Guyda, "Four Decades of Growth Hormone Therapy for Short Children: What Have We Achieved?,"
The Journal of Clinical Endocrinology & Metabolism 84, no. 12 (1999).
53

proposed by Eli Lilly – a rather surprising outcome given the discomfort demonstrated by many
committee members, and one that warrants closer scrutiny.
2.3 Discussion
To what extent can the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee be
regarded as a viable model for untangling future ethical dilemmas? In its present form, this
committee is clearly in no position to tackle broader ethical dilemmas, as illustrated by the
distinction between therapeutic and enhancing uses of hGHs. The FDA is characterized by an
organizational culture centered mostly on safety and efficacy. Tackling broader ethical dilemmas
would be not only on dubious statutory ground and outside of FDA’s core competencies; it
would also not be part of the committee’s charge as established in its charter. 9 Thus, it would be
unfair to criticize existing regulatory structures for failing to address ethical questions that they
were not intended to answer in this first place. The committee recommendation and the FDA
decision to approve the cosmetic use of hGH must be evaluated on their own terms.
At first, it is tempting to conclude that the FDA’s decision was sound. The FDA has made
the hGH treatment available to very short children – children at least 2.25 standard deviations
below the average height for their sex and age. Eli Lilly estimates that in the United States there
are approximately 400,000 of such children. The agency came to its conclusion after what
appears to be a thorough examination of the safety, efficacy, and clinical significance of the
proposed treatment. It also emphasized that its decision was not to be interpreted as a general
expression of support for cosmetic treatments. In this sense, the FDA decision-making process
does not seem to raise any major concerns.
A closer examination of the transcripts suggests a different conclusion. Concerns about
clinical significance notwithstanding, the committee members failed to adequately examine
perhaps the most important aspect of clinical significance – the empirical evidence concerning
the negative impact of short stature on the well-being of ISS children (and short children in
general). Remember that the rationale behind Eli Lilly’s application was based precisely on the
assumption that short stature has an empirically demonstrable and systematic negative impact on
children. As mentioned earlier, one of Eli Lilly’s consultants spent considerable time making this
case, and the committee members seemed generally to accept the presentation’s main conclusion.
In the eyes of most committee members, and indeed most people confronted with this issue,
preventing suffering and long-term psychological harm to short children would be a very strong
rationale for supporting the proposed treatment. But the evidence presented by Eli Lilly was
vigorously disputed by an internationally renowned endocrinologist invited to the meeting by the
9
The committee charter establishes that it is the committee’s responsibility to “[…] review and evaluate data
concerning the safety and effectiveness of marketed and investigational human drug products for use in the
treatment of endocrine and metabolic disorders, and make appropriate recommendations to the Commissioner of
Food and Drugs.” The complete Charter text is available at
http://www.fda.gov/cder/audiences/acspage/Endocrinologiccharter1.htm.
54

FDA. The expert in question pointed to numerous recent studies showing that short stature in
children may be a source of distress but has minimal or no lasting negative effect on their wellbeing.
Yet the subsequent discussion as documented in the transcripts suggests that the expert’s
opinion did not affect the commissioners’ thinking in the least. Nor did any commissioner
actually challenge Eli Lilly’s core assumption that shortness causes significant psychological
harm.
Our own review of the literature also casts considerable doubt on the view that shortness
causes lasting psychological harm. 10 As with many scientific and medical controversies, the
conclusion that short stature does not cause psychological harm is hardly unassailable. However,
it is difficult to ignore two simple facts. First, studies showing psychological harm are generally
very old. More recent empirical data and more sophisticated research designs do not support the
early conclusions. Second, the majority of the studies reviewed do not show harm. Against this
background, the committee’s failure to explore more thoroughly the alleged negative
psychological impact of short statute on children deserves further scrutiny.
There are two main reasons for this myopic behavior. Both of them suggest important
lessons. For one thing, numerous psychological studies have demonstrated that for a dissenting
view to be heard, it must have roughly equal weight as other views. In the case of the committee
meeting on Humatrope, this requirement clearly was not met. As the frustrated dissenter
observed, he was the only critical voice amidst an army of industry representatives, their
advisers, and supporting families. Under these circumstances, a dissenting voice will simply be
ignored, while the dominant view will be reinforced. This phenomenon is known as group
polarization, and it is well documented. 11
Committee composition is the second factor affecting the likelihood that dissenting views
will be heard. The Endocrinologic and Metabolic Drugs Advisory Committee consists of ten
members and an executive secretary. Of the ten committee members at the time of the debate on
Humatrope, eight represented one branch of endocrinology or another. All of them were
university professors, and some of them department chairs. One was a biostatistician, one an
epidemiologist, and one – the “consumer representative” (a term meant to identify with a broader
lay audience) – was a specialist in women’s health. Certainly this was a very distinguished and
knowledgeable panel, but their respective medical backgrounds hardly prepared them to question
psychological or sociological stereotypes. The presence of a single consumer representative on
the committee – the only dissenting voice – had no discernible impact on the committee at large,
as predicted by the literature on committee behavior. This is an excellent example of group
polarization: The homogeneous nature of the Endocrinologic and Metabolic Drugs Advisory
10
11
See Appendix B for details.
See chapter 10.7.1 for an in-depth discussion.
55

Committee tended, predictably, to reinforce widely held beliefs and marginalize dissenting
views. 12
Group polarization is a common phenomenon in small deliberative bodies, and it is probably
responsible for many ill-informed administrative decisions. Its pernicious influence is not limited
to small groups, however, as we show throughout this report. Legislators, trade and professional
groups, and scientific societies, among others, are not immune to this phenomenon. Fortunately,
it appears that in many cases it is relatively easy to reverse group polarization. To this end, small
group decision-making bodies must be chartered so as to ensure that all relevant views are
represented in roughly equal proportions – a straightforward but often neglected consideration.
The preceding discussion suggests that the current system of scientific advisories, as
exemplified by the Endocrinologic and Metabolic Drugs Advisory Committee, is unable to cope
with broader ethical dilemmas (a task it was never intended to perform.) It also shows serious
limitations in discharging its public mandate. Advocates of the status quo may point out that to
ensure balance, the federal government only needs to make sure that the provisions of the
Federal Advisory Committee Act of 1972 (FACA) are properly implemented. FACA governs the
establishment and operation of all federal advisory committees, including FDA scientific
advisory committees. 13 FACA is an example of a good governance law; it was passed mainly to
mitigate the excessive influence of organized interest groups. Among other things, FACA
requires the convening agency to appoint members to an advisory committee so as to ensure that
the committee be “balanced” – in other words, that a broad range of views is represented on the
committee. 14
Can the Endocrinologic and Metabolic Drugs Advisory Committee be considered balanced?
The committee charter calls for appointing members with proven expertise in endocrinology,
epidemiology, or statistics, and for including a consumer advocate with recognized technical
expertise. Given the committee’s charge, this composition seems indeed quite reasonable. Nor is
there any prima facie reason to assume that this committee violates any key FACA provisions.
On the other hand, it is difficult to believe that a committee balanced in any strong sense of the
term is prone to group polarization. On closer examination, the committee charter and FACA
provisions for balanced composition may turn out to be in conflict, but the courts have generally
refrained from providing specific guidance on how to ensure balance. 15
As a result,
administrative agencies traditionally have had considerable latitude in the interpretation of this
provision, latitude that administrations of both parties have routinely exploited for their own
narrow political goals.
12
13
14
15
Ironically, and perhaps surprisingly, deliberation among committee members in this case did not produce
depolarization, but rather the opposite.
See http://www.fda.gov/cder/audiences/acspage/Endocrinologiccharter1.htm.
See Public Law 92-463, Sec. 5(b)(2).
Steven P. Croley and William F. Funk, "The Federal Advisory Committee Act and Good Governance," Yale
Journal on Regulation 14 (1997).
56

2.4 Broadening the Ethical Debate
As it stands, the Endocrinologic and Metabolic Drugs Advisory Committee could be
described as a decision-making body that is likely to routinely recast ethical dilemmas in narrow
medical terms. It is also likely to reduce eminently public choices to private decisions. The heavy
reliance on science advisory boards, the skewed composition of these boards, the limited pool of
ethical arguments presented to these panels, and their inadequate statutory authority all
contribute to this outcome.
Some commentators may argue that that the Public Health Service Act and the Food, Drug,
and Cosmetics Act afford the FDA much more regulatory discretion than suggested by current
FDA regulatory practices. In particular, under some legal theories, the FDA would be able to
include considerations other than safety and efficacy in its approval process. We are in no
position to evaluate the merits of this claim, but even if it could be demonstrated that the FDA
would have to statutory authority to inject ethical considerations into its decision-making
process, the agency is very unlikely to do so. The FDA does not consider regulatory demands
other than those pertaining to safety and efficacy as part if its core mission. In the agency’s view,
these demands represent a regulatory distraction, a misallocation of scarce administrative
resources that drag the agency into legal battles with uncertain outcomes. Importantly, the
agency’s organizational culture and its professional expertise, both of which have developed
around safety and efficacy, make the FDA ill-suited to address broad ethical dilemmas.
But what are the ethical dilemmas neglected by the Endocrinologic and Metabolic Advisory
Committee? In the remainder of this chapter, we touch upon some of the arguments that in our
view have not received sufficient attention. Some have argued that severe hGH deficiency is a
physiological impairment that deserves close medical attention, whereas idiopathic short stature
is not at all a medical condition. 16 Children can be unhappy about many things; they may not like
their noses, for example, but should we be in the business of prescribing nose jobs? In this view,
children suffering from severe hGH deficiency and ISS children do not really represent
commensurable cases. By prescribing hGH treatment for idiopathic shortness, are we not simply
indulging profoundly human but nevertheless unjustifiable parental desires? Should health
insurance plans (that is to say, the public) be required to cover the costs of hGH treatment for an
adolescent who is desperate to follow in his father’s footsteps and embrace a basketball career?
At the other extreme, if there is no solid evidence of ubiquitous and systematic harm to short
children, why should the state encourage the misallocation of scarce financial resources?
These arguments have been made often and do not require further discussion. By contrast,
one question that should have received considerable attention but has barely been acknowledged
is what may be called the medicalization of societal problems. Dr. Nancy Worcester, the
consumer representative on the Endocrinologic and Metabolic Advisory Committee, was the
only commissioner who touched upon this concern, although only marginally so. Not
16
Peter H. Schwartz, "Genetic Breakthroughs and the Limits of Medicine: Short Stature, Growth Hormone, and the
Idea of Dysfunction," St. Thomas Law Review 13 (2001).
57

coincidentally, she was also one of only two commissioners who voted against the Eli Lilly
application. 17 In our view, this concern lies at the heart of many contemporary controversies over
new reproductive technologies and biomedical research, and it is worth exploring in some depth.
In its most general form, the argument goes like this: New scientific and medical
developments have a differential impact on society. Some technologies tend to reinforce preexisting,
widespread beliefs and cultural orientations; they resonate with the public and as a
result they are quickly embraced. Others may actually be incompatible with widely shared
cultural values. This means that the latter may be at a disadvantage compared to other
technologies more in tune with domestic traditions, values, and orientations. New technologies,
in other words, do not fall on a culturally neutral ground; powerful, pre-existing habits of the
heart and mind tend to nurture some and reject others. 18
Applied to the case of human growth hormone, this argument suggests that the tendency to
describe idiopathic shortness as a condition deserving medical attention is informed in large
measure by at least three deeply entrenched American values: (10 the unshakable belief in the
power of technology to solve even the most intractable problems, including political and social
ones; (2) a strong sense of individual responsibility and self-reliance; and (3) a deep-seated
distrust of government. 19 The obsession with restoring physical height through medication rather
than by focusing on the political means to fight intolerance for physical differences is but one
example of a pervasive tendency in the contemporary United States to redefine social problems
as technological challenges, and to rely on private initiative rather than on political action. It is
not too difficult, then, to predict the impact that hGH availability would have on parents with ISS
children; it would reinforce a view of short stature as a medical condition rather than as a
manifestation (albeit a mild one) of intolerance, to be cured by medical means rather than
addressed by PTAs, school districts, and local governments.
The use of synthetic hGH to treat shortness is only the latest example of the medicalization
of societal problems. Supposedly miraculous cures peddled as means to solve social and political
problems have a long history. In the 1930s, for example, an entrepreneur made a fortune for
himself by selling an ointment to African-Americans that promised – correctly as it turned out, at
least for a limited period of time – to “whiten” their skin. 20 One could easily imagine a cosmetic
product that, unlike its predecessor, has a permanent whitening effect; should this treatment
receive FDA blessing only because it is both safe and effective? Wouldn’t many of us, and not
only African-Americans, reject the notion that racial discrimination should be fought by
medication rather than by political means?
17
18
19
20
Center for Drug Evaluation and Research, "Endocrinologic and Metabolic Drugs Advisory Committee Meeting,"
p.322.
Langdon Winner, "Technology Today: Utopia or Dystopia?," Social Research 64, no. 3 (1997).
Seymour Martin Lipset, American Exceptionalism: A Double-Edged Sword (New York: W.W. Norton &
Company, 1996).
Carl Elliott, Better Than Well: American Medicine Meets the American Dream (New York: W.W. Norton &
Company, 2003), p.191-93.
58

Whether the broad availability of synthetic hGH will erode our tolerance for physical
differences and perhaps, over time, also undermine now widely shared notions of tolerance
remains to be seen, but this would certainly be a price too high to pay. The incessant drive
toward physical perfection, as illustrated by the staggering sums of money spent every year on
cosmetics and plastic surgery, is a reminder that in contemporary America, certain forms of
intolerance have already achieved the status of national obsession. The popularity of antidepressants,
on the other end, seems to suggest not merely that many Americans are unable to
cope with the difficulties of modern life, but that the pressure to live up to certain supposedly
widespread notions of success and “the good life” has become consuming. 21
The case of the synthetic hGH strongly suggests that existing regulatory institutions are
simply inadequate to address the challenges raised by new reproductive treatments and
biomedical research. In Homer’s Odyssey, Achilles resisted the suave but deadly chants of the
Sirens by ordering his crew to bind him to the mast of his boat. Like modern argonauts, we may
soon be exposed to the chants of medical and scientific Sirens we may be too weak to resist.
Achilles’ response to the Sirens’ threatening chants is an acknowledgment both of human frailty
and ingenuity. Modern societies have developed elaborate ways to resist temptation. Mindful of
our weakness, we often delegate to regulatory agencies the task of protecting us against our selfdestructive
inclinations. 22 New reproductive treatments and medical technologies are only the
latest illustration of a technological and scientific development that perhaps we are too weak to
control. It is certainly not too late to take measures that will protect us against ourselves, but to
do so, contemporary debates about new reproductive and medical technologies must be moved
decidedly into the public realm. This report is a contribution to this debate.
21
22
Peter D. Kramer, Listening to Prozac: The Landmark Book About Antidepressants and the Remaking of the Self
(New York: Penguin Books, 1997).
Modern commentators speak of second-order preferences, i.e., preferences about preferences. For example, a
drinking habit may be described as a first-order preference, and regulations against drinking as an example of a
second-order preference. For a discussion, see Cass Sunstein and Edna Ullmann-Margalit, "Second-Order
Decisions," Ethics 110 (1999).
59

2.5 Bibliography
American Academy of Pediatrics, and Committee on Drugs and Committee on Bioethics.
"Considerations Related to the Use of Recombinant Human Growth Hormone in
Children." Pediatrics 99, no. 1 (1997): 122-29.
Center for Drug Evaluation and Research, Food and Drug Administration. "Endocrinologic and
Metabolic Drugs Advisory Committee Meeting." edited by Food and Drug
Administration Department of Health and Human Services, October 7, 2003.
Croley, Steven P., and William F. Funk. "The Federal Advisory Committee Act and Good
Governance." Yale Journal on Regulation 14 (1997): 451-539.
Elliott, Carl. Better Than Well: American Medicine Meets the American Dream. New York:
W.W. Norton & Company, 2003.
Guyda, Harvey J. "Four Decades of Growth Hormone Therapy for Short Children: What Have
We Achieved?" The Journal of Clinical Endocrinology & Metabolism 84, no. 12 (1999):
4307-16.
Health Technology Advisory Committee, Minnesota Department of Health. The Use of Growth
Hormone for Children with Idiopathic Short Stature Minnesota Department of Health,
2000 [cited April 24, 2006]. Available from http://www.health.state.mn.us/htac/hgh.htm.
Kramer, Peter D. Listening to Prozac: The Landmark Book About Antidepressants and the
Remaking of the Self. New York: Penguin Books, 1997.
Lipset, Seymour Martin. American Exceptionalism: A Double-Edged Sword. New York: W.W.
Norton & Company, 1996.
Schwartz, Peter H. "Genetic Breakthroughs and the Limits of Medicine: Short Stature, Growth
Hormone, and the Idea of Dysfunction." St. Thomas Law Review 13 (2001): 965-78.
Sunstein, Cass, and Edna Ullmann-Margalit. "Second-Order Decisions." Ethics 110 (1999): 5-
31.
Winner, Langdon. "Technology Today: Utopia or Dystopia?" Social Research 64, no. 3 (1997):
989-1017.
61

3 Ethical Principles
No proposal for regulation can begin without a discussion of the larger ends that regulation
is intended to serve. A great deal of regulation in the United States has come about as a result of
specific harms or incidents, like the sulfanilamide elixir scandal that led to passage of the Food,
Drug, and Cosmetics Act, or more recently the Enron and WorldCom accounting scandals that
paved the way for passage of the Sarbanes-Oxley reforms. Our proposal to regulate human
biomedicine is different: It is being driven not in response to pressing current problems, but
rather in anticipation of possible future problems that fast-moving technologies might introduce.
We will begin by laying out a general set of ethical principles that we believe should guide
regulation in the domain we have defined in the first chapter – namely, technologies and medical
practices related to human reproduction and to biomedical research involving the use and/or
destruction of human embryos. We believe that these general principles are ones that the
American public will broadly support, and we have considerable polling data to back this up (see
chapter 8). These principles are similar in many instances to those laid out in the 2004 report by
the President’s Council on Bioethics, “Reproduction and Responsibility: The Regulation of New
Biotechnologies.” The following section will list the principles, and elucidate some of their more
concrete implications.
3.1 General Ethical Principles Guiding the Regulation of Technologies and Medical
Practices Related to Human Reproduction
We believe that human reproduction is a particularly important part of human life, and that
society has an inherent interest in protecting the human values associated with it. The following
is a set of ethical standards that we believe any regulatory system touching on this domain should
promote. These guiding principles touch mainly on the means and the ends of assisted
reproduction, and only secondarily on issues of access. Access is partly examined in chapter 7, in
which we discuss possible constitutional constraints on the regulation of ARTs, but is otherwise
not a subject of this discussion. The ethical principles that we endorse are as follows:
• The well-being and health of children should be protected.
• Biomedical procedures on human embryos must respect their intermediate moral
status.
• Access to ARTs on the part of infertile couples should be promoted.
• The well-being and health of women should be protected.
• Free and informed consent must be required on the part of those making use of
ARTs.
63

• Limits on the commercialization of eggs, sperm, and embryos should be imposed.
• Therapeutic uses should be favored over enhancement uses of biomedicine.
Let us discuss each of these principles in turn.
The well-being and health of children. Since reproduction inherently aims to create
children, the welfare of children ought to be placed first and foremost as an objective of
regulation. We believe that this means, in the first instance, better and more systematic
monitoring of health outcomes, including long-term longitudinal surveys, of IVF children.
Compared to other developed countries, public oversight of ARTs in the United States is limited,
and funds to carry out studies have thus far been limited.
It may seem obvious that the well-being and health of children ought to have priority over
the interests of other stakeholders in reproductive medicine, including parents, doctors, clinics,
and biomedical researchers. Many discussions of new reproductive technologies, however, often
put the wishes and desires of potential parents foremost. Clearly, parents who want children also
want the best for their children, and so the law generally allows them generous discretion in
following their own instincts, under the assumption that this will also lead to good outcomes for
their children. But it is not always necessarily the case that what parents want will correspond to
the best interest of their children. This is most obviously true in the case of mothers who drink
alcohol or take drugs while pregnant. There is also the case of a deaf lesbian couple that wanted
to intentionally disable the hearing of their child so that the child would be part of their deaf
“culture.” 1
We interpret “well-being and health” broadly to mean not just physical health, but
psychological and social well-being as well. This means, among other things, that every child
has the right to be biologically related to a mother and a father, even though they may be brought
up in a variety of households in which the biological mother and father may be absent. We
believe that this right overrides the interests of parents in creating biological offspring through
novel medical techniques, like cloning or the harvesting of fetal eggs (see the following section
on prohibited activities).
The intermediate moral status of human embryos. We do not believe that an embryo is
the moral equivalent of a human being. The potential for an embryo to eventually develop into a
child, per se, does not establish equality. Just like an acorn and an oak tree are not identical
objects, so there are ethically meaningful differences between an embryo and a fully developed
human being. At the other end, we don’t share the view, common among scientists, that a human
embryo is simply a tiny clump of cells that can be manipulated at will. Embryos occupy an
ethically gray zone – they are due some respect, but not the same respect due to human beings.
Equal access to ARTs on the part of infertile couples. At this point, approximately two
million children have been born worldwide through IVF. The benefits of this technology to
1
M. Spriggs, "Lesbian Couple Create a Child Who Is Deaf Like Them," Journal of Medical Ethics 28 (2002).
64

infertile parents have been enormous, and equal access to it ought to be a priority. In the United
States, however, treatment for infertility is often not regarded as an insurable medical condition,
but rather as a health option. Insurance coverage varies by state, and for many Americans, IVF is
cost-prohibitive. Expanding the availability of safe ARTs should be a policy priority. 2
An
unproblematic focus of this policy should be infertile heterosexual couples, whether married or
not. An important and largely unresolved question is whether the benefits of this policy should
be extended to singles, minors, homosexual couples, and women who would like to procreate
using the gametes of their recently deceased husbands. As mentioned earlier in this report, we
focus mainly on the ends and the technological means, and only marginally on questions of
access.
The well-being and health of women. ARTs frequently involve special risks to women,
particularly due to the need to take fertility drugs that stimulate ovulation. Most ARTs involve
invasive medical procedures; new techniques that may become available in the future could lead
to pregnancy complications that do not exist now. We place the priority of women’s well-being
and health somewhat lower than that of children and of infertile couples, only because the
women who take these risks generally do so voluntarily and in full knowledge of possible
adverse consequences.
Free and informed consent. It is important to recognize that a great deal of what happens
in IVF clinics constitutes a form of experimental medicine, as techniques like intracytoplasmic
sperm injection (ICSI) and pre-implantation genetic diagnosis (PGD) move from the laboratory
directly to clinical practice. Many techniques have never been tested in animal models, and while
there have not to date been any major problems experienced with new technologies leading to,
for example, major birth defects, this remains a constant possibility. It is very important,
therefore, that parents be fully informed ahead of time as to existing risks, and in cases where
procedures are genuinely novel, that they be informed of this as well. This makes doubly
important the collection of comprehensive and comparable data on the long-term health
consequences of different ARTs and procedures to ensure that doctors and clinics have the
proper incentives to inform their patients fully and adequately of whatever risks are known to
exist.
Limits to commercialization. While the practice of medicine using artificial reproductive
technologies constitutes a business for the doctors and clinics participating in it, we believe that
there should be limits to the commercialization of many aspects of reproduction. This involves
limits on production and sale of eggs and sperm, and particularly on the production and sale of
embryos. In particular, we believe that the U.S. Patent and Trademark Office should not issue
patents on embryos or fetuses at any stage of development.
Therapeutic over enhancement uses of biomedicine. We believe that the priority in
biomedical research and clinical practice ought to be given to therapeutic ends – i.e., to healing
2
For an in-depth discussion of the economics of the ART market, see Debora L. Spar, The Baby Business: How
Money, Science, and Politics Drive the Commerce of Conception (Boston, MA: Harvard Business School Press,
2006).
65

the sick and relieving the pain and suffering of those afflicted with pathological conditions. One
of the large issues opened up by many new biotechnologies is the possibility that the very same
techniques used for therapeutic purposes could also be used to enhance the qualities of children
who suffer from no abnormal or pathological conditions. There is very little disagreement over
the therapeutic uses of medicine, but there is a great deal of societal unease over so-called
“enhancement” uses of biomedicine, for example, the use of growth hormone to make a child of
average height taller than the mean.
We do not believe that this unease should translate mechanically into blanket prohibitions or
red lines. Many people have argued (1s) that there is no clear distinction between therapeutic and
enhancement uses of biomedicine; 3 (2) that in any case we permit many procedures like breast
implants or cosmetic surgery that constitute enhancement; and (3) that enhancement technologies
will be positively desirable as a means of overcoming limited existing human capacities.
We believe that these are serious arguments deserving full discussion – fuller, indeed, than
we can provide here. 4
While the borderline between therapeutic and enhancement uses of
biomedical technologies is often unclear, the distinction remains a valid and important one.
Using PGD or gene therapy to prevent a genetic disorder like Huntington’s or Tay-Sachs is
clearly quite different from using these techniques to produce children with different hair color
or height. The United States already sets regulatory boundaries between the therapeutic and
enhancement uses of various psychotropic drugs like selective serotonin reuptake inhibitors
(SSRIs) and Ritalin to treat depression and attention deficit hyperactivity disorder (ADHD),
where the borderline between pathology and normality can be extremely ambiguous.
The use of biomedicine for enhancement purposes raises at least three complex social and ethical
issues. The first concerns equality and equal access. While therapeutic uses of medicine pull
people up to the mean, enhancement uses will potentially increase natural inequalities in ways
that are likely to add to existing social inequalities. Second, many potential targets of
enhancement confer only relative gains, which may be advantageous for the individuals seeking
them, but not for society as a whole. An existing example is the widespread use of sex selection
techniques in some parts of Asia, which has produced large-scale imbalances between boys and
girls. While parents may think that having a son confers social advantages, most societies
encounter an array of problems when sex ratios fall out of balance. Finally, enhancement raises
ethically troubling arguments over the nature of human goods. Potential targets of enhancement,
like skin color or proclivities towards homosexuality, are not generally accepted as bad things to
be overcome. Enhancement may also produce unintended consequences, particularly if they lead
3
4
There are many other examples of cases where the distinction between therapy and enhancement is blurred. Is
offering heart-bypass surgery or chemotherapy to an 85-year-old patient suffering from heart disease or cancer
truly therapeutic, or does it amount in effect to an unnatural form of life-extension, and thus enhancement? Many
drugs like Ritalin can be taken for either therapeutic or enhancement purposes; the diagnostic criteria for
conditions like ADHD that distinguish one use from the other are flexible, and to some extent subjective.
For an excellent discussion of the many dimensions of enhancement, see the President’s Council on Bioethics,
Beyond Therapy: Biotechnology and the Pursuit of Happiness (Washington, D.C.: Government Printing Office,
2003).
66

to population-level changes in human characteristics (as is already the case with sex selection in
Asia).
It is a well-established utilitarian principle that greater risks are permissible when treating a
clearly pathological condition than in cases of elective treatment. Certainly, in terms of resource
allocation, there is no question that therapy ought to have much higher priority than
enhancement. Yet while it is neither possible nor desirable for society to ban enhancement
outright, it is perfectly legitimate for the government to raise higher regulatory hurdles and steer
resources away from practices aimed at enhancement rather than therapy.
3.2 Translating Principles into Rules
These general principles, then, need to be translated into specific rules that would be used to
guide regulators. These rules would be divided into two categories: (1) activities that we believe
ought to be banned outright, and (2) activities that should be permitted but regulated. Neither list
is meant to be definitive; they reflect our interpretation of how the principles outlined above
should be interpreted in light of technological possibilities that either exist now or can be
anticipated based on current trends. Some of our choices – for example, whether research
cloning ought to be banned or regulated – will be extremely controversial. It should be noted,
however, that the same regulatory institution can preside over different sets of rules. For
example, the new Assisted Human Reproduction Agency of Canada bans research cloning, while
the British Human Fertilisation and Embryology Authority permits it. In most other respects,
these agencies look very similar. (Indeed, the Canadian agency was modeled after the HFEA.)
3.3 Activities to Be Prohibited
We believe that there are several activities made possible by biotechnology that ought to be
prohibited outright, with prohibitions enforced through criminal sanctions. The role of a
regulatory body would be twofold – to enforce the prohibitions, with some scope for interpreting
their meaning, and to promulgate regulations in accordance with the ethical guidelines
established by Congress. We believe that prohibited activities should include the following:
• Reproductive cloning
• Human-animal chimera and hybrid creation
• Germ-line genetic modifications
• New reproductive possibilities that alter the biological relationship of parents and
children
• Commercialization of certain aspects of human reproduction
Reproductive cloning. As indicated in chapter 8.3, a large majority of Americans do not
favor reproductive cloning; all versions of the cloning legislation that have been introduced in
Congress since 2001 have included bans on reproductive cloning. The reasons that Americans
67

give for opposing this practice vary; some cite safety reasons while others believe that the
possibility is inherently wrong or distasteful. As the National Bioethics Advisory Committee and
the President’s Council on Bioethics have both stated in their reports on cloning, human
reproductive cloning is not today something that can be done safely, and for that reason alone
should be banned on the basis of the principle that gives priority to the health and well-being of
children.
Creation of chimeras and hybrids. Following the recommendations of the President’s
Council on Bioethics, we believe that the creation of human-animal hybrid embryos – the
fertilization of a human egg with animal sperm or the use of human sperm to fertilize an animal
egg – should be banned. Other situations in which human and animals cells, tissues, and organs
simply are mixed are less problematic and should not be subject to an outright ban. These
include the many forms of chimerism that are currently used in biomedical research, such as the
implanting of human stem cells in animal tissues. Animal-derived organs are now routinely
implanted in humans, and in the future, animal-derived genes may be available for treating
human diseases; in our view, all of these are by and large legitimate activities. There may be
complex cases where the degree of mixing of human and animal may become ethically
problematic; we believe that determining this boundary is something that can be left to the
regulatory authority, at least initially.
Germ-line genetic modifications. Germ-line modifications of human beings, of the sort
that is now done routinely with plants and animals, cannot now be done safely and should
therefore be banned. Germ-line modifications would necessarily involve a kind of
experimentation on human beings who clearly will not be able to give their informed consent,
and therefore it violates the first and fourth ethical principles laid out above.
There is considerable debate over how far in the future human germ-line engineering lies.
While many until recently have derided this possibility as a fantasy, it appears that stem cell
research may provide a fast and safe route to germ-line genetic modifications. 5 If and when
human germ-line genetic modifications become possible and predictably safe, it may be
necessary to re-open the question of whether the technique should be banned or merely
regulated. Some people believe that the technique itself poses ethical problems, because it
involves changes not just to the genotype of the child in question, but to all of that child’s
subsequent descendants. If a safe and effective means of correcting heritable genetic disorders
through germ-line modification becomes available, conceivably germ-line genetic modifications
could be moved from the prohibited to the regulated category. The undeniable benefits of this
move notwithstanding we believe human germ-line genetic modifications should remained
banned. In our view the risk that this technology would be abused far outweigh its medical
benefits.
5
Susannah Baruch et al., "Human Germline Genetic Modification: Issues and Options for Policymakers,"
(Washington, D.C.: Genetics and Public Policy Center, 2005).
68

New reproductive possibilities that alter the biological relationship of parents and
children. There are a number of technologies emerging that will make possible the creation of
children who are not the offspring of one man and one woman, as every human child has been up
to now in the history of our species. Laboratory research has suggested possibilities such as
reproductive cloning; the creation of artificial oocytes from stem cells (which will, in theory,
allow males to produce eggs and females sperm); embryo fusing (which could lead to children
with more than two biological parents); or the harvesting of fetal eggs (which would lead to an
offspring whose mother had never been born). We believe that the first ethical principle
enunciated above, placing priority on the well-being of children, gives all children a right to be
born out of the union of a man and a woman, and that technologies that alter this fundamental
relationship should be banned.
Patenting of human embryos. We believe that property rights to human embryos should be
banned. Property rights are usually granted to stimulate research and innovation; there will be
plenty of other incentives to perform necessary embryo research in the absence of ownership
rights in specific embryos.
3.4 Activities to Be Regulated
There are other activities that we believe are ethically legitimate but ought to be carried out
under carefully controlled circumstances. These include: 6
• Research cloning
• Pre-implantation genetic diagnosis
• Biomedical research involving early-stage embryos or blastocysts
• Commercialization of elements of human reproduction
Research cloning. We believe that research cloning should be permitted, but that it should
be tightly regulated. We see why many people who are not troubled by the use of excess
embryos in stem cell research may yet oppose the deliberate creation of cloned embryos for
research purposes. We believe, however, that whatever extra instrumentalization this act may
imply does not outweigh the gains potentially to be derived from this kind of research. It is,
however, particularly important for the regulatory authority to monitor and control this kind of
research very carefully – not just because of what we call the intermediate moral status of
embryos, but also because it is the only way to enforce a ban on reproductive cloning. That is, if
a large industry dedicated to producing cloned embryos ever comes into being, it will be much
more difficult to take one of those embryos and implant it into a woman’s uterus for the purpose
of creating a child if the regulatory authority registers and tracks every such embryo.
6
Note that this list is not meant to be exhaustive. In chapter 4 we discuss many more instances of ethically
problematic medical and scientific developments that may need to be regulated.
69

We recognize that for some people, the fact that we have put research cloning in the
“regulated” and not the “prohibited” category will simply cause them to stop reading further,
because they feel that our project is simply endorsing the deliberate creation and destruction of
nascent life. We would point out, however, that if we were to move this activity from the
regulated to the prohibited category, we would in effect be transforming the British system into
the Canadian one – a system that in virtually all other respects would look identical. Thus, if a
societal consensus develops that believes research cloning to be clearly wrong, one would still
want to create the kind of institution we are laying out here.
Pre-implantation genetic diagnosis. PGD is a service performed by many fertility clinics.
We believe that it is an important way for couples with heritable genetic disorders to ensure that
those conditions are not passed down to their children. On the other hand, PGD involves certain
kinds of risks and creates incentives (for example, for the production of large numbers of eggs
and embryos) that could pose serious health problems for the women involved. Using PGD for
non-therapeutic purposes raises a host of ethical issues, and should be strongly discouraged by
the regulatory system.
Biomedical research involving early-stage embryos or blastocysts. We believe that
biomedical research on embryos or blastocysts is important and legitimate, but that it ought to be
done under carefully controlled circumstances, given the intermediate moral status of embryos.
This means that the regulatory authority should monitor and control the creation and transfer of
all embryos used for these purposes, much as the British HFEA does currently. This kind of
regulatory capacity will also be necessary in order to enforce any reproductive cloning ban.
Commercialization of elements of human reproduction. We believe that the buying and
selling of human embryos should be strictly regulated, again in keeping with their intermediate
moral status. We believe that embryos can be used for research purposes, and that a limited
market should be allowed to develop to facilitate their transfer (for example, excess embryos
from IVF clinics), but that all such transfers should be carefully tracked by the regulatory
authority. We also believe that the donation of embryos, eggs, and sperm for reproductive
purposes should be regulated, and that the free and unrestricted trade of human gametes,
including sperm, should be prohibited.
3.5 Next Steps
While some readers may disagree with us on our suggestions to prohibit or regulate a given
medical procedure or a certain type of research, few would reject the twin notions that
distinguishing between ethically acceptable and unacceptable practices of biomedicine should be
done by legislative means, and that these distinctions should be informed by a set a coherent
ethical principles. In this sense, which medical procedures or research protocols should be
banned and which ones should be regulated is less important than establishing the principle that a
new regulatory infrastructure backed by a statutory framework is needed and that this new
statutory framework should be informed by a set of broadly acceptable ethical principles.
70

Accordingly, our proposal for a new regulatory entity is largely immune with regard to changes
in the medical procedures or research protocols to be banned or regulated. Ours, in other words is
an argument for selectively strengthening the administrative state and not merely an examination
of arguments for or against the medical procedure or the scientific experiment of the day, an
argument that is laid out in the remainder of this report.
71

3.6 Bibliography
Baruch, Susannah, Audrey Huang, Daryl Pritchard, Andrea Kalfoglou, Gail Javitt, Rick
Borchelt, Joan Scott, and Kathy Hudson. "Human Germline Genetic Modification: Issues
and Options for Policymakers." Washington, D.C.: Genetics and Public Policy Center,
2005.
President’s Council on Bioethics. Beyond Therapy: Biotechnology and the Pursuit of Happiness
Washington, D.C.: Government Printing Office, 2003.
Spar, Debora L. The Baby Business: How Money, Science, and Politics Drive the Commerce of
Conception. Boston, MA: Harvard Business School Press, 2006.
Spriggs, M. "Lesbian Couple Create a Child Who Is Deaf Like Them." Journal of Medical
Ethics 28 (2002): 283.
73

4 New Frontiers of Reproductive Science and Medicine
4.1 Areas of Inquiry
In chapter 3, we introduced several ethical principles germane to any discussion of
reproductive technologies and biomedical research. We have also provided a few illustrations of
how these principles may inform political choices. In this chapter, we turn our attention to
several recent developments in reproductive medicine and biomedical research and discuss some
of the ethical concerns they may raise. We do so by characterizing each of these developments as
an instance of a broader class of cases – in other words, by adopting a taxonomy of reproductive
treatments and biomedical research. This approach represents a significant departure from the
practice, common among policy-makers and legal scholars, to focus narrowly on just one or
perhaps two specific applications of a medical or scientific development.
There are obvious reasons for taking a broader approach to discussing controversial ethical
dilemmas. When the Congress decided that aviation needed a separate administrative entity
responsible for ensuring its safety, it did not charged the newly established FAA with regulating
only the types of aircrafts existing at the time. The FAA was responsible for aviation safety in
general, i.e., for the safety of all existing and future aircraft models. Similarly, the FDA is
charged with ensuring the safety and efficacy of most current and future drugs, biologics, and
medical devices, not just of those in existence at the time its enabling legislation was passed.
Translated to our context, this means, for example, that we consider intracytoplasmic sperm
injection (ICSI) an instance of a standard reproductive technique, while pre-implantation genetic
diagnosis (PGD) is better described as a technology of reproductive customization. The former
type of reproductive treatment raises mainly health and safety concerns. The latter is
controversial for reasons other than just health and safety.
Standard reproductive techniques and technologies of reproductive customizations are two
of four distinct policy domains to be discussed in this chapter. The other two are innovative
reproductive treatments and biomedical research involving human reproductive tissues. Taken
together, these four policy domains define the scope of possible legislative and regulatory
interventions to be discussed in this report. As for any other typology, there may be instances of
reproductive treatments or biomedical research that cannot unambiguously be assigned to a
specific category. Some would probably consider ICSI an instance of an innovative rather than a
standard reproductive technique. Other examples could be found. These difficulties are intrinsic
to any classificatory scheme, and must be dealt with on a case-by-case basis. It is also worth
mentioning that ours is certainly not the only possible categorization. Other equally useful
75

taxonomies are likely to exist. For example, in “Reproduction and Responsibility,” the
President’s Council on Bioethics adopts a similar but by no means identical taxonomy. 1
The commercialization of reproductive treatments would require a separate discussion. By
this term, we mean both the commercial trade of human reproductive tissues and the various
contractual arrangements made possible by the market for reproductive tissues. Many
reproductive treatments, standard or otherwise, raise distinctive ethical and legal questions if the
gametes involved stem from one or more third parties. Also to be included in this category is
surrogacy, or the delegation of a pregnancy to a surrogate mother. While these questions are by
no means trivial or negligible, in this report we will not discuss them in detail. The
transformation of human procreation from an intimate act to a set of contractual obligations is a
tendency that certainly does not leave us indifferent. At the same time, this trend is not new, and
does not raise fundamental new ethical dilemmas. For this reason, in this report we focus mainly
on new technological possibilities in the narrow sense of this term.
Our classificatory scheme is designed to emphasize what we believe are distinctive
attributes of various reproductive technologies and lines of biomedical research. By classifying a
new reproductive technique as an instance of a familiar type of reproductive treatment, policymakers
would have at their disposal several tried and tested ethical arguments. Reliance on
ethical precedents would of course greatly simplify the task of identifying the most appropriate
regulatory response. This is an important benefit, considering the often puzzling nature of new
bioethical dilemmas. A quasi-judicial approach to the resolution of controversial ethical
questions would also minimize the opportunities for interest groups to influence or distort the
regulatory process. In the process, it would make judicial review a less attractive option. Finally,
a classificatory scheme would discipline regulators by encouraging the adoption of consistent
policies, thus reducing the scope for arbitrary and capricious agency behavior. In sum, a
taxonomy of reproductive treatments and biomedical research would increase both the
consistency and fairness of the rule-making process. 2
1
2
There are considerable similarities here between resolving classificatory ambiguity and the task faced by
common law judges (and the Supreme Court, for that matter) in determining exactly which precedents are
relevant to judicial case. We will return to this question in chapter 7.
Ethicists may find the approach proposed here reminiscent of casuistry. Cf. Carson Strong, Ethics in
Reproductive and Perinatal Medicine: A New Framework (New Haven, CT: Yale University Press, 1997).
Social scientists could point out that classificatory schemes have been at the center of heated debates in the
sociology of science for many years. See Barry Barnes, "On the Conventional Character of Knowledge and
Cognition," in Science Observed. Perspectives on the Social Study of Science, ed. Karin Knorr-Cetina and
Michael Mulkay (London: Sage Publications, 1983); Barry Barnes, David Bloor, and John Henry, Scientific
Knowledge: A Sociological Analysis (Chicago, IL: University of Chicago Press, 1996); David Bloor,
Wittgenstein, Rules and Institutions (London: Routledge, 1997); Harry M. Collins, Changing Order: Replication
and Induction in Scientific Practice (Chicago, IL: University of Chicago Press, 1992); Harry M. Collins and
Trevor Pinch, The Golem. What Everyone Should Know About Science (Cambridge, UK: Cambridge University
Press, 1993); Mary Douglas, Risk and Blame: Essays in Cultural Theory (London: Routledge, 1992).
76

4.2 Standard Reproductive Techniques
Standard reproductive treatments are the first type of reproductive treatment to be discussed
in this chapter. These are treatments that have been in use for many years, are quite familiar to
ART practitioners, and are part of the curriculum of any medical school. In addition, there is
widespread agreement among ART practitioners on how to perform these procedures, at least
with regard to their main steps. Standard reproductive procedures include IVF, gamete
intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), intrauterine insemination
with washed sperm (IUI), and intravaginal culture (fertilization of oocytes in an air-free plastic
capsule placed into the maternal vagina). 3 In this category, we also include well-established
procedures such as embryo and sperm cryopreservation and micromanipulations such as ICSI.
Strictly speaking, these are not reproductive treatments; they may be regarded as preliminary or
ancillary procedures performed prior to an actual reproductive treatment. ICSI, for example, is
not a reproductive procedure; it is often used to overcome male infertility, and may be performed
as part of an IVF cycle.
The constitutive attribute of standard reproductive procedures is their largely
uncontroversial nature. The ethical concerns raised by these procedures are limited mostly to the
health and safety risks for the mother and the child. 4 The child’s well-being and the health and
safety of the woman undergoing ART treatments are two of the guiding ethical principles
identified in chapter 3. It is not our intention to examine in great detail possible health and safety
risks associated with standard reproductive techniques, but a few observations are in order.
Thirty years after the first “test-tube” baby was born, it remains very difficult to reliably
quantify the health and safety risks associated with ART procedures. In the United States, a
robust system of health and safety monitoring for ART children does not exist. Implementation
costs, lack of government funding, excessive professional fragmentation in the medical
profession, and logistical difficulties all have contributed to exacerbating this problem. ART
practitioners, for example, follow a pregnancy only for the first three months – they do not
examine the newborn baby, nor do they conduct follow-up examinations. 5
In addition, a
meaningful comparison of children born through ART and naturally conceived children requires
a matched parental control group. In practice, this requirement can rarely be met, as couples
seeking ART services by definition are not representative of the general population. This means
3
4
5
Centers for Disease Control and Prevention, "Survey of Assisted Reproductive Technology: Embryo Laboratory
Procedures and Practices. Appendix G: Survey Summary Responses," (Atlanta, GA: 1999).
Mostly, but not exclusively. Case in point is the wish of an Australian woman to become pregnant with the
sperm of her deceased husband, a wish the Australian Supreme Court in 2005 granted her after an eight-year
legal battle. Similar cases have been reported in the United States and Britain.
Laura A. Schieve et al., "Assessment of Outcomes for Assisted Reproductive Technology: Overview of Issues
and the U.S. Experience in Establishing a Surveillance System," in Current Practices and Controversies in
Assisted Reproduction. Report of a Meeting On "Medical Ethical and Social Aspects of Assisted Reproduction" ,
September 17-21 2001, ed. Effy Vayena, Patrick Rowe, and David P. Griffin (Geneva, Switzerland: World
Health Organization, 2002), p.364-65.
77

that an investigator may not be able to ascertain with a high degree of confidence whether an
observed higher incidence of certain conditions among ART children is attributable to the ART
treatment itself, or whether the cause lies with the parents.
Partly motivated by the recommendations contained in “Reproduction and Responsibility,”
and partly triggered by studies reporting a significantly higher percentage of birth defects in
children born through IVF and ICSI, 6 the American Society for Reproductive Medicine (ASRM)
announced in 2003 that it was convening a panel of experts to thoroughly review the available
empirical evidence on the health and safety risks of ART treatments. The panel presented the
study’s main findings at the 2004 Annual Meeting of the American Society of Human Genetics
(ASHG). It identified more than 2,400 studies pertaining to the health and safety of ARTs,
selected 169 studies for further scrutiny, and ignored more than 2,000 studies that did not meet
the panel’s criteria for inclusion in the study. 7 Based on this evidence, the panel concluded that
there is no reason for concern, with a notable exception – they found “suggestive but not
conclusive evidence” that ART children may suffer from a higher incidence of two rare
disorders, Angelman and Beckwith-Wiedemann syndromes.
In theory at least, this review should have provided definitive answers to the question of
whether ART treatments expose ART children to elevated health and safety risks. Unfortunately,
definitive answers are not forthcoming. Although the study’s main conclusions have been
reported widely by the news media, as of this writing the report has not been made available to
the public, and it has not been published in a peer-reviewed journal. In addition, the experts
selected by the Genetics and Public Policy Institute to conduct the study represent the ART
industry itself; thus, the study in essence amounts to a self-evaluation. While this is not
necessarily a reason to dismiss the report’s findings, the self-evaluatory nature of this report does
cast some doubts on its credibility. In fairness, evaluative efforts often face a trade-off between
recruiting the best experts in a given field of inquiry and ensuring independence and credibility.
At the same time, the public release of this report certainly would have increased the credibility
of the panel’s findings.
As our report is focused on new reproductive technologies rather than on standard
reproductive treatments, we won’t delve into health and safety issues in great detail.
Conversations with reproductive endocrinologists have shown that the profession generally is
dismissive of any concerns about the health and safety of assisted reproductive technologies.
These same conversations also show that practitioners seem to be unaware of studies showing a
statistical relationship between ART treatments and increased health risks. For this reason, we
felt it important to include in this report several illustrations of elevated health and safety risks
associated with ART treatments, which are included in Appendix C. (Appendix C focuses
exclusively on IVF, which remains by far the most common standard ART treatment in the
6
7
Michèle Hansen et al., "The Risk of Major Birth Defects after Intracytoplasmic Sperm Injection and in Vitro
Fertilization," New England Journal of Medicine 346, no. 10 (2002).
Tracy Hampton, "Panel Reviews Health Effects Data for Assisted Reproductive Technologies," Journal of the
American Medical Association 292, no. 24 (2004).
78

United States. According to a 2002 CDC survey of ART success rates, IVF accounts for more
than 90 percent of all performed cycles involving fresh non-donor eggs.) 8
IVF safety has received considerable attention in the clinical literature, though mostly
abroad. Among the risks associated with IVF mentioned in the literature are birth defects, low
birth weight, neurological disorders, ectopic pregnancies, craniosynostosis, Beckwith-
Wiedemann syndrome, Angelman syndrome, and the cloacal-bladder exstrophy-epispadias
complex. Some of these risks are minute, while others are quite large. In most cases, however, it
should be remembered that these risks reflect statistical associations and not causal relationships.
Before turning our attention to innovative reproductive treatments, a few words about what
has become known as collaborative reproduction are in order. 9 Collaborative reproduction ranges
from fairly prosaic procedures, such as sperm donation, to medical interventions, such as oocyte
and embryo donation. In the United States, sperm donation is a well-established practice,
facilitated by numerous sperm banks. (Interestingly, no one seems to know just how many, even
though the FDA now requires sperm banks to be registered.) 10 From a public health perspective,
this practice is by no means unproblematic. In the late 1990s, the need to prevent the spread of
infectious diseases prompted the FDA to regulate the trade of human tissues, including sperm,
oocyte, and embryo donation. 11
Sperm donation does raise some important ethical questions that go beyond considerations
of safety and efficacy. There remains considerable skepticism about the wisdom of tolerating a
free market for sperm. Much more controversial and problematic from an ethical standpoint are
oocyte and embryo donation. Collaborative reproduction involving oocytes is far less common
than anonymous sperm donation, partly because retrieving oocytes is a costly and painful
medical procedure, but also because oocytes are far more difficult to preserve, though as we
show below, cryopreservation technologies are making progress. The use of third-party embryos
remains very uncommon, in large measure because a full-fledged market for embryos seems to
many to be a very problematic proposition. Not coincidentally, only approximately two percent
of cryopreserved embryos have been put up for adoption – less than number of embryos donated
for research. 12
In some extreme cases, four individuals may be involved in the reproductive process: the
prospective legal parents and the oocyte and the sperm donor. A surrogate mother may also
8
9
10
11
12
Centers for Disease Control and Prevention, "2002 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," (Atlanta, GA: National Center for Chronic Disease Prevention and
Health Promotion, Division of Reproductive Health, 2004).
Helen M. Alvare, "The Case for Regulating Collaborative Reproduction: A Children's Rights Perspective,"
Harvard Journal on Legislation 40 (2003); Kenneth Baum, "Golden Eggs: Towards the Rational Regulation of
Oocyte Donation," Brigham Young University Law Review (2001).
Note that “donation” in this context should not be interpreted literally. Sperm donation in the United States is a
lucrative business and an industry, complete with its own trade association.
The FDA has promulgated three main new rules: the “establishment registration and listing” rule, the “donor
eligibility” rule, and the “good tissue practice” rule. See chapter 5.1.2 for details.
William Saletan, Leave No Embryo Behind (June 3, 2005 [cited March 14, 2006]).
79

ecome part of this complex transaction, raising the total number of individuals involved to five.
These contractual arrangements raise numerous legal questions, for which few if any legally
binding answers have been provided. For example, how should the rights and obligations of
prospective parents vis-à-vis a surrogate mother be defined? Should the anonymity of the sperm
and oocyte donors enjoy unqualified protection? What rules, if any, should apply to embryo
adoption? As this brief discussion demonstrates, collaborative reproduction may raise a host of
difficult ethical questions. These are not new questions for the most part, and they are issues that
have been debated frequently by bioethicists and legal scholars, though as is often the case, there
has been very little consensus. In this report, we discuss these questions only tangentially, mainly
in the chapter 7.
4.3 Innovative Reproductive Treatments
The term “innovative reproductive treatment” identifies any procedure performed by a
reproductive endocrinologist designed to induce a pregnancy. While the aim of standard and
innovative reproductive treatments remains the same – namely, achieving a pregnancy –
innovative reproductive treatments differ significantly from the standard reproductive procedures
discussed in the preceding section: The nature and the magnitude of the health and safety risks
involved differ significantly. When performing an innovative reproductive treatment, an ART
practitioner is very unlikely to know the precise nature of the risks to the mother and the baby.
To the extent that the nature of the risks involved is familiar, very little is known about statistical
probabilities. This is in marked contrast to standard reproductive procedures, where the nature of
the risks involved is usually well-known and the magnitude of the risks is also familiar, though
not always with a high degree of accuracy. This situation reflects a simple fact: While standard
reproductive procedures have been the subject of numerous epidemiological studies, innovative
reproductive treatments, by their nature, are performed largely without the benefit of clinical
information.
The innovative reproductive treatments discussed below raise more than just health and
safety concerns. These concerns range from the allegation that ART practitioners, for all intents
and purposes, are experimenting on human subjects, unconstrained by the usual regulatory
checks, to the view that children should not have more than two genetic parents, or that children
should not be created from unborn mothers. Whatever the nature of the specific ethical concern
raised in each case, innovative reproductive treatments can easily be distinguished from standard
reproductive procedures precisely because they are very likely to raise significant ethical
concerns.
Unlike standard reproductive procedures, innovative reproductive treatments tend to be
poorly documented and often are not familiar to ART practitioners. This is not entirely
surprising, as these treatments generally are attempted only when the usual standard techniques
have been tried and have failed. The controversial nature of innovative reproductive treatments
may also induce some ART practitioners to avoid publicity. When information about a novel
80

treatment surfaces, it is usually an indication that the treatment has been performed with some
success, as has been the case for ooplasm transfer. 13
The cases discussed below were gleaned from the news media or obtained from targeted
bibliographic searches. Not coincidentally, despite our best efforts, we have not been able to
obtain first-hand information about these treatments from industry representatives. The following
discussion is intended to provide a sense of what constitutes an innovative reproductive
procedure, and what ethical concerns these procedures might raise. How policy-makers should
respond to these challenges is the topic of chapter 11.
4.3.1 Tinkering with Biological Parenthood
Over the last few years, several reproductive technologies have been developed to address
specific forms of infertility or to prevent passing on genetic diseases. These novel treatments
have two attributes in common: The children so conceived have three genetic parents, and the
treatments produce inheritable genetic modifications, though they are not instances of human
genetic engineering in the narrow sense of this term. 14
These treatments include ooplasm
transfer, a technique developed in the early 1990s, and various forms of reproduction by nuclear
transfer. (The term “reproduction by nuclear transfer” is ours. Surprisingly, these techniques
have not been associated with a specific medical term – another indication perhaps of their
experimental nature.)
Reproductive specialists developed ooplasm transfer in an effort to remedy a form of
infertility attributable to shortcomings in the cytoplasm of the egg. In this procedure, the egg is
fertilized as in any other IVF cycle, but before it is transferred back to the uterus, its cytoplasm is
replaced with the cytoplasm of a younger, healthy egg. According to news stories, the technique
has been quite successful. 15 Worldwide, at least 30 women have become pregnant through
ooplasm transfer. However, in July of 2001, the FDA effectively banned this procedure by
declaring ooplasm transfer as a “clinical investigation.” Conducting a clinical investigation
requires the submission of an investigational new drug (IND) application, a requirement that has
since discouraged ART practitioners from performing this experimental medical procedure. 16
13
14
15
16
Jason A. Barritt et al., "Mitochondria in Human Offspring Derived from Ooplasmic Transplantation," Human
Reproduction 16, no. 3 (2001).
Erik Parens and Eric Juengst, "Inadvertently Crossing the Germ Line," Science 292, no. 5516 (2001).
Leila Abboud, "FDA Seeks Rigorous Review of New Fertility Treatment," Wall Street Journal, October 7, 2002;
Gina Kolata, "Babies Born in Experiment Have Genes from Three People," New York Times, May 5, 2001;
Helen Pearson, Egg Injection Boosts Fertility – New Mitochondria May Pep up Ageing Eggs, without Creating
'Three-Parent' Babies (news@nature.com, October 20, 2004 [cited April 26, 2006]); available from
http://www.nature.com/news/2004/041018/full/041018-10.html; Treatment for Infertile Women Yields Babies
with Three Sets of Genes (Kaiser Family Foundation, May 7, 2001 [cited August 2, 2005]); available from
http://report.kff.org/archive/repro/2001/5/kr010507.11.htm.
See the letter to sponsors and researchers, available at http://www.fda.gov/cber/ltr/cytotrans070601.htm. How
the FDA managed to prohibit ooplasm transfer provides an illustration of the limits imposed by the current
statutory framework on this agency. The FDA does not have jurisdiction over surgical and medical procedures,
and it is therefore not entirely clear whether its authority extends to the field of reproductive medicine in general,
81

These concerns are not unfounded, as two embryos created by this technique but later aborted
had Turner Syndrome. 17
The same FDA requirements apply to a form of nuclear transfer developed at a New York
City hospital in the early 1990s. In this case, cytoplasm is not merely replaced. Researchers
fertilize not one but two eggs, one from the prospective mother, and one from an anonymous
donor. The nucleus from the donated egg is then removed and replaced with the nucleus from the
prospective mother’s egg. In an effort to circumvent FDA regulations, a leading U.S. scientist in
2001 decided to outsource the procedure to colleagues in China. The Chinese researchers
transferred two embryos. The procedure was successful, but the fetuses died at weeks 24 and 29,
respectively, due to complications apparently unrelated to the technique used in the experiment. 18
Had a child been born with this technique, he or she would have had genetic material not from
two, but from three individuals – his or her genetic parents as well from the egg donor. This is so
because the cytoplasm of the donor egg (or any other cell) contains mitochondrial DNA. 19
Slightly different concerns are raised by a very similar procedure recently proposed by
British scientists. 20 In this case, only one embryo is created, from the gametes of the two
prospective parents. To avoid health risks associated with the egg’s mitochondria, the nucleus is
removed and inserted in a healthy egg from an anonymous donor. Unlike the preceding
procedure, this technique is meant to benefit both the parents and the child, who otherwise might
have been born with degenerative genetic diseases. 21 These children would also carry genetic
material from three persons.
All of these procedures raise ethical concerns above and beyond health and safety
considerations. A reproductive procedure that creates babies carrying DNA from three
individuals – and therefore with three genetic parents – is problematic enough to preclude its
wide adoption based exclusively on effectiveness. Scientists have pointed out that the amount of
17
18
19
20
21
and to ooplasm transfer in particular. Be that as it may, until ART professionals successfully challenge the FDA
in court, for all intents and purposes, ooplasm transfer cannot be performed in the United States.
Ooplasm Transfer as Method to Treat Female Infertility (FDA’s Biological Response Modifiers Advisory
Committee Meeting, May 9, 2002 [cited August 2, 2005]); available from
http://www.fda.gov/OHRMS/DOCKETS/ac/02/briefing/3855B1_01.pdf
Shaoni Bhattacharya and Sylvia Pagàn Westphal, Controversial Three-Parent Pregnancy Revealed (New
Scientist, October 14, 2003 [cited August 2, 2005]); available from
http://www.newscientist.com/article.ns?id=dn4266 ; David Derbyshire, Foetuses Had Three Genetic Parents
(Telegraph Group, October 13, 2003 [cited August 2, 2005]); Denise Grady, "Where Anti-Clone Collides with
Pro-Baby," International Herald Tribune, October 15, 2003; Steve Kirschner, "The Ooplasm Transfer Debate,"
Genomics and Proteomics, November 1, 2002; Rick Weiss, "U.S.-Banned Fertility Method Tried in China:
Woman Became Pregnant through Egg Transfer Technique but Lost All Three Fetuses," Washington Post,
October 14, 2003.
Mitochondria can be described as a cell’s energy source.
James Randerson, Scientists Seek to Create 'Three-Parent' Babies (New Scientist, October 19, 2004, 2004 [cited
August 2, 2005]); available from http://www.newscientist.com/article.ns?id=dn6547; Ian Sample, "Can a Baby
Have Two Mothers?," The Guardian, October 21, 2004.
For an extensive discussion of ooplasm transfer for therapeutic uses, see John A. Robertson, "Oocyte Cytoplasm
Transfer and the Ethics of Germ-Line Intervention," Journal of Law, Medicine & Ethics 26 (1998).
82

inherited foreign DNA is minuscule, and it is therefore a gross exaggeration to claim that a child
has three genetic parents. In our view, the fact that these children receive only approximately 35
genes from a third party is largely irrelevant. What is disturbing is that these reproductive
treatments undermine a fundamental biological principle – namely that every human being has a
biological mother and father. At stake in this case is not only the health of these children, but
also their well-being and the impact that having three genetic parents may have on their
psychological development and on the development of their identities.
Whether the implications of departing from this principle are serious enough to justify a ban
remains to be seen. What is clear is that this question should not be settled by ART practitioners
and patients, nor should it be decided simply in instrumental terms or portrayed as a purely
private choice removed from public scrutiny. 22 Its resolution entails making a choice among
competing goods, a choice that should be made at the legislative or more likely at the regulatory
level, and not delegated to a profession and its clients. The fact that the U.S. scientist who
developed one of these techniques decided to circumvent FDA regulations by conducting the
experiment in China only underscores the need for a broader involvement of governmental
authorities.
4.3.2 Oocyte Cryopreservation (Freezing of Human Eggs)
For a variety of reasons, including the large size of eggs, freezing human oocytes is
considerably more difficult than cryopreserving sperm or embryos. According to ART
practitioners, only approximately 100 women to date have become pregnant using a thawed egg.
The procedure is universally considered experimental. Its success rate compared to standard
reproductive techniques is low, approximately 15 percent, though researchers are hard at work to
improve it. 23 The main rationale for developing this technology is therapeutic: Freezing eggs
could help certain patients, especially young women, preserve their fertility despite devastating
conditions or treatments with damaging side effects such as radiation therapy. 24
Because of the experimental nature of oocyte cryopreservation, the procedure’s health and
safety risks to women and their offspring are largely unknown. What makes oocyte
22
23
24
This approach usually translates into an excessive preoccupation for informed consent, to the detriment of any
other considerations. See for example Andrea Bonnicksen, "Innovative ARTs and Informed Consent,"
(Gaithersburg, MD: FDA’s Biological Response Modifiers Advisory Committee Meeting, 2002).
Sarah Boseley, "Frozen Egg Baby Hailed as Fertility Milestone," The Guardian, October 11, 2002; First Frozen
Egg Babies to Be Born in May (Xinhuanet (Xinhua News Agency), March 30, 2004 [cited August 2, 2005]);
available from http://news.xinhuanet.com/english/2004-03/30/content_1391270.htm; Christina Ianzito, "Putting
Your Eggs in a Different Basket," The Washington Post, September 21, 2004; Jeremy Laurance, "Italian Births
Raise Hopes for Egg-Freezing Treatment," The Independent, September 15, 2004; Linda Marsa, "Frozen Eggs
Yield Promising Results," Los Angeles Times, September 20, 2004; Helen Pearson, "Infertility Specialists
Counsel Caution over Frozen Eggs – Reproduction Techniques Not Ready for Prime Time," Nature 431, no.
7011 (2004); Shari Roan, "Fertility in Reserve," Los Angeles Times, February 2, 2003; Sally Wadyka, "For
Women Worried About Fertility, Egg Bank Is a New Option," New York Times, September 21, 2004.
On the state of this technology, see Brandon Bankowski et al., "The Social Implications of Embryo
Cryopreservation," Fertility and Sterility 84, no. 4 (2005), p.829-30.
83

cryopreservation a good example of an innovative reproductive procedure, however, is its
unclear but potentially far-reaching societal impact. Oocyte cryopreservation is beginning to
transform itself from a purely therapeutic procedure to an elective one. ART practitioners, while
cautioning that this technology is still very much under development, are already considering the
possibility that egg freezing could also be an attractive solution for professional women trying to
reconcile career goals and the desire for a family. Not surprisingly, some entrepreneurs have
already caught on and started offering egg cryopreservation as a commercial service. 25
It is easy to anticipate at least a few of the consequences that the broad availability of this
reproductive option might have on society. 26 Over time, egg cryopreservation may lead to a
reduction in the number of frozen embryos. While many would welcome this development, its
impact may not be unambiguously positive. For example, the availability of cryopreserved
embryos for research is likely to diminish. The exact number of cryopreserved embryos currently
donated for research is unknown, but it is likely very few. Further reducing this limited pool of
available embryos might undermine the delicate political compromise negotiated in many
industrialized countries on stem cell research, and may also induce scientists to advocate a much
more liberal (and much more controversial) policy for deriving new stem cell lines.
Egg cryopreservation would also stimulate the emergence of a whole new and very lucrative
industry devoted to the retrieval, storage, and sale of human oocytes. This is certainly not a
development that many would welcome. The free trade of oocytes could expose women –
especially young, poor, or uneducated women – to significant risks. But perhaps the most
troubling and the least discussed consequence of making oocyte cryopreservation widely
available is precisely what is currently being touted as one of its main benefits – the woman’s
ability to choose the precise time of procreation. 27 What to well-educated and ambitious women
understandably appears to be a very attractive option could have several less desirable
consequences. For example, the average parental age would likely increase, perhaps dramatically
so. Whether having older parents would be detrimental to a child’s development is unclear, and
we are not suggesting that is necessarily so, but it is certainly a question worth pondering.
Delayed reproduction may also turn into less reproduction or no reproduction at all. A
successful professional career may dissuade many women from considering motherhood at a
later age. Some may argue that if this development makes it easier for women to pursue a
professional career, it should be a reason for celebration, not a possible cause for concern. Others
may disagree. Also worth pondering is whether oocyte cryopreservation might further weaken
25
26
27
For example, on its Web site, the Fertility Institutes in California aggressively promotes their “frozen donor egg
bank.” See http://www.fertility-docs.com/egg_freezing_right.phtml.
For a fuller discussion, see Baum, "Golden Eggs: Towards the Rational Regulation of Oocyte Donation";
Margaret Jane Radin, "Market-Inalienability," Harvard Law Review 100 (1987).
Not everyone agrees. See John A. Robertson, "Technology and Motherhood: Legal and Ethical Issues in Human
Egg Donation," Case Western Reserve Law Review 39 (1989).
84

the institution of the family, as increased individual autonomy may make it more difficult for
prospective parents to reach a consensus on when to have a baby. 28
That egg cryopreservation is rapidly becoming a matter of public concern is demonstrated
by the interest that the American Society for Reproductive Medicine has taken in this issue. In a
recently published report titled “Ovarian Tissue and Oocyte Cryopreservation,” the ASRM
discusses whether egg freezing should serve exclusively therapeutic purposes, or whether it
should also be recommended as a means to defer procreation. The report concludes that oocyte
cryopreservation should be offered exclusively for therapeutic reasons, 29 based exclusively on
health and safety considerations. The ASRM does not explore the potential broader societal
implications of widespread adoption of this technology – in our view, one more reason to
broaden the debate on new reproductive technologies.
4.3.3 Co-Culture
The FDA considers co-culture an instance of xenotransplantation. 30 In co-culture, human
embryos come into contact with animal cells outside the human body. In FDA terminology, the
recipient of an embryo cultivated on non-human tissues is therefore the recipient of a
xenotransplantation “product.” As a laboratory technique, co-culture is not new. According to
news reports, fertility clinics started offering co-culture to select patients as early as 1989. The
technique is actually older than that. It was developed in the 1960s and tested on mice and rats,
but never on humans before it was offered as a reproductive service.
Co-culture meets all the requirements of an innovative reproductive procedure. It only came
to regulators’ attention in 2002, although it has been around for much longer. 31
It is not
commonly used and it is certainly not considered a standard reproductive procedure by the CDC
or by ART professionals. To our knowledge, the long-term health and safety impact of this
technology on children has never been studied. Clearly, co-culture is likely to meet with
considerable resistance both on safety and ethical grounds.
28
29
30
31
Some may argue that this argument is discriminatory, as men, for all intents and purposes, already have the
ability to delay reproductive choices. However, this argument is not entirely convincing, as men’s ability to
procreate well into old age is not the result of any medical progress.
Practice Committee of the American Society for Reproductive Medicine, "Ovarian Tissue and Oocyte
Cryopreservation," Fertility and Sterility 82, no. 4 (2004).
See http://www.fda.gov/cber/infosheets/humembclin.htm.
Medical researchers have been experimenting with co-culture as a means to improve ART success rates for quite
some time, but it appears that they have done so mostly on animal models. See H.L Feng et al., "Fertilization and
Early Embryology: Effect of Different Co-Culture Systems in Early Human Embryo Development," Human
Reproduction 11 (1996); F.S. Nietro et al., "The Effects of Cocolture with Autologous Cryopreserved
Endometrial Cells on Human in Vitro Fertilization and Early Embryo Morphology: A Randomized Study,"
Journal of Assisted Reproduction and Genetics 13 (1996); J. Thibodeaux and R. Godke, "In Vitro Enhancement
of Early Stage Embryos with Coculture," Archives of Pathology and Laboratory Medicine 116 (1992); K.E.
Wiemer et al., "Embryonic Morphology and Rate of Implantation of Human Embryos Following Coculture on
Bovine Oviductal Epethelial Cells," Human Reproduction 8 (1993).
85

A 2003 news story published in Popular Science magazine describes in some detail the
motivation for performing this procedure, and the procedure itself. 32 The technique is used to
cure particularly difficult cases of infertility. In this case, the wife’s reproductive organs were
severely dysfunctional, and her immune system had rejected her husband’s sperm. In addition,
the husband’s sperm count was very low and of poor quality. After traditional reproductive
treatments failed to result in pregnancy, the couple was persuaded to try co-culture. The
woman’s eggs were retrieved, fertilized in vitro, and grown for several days on tissue obtained
from a cow uterus. The embryos were then transferred back into the woman’s uterus. The
technique was quite successful. The couple now has three children, all of them conceived
through co-culture.
The story provides an excellent illustration of both parental desperation and of the risky
choices parents and their doctors are willing to make. According to the news story the couple is
not apologetic for trying a largely untested technique. Asked whether he was concerned about
possible long-term effects on his children the father replied:
Is there a possibility of long-term effects? Yeah, there is. And that worries us. But even if we’d
found the kids would be at higher risk, we would have still done it all. 33
As this quote illustrates, there seems to be some justification to the view that parents do not
necessarily or always have the best interest of their offspring at heart. More generally, our
discussion of co-culture suggests that innovative reproductive treatments should not be
performed on a routine basis until safety and ethical concerns have not properly been addressed.
To this end, it is necessary to broaden the debate about the future of reproductive technologies
beyond the narrow circle of ART practitioners and patient groups.
4.3.4 Other Experiments
That some reproductive endocrinologists and scientists are willing to push the ethical
envelope is illustrated by the following two instances of (failed) innovative reproductive
treatments. In the first case, a group of Israeli scientists demonstrated that oocytes retrieved from
aborted fetuses can be fertilized and may be viable. In the second case, a U.S. researcher created
a chimeric human embryo by adding cells from a male embryo to a female human embryo.
Oocytes grown from aborted fetuses – to our knowledge – have not actually been used in a
clinical setting. Had the fertilized eggs in the aforementioned case been transferred to a woman’s
uterus, a child might have been conceived by an unborn mother – a very problematic proposition
at best, and an utterly unacceptable procedure at worst. As for other innovative treatments, there
is a perfectly plausible, if purely instrumental, reason for developing this procedure. The Israeli
scientists argued that aborted fetuses are a precious source of human tissue, and that retrieving
oocytes from these fetuses would circumvent many of the ethical problems normally associated
with the retrieval of human oocytes from adult females. That this argument is incomplete goes
32
33
Rebecca Skloot, "Sally Has 2 Mommies and 1 Daddy," Popular Science, March 1, 2003.
Ibid.
86

almost without saying. Children born through this procedure could suffer severe psychological
harm, as a crucial aspect of their personal identity – a biological mother – would be missing.
Interestingly, the scientists in question were not prepared to re-examine the rationale for
conducting this line of research despite the outcry that the experiment generated among their
peers. 34 They simply acknowledged the strong negative reactions their experiment produced,
noting that “probably, in some places, it will be ethically acceptable.” 35
Another case of an innovative reproductive treatment that met with considerable resistance
from the ART community was the announcement by a U.S. researcher that he had added cells
from a male embryo to a female embryo, thus creating a chimeric human embryo. 36 The creation
of chimeras is nothing new in biology, but this appeared to be the first documented case of a
researcher actually creating and growing, albeit for only a few days, a human chimera.
The justification offered by the researcher for creating the chimeric human embryo was
rather nebulous. The experiment was designed to test an innovative therapy to cure severe
combined immunodeficiency (SCID), also known as “bubble boy disease.” By adding healthy
embryo cells to a diseased embryo, the resulting baby is likely to acquire healthy cells that might
be able to fight the disease. This, at least, was the hope expressed by the researcher in this case.
The scientist decided to add male embryo cells to a female embryo because male embryo cells
are easier to track. The researcher was hoping that the male embryo cells would distribute
homogeneously over the female embryos, which apparently they did. In this narrow, sense the
experiment was successful.
The sharply negative reaction the announcement of this experiment produced is both a
testimony to a shared sense of professional responsibility among the members of the ART
community and a demonstration of the limits of professional self-regulation. Many of the
researcher’s colleagues questioned the scientific rationale for conducting this experiment. They
also emphasized the damage that the announcement of this experiment might cause to the
reputation of the entire ART industry.
Some may interpret these statements as an illustration of reputational incentives at work. 37
In a narrow sense, this is true, but it would be misleading to draw broad lessons from this
34
35
36
37
Shaoni Bhattacharya, Aborted Fetuses Could Become 'Unborn Mothers' (New Scientist, July 1, 2003 [cited
August 2, 2005]); available from http://www.newscientist.com/news/news.jsp?id=ns99993889; Ian Sample,
"Prospect of Babies from Unborn Mothers," The Guardian, July 1, 2003; Jeevan Vasagar, "Use of Foetal Eggs
Grotesque, Say Campaigners," The Guardian, July 2, 2003.
Bhattacharya, Aborted Fetuses Could Become 'Unborn Mothers' ([cited).
Shaoni Bhattacharya, 'She-Male' Embryos Created in Lab (New Scientist, July 3, 2003 [cited April 26, 2006]);
available from http://www.newscientist.com/news/news.jsp?id=ns99993905; Steve Connor, "Scientists Outraged
over Fusion of Male and Female Embryos Condemn Attempt to Combine Male and Female Cells," The
Independent, July 3, 2003; Emma Ross, "European Group Denounces Chimera Embryo," Associated Press, July
2, 2003; Ian Sample, "Scientists Hit out at Creator of 'She-Males'," The Guardian, July 3, 2003.
See, for example, David Charny, "Nonlegal Sanctions in Commercial Relationships," Harvard Law Review 104
(1990); Ronald J. Mann, "Verification Institutions in Financial Transactons," Georgetown Law Journal 87
(1999); Eric A. Posner, "The Regulation of Groups: The Influence of Legal and Nonlegal Sanctions on
Collective Action," University of Chicago Law Review 63 (1996).
87

episode. Reputational incentives are an effective sanctioning mechanism only when highly
visible controversies erupt. As mentioned earlier, innovative reproductive treatments generally
are conducted discreetly; the news media, regulators, and the public learn about these
experiments only sporadically, and sometimes not at all. In this sense, the role of reputational
incentives as an effective sanctioning mechanism must be regarded as quite limited.
4.4 Reproductive Customization Technologies
While the reproductive technologies discussed so far were initially developed exclusively
for therapeutic reasons, in this section we turn to ART treatments that are not designed to treat a
physiological condition, though they do have some specific medical applications. The primary
use of these reproductive technologies is simply the accommodation of parental wishes of one
kind or another. In this sense, these are reproductive customization technologies rather than
reproductive treatments, in the narrow sense of this term. They are intended to provide
prospective parents with the means to exercise control over the reproductive process rather than
simply to help them conceive.
With this type of technology, we enter into one of the most controversial areas of
reproductive medicine. Unlike innovative reproductive treatments – where the technical means
may be controversial but the goal served (procreation) remains the same – in the present case we
are dealing with technologies that are beginning to redefine the very meaning and nature of
procreation. They do so not in a dramatic or spectacular way, to be sure. Some uses of these
technologies, considered in isolation, could even be described as prosaic. From a pragmatic
perspective, it is difficult to quarrel with a mother who, after having three boys, wishes to have a
girl. But, as is so often the case in the field of artificial reproduction, things are not quite so
simple. Many people feel uncomfortable with suggestions that conception could be customized,
though they may not be able to articulate the precise reasons for their discomfort. Others, fearing
the degradation of human reproduction to a commercial transaction, will find any technology of
customization altogether unacceptable. Still others take the opposite stance, advocating freedom
of choice in matters considered purely private. 38
An obvious example of the non-therapeutic use of a reproductive technology is elective sex
selection. Currently, two options exist to choose the sex of a child – pre-implantation genetic
diagnosis and MicroSort ® . While MicroSort is still being tested, PGD is already available.
Reliable data is hard to come by, but according to industry insiders, PGD is rapidly gaining
popularity as a sex-selection technology. Another example of a reproductive technology’s nontherapeutic
use is genetic engineering, i.e., germ-line genetic modification. Human genetic
engineering, just a few years ago derided by many scientists as en entirely speculative and utterly
irrelevant scenario, is becoming a reality much more rapidly than was initially anticipated, as a
38
In this regard, some of the ethical principles introduced in chapter 3 – such as privileging therapeutic over
enhancing uses of reproductive technologies and protecting the health and well-being of children, but also
promoting access to reproductive technologies – may be able to structure these controversies.
88

ecent review of the scientific literature conducted by the Johns Hopkins University Genetics and
Public Policy Center indicates. 39
The notion of reproductive customization raises the question of whether it is actually
possible to accurately distinguish between therapeutic and enhancing uses of reproductive
technologies. Professional bioethicists have often criticized this distinction has being
conceptually weak and incapable of resolving most ethical dilemmas. Technically, these
criticisms may be correct, but it would be utterly misleading to conclude that ambiguous
conceptual categories should play no role in public debates and in policy-making. Were all
categorical ambiguities to be banned from public discourse, it would no longer be possible to
pass laws or craft policies. As the human growth hormone case discussed in chapter 2 has shown,
even two seemingly straightforward categories like safety and efficacy are not free of
ambiguities. This has not prevented the FDA from routinely using safety and efficacy as its main
guiding principles in rule-making.
Against this background, whether a general audience finds the distinction between
therapeutic and enhancing applications of reproductive technologies useful is a question of some
import. Two surveys, one conducted in the United States and the other in Germany, shed some
light on this issue. The Genetics and Public Policy Center has conducted extensive research on
public attitudes toward new reproductive and genetic technologies in the United States. In 2002,
it surveyed the awareness of 1,211 Americans ages 18 and older about genetic technology. Of
particular interest to our discussion is the following question:
Would you approve or disapprove if parents were
offered a way to use pre-implantation genetic diagnosis
to:
(a) make sure their baby does NOT have a serious
genetic disease?
(b) make sure their baby would be a good match to
donate his or her blood or tissue to a brother or sister
who is sick and in need of a transplant?
(c) make sure their baby does NOT have a tendency to
develop a disease like cancer when he or she is an
adult?
Approve Disapprove Don’t Know Refused to
Answer
74 22 4 *
69 25 5 1
60 33 6 *
(d) choose the sex of their child? 28 68 4 *
39
Germ-line genetic modification is possible in laboratory animals, and some techniques could be adapted for use
in humans, although none have been tried. Scientists are able to replace a faulty gene with a “normal” copy in
mouse embryonic stem cells, and then introduce those stem cells into an early mouse embryo, where they can
give rise to genetically modified sperm or eggs. The next generation of mice that results from the modified
sperm or eggs contains the “normal” copy of the gene. It is now possible to replace a gene in human embryonic
stem cells, overcoming a huge obstacle to human germ-line genetic modification. In addition, scientists have
been able to derive genetically modified sperm directly from mouse stem cells. Together, these developments
suggest that human germ-line genetic modification may not be as far off as we thought even five years ago. Cf.
Baruch et al., "Human Germline Genetic Modification: Issues and Options for Policymakers," p.5.
89

Would you approve or disapprove if parents were
offered a way to use pre-implantation genetic diagnosis
to:
(e) make sure their baby has desirable characteristics,
such as high intelligence and strength?
Approve Disapprove Don’t Know Refused to
Answer
22 72 5 *
Table 1: Attitudes toward various uses of pre-implantation genetic diagnosis. 40
As this table demonstrates, U.S. respondents seem to make a clear distinction between
therapeutic uses of PGD (questions a, b, and c) and reproductive customization (questions d and
e). A two-thirds to three-quarter majority supports therapeutic uses, while a very similar
proportion rejects customization. Similar results emerged from a survey recently conducted in
Germany. The detailed results have not yet been published, but a summary is available. 41
Researchers interviewed 416 former East Germans and 1,694 former West Germans ages 18 to
50 in late 2003. Of all respondents, 76 percent favored legalizing therapeutic uses of PGD, such
as screening for genetic diseases, a procedure that is banned in Germany. Only 20 percent of
respondents favored maintaining a strict ban on any use of PGD. It is noteworthy that the
proportion of respondents supporting legalizing therapeutic uses of PGD is very similar to the
proportion of U.S. respondents who favor the use of PGD for the same therapeutic purposes. In
sum, its conceptual ambiguities notwithstanding, the distinction between therapeutic and
enhancing uses of PGD (and of genetic engineering more broadly) provides a useful framework
for structuring public debates on the acceptable uses of this technology.
In the next two sections, we discuss some of the ethical concerns that technologies of
customization could raise. The technologies in question are MicroSort, a technique specifically
designed to select the sex of a child, and pre-implantation genetic diagnosis for non-therapeutic
reasons.
4.4.1 Technologies of Sex-Selection: MicroSort
MicroSort is a technology designed to select the sex of embryos. Male and female embryos
come in slightly different sizes, a difference that MicroSort depends on to separate them.
According to the technology’s developer, the Genetics & IVF Institute located in Fairfax,
Virginia, MicroSort has a success rate of 91 percent for female and 76 percent for male
embryos. 42 The Genetics & IVF Institute is currently in the process of conducting an FDAapproved
clinical trial. When the FDA will approve MicroSort is unclear.
40
41
42
Genetics and Public Policy Center, "Public Awareness and Attitudes About Genetic Technology," (Washington,
D.C.: Johns Hopkins University, 2002), p.7.
Ada Borkenhagen et al., "Was Denken Die Deutsche Bevölkerung Und Kinderwunschpaare Über Die PID? Eine
Vergleichende Studie," (Fertility Center Berlin, DRK-Clinics Westend, Leipzig University, Department of
Medical Psychology and Medical Sociology, 2004).
See http://www.microsort.com/. See also Joseph G. Schenker, "Gender Selection: Cultural and Religious
Perspectives," Journal of Assisted Reproduction and Genetics 19, no. 9 (2002), p.403.
90

Aware of the controversial nature of this technology, the institute currently offers its
services only for the purpose of “family balance.” This term identifies families that, after having
several children of one sex, desire to have a baby of the opposite sex. According to the institute,
the demand for sex-selection services is very strong and is by no means limited to families
seeking “balance.” This suggests that the market for this technology is much larger than the
demand for family balance indicates, though it is unclear just how large this market might be. It
is certainly large enough to make investors in the Genetics & IVF Institute very rich. For this
reason, it is very unlikely that the institute will continue offering its services exclusively for the
purpose of family balance once it receives FDA approval for this sex-selection technology. The
FDA, for its part, has no authority to limit the use of MicroSort if it has deemed the technology
both safe and effective.
Should anyone be concerned about the widespread use of sex-selection technologies such as
MicroSort? Providing a definitive answer to this question is surprisingly difficult. Some
commentators have pointed out that in countries where sex-selection technologies (of any kind)
have been available for some time, male and female birth ratios have experienced dramatic
distortions. In Korea, Taiwan, China, and India, for example, patriarchal values and perverse
economic incentives have produced strong familial preferences for boys; female infanticide has
often been the result. In more recent times, the increasing availability of medical technologies
such as ultrasound imaging and amniocentesis has produced an astounding number of selective
abortions, shifting birth ratios from a normal 102-103 boys to 100 girls to 120 boys for 100 girls
and higher. The consequences are predictable – pervasive scarcity of females and an associated
increase in social unrest and crime attributable to a growing population of young, unattached
males. 43
One may argue that Western industrialized countries are very unlikely to face this problem.
The empirical evidence in this regard is mixed. A handful of European surveys have consistently
shown that the sex of the first-born child is largely a matter of indifference. In Germany, only 14
percent of respondents have a clear preference for a boy, 10 percent for a girl, and 76 percent of
respondents claims to be indifferent. 44 Similar results were obtained in the United Kingdom,
where 12 percent of respondents would prefer a boy as their first-born child, and 19 percent a
girl, the rest being indifferent. 45 On the other end, a survey of 17 European countries found a
43
44
45
M. Ansari-Lari and M. Saadat, "Changing Sex Ratios in Iran 1976-2000," Journal of Epidemiology and
Community Health 56 (2002); Cecilia L. W. Chan et al., "Gender Selection in China: Its Meanings and
Implications," Journal of Assisted Reproduction and Genetics 19, no. 9 (2002); Elizabeth Hervey Stephen,
"Demographic Implications of Reproductive Technologies," Population Research and Policy Review 19, no. 4
(2000).
E. Dahl et al., "Preconception Sex Selection for Non-Medical Reasons: A Representative Survey from
Germany," Human Reproduction 18, no. 10 (2003).
H. Statham et al., "Choice of Baby's Sex," Lancet 341, no. 8844 (1993).
91

strong preference for a mixed family, 46 suggesting that there may indeed be a significant demand
for sex-selection services, at least for the purpose of “family balancing.”
Policy preferences seem consistent with general attitudes. A recently released consultative
report on sex selection prepared by the British HFEA shows that 82 percent disagreed with the
statement “The use of sperm sorting should be permitted in sex selection for non-medical
reasons.” 47
Even sex selection for the purpose of “family balancing” did not gather much
sympathy – 82 percent again rejected this option. 48 Similar results were obtained by a much more
rigorous survey conducted in Germany, 49 where 92 percent of respondents were not interested in
using sperm-sorting technology to select the sex of a child. Postulating that the sex-selection
process could be carried out in a much more straightforward way did not change this pattern. 50
The data for the United States is somewhat more ambiguous. A study conducted in the early
1990s, along with a 2002 survey, suggests that the preference for a male first child in the United
States is much higher than in Europe, ranging between 58 percent for men and 40 percent for
women. 51 The 2002 study puts the proportion of respondents that would be willing to use sexselection
technologies, if available, at 21 percent. Of this 21 percent, men would overwhelmingly
prefer a boy (75 percent), whereas women had only a slight preference for boys (56 percent).
These results were obtained from a non-random sample of undergraduate students, and should
not be taken at face value. A much more rigorous and recent study produced somewhat different
results. 52 A representative sample of 1,197 individuals ages 18 to 45 was asked five questions
designed to elicit possible preference for a sex and interest in using a sex-selection technology.
As with prior studies, participants in this survey expressed a fairly strong preference for a male
first born (39 percent), 19 percent would prefer a girl and 42 percent were indifferent. The actual
interest in using sex-selection technologies, however, is modest. Only 8 percent of respondents,
given its estimated cost, would consider using a sex-selection technology. This figure increases
to 18 percent if the sex of a child could be chosen simply by medication, whereas 59 percent
were still uninterested. A somewhat similar pattern emerges from a large, comparative survey of
practitioners and the general population on the acceptability of potentially controversial
46
47
48
49
50
51
52
Karsten Hank and Hans-Peter Kohler, "Gender Preferences for Children in Europe: Empirical Results from 17
FFS Countries," Demographic Research 2, no. 1 (2000).
Human Fertilisation and Embryology Authority (HFEA), "HFEA Annual Report 2003/04," (London: 2004),
p.24.
Ibid.
Dahl et al., "Preconception Sex Selection for Non-Medical Reasons: A Representative Survey from Germany."
“Suppose there was a medication enabling parents to choose the sex of their children. Couples simply had to
ingest a blue pill to ensure the birth of a boy, or a pink pill to ensure the birth of a girl. Would you take
advantage of such medication?”Ibid., p.2232.
Roberta Steinbacher and Faith Gilroy, "Sex Selection Technology: A Prediction of Its Use and Effect," Journal
of Psychology 124, no. 3 (1990); Doreen Swetkis, Faith Gilroy, and Roberta Steinbacher, "Firstborn Preference
and Attitudes toward Using Sex Selection Technology," The Journal of Genetic Psychology 163, no. 2 (2002).
Edgar Dahl et al., "Preconception Sex Selection Demand and Preferences in the United States," Fertility and
Sterility 85, no. 2 (2006).
92

diagnostic technologies. This study found that there is strong opposition to elective sex selection
in all countries, but less so in the United States. 53
What should we make of this data? There is no strong empirical evidence to suggest that at
the present time, the broad availability of sex-selection technologies such as MicroSort would
induce prospective parents to systematically choose one sex over the other. At the same time,
this finding does not render superfluous a broad public debate about the use and abuse of sexselection
technologies. Some commentators, though not necessarily worried about skewed sex
ratios, are concerned about the impact that the broad availability of this technology might have
on our very understanding of procreation, reducing it to an act of design – an expression of
parental whims. Still others fear that sex selection may fuel sexual discrimination. 54 These are all
legitimate concerns that should be examined in some detail before moving forward with this
technology on a grand scale.
4.4.2 Pre-Implantation Genetic Diagnosis for Therapeutic Uses
To date, pre-implantation genetic diagnosis is the one reproductive procedure that comes
closest to the ideal of a technology of reproductive customization. First tested in 1989, PGD
consists essentially of removing one cell from a blastocyst at the eight-cell stage. The cell so
removed allows the ART practitioner to conduct a variety of genetic tests. Embryos can be
screened for genetic diseases, for the predisposition to a genetic disease, and for sex-linked
diseases. They can also be selected for specific physiological attributes such as blood type. In
principle at least, PGD could also be used to screen embryos for any physiological attribute or
higher trait, provided science could identify the genetic foundations of these attributes. 55 Even
under the best of circumstances, however, PGD is a very cumbersome technology of
customization, and a passive one: It only allows the screening of existing embryos, but not the
creation of embryos with specific physiological attributes. In this sense, PGD is a far cry from
true genetic engineering.
Much has been said and written about PGD, and we will not rehash that discussion here
other than to note that the ethical import of genetic screening is not determined simply by its
limited ability to serve as a tool of procreative customization. The practice of genetic screening is
53
54
55
Dorothy C. Wertz et al., "Has Patient Autonomy Gone Too Far? Geneticists' Views in 36 Nations," The
American Journal of Bioethics 2, no. 4 (2002).
Lisa Belkin, "Getting the Girl," New York Times Magazine, July 25, 1999; Ethics Committee of the American
Society for Reproductive Medicine, "Preconception Gender Selection for Nonmedical Reasons," Fertility and
Sterility 75 (2001); Charles Hanson, Lars Hamberger, and Per Olof Janson, "Is Any Form of Gender Selection
Ethical?," Journal of Assisted Reproduction and Genetics 19, no. 9 (2002); John A. Robertson, "Preconception
Gender Selection," American Journal of Bioethics 1, no. 1 (2001); E. Scott Sills and Gianpiero D. Palermo,
"Preimplantation Genetic Diagnosis for Elective Sex Selection, the IVF Market Economy, and the Child –
Another Long Day's Journey into Night?," Journal of Assisted Reproduction and Genetics 19, no. 9 (2002).
For an overview, seeGenetics and Public Policy Center, "Preimplantation Genetic Diagnosis. A Discussion of
Challenges, Concerns, and Preliminary Policy Options Related to Genetic Testing of Human Embryos,"
(Washington, D.C.: Genetics and Public Policy Center, 2003).
93

controversial not because it provides an effective means to customize conception (which
currently it does not), but rather for its potential ability to undermine widely shared cultural
conceptions of equality and tolerance, those intangible values so often taken for granted but
indispensable to any functioning democracy. 56
A second instance of customized conception is the use of PGD for tissue matching.
Typically, this procedure is attempted when parents with a child affected by an incurable disease
are unable to find a compatible tissue donor. In these cases, ART specialists may resort to PGD
to screen for specific physiological attributes. For example, doctors may try to strengthen the
failing immune system of a child affected by Diamond Blackfan Anemia (DBA), a painful and
incurable disease, by extracting stem cells from the umbilical cord of a baby selected to be a
tissue match.
What should we make of this practice? Are we facing a deplorable application of PGD, or
are we simply using PGD for therapeutic purposes? Is the well-being of the children created
solely to benefit an older sibling imperiled, or can we assume that they will be welcomed into the
family? Do these manipulative medical procedures prepare us to more readily accept future
reproductive techniques expressly designed to customize conception rather than to treat a
medical condition? Medical professionals offer the following rationale for performing this
procedure: Tissue matching is a straightforward case of a therapeutic use of PGD. A young child
would die if the procedure were not performed. In addition, the older sibling is not saved at the
expense of the younger one. The life of the younger child is not traded against the life of his or
her afflicted older sibling. Furthermore, what reasons could possibly justify losing a child if he or
she could indeed be saved?
Pro-life groups offer a very different assessment. They point to the instrumental nature of
this procedure, i.e., a child being conceived exclusively to benefit an older sibling. They also are
disturbed by the need to create (and discard) numerous embryos before a suitable one is found.
Advocates for the disabled, for their part, have vehemently criticized genetic screening and tissue
matching, arguing that it amounts to a eugenic program against the disabled. According to these
groups, PGD likely will foster a culture of perfection incompatible with liberal values of mutual
tolerance and respect. The news media, for its part, has fueled these controversies by
characterizing tissue matching as the creation of “designer babies.” 57 The term is obviously
meant to provoke, but it is not entirely without justification.
It is useful to examine how the British Human Fertilisation and Embryology Authority has
addressed this dilemma. The British Parliament established the HFEA in 1990 when it passed the
Human Fertilisation and Embryology Act. Among other things, the Parliament delegated to the
HFEA responsibility for addressing the ethical controversies generated by new developments in
56
57
Francis Fukuyama, Our Post-Human Future: Consequences of the Biotechnology Revolution (New York: Farrar,
Straus and Giroux, 2002).
Shaoni Bhattacharya, Banned 'Designer Baby' Is Born in UK (New Scientist, June 19, 2003 [cited April 26,
2006]); available from http://www.newscientist.com/news/print.jsp?id=ns99993854; Colin Blackstock,
"Matched and Hatched, Britain's First 'Designer Baby' Born to Save Brother," The Guardian, June 19, 2003.
94

eproductive medicine (See chapter 6.4 for a more detailed discussion of the act and the agency).
Whether the use of PGD for tissue matching should be allowed, and if so under what
circumstances, is exactly the kind of controversy the HFEA was designed to settle.
Until recently, it was HFEA policy to authorize PGD only when the procedure would also
benefit the future baby, for example, by preventing the birth of a child with an inheritable
disease. Thus, the HFEA favored a view of PGD that emphasized therapeutic applications, but
only in a very narrow sense. Not every therapeutic use of PGD is designed to benefit the childto-be,
and under HFEA policy, certain applications were prohibited. For instance, Diamond
Blackfan Anemia is not an inheritable condition, so performing PGD to produce a tissue match
for a child affected by DBA would benefit the older sibling but not the future baby. Consistent
with its policy, the HFEA turned down demands to authorize the use of PGD to save children
affected by DBA. 58
By contrast, the HFEA approved performing PGD to cure cases of
Thalassemia. Unlike DBA, Thalassemia is an inheritable disease. In this case, PGD benefits the
child-to-be as well as the older child.
Not surprisingly, parents whose PGD applications were turned down challenged the HFEA
policy in court. In July of 2004, following a string of judicial decisions, the HFEA changed its
policy regarding tissue matching to allow this procedure to be performed even when no
inheritable disease is involved. 59
One may or may not agree with HFEA policies, but there is one important benefit from
resolving this and similar controversies through the regulatory and judicial system rather than
through private choices. One provision of the British Human Fertilisation and Embryology Act
of 1990 requires the HFEA to explicitly include in its consideration the well-being of children.
While the parents of children affected by Diamond Blackfan Anemia understandably disagreed
sharply with the earlier HFEA policy on PGD, the policy was clearly informed by the HFEA
obligation to balance parental interests and the well-being of future children. As we have shown
in this chapter, private choices tend to privilege parental interest, to the detriment of ART
children. In this sense, a regulatory approach to deciding what at first may appear as purely
private choices is preferable to delegating these choices to parents and the medical profession.
4.5 Biomedical Research Involving Reproductive Tissues
The fourth and last policy area to be examined in this chapter is research involving
reproductive tissues. By reproductive tissues we mean oocytes, sperm, and embryos, either
human or animal. The lines of research discussed in this section can be grouped into two distinct
categories. On the one end, we find research aimed at exploring issues pertaining specifically to
human reproduction and infertility. This kind of research may loosely be referred to as ART
58
According to news reports, parents whose applications were turned down by the HFEA were able to get the
treatment in the United States.
59
"High Court Ban on 'Designer Babies' Overturned," The Guardian, April 8, 2003; 'Saviour Sibling' Perfect
Genetic Match for Brother (BioNews, 320, August 8, 2005 [cited April 26, 2006]).
95

esearch. On the other end are situated research protocols that involve the use and manipulation
of human reproductive tissues but focus on medical research more broadly. Stem cell research
provides an illustration; it depends on the availability of human embryos but is largely unrelated
to questions pertaining to the study of infertility, though advances may come about as an
unanticipated benefit.
This ambiguity cannot easily be eliminated. Both areas of research touch upon the beginning
of human life, and both types of research make use of human reproductive tissues. In addition,
there is a considerable amount of organizational and institutional overlapping; many scientists
involved in one kind of research are also involved in the other. Both kinds of research often are
conducted at the same research organization. And, as we show below, experimentation in these
two areas of research raise significant ethical concerns. For all these reasons, we decided not to
distinguish explicitly between medical research involving the use of reproductive tissues and
ART research proper.
Research protocols in this area raise a fairly unique set of ethical questions. By its nature,
research on reproductive tissues is very unlikely to have an immediate impact on children and/or
their parents. It is also not very likely to affect the practice of medicine, at least in the short term,
nor does it undermine important societal values. In this sense, the immediate, short-term risks
associated with these research activities are relatively modest. The destruction of human
embryos for research purposes of course remains a very contentious and problematic proposition.
It is certainly an important (if not the most important) ethical concern raised by biomedical
research involving reproductive tissues. On the other hand, excessive attention to research
involving human embryos tends to ignore other important research developments. These research
protocols are problematic not because of immediate ethical concerns, but for difficult ethical
dilemmas they are likely to produce in the not-too-distant future.
Before discussing actual cases of problematic scientific protocols, we need to respond to an
important criticism. Science advocates insist that regulatory interventions should be explored
only in the presence of immediate and clear harm. In this view, harmful effects that have yet to
manifest themselves do not justify government interventions. 60 The concept of the slippery slope,
a metaphorical term used to identify a technological trajectory associated with undesirable
societal consequences, has been described by these critics simply as a rhetorical device invoked
by technology skeptics unable to muster specific reasons for opposing a scientific or
technological development.
We submit that this argument is itself the manifestation of an unreconstructed faith in
another kind of slope – the virtuous slope. If we apply the critics’ reasoning to a potentially
beneficial line of research, we may say that as long as the research has not produced any useful
results, there is simply no reason to assume that these results will materialize. Therefore, there is
no prima facie reason to shield research activities from governmental interventions. Rejecting
60
John A. Robertson, "Two Models of Human Cloning," Hofstra Law Review 27 (1999); Eugene Volokh, "The
Mechanisms of the Slippery Slope," Harvard Law Review 116 (2003).
96

this argument implies that there is a causal connection between today’s research protocols and
tomorrow’s cures, i.e., a virtuous slope that connects the current research to future beneficial
outcomes, or at least a very strong presumption that today’s research will produce tomorrow’s
cures. But if a virtuous slope exists, why should we assume that a slippery one does not?
Technological optimism denies the relevance of the slippery slope – the view that a technology
could move in a detrimental direction in a fairly predictable way – but does so by assuming that
science and technology indeed move in a predictably beneficial fashion, developing along a
virtuous slope. To put it in cruder terms, it is simply incoherent to argue that science and
technology are riding a virtuous trajectory and therefore should be protected from governmental
intervention, but to deny that science and technology could actually find themselves on a
trajectory to societal harm. Why should harm presumptively be proved if benefits cannot
presumptively be demonstrated?
We are not suggesting that the slippery slope concept necessarily implies early and
aggressive regulatory interventions. What it does suggest is that scientific research should be
monitored much more systematically. We shouldn’t regulate research lightly, but we don’t want
to be surprised by problematic and perhaps irreversible scientific developments. A system of
monitoring serves not only as an early warning system – it may also help identify unanticipated
interactions among seemingly independent lines of research. Considered in isolation, many of the
experiments discussed in this section may not raise significant concerns. Their significance
changes dramatically if examined in the context of other scientific experiments. 61
A few
experiments on mice demonstrating that it is possible to derive sperm cell precursors from stem
cells may not mean much. If we learn that it is also possible to derive oocytes from stem cells,
and that it has been demonstrated that sperm cells can be genetically manipulated, the original
research results begin to appear in an entirely new light.
Much of the information used in the remainder of this section was gleaned from science
magazines and news reports and through extensive online research. Efforts to obtain first-hand
information about these experiments have produced very modest results – another indication,
perhaps, of the need to more closely monitor research involving reproductive tissues.
4.5.1 Cloning Technologies
Cloning (or somatic cell nuclear transfer, as some leading scientists would like the rest of
the world to call this process) 62 provides a good illustration of a procedure that is of considerable
import both to assisted reproduction and to medical research: Whether one contemplates
reproductive or research cloning, the actual process is identical. In essence, it consists of
removing the genetic material (the nucleus) from a donated oocyte and replacing it with the
61
62
Not coincidentally, unanticipated interactions among the components of a technical system are one key attribute
of technological complexity. Cf. Charles Perrow, Normal Accidents: Living with High Risk Technologies (New
York: Basic Books, 1984). See also Nathan Rosenberg, "Why Technology Forecasts Often Fail," The Futurist
July 1 (1995).
Bert Vogelstein, Bruce Alberts, and Kenneth Shine, "Please Don't Call It Cloning," Science 295 (2002).
97

nucleus of a somatic cell, such as a skin cell. To trigger the process of cell division, the
“unfertilized embryo” is exposed to a short burst of electricity. 63 If successful, somatic cell
nuclear transfer produces an individual that is an almost perfect genetic replica of the somatic
cell donor – almost perfect because the clone will share with the egg donor the genetic material
contained in her mitochondria, genes that are obviously not present in the somatic cell of the
individual that has been cloned.
Reproductive and research cloning raise distinct ethical questions. Reproductive cloning in
particular has received considerable attention. 64 Many arguments have been put forward both in
favor of and against what some have described as a reproductive procedure, and what others
have more accurately but unsuccessfully characterized as human replication. 65 These questions
have been extensively debated, and we see no reason to contribute to that debate here, other than
to point out that it is very unlikely that the general public will ever consider this procedure an
acceptable procreative option, even if it can be performed safely. 66
With regard to research cloning, the situation is more interesting. In the last few years, the
rationale offered by scientists for conducting somatic cell nuclear transfer in humans has
changed significantly. Initially, the scientific community described this procedure as an
indispensable prerequisite for creating organs compatible the recipient’s immune system. But
critics have pointed out that scientists are many years away from being able to precisely control
the development of stem cells, a situation that apparently has been the source of considerable
frustration among developmental biologists.
Public skepticism has induced the scientific community to adopt a different rationale for
research cloning – that it is an important technique that would allow scientists to develop a much
better understanding of the development of genetic diseases that cannot otherwise be studied. An
example is Parkinson’s disease, a degenerative condition of the brain that obviously cannot be
studied in adult subjects. The emphasis thus has shifted from applied to fundamental medical
research.
Other scientists are not ready to abandon the initial vision of growing replacement organs
just yet. It has been shown that if human embryonic germ cells are derived from five-, six-,
seven-, and 11-week-old primordial germ cells (i.e., germ cells of a fetus several weeks old),
they can be injected or grafted onto a diseased organ, where they continue their development. 67
Other experiments have demonstrated that cloning makes it possible to produce specialized
63
64
65
66
67
Strictly speaking, the term “unfertilized embryo” is meaningless. Unfortunately, a proper technical term for this
biological construction does not exist.
See, for example, Glenn McGee, ed., The Human Cloning Debate (Berkeley, CA: Berkeley Hills Books, 2002);
President’s Council on Bioethics, "Human Cloning and Human Dignity: An Ethical Inquiry," (Washington,
D.C.: 2002).
George J. Annas, "Human Cloning: A Choice or an Echo?," Dayton Law Review 23 (1998).
In this regard, see also the survey data in chapter 8.
Michael J. Shamblott et al., "Human Embryonic Germ Cell Derivates Express a Broad Range of
Developmentally Distinct Markers and Proliferate Extensively in Vitro," Proceedings of the National Academy
of Sciences 98, no. 1 (2001).
98

cellular tissue compatible with the somatic cell donor. For these techniques to work effectively,
however, it is necessary to grow a cloned embryo well beyond the customary 10 to 14 days. In
addition, these embryos, for now at least, must be grown in vivo (in other words, in a mother’s
uterus) and subsequently aborted; embryos grown in vitro, for reasons not entirely understood,
have not shown the same effectiveness. 68
These experiments have been conducted on animal models. Exactly how long cloned
human embryos would have to be grown in vivo is not clear. What is clear is that the derivation
of suitable cellular tissue would require aborting a developing human embryo at a fairly
advanced stage, or perhaps even a fetus, to “culture” an embryo well beyond the customary 10 to
14 days. What is interesting about this case is that no one really can say with a high degree of
confidence that these experiments have not already been replicated in humans. Also telling is the
fact that while public debates about new biomedical research in the last several years have
focused almost exclusively on stem cells derived from early-stage embryos, several research
groups were already experimenting with stem cells derived from animal embryos several weeks
or even a few months old. 69
What should we make of these developments? As a perceptive reporter has noted, these
experiments may challenge the notion that stem cell lines should only be derived from 10- to 14–
day-old embryos. Why stop at 14 days? What are the specific reasons for this constraint? It
appears that the justification for the 14-day rule is pretty thin – thin enough, in any case, to
convince many that it may be worthwhile exploring the possibility of extending the cutoff date
for experimenting on human embryos to three weeks or a month. We are certainly not advocating
this measure. What this story suggests is that the concept of a slippery slope is not simply a
rhetorical device invoked by opponents to stymie scientific and medical progress. It is a concern
expressed even by leading scientists, as the following statement made at a 2003 meeting of the
President’s Council on Bioethics implicitly illustrates:
[…] I am concerned, I mean, as a biologist I'm concerned. I'm concerned about a number of issues.
It makes it sound as if most of the time that scientists aren't concerned, that we're just going along
in a fashion that, you know, science for science sake.
And I only have to remind you over the last few months to see the use of human embryonic stem
cells in mouse chimeras, the use of chimeric human embryos that has been done, that you say
there's no reason that these things should have been done. I mean, there's no scientific basis for
this.
68
69
Benjamin Dekel et al., "Human and Porcine Early Kidney Precursors as a New Source for Transplantation,"
Nature Medicine 9, no. 1 (2003); Robert Lanza et al., "Regeneration of the Infarcted Heart with Stem Cells
Derived by Nuclear Transplantation," Circulation Research 94 (2004); Robert P. Lanza et al., "Generation of
Histocompatible Tissues Using Nuclear Transplantation," Nature Biotechnology 20 (2002); Robert Lanza et al.,
"Long-Term Bocine Hematopoietic Engraftment with Clone-Derived Stem Cells," Cloning and Stem Cells 7, no.
2 (2005).
A fuller account of this story can be found in William Saletan, The Organ Factory (Slate, July 25, 2005 [cited
September 27, 2005]); available from http://slate.msn.com/id/2123269/entry/2123270/.
99

And we have to have some degree – and I'm not going to call it regulation, I don't like that term,
obviously, but there has to be some consensus as to what should be permitted and shouldn't be
permitted in almost a global way. 70
As for other lines of medical research discussed in this chapter, there is no reason to
entertain immediate radical regulatory interventions. The sense of unease that these experiments
are likely to trigger in many readers is, however, a clear indication that potentially controversial
medical research can only move forward if adequate legal safeguards are put in place and if
Congress takes the necessary steps to ensure compliance. That we learned about these
experiments serendipitously only underscores just how precarious our ability to identify and
monitor momentous scientific developments is. There is a subtle but important difference
between trust and blind trust. A much more systematic approach to monitoring scientific
activities would go a long way toward restoring public confidence in the scientific enterprise.
4.5.2 Making Sperm
Over the last few years, science magazines and scientific journals have reported on several
important experiments pertaining to the creation of human sperm. Like other research protocols
discussed in this section, none of these experiments, taken in isolation, is of immediate relevance
to clinicians, and they do not, therefore, raise immediate ethical concerns. All of them, however,
are suggestive of momentous future clinical applications.
The first two experiments involved growing sperm in mice. Already, in 2002, a research
group had succeeded in grafting testicular tissue from goats and pigs under the skin of mice. 71
The experiment showed that the immature testicular tissue does indeed develop into normal
sperm. In the fall of 2004, researchers at Yale University conducted a similar experiment, this
time using human testicular tissue. They were able to growth testicular tissue taken from adult
humans with immature testes under the skin of mice. The tissue was still viable after 19 weeks,
when it was retrieved for analysis. 72 According to the researchers, these experiments eventually
should allow development of a technique that could restore fertility in children undergoing
chemotherapy. More generally, this line of research should lead to more effective cures for male
infertility.
Should anyone be concerned about this line of research? From a narrow, utilitarian point of
view, these experiments, per se, do not seem to raise any serious ethical concerns. After all, their
declared goal is purely therapeutic, and it would be difficult to argue that anyone would be
harmed by the clinical applications of these techniques. At the same time, the claim that these
experiments have no broader significance presumes that the technology in question will be used
70
71
72
John P. Gearhart, Rudolf Jaenisch, and David Prentice, Stem Cell Research: Recent Scientific and Clinical
Developments (Session 3, President's Council on Bioethics Meeting, July 24-25, 2003 [cited September 16,
2005]); available from http://www.bioethics.gov/transcripts/july03/session3.html.
James Meek, "Mice May Provide Human Sperm Bank," The Guardian, August 15, 2002.
James Randerson, "Human Testicular Tissue Grown in Mice," New Scientist, October 19, 2004.
100

exclusively for the purpose it was developed for, an assumption obviously not supported by the
history of science and medicine.
A far more consequential research protocol involving the production of sperm was reported
from Japan in 2003. 73 In this experiment, the Japanese researchers cultivated embryonic stem
cells in a culture known to stimulate the growth of sperm. They then took these cells and
implanted them in mice testes, where apparently they fully developed into sperm. The
researchers retrieved the sperm and fertilized mice eggs, which began to divide.
According to the Japanese researcher, the study should improve our understanding of
embryonic development. The scientists were not secretive about what this generic statement may
mean. Their goal, according to one news story, was to enhance our ability to engineer sperm –
i.e., to produce artificial sperm based on specific genetic criteria. This could become possible
because, as the researchers pointed out, scientists already know how to insert genes into stem
cells.
Engineering sperm? Perhaps the Japanese scientist was simply naïve; or perhaps he
sincerely believed that engineering sperm is a research proposition as legitimate and
unproblematic as any other. Whatever the case may be, the view that human sperm could in the
not-too-distant future be genetically engineered to meet specific parental desires is qualitatively
different from the kind of rationales offered by scientists involved in potentially controversial
medical research. Whether there may be reasons good enough to justify engineering sperm
remains to be seen, but this question certainly cannot be decided by the scientific community
alone. 74
A more advanced version of the Japanese experiment was conducted by Harvard University
scientists in 2003. 75 In this case, the scientists were able to grow sperm cell precursors entirely in
a lab dish; implantation in testes was not necessary. They then injected these sperm-like cells
into a mouse egg cell. In some cases, the fertilized egg developed into an early-stage embryo, or
blastocyst. The scientists then tried to impregnate a mouse, without success. The Harvard group
is now replicating these results in human embryonic stem cells. The researchers were careful to
emphasize the scientific nature of their experiment and explicitly downplayed the possibility of
developing cures for male infertility. In essence, this method for producing sperm cell precursors
allows scientists to study imprinting, the process that regulates which genes are turned on or off
during embryo development, depending on whether they are inherited from the mother or the
73
74
75
Stem Cells Stimulated to Be Sperm (Associated Press, September 15, 2003 [cited August 2, 2005]); available
from http://www.wired.com/news/medtech/0,1286,60454,00.html; Rick Weiss, "Sperm Made from Stem Cells:
Development in Mice Raises Issues for Human Reproduction," Washington Post, September 16, 2003.
That this research was conducted at a privately funded university only underscores the need for public oversight.
Josh Chamot and Leslie Fink, Researchers Engineer Mouse Embryonic Stem Cells to Form Sperm Cell
Precursors (National Science Foundation, Office of Legislative and Public Affairs, December 10, 2003 [cited
August 3, 2005]); available from http://www.nsf.gov/od/lpa/news/03/pr03142.htm; Sylvia Pagàn Westphal,
"Stem Cells Can Become 'Normal Sperm'," New Scientist, May 7, 2003; Gretchen Vogel, "Embryonic Stem
Cells: Scientists Make Sperm in a Dish," Science 302, no. 5652 (2003).
101

father. The experiment could also lead to a better understanding of cancer development, and of
the causes of birth defects and of male infertility.
Another suggestive experiment was conducted in 2004 by a group of U.S. and Japanese
scientists. The researchers managed to insert foreign DNA into the spermatogonia (or immature
sperm cells) of zebra fish and to growth them to maturity. This was the first time that researchers
had succeeded in culturing entirely in vitro spermatogonia of a species other than mice. The
zebra fish is a popular animal model in developmental biology because it shares many of the
same genes with humans, and because its embryos are transparent. 76 The researchers used the
cultivated sperm to fertilize zebra fish eggs. Of 1,100 eggs exposed to the genetically modified
sperm, 104 were fertilized and 89 grew into zebra fish. Of these, five carried the foreign gene.
One possible clinical application of this research is gene therapy. If perfected in humans,
this technique would enable scientists to genetically modify sperm, either by adding a specific
gene or by removing a defective gene, so as to prevent passing on a genetic disease. Clinical
applications, however, are many years away. A much more likely application of this technique is
the efficient creation of transgenic animals. Current techniques to engineer transgenic animals
are not very effective. Many animals so created display “mosaicism,” i.e., only a fairly small
fraction of the animal’s cells carries the foreign gene.
The experiments described in this section raise several important ethical questions. Is
research on human sperm simply another form of medical research, or is it necessary to
scrutinize this line of research more carefully? Should bright lines be drawn only when this
research comes to fruition? Should these research efforts succeed in producing viable human
sperm from embryonic stem cells, what kind of constraints, if any, should society impose on the
production of sperm from embryonic stem cells? For example, should it be permissible for ART
practitioners to create embryos using sperm derived from stem cells? In other words, should it be
possible for children to be born from unborn parents? We think not. The fact that many children
have been born from anonymous sperm donors does not provide a rationale for creating children
without biological parents or with ambiguous biological roots. Not coincidentally, in recent
times, the news media has reported on the concerted (and increasingly successful) efforts by
teenagers born through anonymous sperm donations to track down their biological parents –
another indication of the powerful role and the importance of biological origins on one’s sense of
identity. 77 On the other end, would it be acceptable to offer young boys affected by leukemia a
chance protect their reproductive chances? Certainly. A regulatory agency is in an excellent
position to proscribe the former procedure and regulate the latter.
76
77
Philip Cohen, "Test-Tube Sperm Get New Genes," New Scientist, January 26, 2004; Human GM Sperm Will Be
Possible One Day, Researchers Indicate (Medical News Today, January 28, 2004 [cited August 3, 2005]); Tim
Radford, "Scientists Modify Sperm to Add New Fish to the Gene Pool," The Guardian, January 27, 2004; Geoff
Spencer, Transgenic Animals Produced Using Cultured Sperm: Study Opens New Possibilities for Biological
Research, Gene Therapy (NIH News, National Institutes of Health, January 26, 2004 [cited August 3, 2005]);
available from http://www.nih.gov/news/pr/jan2004/nhgri-26.htm.
Amy Harmon, "Hello, I'm Your Sister. Our Father Is Donor 150," The New York Times, November 20, 2005;
Rob Stein, "Found on the Web, with DNA: A Boy's Father," The Washington Post, November 13, 2005.
102

4.5.3 Making Eggs
After twenty years of research on mouse embryonic stem cells (ESCs), scientists have been
able to coax these cells into just about any kind of cell. Since a group of researchers at the
University of Pennsylvania announced in 2003 that they had succeeded in transforming mouse
ESCs into eggs, it has now been demonstrated that mouse ESCs can indeed be converted into
any kind of mouse cell – i.e., that they are totipotent. 78 Coaxing mouse stem cells into becoming
oocytes did not require a sophisticated cocktail of growth factors, a fact prompting optimism in
the scientific community about replicating these results in higher mammals, primates, and
humans. The eggs were produced through a process similar to ovulation. The oocytes underwent
meiosis, the process by which eggs and sperm give up half of their genetic material, and
produced embryo-like structures through a process known as “parthenogenesis.” Interestingly,
eggs were produced by both female and male ESCs.
What is the scientific rationale for this experiment? According to the University of
Pennsylvania scientists, the experiment could defuse many concerns surrounding research
cloning. Somatic cell nuclear transfer is notoriously very inefficient and requires a large number
of oocytes to succeed. Retrieving human oocytes in large numbers is an ethically questionable
undertaking at best and an unacceptable proposition at worst. The researchers hope that
dramatically increasing the availability of oocytes will change the terms of the debate about
research cloning: If embryos could entirely be produced in vitro, many opponents of research
cloning might find this line of research far less objectionable. A large supply of artificial eggs
would also prevent a market for natural oocytes from emerging; the scientists also indicated that
their research could advance our understanding of infertility and of menopause.
The rationale offered by these scientists for attempting to produce artificial oocytes is
laudable and hopefully not entirely unrealistic. But as pointed out earlier, important scientific
experiments often have applications not anticipated by the researchers. In the present case, it is
not too difficult to identify some of these unanticipated consequences. As noted above, scientists
have made eggs not only from female, but also from male embryonic stem cells. Conceivably,
then, a gay couple may be able to produce their own genetically related children through IVF and
surrogacy. In this scenario, one man would contribute the sperm and the other the eggs. While
some in the gay community may salute this development as an important step toward equal
access to parenthood, others may point to possible deleterious consequences for the well-being
and the personal identity of children. In allowing men to become mothers, this procedure would
also undermine the principle that each child should have a genetic father and mother.
78
Claire Ainsworth, "Artificial Human Eggs Created," New Scientist, July 2, 2001; Rachel Nowak, "Mice Born
from Rat-Matured Eggs," New Scientist, September 28, 2002; Sylvia Pagàn Westphal, "Embryonic Stem Cells
Turned into Eggs," New Scientist, May 1, 2003; Azim Surani, "Stem Cells: How to Make Eggs and Sperm,"
Nature 427 (2004); Nicholas Wade, "Pennsylvania Researchers Turn Stem Cells to Egg Cells," New York Times,
May 2, 2003; Rick Weiss, "In Laboratory, Ordinary Stem Cells Are Turned into Eggs," Washington Post, May 2,
2002.
103

The availability of oocytes in large numbers would also make it much more attractive for
prospective parents seeking an egg donor to consider genetically engineered eggs. As noted
elsewhere, scientists have already developed the ability to insert and remove specific genes in
embryonic stem cells. Genetically modified stem cells could be used as means to produce eggs
with specific genetic traits, in the process making genetic modifications inheritable. A more
realistic consequence of this line of research is the postponement of motherhood. Being able to
replenish their own supply of eggs through somatic cell nuclear transfer could become a
proposition too attractive for many women to resist. 79
4.5.4 Remaking the Machinery of Gestation
“Ectogenesis” is the technical term used to identify the gestation of a baby outside a
woman’s womb. Two recent experiments suggest that this possibility may not be as hypothetical
as it seems. In one experiment, a group of scientists at Cornell University Medical College in
New York took human uterine tissue samples and grew them on a model uterus. To the
scientists’ amazement, embryos implanted in this tissue survived and developed for six days
before the experiment was terminated. 80 Japanese scientists, for their part managed, to gestate
goats in a fully artificial womb for three weeks. 81 Whether these experiments are consequential
in any way is not entirely clear. Some have argued that it is impossible, for a variety of
physiological reasons, to actually design a fully functional human ectogenetic chamber. 82
Detailed information about scientific and medical progress in this area is sparse, and clinical
applications appear to be years away. If the debate about genetic engineering is any indication
however, progress in this area may occur much faster than anticipated. A brief discussion of
possible societal consequences is therefore appropriate.
79
80
81
82
Incidentally, there is some evidence that the natural supply of eggs, contrary to common opinion, may not be
limited after all. In mid-2004, it was widely reported by the news media that ovaries – at least in mice – are
capable of producing fresh eggs throughout their adult life Helen R. Pilcher, Could We Defeat the Menopause?
Mouse Ovaries Offer up Secret of New Egg Cells (News@nature.com, July 1, 2004 [cited April 26, 2006]);
available from http://www.nature.com/nsu/040628/040628-18.html. Whether this result can be reproduced in
humans is unclear, but the researchers who conducted the experiment pointed out that female flies, fish, birds,
and now mice all do make new eggs throughout life, and that there is no reason to assume that this would be
different in humans
It is unclear whether the scientist in question, Dr. Hung-Ching Liu, has published the results of this experiment.
An account of the Japanese experiments can be found in N. Unno et al., "Development of an Artificial Placenta:
Survival of Isolated Goat Fetuses for Three Weeks with Umbilical Arteriovenous Extracorporeal Membrane
Oxygenation," Fetal Diagnosis & Therapy 5 (1990). and Ronald Bailey, Babies in a Bottle: Artificial Wombs
and the Beginning of Human Life (Reason, August 20, 2003 [cited April 26, 2006]); available from
http://reason.com/rb/rb082003.shtml; Y. Kubawara et al., "Long-Term Extrauterine Incubation of Isolated Goat
Fetuses," Artificial Organs 13 (1989); Robin McKie, "Men Redundant? Now We Don't Need Women Either,"
The Guardian, February 10, 2002; Jeremy Rifkin, "The End of Pregnancy," The Guardian, January 17, 2002;
Sacha Zimmerman, "Fetal Position: The Real Threat to Roe V. Wade," The New Republic, August 13, 2003.
See Bailey, Babies in a Bottle: Artificial Wombs and the Beginning of Human Life ([cited).. Curiously, this
author’s skepticism is in stark contrast to his otherwise enthusiastic support for many other controversial medical
and technological developments.
104

As for many other medical technologies, experiments involving ectogenetic chambers have
been conducted with a narrow therapeutic goal in mind. In this case, scientists had hoped to save
the lives of extremely premature babies and to help women with uterine malformations to
become pregnant. The possible applications of an ectogenetic chamber do not stop here,
however. Once this technology has been fully developed, some perfectly healthy women may
find it attractive to avoid the hassles and the pains, not to mention the forced temporary
retirement, associated with pregnancy by “outsourcing” it to a machine. Women may not be the
only ones to find this option attractive. The availability of ectogenetic chambers may induce
business firms to adopt policies that strongly encourage their female employees to accept
artificial pregnancies. Health insurance companies may find an artificial pregnancy more costeffective
and less risky than a natural one. An entirely artificial gestation could also have a
dramatic impact on the abortion debate. A key argument of the pro-choice camp – that the state
cannot impose on women the physical and emotional burdens associated with an unwanted
pregnancy – would suddenly be removed from the equation. 83
Also of considerable import are possible risks to the health and well-being of the babies.
These risks are all but unknown, but they may well be significant. For example, we know that
fetuses respond to the mother’s heartbeat and to her emotions. Can we really dispense with these
subtle but perhaps critical interactions? One may also wonder whether an artificial pregnancy
would weaken the bond between mother and child. How can we be so sure that we will be able to
redesign in just a few years what took nature millions of years to create and perfect? Even if we
could accomplish this feat, should this practice be indulged or even encouraged for the sake of
avoiding stretch marks, weight gain, and overall inconvenience? Is economic efficiency reason
enough for tolerating this practice? Is this technology really liberating, as some feminists no
doubt will claim? Or should it rather be viewed as a particularly perverse attempt by a maledominated
society to marginalize women?
It is neither our intention nor our desire to provide definitive answers to these questions.
More important to the present discussion is the observation that the broad availability of
ectogenetic chambers is likely to spark a variety of applications, ranging from the purely
therapeutic to the dubious and the downright unacceptable. And as for other scientific and
medical developments discussed in this report, only a regulatory agency would have both the
expertise and the legitimacy to distinguish between acceptable and unacceptable uses of this
technology.
4.5.5 Hybrids and Chimeras
Their vaguely menacing names notwithstanding, we are all familiar with hybrids and
chimeras. A hybrid is simply the result of the fertilization of one species’ egg with another
species’ sperm. Mules, the offspring of a female horse and a male donkey, are a classic example.
In Greek mythology, a chimera is a monstrous animal with the head of a lion, the body of a goat,
83
Zimmerman, "Fetal Position: The Real Threat to Roe V. Wade."
105

and the tail of serpent. In biology, chimeric animals consist of cells from at least two genetically
distinct progenitors, either two different animals or a human and an animal. They can be created
in a variety of ways – for example, by inserting cells from one species into the embryo or the
fetus of another. Stem cells have also been used for this purpose. Chimeras can be conceived
naturally, such as when twin embryos fuse (a rare but not unknown phenomenon).
If there ever was a truly horrifying scenario to the average person, it is the possibility that
scientists one day could create entities that are neither clearly human nor animal. The term
“humanzee” evokes precisely this kind of imagery. The “humanzee” is a creature that is half
human and half chimpanzee. Why anyone would want to create a humanzee is of course a very
important question that has not received convincing answers. Some have suggested that
humanzees could perform degrading and dangerous tasks; others, that they could be designed to
serve as soldiers. A more realistic proposition is the possibility that chimeric individuals could be
created for superior athletic performance. Whatever the rationale for creating a human-animal
chimera, should a suitable technology become available, it is not at all implausible that some
individuals may want to use it, despite the unanimous opposition of the scientific community and
the ART industry. This situation is reminiscent of reproductive cloning, and raises similar ethical
concerns.
It is relatively easy to justify banning the creation of anything resembling a humanzee or a
super-athlete. The ethical arguments in this case are not too dissimilar from those offered to ban
reproductive cloning. Respect for individual autonomy prevents us from establishing in advance
the ultimate purpose of any human life, including human chimeric life. Creation of such a hybrid
furthermore raises nightmarish questions of moral status, such as what kinds of political rights
such a creature would have. On the other end, there may well be lines of research involving
chimeras and/or hybrids that could be justified, both from a scientific and an ethical standpoint.
To our knowledge, there have been only two published experiments involving the creation
of human-animal hybrids, both conducted in 2003. In one of these experiments, a Chinese
scientist removed the nuclei from rabbit eggs and replaced them with human nuclei obtained
from the skin of two five-year-old boys, two men, and a 60-year old woman. 84 The experiment is
noteworthy not only because human-animal embryos were created for the first time, but also
because it was the first documented case of somatic cell nuclear transfer in humans. It was, in
other words, a cloning experiment. As disturbing as this experiment may appear, it was
conducted for a straightforward reason. The Chinese scientist was hoping to develop a technique
for producing what may be called ethical embryos – embryos that could be produced in large
numbers and used as a source of human stem cells without stirring public controversies.
Predictably, the experiment did trigger a controversy, but not because of the procedure involved.
84
"China's Human-Cloning Policy Fudges Law on Cross-Species Fusions," Nature 427 (2004); Carina Dennis,
"Chinese Fusion Method Promises Fresh Route to Human Stem Cells," Nature 424 (2003); Antonio Regalado,
"Chinese Scientists Report Advance in Stem-Cell Work," Wall Street Journal, August 13, 2003; Rick Weiss,
"Cloning Yields Human-Rabbit Hybrid Embryo," Washington Post, August 14, 2003; Richard Yallop,
"Professor Backs Use of Hybrid Embryos," The Australian, October 28, 2004.
106

Several scientists expressed serious doubts about the claim that the cells derived from these
embryos were indeed embryonic stem cells, because the Chinese researcher failed to demonstrate
that the resulting cells were indeed able to self-replicate indefinitely.
One possible way to interpret this line of research is to compare it to xenotransplantation.
The transplantation of animal organs into the human body is now common practice in the United
States and abroad. Numerous tissue banks exist, and the FDA has thoroughly regulated this field
of medicine. Perhaps this experiment could be described as an instance of xenotransplantation; as
controversial as transplantation of animal organs into the human body once was, it now has
become an accepted medical practice.
In a similar direction points a line of research involving the creation of chimeric sheep. 85 In
these experiments, a group of scientists at the University of Nevada in Reno injected human
embryonic stem cells into the fetuses of sheep. What is distinctive about these experiments is that
the proportion of human cells in some organs (including the skin, the liver, the heart, and the
pancreas) is unusually large – between 7 and 15 percent. The researchers hope eventually to be
able to grow animals whose organs will not be rejected by humans. Clinical applications remain
a distant goal, however.
An important open question is whether the injected human stem cells might end up in the
brains of these animals in significant numbers. At this time, scientists are simply unable to
provide definitive answers, though they do not exclude this possibility. Nor is it clear that an
animal with a significant proportion of human brain cells would have any human cognitive
capacities. That scientists at this time are unable to provide even the beginning of an answer to
this question is certainly a good reason to carefully monitor these experiments. Precisely this
question was raised at a conference organized in October of 2004 by the National Academy of
Sciences in Washington, D.C. 86 The question was prompted by research being conducted at
Stanford University involving the injection of diseased human embryonic stem cells into animal
models. 87 To this end, scientists have created mice with a substantial proportion of humanderived
brain cells. This raises, of course, the possibility that mice could acquire human-like
cognitive capabilities, a possibility that some scientists participating in the conference seemed to
take seriously. Also problematic to participating scientists was prospect that male and female
chimeric mice could mate. Other scientists expressed doubts about the wisdom of creating
chimeric mice to study disease development. 88
The discussion among participating scientists showed that researchers are not of one opinion
about the wisdom of quickly moving forward in this area. Some have argued, quite reasonably in
85
86
87
88
Sylvia Pagàn Westphal, "'Humanised' Organs Can Be Grown in Animals," New Scientist, December 17, 2003.
Erika Check, "Biologists Seek Consensus on Guidelines for Stem-Cell Research," Nature 431 (2004).
For a moderately technical overview, see the presentation by Professor Irving Weissman prepared for the
Conference on Guidelines for Human Embryonic Stem Cell Research, organized by the National Academies and
held in Washington, D.C., on October 12-13, 2004 (available at
http://dels.nas.edu/bls/stemcells/powerpoints.html).
Nicholas Wade, "Is the World Ready for a Man-Mouse?," International Herald Tribune, November 28, 2002.
107

our view, that the scientific community, as part of its self-regulatory efforts, should first try to
determine which experiments involving chimeric animals should be considered unproblematic,
which ones are questionable, and which ones should be avoided entirely before moving forward.
That this suggestion was ignored is more evidence that a regulatory intervention in this area may
indeed be necessary.
108

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5 The Current Legal and Regulatory Framework
In this chapter, we examine in some detail whether the current statutory and regulatory
framework would provide a basis for addressing future biomedical controversies. We are
certainly not the first ones to conduct this exercise. A noteworthy precedent is the President’s
Council on Bioethics report “Reproduction and Responsibility: The Regulation of New
Biotechnologies.” This report examined in great detail whether various federal statutes provide
sufficient authority to regulate a number of specific reproductive and medical technologies. Here
we take a somewhat different approach. We are less interested in the power of the federal
government to bring under its control specific reproductive technologies than in the suitability of
individual statutes to provide a robust platform for (a) monitoring the emergence of new
reproductive and medical technologies, (b) adjudicating among conflicting societal interests
pertaining to the use of these technologies, and (c) monitoring and assuring compliance.
5.1 Federal Legislation
5.1.1 The Fertility Clinic Success Rate and Certification Act of 1992
The only existing statute at the federal level specifically focused on reproductive medicine is
the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). FCSRCA was
enacted in response to widespread concerns among patients and consumer groups about the
accuracy of success rates published by fertility clinics. Success rates were and remain the most
important device for fertility clinics to promote themselves and attract new patients. Fertility
clinics operate in a very competitive economic environment, one that may induce some clinics to
make inaccurate, misleading, or downright false statements about their success rates. High
success rates, in the eyes of prospective patients, are of course of paramount importance in the
selection of an ART program. Competition among ART clinics is made fiercer by the fact that in
the United States, very few health insurance plans offer coverage for fertility treatments.
With FCSRCA, the Congress, in cooperation with the Society for Assisted Reproductive
Technology (SART) and the American Society of Reproductive Medicine, established legally
binding standards for measuring and reporting ART success rates. It also required the CDC to
devise a model program for the inspection and certification of embryo laboratories.
The scope of FCSRCA is narrow: It applies exclusively to embryo laboratories, i.e., to
facilities “in which human oocytes are subject to assisted reproductive technology treatment or
procedures based on manipulation of oocytes or embryos which are subject to implantation.” 1
Thus, the act does not reach laboratories that conduct research on human oocytes or sperm at
1
See 42 USC 263a-7(2).
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iotech companies or university clinics, nor does it reach privately funded laboratories
conducting research on human development proper – i.e., on human embryos.
The statute defines success rate as the ratio between the number of achieved pregnancies and
“...the number of ovarian stimulation procedures attempted.” 2 ART treatments include only those
fertility treatments that involve the handling of both eggs and sperm. As a result, assisted (or
artificial) insemination (also known as intrauterine insemination, or IUI) and treatments that
consist only of ovarian stimulation (without egg retrieval) are not considered ART procedures.
The CDC, in cooperation with SART, now publishes success rates on a yearly basis. These
reports are intended both as a decision-making tool and as an educational resource for
prospective parents. 3
Measuring ART success rates is only one of two FCSRCA components. The other requires
the Department of Health and Human Services (HHS), through the CDC, to develop a model
program for the inspection and certification of embryo laboratories. The program, to be
implemented by the states, is voluntary. The delegation of the program’s implementation to the
states seems to reflect Congress’ desire to respect regional and cultural differences in this very
sensitive policy area. The CDC published the actual program requirements only in 1999, mainly
due to lack of funding. 4 To our knowledge, no state has yet implemented it.
The program is modeled after similar ones in other industrialized countries. Requirements
include developing standards and procedures to ensure consistency in performing ART
treatments, 5 standards for record-keeping of laboratory tests and ART treatments, 6 and standards
for maintaining written records about personnel and facilities. 7 An important element of the
model program is inspections, to be conducted periodically and unannounced by the states or by
accredited professional and trade organizations. The program includes specific criteria for an
organization to qualify as an accreditation organization. The performance of each accreditation
organization is reviewed on an annual basis. Inadequate performance can result in the withdrawal
of accreditation. The implementation of the model program can be in part or fully funded
through the user fees. 8
What role, if any, could FCSRCA play as a key component of a future regulatory system?
The short answer to this question is that it would be a modest one. At most, the FCSRCA could
provide a basic regulatory infrastructure on which additional statutory and regulatory
components could be built. For example, the reporting system designed to measure success rates
2
3
4
5
6
7
8
See 42 USC 263a-1 (b)(2).
All reports are available in electronic form at http://www.cdc.gov/reproductivehealth/ART/index.htm.
Department of Health and Human Services (Centers for Disease Control and Prevention), "Implementation of the
Fertility Clinic Success Rate and Certification Act of 1992 – a Model Program for the Certification of Embryo
Laboratories; Notice," Federal Register 64, no. 139 (1999).
See 42 USC 263a-2 (d)(1) and (d)(2).
See 42 USC 263a-2 (d)(3).
See 42 USC 263a-2 (d)(4).
See 42 USC 263a-6.
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on a clinic-by-clinic basis could be expanded to monitor the health and well-being of newborn
children up to approximately one year of age. This is the age at which most birth and congenital
defects not detectable at birth become apparent. As shown in Appendix C, there remains
considerable uncertainty about the relationship between the use of ART technologies and the
frequency of various birth and genetic defects. An extended system of health monitoring would
go a long way to improving our limited knowledge of the possible risks associated with ART
technologies. Obviously, there would be costs associated with the implementation and operation
of an extended system of monitoring, costs that could be defrayed in part through user fees and
in part through governmental contributions.
The model program is clearly not designed to substantively regulate the practice of
reproductive medicine. Its requirements reveal a ubiquitous concern for procedural matters.
These requirements do not in any way impinge upon the professional autonomy and judgment of
the medical profession, or for that matter restrict the options available to prospective parents. In
fact, the statute explicitly prevents regulators from intervening directly in this field of medicine.
FCSRA prohibits “establish[ing] any regulation, standard, or requirement which has the effect of
exercising supervision or control over the practice of medicine in assisted reproductive
technology programs.” 9 In this sense, the model program should be regarded as a regulatory
infrastructure that could play a useful role should Congress decide to intervene more directly in
the field of reproductive medicine. For example, tracking the creation, import, export, and
exchange of human embryos would require only minimal changes. 10 The model program would
also facilitate detecting violations of prohibited practices, such as the for-profit trade of oocytes
or embryos, and the misuse or unauthorized destruction of embryos. 11
It should be noted that the model program as described by the CDC is comprehensive and
quite detailed. Its implementation would no doubt cause additional, and possibly significant,
costs to ART clinics. Yet the program can hardly be described as a case of administrative
overzealousness. The CDC has made clear that many requirements included in the model
program are based on existing ART programs, such as the College of American Pathologists
(CAP) certification program for embryo labs and other state, federal, and international ART
programs. 12 The addendum lists several professional organizations the CDC has consulted with
to develop this program. Thus the model program, comprehensive and cumbersome as it may be,
simply reflects the state of the art in managing embryo labs as it has emerged in consultation
with all relevant professional and trade associations.
9
10
11
12
42 USC 263a-2(i).
We are not suggesting that embryos currently are being bought and sold in large numbers. Should the donation
of cryopreserved embryos for research become common practice, tracking embryo donation would become
considerably more important.
See Department of Health and Human Services (Centers for Disease Control and Prevention), "Implementation
of the Fertility Clinic Success Rate and Certification Act of 1992 – a Model Program for the Certification of
Embryo Laboratories; Notice," Section C 39388- 91.
See Ibid. Introduction and background sections.
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As an infrastructure of quality assurance and monitoring, the model program has one glaring
limitation: It does not reach all laboratories involved in the use and manipulation of embryos.
Laboratories that create embryos for purposes other than reproduction do not fall under FCSRCA
jurisdiction. Nor is FCSRCA’s emphasis to protect the health and safety of the patients, establish
appropriate personnel qualifications, or ensure consistency in the quality of medical procedures
of any relevance to conducting research. Other elements of the model program, such as recordkeeping
requirements for reproductive tissues, could, however, be extended to research labs at
biotech companies and university hospitals.
In addition to its inability to reach any of the controversial reproductive procedures or
research protocols, the model program includes only weak sanctions. HHS, through the CDC,
makes inspection results public and has the authority to revoke the certification of third-party
inspectors. 13 This approach may be described as enforcement by disclosure, and under certain
circumstances it can indeed be effective – for example, when disclosed information negatively
affects an organization’s public image. Bad publicity is often associated with negative economic
consequences, reason enough for an organization to stay in compliance with applicable laws and
regulations. In the present case, however, neither ART clinics nor third-party inspectors are
likely to suffer significant financial losses from a poor inspection record. Neither one of these
types of organizations has enough public visibility to fear the negative consequences of bad
publicity.
5.1.2 Public Health Service Act
The use and manipulation of reproductive tissues, including embryos, is not entirely beyond
the reach of the FDA. Section 361 of the Public Health Service Act (PHSA) gives the FDA the
authority to promulgate rules and regulations to prevent the introduction, transmission, and
spread of communicable diseases between the states or from foreign countries into the United
States. In this area, the FDA has exercised its authority selectively. While blood and bloodrelated
products have traditionally received considerable scrutiny, other biological products have
remained essentially unregulated. In response to the rapid growth in the commercial trade of
human tissues, the agency announced in 1997 its plans to implement a comprehensive regulatory
system aimed at minimizing health risks involved in the transplantation of human tissues,
improving understanding of the human tissue bank industry, monitoring new developments, and
institutionalizing communication and information exchange with industry members. These plans
are set out in two documents: “A Proposed Approach to the Regulation of Cellular and Tissue-
Based Products” and “Reinventing the Regulation of Human Tissue.” 14 The new regulatory
framework consists of three main rules: an “establishment registration and listing” rule, a “donor
13
14
See 42 USC 263a-3(c).
See http://www.fda.gov/cber/gdlns/celltissue.pdf and http://www.fda.gov/cber/tissue/rego.htm, respectively.
Programmatic documents and proposed interim and final rules can be found at
http://www.fda.gov/cber/tissue/docs.htm. See also Martha A. Wells, "Overview of FDA Regulation of Human
Cellular and Tissue-Based Products," Food and Drug Law Journal 52 (1997).
120

eligibility” rule, and a “good tissue practice” rule, 15 all of which have been finalized, pending
some minor changes.
Of particular interest to the present discussion are the first two rules on “establishment
registration” and ”donor eligibility.” The first rule simply requires all tissue manufacturers,
including ART programs and sperm and oocyte banks, to register with the FDA and to provide a
listing of the human tissues produced, stored, or manipulated. Registration consists of a one-page
form, to be updated twice a year. 16 Upon completion of the registration process, it will be
possible for the first time to determine the exact number and type of reproductive tissue facilities
in the United States. While the number of ART programs is well-known, no accurate information
was available until recently on the number of sperm and oocyte banks operating in the United
States. Estimates ranged from less than 100 to more than 1,000. 17 Its simplicity notwithstanding,
this rule is an essential element of any regulatory infrastructure aimed at monitoring the ART
industry.
Donor screening and testing requirements set forth in the second rule (“donor eligibility”)
are not central to the present discussion. The rule would be of considerable import if Congress
decided to monitor and/or regulate the trade of reproductive tissues. As discussed in chapter 6,
most countries that recently have passed regulation in the area of reproductive medicine have
restricted, in some cases severely, the free and commercial trade of reproductive tissues. The
“donor eligibility” rule requires not only that donors be screened and tested, but that the
reproductive tissue establishments maintain documentation about all reproductive tissues. The
rule has detailed provisions for the information that must be attached to reproductive tissues at
all times. 18 In addition to the test results, a unique identification code associated with the donor
must be included. Tissue banks must retain these records for at least 10 years.
If the U.S. public, through Congress or a regulatory agency, determined that the trade of
oocytes should be permitted but only as a non-commercial activity, the “donor eligibility” rule
would considerably facilitate the agency’s monitoring and enforcement efforts. To this end, the
labeling requirements would have to be updated to include some basic financial information
about each transaction. More generally, this rule may also be regarded as a first important step
15
16
17
18
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 207, 807, and 1271.
Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final
Rule," Federal Register 66, no. 13 (2001).
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 210, 211, 820, and
1271. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,"
Federal Register 69, no. 101 (2004).
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 16, 1270, and
1271," Federal Register 69, no. 226 (2004).
See http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3356.doc.
In 1997, Ginsberg put this number at 400, but the source was a New York Times news story whose source was
unnamed. See Karen M. Ginsberg, "FDA Approved? A Critique of the Artificial Insemination Industry in the
United States," University of Michigan Journal of Law Reform 30 (1997), p.826.
Department of Health and Human Services (Food and Drug Administration), "21 CFR Parts 16, 1270, and
1271," p.1271.55.
121

toward implementing a comprehensive system for monitoring embryo donation and, depending
on political preferences, for monitoring oocytes as well. Finally, the rule includes specific
enforcement provisions, although it has an important limitation: It does not extend to research
and educational establishments. From a public health standpoint, this is perfectly reasonable, but
it is a crucial limitation in terms of monitoring capabilities.
In this new scheme, the FDA considers reproductive tissues (defined as eggs, sperm, and
embryos) a low-risk category; they are subject to minimal manipulation, and usually they are
exchanged between sexually intimate partners. In this case, the FDA merely recommends donor
screening. This means that ART clinics, with certain exceptions, are not subject to the new
screening, reporting, and labeling requirements. Sperm banks, however, must comply with the
new FDA rules. Should cryopreservation technologies improve to the point of allowing the
freezing of eggs, oocyte banks would also fall under the purview of these new rules.
5.1.3 The Clinical and Laboratory Amendments of 1988
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) was designed to ensure
that clinical laboratories around the country meet minimal quality and safety standards. It also
imposes minimal requirements on the professional qualifications of laboratory personnel. In
essence, CLIA’s mandate is to guarantee that tests performed on human tissues and materials
provide accurate and reliable information “for the diagnosis, prevention, or treatment of any
disease.” As this brief description already indicates, CLIA is very unlikely to reach actual
practices of reproductive medicine; the statute applies exclusively to clinical tests “for the
diagnosis, prevention, or treatment of any disease ... or the assessment of the health of human
beings.” 19 For example, CLIA would reach testing of semen and ova, but not the actual IVF
treatment. CLIA would presumably extend to PGD (the procedure of extracting and testing a cell
from an early-stage embryo), but it certainly does not provide a statutory basis for crafting
guidelines aimed at informing when performing PGD may or may not be appropriate. As for
research laboratories, to the extent that they do not offer clinical services, they are explicitly
exempt from compliance with CLIA.
CLIA clearly was not designed to resolve controversies produced by new reproductive
technologies or novel research protocols. Scholars seem to agree that CLIA so far has been
ineffectual even in ensuring the effectiveness of genetic tests. 20 Others have noted that the Center
for Medicare and Medicaid Services (CMS), which administers this statute, has been plagued
with monitoring and enforcement problems. This is hardly surprising, given that according to
CMS as of December of 2003, there were 184,000 laboratories in the United States. Monitoring
19
20
See 42 U.S.C. 263a(a) (1994).
Lori B. Andrews, "A Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health and
Fundamental Rights Models," Washington University Law Quarterly 79 (2001), p.256-57; Anny Huang, "FDA
Regulation of Genetic Testing: Institutional Reluctance and Public Guardianship," Food and Drug Law Journal
53 (1998); Michael J. Malinowski and Robin J.R. Blatt, "Commercialization of Genetic Testing Services: The
FDA, Market Forces, and Biological Tarot Cards," Tulane Law Review 71 (1997).
122

and enforcement difficulties can partly be explained by the fact that CLIA merely requires labs
to identify themselves for certification. It appears that many small labs are not aware of this
requirement. Compliance rates, while improving over time, remain a concern, especially among
physician office labs.
To the extent that CLIA reaches embryology and other laboratories that perform clinical
tests for ART clinics, this statute could serve as a useful tool for monitoring and quality
assurance, assuming that a sufficient proportion of all embryology and andrology labs have
indeed registered with the program. What makes CLIA relevant to our discussion is not the
statute per se, but the administering agency. CMS, if adequately funded, could be a suitable
administrative host for a newly created regulatory agency. Unlike NIH, CMS does not have
strong institutional ties to the scientific community. Nor does it have strong ties to the ART
sector, as the CDC does. In addition, CMS and the biotech industry do not have a history of
collaboration. CMS does, however, have considerable expertise in regulating a large, dispersed
and diverse population of laboratories, and it would clearly have the scientific and medical
expertise to carry out this task in an efficient manner.
5.1.4 Institutional Review Boards and Human Subject Protection
It is no exaggeration to say that scientists, ART specialists, and biotech companies – not to
mention many ethicists – tend to view institutional review boards as a panacea for resolving any
and every ethical controversy. Congress often shares this assumption. Recent Congressional bills
such as Senate Bill S. 303 require IRB approval for research protocols involving stem cells,
probably on the assumption that an IRB review would take care of the surrounding controversies.
Some reasonable prima facie arguments can indeed be offered for relying on IRBs as a
means to untangle ethical controversies. IRBs are a decentralized and flexible system of
decision-making. To many scientists in academia and in the private sector, they are highly
preferable to a rigid and slow-moving federal bureaucracy. According to this view, IRBs are in a
much better position to take into account highly contingent factors and local peculiarities that a
federal system of oversight, by its very nature, would be forced to ignore. In addition, affected
organizations such as research hospitals, universities, and biotech companies are all very familiar
with this system of review. 21
In our view, most of these arguments do not stand up to closer scrutiny. Before delving into
this discussion, however, a brief discussion of the IRB review system is necessary. There are two
distinct but very similar sets of FDA regulations governing experimentation on human subjects
and the establishment of an IRB: The “Common Rule” has jurisdiction over federally funded
21
This view is based largely on past experience with clinical ethics consultations. See, for example, Susan B.
Rubin and Laurie Zoloth, "Clinical Ethics and the Road Less Taken: Mapping the Future by Tracking the Past,"
Journal of Law, Medicine and Ethics 32 (2004). In the context of clinical consultations on highly private matters,
this position is commendable. We are far from convinced that the same approach is viable in the context of
modern-day biomedical research.
123

clinical research, 22 while the FDA has its own set of regulations governing privately funded
clinical trials. 23 Many of the observations in the remainder of this section apply to both sets of
regulations.
A first important observation is that both regulations define research in very narrow and
technical terms. Consider, for example, how the Common Rule defines research: “Research
means a systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge.” 24 While this is certainly an
acceptable definition of research, it is a very narrow one. Experimental medical procedures such
as those often performed in the ART industry would not fit this definition of research, as they are
not performed for the purpose of contributing to generalizable knowledge and they can hardly be
described as “systematic investigations.” 25 In addition, they are generally not funded by the
federal government. 26 As for controversial research protocols, they often do involve human
subjects, but only in a marginal sense of this term. To the extent that reproductive tissues are
obtained from human donors, human subjects would indeed be involved in research. For
example, the donation of embryos, oocytes, and sperm would require free and informed consent,
and would therefore trigger an IRB review. We certainly do not want to minimize the importance
of this review, but it must be said that reviewing informed consent forms simply will not reassure
the critics of experiments involving human reproductive tissues. On the other end, current
regulations would be wholly inadequate to address the health, safety, and ethical concerns raised
by clinical trials involving inheritable genetic modifications, as for example in the case of the
genetic modification of pre-implantation embryos. 27 In sum, neither the Common Rule nor 21
C.F.R. 50 and 56 are likely to reach experimental reproductive procedures nor are research
protocols themselves significantly affected by these regulations.
Could IRBs be reformed so as to become an effective and credible institution for the
adjudication of controversial ethical disputes? Technically yes, but practically no, if one
22
23
24
25
26
27
See 45 C.F.R. 46.
See 21 C.F.R. 50 and 56.
See 45 C.F.R. Sec. 46.102 (d).
There is an extensive literature on the distinction between medical research and medical experimental treatments.
We are certainly not arguing that innovative medical procedures should always be subject to IRB review, nor
that such procedures are not legitimate. Medicine remains in many ways an art, one that often requires medical
practitioners to depart from standard medical practice. Surgery provides a striking illustration. On the other end,
as we discuss in more detail in chapter 13, so-called innovative treatments on occasion amount to little more than
experimentation on human subjects free of any of the usual checks imposed on clinical trials. See Amer S.
Ahmed, "The Last Twist of the Knife: Encouraging the Regulation of Innovative Surgical Procedures,"
Columbia Law Review 105 (2005); Nancy M.P. King, "The Line between Clinical Innovation and Human
Experimentation," Seton Hall Law Review 32 (2002); Lars Noah, "Informed Consent and the Elusive Dichotomy
between Standard and Experimental Therapy," American Journal of Law and Medicine 28 (2002).
Federal funding of embryo research has been prohibited since 1996. Research on eggs and sperm is not subject
to this ban.
For an in-depth discussion, see Rebecca Dresser, "Genetic Modification of Preimplantation Embryos: Toward
Adequate Human Research Policies," Milbank Quarterly 82, no. 1 (2004).
124

considers the scope and depth of the necessary changes. Consider first the central task an IRB is
called upon to perform – namely, the evaluation of the risk and benefits of research on human
subjects. First, the legal definition of research would have to be broadened. Second, the scope of
IRB review would have to be updated. For instance, the Common Rule currently limits the scope
of the risks IRBs are required to consider: “The IRB should not consider possible long-range
effects of applying knowledge gained in the research (for example, the possible effects of the
research on public policy) as among those research risks that fall within the purview of its
responsibility.” 28
This qualification all but precludes IRBs from including broader societal
concerns as described in chapters 2 and 4. Third, the rules governing the appointments to an IRB
would have to undergo fundamental changes. IRBs consist largely of scientists and clinicians.
While the regulations governing the establishment and operation of IRBs require that at least one
individual with no connections to science and medicine be included, this is hardly a guarantee of
a broad and balanced examination of ethical concerns.
How the appointment rules could be modified so as to broaden the range and depth of
ethical views represented on an IRB is not entirely clear. The inclusion of bioethicists is a first
necessary but by no means sufficient step. As we show in more detail in chapter 10.2,
professional bioethicists and the general public take very different approaches to evaluating
controversial medical procedures. 29 These differences cannot easily be reconciled or ignored.
Broadening the participation to include laypersons is probably another necessary step, but the
implementation of this requirement is fraught with conceptual and practical difficulties. In sum,
the scope and depth of the necessary reforms are so significant as to require a fundamental
redesign of the IRB system of review.
Commentators have also noted several operational problems affecting the current system. 30
Decision-making procedures within IRBs are a major source of concern. IRBs do not provide a
written justification for their decisions, and their meetings generally are not public. Individual
IRB members are not required to explain their positions; assessments of risks and benefits often
are impressionistic. Minutes are available, but they are rarely detailed enough to provide insight
into the decision-making process. 31 Minimal procedural standards all but ensure that in similar
cases, IRBs will produce inconsistent results. In sum, IRBs do not operate according to
28
29
30
31
See 45 C.F.R. Sec. 46.102 (d).
Susan L. Erikson, "Post-Diagnostic Abortion in Germany: Reproduction Gone Awry, Again?," Social Science &
Medicine 56 (2003); Jackie Leach Sculley, Christine Rippberger, and Christoph Rehmann-Sutter, "Non-
Professional Evaluation of Gene Therapy Ethics," Social Science & Medicine 58 (2004); Wertz et al., "Has
Patient Autonomy Gone Too Far? Geneticists' Views in 36 Nations."
Carl H. Coleman, "Rationalizing Risk Assessment in Human Subject Research," Arizona Law Review 46 (2004);
Ezekiel J. Emanuel et al., "Oversight of Human Participants Research: Identifying Problems to Evaluate Reform
Proposals," Annals of Internal Medicine 141, no. 4 (2004); General Accounting Office, "Scientific Research:
Continued Vigilance Critical to Protecting Human Subjects," (Washington, D.C.: GAO/HEHS publication no.
GAO/HEHS-96-72, 1996).
Coleman, "Rationalizing Risk Assessment in Human Subject Research."
125

principles of good governance as federal regulatory agencies or administrative law judges are
required to do.
5.1.5 Federal Funding of Embryo Research
A major obstacle to improving the safety and effectiveness of ART treatments and to
conducting advanced medical research is the Congressional ban on federal funding of embryo
research. This prohibition came in the form of an amendment to the Health and Human Services
Appropriation Bill of 1996, the so-called Dickey-Wicker Amendment. The amendment has been
reauthorized every year since its introduction, and there is no indication that Congress will lift
this ban soon. 32
Some commentators regard this ban as the only ethical position consistent with the
government’s strong preference for the respect of nascent human life. This may seem at first a
coherent attitude. On closer examination, however, this policy also has produced ethical
contradictions. If respect for nascent human life is of paramount importance, it cannot be
acceptable for the U.S. government to simply ignore privately funded experimentation on human
embryos. The U.S. government has not legalized or otherwise endorsed privately funded
research, but this lack of enthusiasm certainly has not prevented many biotech companies from
conducting research on human embryos, activities that a consistent ethical position should
explicitly condemn.
From a practical standpoint, the ban on funding human embryo research has had some
perverse consequences. In all likelihood, the Dickey-Wicker Amendment has kept medical
technology from improving ART success rates, and therefore has contributed to the creation and
destruction of more human embryos than absolutely necessary. It has also undermined efforts to
better understand the causes of infertility, and probably hindered the development of more
effective ART techniques. These unintended consequences have most likely increased rather
than diminished the instrumental use of human embryos.
Perhaps most importantly, with this ban, the government has lost its ability to oversee
embryo research in the private sector. Elected officials may still find that the Dickey-Wicker
Amendment is the only defensible ethical position in this matter, but they should come to this
conclusion after taking into account both the intended and unintended consequences of this
position.
5.1.6 The National Organ Transplantation Act
The National Organ Transplantation Act of 1984 makes it “unlawful for any person to
knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for
use in human transplantation if the transfer affects interstate commerce.” 33 The act defines the
meaning of “human organ” in very broad terms. It includes, among other things, fetal tissues
32
33
As, for example, in the most recent appropriation bill, S. 2810, Sec. 510.
See 42 USCS 274e (2004)(a).
126

and/or any organs derived from human fetuses. It also establishes substantial penalties for
violating its provisions. However, legal scholars agree that this act does not reach the trade of
human gametes. It appears that no judicial decision has ever construed the meaning of “human
organ” to include gametes. 34
Hence, for the purpose of this report, the National Organ
Transplantation Act is immaterial.
5.1.7 Regulation by Tort
Conceivably, the practice of reproductive medicine could also be regulated through the tort
system. Malpractice litigation is based on the notion that a plaintiff, in order to prevail, must
demonstrate that he or she is owed a duty of care, and that the attending physician has harmed
the plaintiff by violating this duty. Combined with often-draconian verdicts, this system is
supposed to induce medical professionals to establish appropriate standards of care and to ensure
that practitioners follow them scrupulously.
An obvious limitation of this system is its focus on procedures rather than on the merits of
an expected outcome. For example, whether sex selection for non-therapeutic uses is an ethically
acceptable reproductive procedure cannot be decided through tort litigation. Litigation in this
case can only determine whether a patient was harmed, and whether harm can be attributed to
medical malpractice. In the case of many ethically controversial treatments, making these twin
determinations is no easy task. For example, is it really possible to claim that failure to deliver a
baby of the desired sex amounts to medical malpractice? Certainly the “outcome” was undesired,
but can a baby of the “wrong” sex really produce harm? Assuming some notion of harm is
recognized by the court, what standard of care has been violated in this case?
One can easily imagine many variations on this scenario. Pre-implantation genetic diagnosis
to screen for dreadful diseases and ooplasm transfer to treat extreme cases of infertility provide
two examples. How the courts may decide these cases is an interesting question for legal scholars
to ponder, but it is beyond the scope of the present discussion. Presumably, litigation in this area
would prompt ART clinics to scrutinize more carefully the harm that novel reproductive
technologies and innovative treatments might cause and to establish appropriate standards of
care. 35
This development certainly would be most welcome, but standards of care all by
themselves are of little importance in adjudicating competing ethical claims.
5.1.8 Regulation by the Market
Regulation can occur through market mechanisms as well. There are many precedents in this
area. Consumers may prefer products certified to have been produced in an environmentally
34
35
President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies,
p.151-52.
In recent times, serious doubts have emerged about the effectiveness of malpractice litigation in improving
medical standards of care. An excellent introduction to this issue is Atul Gawande, Complications: Decisions
and Dilemmas of a Surgeon's Life (London: Profile Books, 2002).
127

sustainable way. Examples include chocolate, coffee, fruits, vegetables, and furniture. In other
cases, the products in questions have been manufactured in accordance with broadly accepted
social standards. The textile and toy industries have made significant efforts in this area. 36 A key
reason for the success of these initiatives is the very active role played by international
nongovernmental groups. It is also fair to say that despite unresolved questions of legitimacy, the
social and environmental causes advanced by these groups are broadly in line with consumers’
preferences in industrialized countries. Unfortunately, this is not the case with consumer groups
associated with the ART industry. Groups like the National Infertility Association (known as
RESOLVE) and the American Fertility Association (AFA) espouse what may be described as a
purely self-interested perspective on many issues associated with reproductive technologies. For
example, in its response to early drafts of the President’s Council on Bioethics report,
“Reproduction and Responsibility,” RESOLVE made it quite clear that access to reproductive
technologies and the cost of reproductive services eclipse any consideration pertaining to the
health and well-being of children:
[…] At the outset, it must be stated that additional reporting requirements necessarily increase the
costs of providing treatment for infertility, and these costs will be borne by patients. We do not
support additional reporting requirements that will further burden the medical profession, making
fertility treatment more expensive for patients and less accessible to them, without providing
substantial benefits for the patients.
[…] While always concerned about material side effects of treatments, RESOLVE believes it is
too soon to launch mandatory reporting until it is known through ongoing and proposed studies
that the risks are substantial enough to justify burdening doctors and raising what may be needless
concerns in patients. 37
In this case at least, it is clear that public interest groups cannot be expected to advance the
public interest.
5.2 Recent Legislative Initiatives
5.2.1 Congressional Initiatives
Over the last few years, most OECD (Organisation for Economic Co-operation and
Development) countries have passed legislation in the areas of new reproductive technologies
and biomedical research. Many Asian countries also have crafted or are in the process of crafting
new laws in this area. Only one country so far has failed to take any legislative measures – the
United States. To some extent, the legislative gridlock in this area is a direct consequence of the
U.S. system of divided government. According to the Center for Public Integrity in Washington,
36
37
See, for example, Peter Fallon and Zafiris Tzannatos, "Child Labor: Issues and Directions for the World Bank,"
in Social Protection, Human Development Network (Washington, D.C.: The World Bank, 1998); Charles Sabel,
Dara O'Rourke, and Archon Fung, "Ratcheting Labor Standards: Regulation for Continuous Improvements in the
Global Workplace," (John F. Kennedy School of Government, Harvard University, 2000).
A letter dated October 2, 2003, from RESOLVE Board Chairperson Vicki Baldwin to the President’s Council on
Bioethics on an early draft of the report. Letter on file with the authors.
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D.C., since 2001, the Congress has attempted more than 40 times to pass legislation related to
cloning and stem cell research. 38 None of these initiatives has become law. A review of the
legislation proposed since 2001 shows that the proposed bills fall in two main categories. Many
legislative proposals simply aim at prohibiting any kind of cloning research, independently of its
purpose. In the second category, we find bills that explicitly ban and often criminalize cloning
for reproductive purposes, but legalize research cloning.
We believe that none of these bills represents an adequate response to current ethical
controversies. Broad legislative bans are too blunt a response in light of the need to make fine
distinctions between acceptable and unacceptable applications of new reproductive technologies
and medical research. On the other hand, distinguishing between reproductive and research
cloning is only the first step toward addressing ethical controversies, of which many more would
remain unresolved. To appreciate just how narrow the focus of legislative debates in the United
States has been, one only needs to compare the scope of U.S. legislative efforts with legislative
proposals in other OECD countries. As Table 16 and Table 17 in Appendix H demonstrate, most
European and Asian countries have found it necessary to provide legal guidance not only for
cloning research, but also for embryo research, pre-implantation genetic diagnosis (and sex
selection), the creation of chimerical animals and hybrids, germ-line genetic engineering,
reproductive services, and the trade of human gametes. By contract, the United States is the only
country that has enacted little or no legislation in most of these areas.
5.2.2 Senate Bill 303
In this section, we examine in some detail Senate Bill 303, a bill that has been praised by
many as a reasonable legislative answer to the current legislative gridlock over cloning research,
but has been opposed in the Senate by pro-life legislators. S. 303 was passed by the House of
Representatives and referred to the Senate Judiciary Committee in 2003, where it has been
languishing ever since. Its official title is the “Human Cloning Ban and Stem Cell Research
Protection Act of 2003.” As the name suggests, it consists of two distinct parts, Title I, the
“Prohibition of Human Cloning,” and Title II, “Ethical Requirements for Nuclear
Transplantation Research.”
Title I is a straightforward ban on reproductive cloning. It instructs the Department of
Justice to adopt measures to detect possible violations, in collaborations with state and local
authorities. Penalties for performing or attempting to perform human reproductive cloning are
among the most severe in the world – imprisonment for up to ten years and a fine of up to a
million dollars. Section 102(a) instructs the Justice Department, among other things, to prepare
and submit a report to the Senate Judiciary Committee that describes the actions taken by the
Attorney General to enforce the ban on reproductive cloning.
Which measures the Justice Department would have taken to ensure compliance we will
never know. It could have required any individual or institution that plans to conduct research
38
See Appendix D for an overview.
129

cloning to register with the Department, as proposed by earlier bills. Alternatively, it could have
conducted random inspections, in cooperation with the states, as it does in enforcing
environmental statutes. What is clear is that S. 303 does not explicitly require the Justice
Department to design and implement a robust system of embryo registration and tracking. Nor is
it clear that the bill would have authorized the Justice Department to implement such a system.
In sum, S. 303 offers insufficient guarantees to opponents of reproductive cloning that if nuclear
transplantation research were to be legalized, the Justice Department would have had both the
legal authority and the administrative resources to prevent and to sanction abuses. Without a
comprehensive system of oversight, the legal distinction between reproductive and research
cloning is not credible.
Title II establishes a legal framework for conducting research cloning, in this bill referred to
as “nuclear transplantation research.” Specifically, Section 499A(b) requires that nuclear
transplantation research be reviewed by an institutional review board, and that informed consent
be obtained from the human subjects involved in the research, most notably from the women
donating their oocytes. Section 499A(d) limits the use of and experimentation on “unfertilized
blastocysts” – i.e., on cloned embryos up to 14 days old – and prohibits their purchase or sale.
IRB review and informed consent clearly are meant to reassure critics that nuclear
transplantation research would be conducted in accordance with strict ethical standards.
For those who believe that embryos have the same moral status as newborn infants, S. 303
simply is unacceptable, whether or not the bill includes appropriate legal safeguards; it
legitimizes embryo research, legalizes the destruction of embryos, and paves the way for federal
funding of research in this area. As noted in the introductory chapter, this is not our position. We
believe that embryos have an intermediate moral status, and that research on embryos is morally
acceptable if appropriate legal safeguards are put in place. Unfortunately, from an administrative
and regulatory standpoint, Title II falls short of providing a legal framework capable of
reassuring a skeptical public. As we have shown earlier in this chapter, IRBs are wholly
unsuitable to review ethically controversial research proposals. In addition, Title II does not
make any provisions for the establishment of an embryo tracking system, in the shape of either a
reporting or a licensing scheme. One may argue that it would have been the Justice Department’s
responsibility to ensure that nuclear transplantation is conducted exclusively for research
purposes, but as we have shown above, Senate Bill 303 is in this regard too generic and quite
possibly inadequate.
In sum, far from being a reasonable compromise, S. 303 would allow the research
community to move forward with highly controversial research with only minimal legal
oversight. S. 303 simply does not provide a credible institutional mechanism for resolving the
inevitable controversies that any research protocol involving nuclear transplantation would
generate, nor does it require the adoption of effective safeguards against possible abuses.
Compare this legislative proposal with the situation in Britain. Critics on this side of the
Atlantic have argued that the British approach is too permissive. The American scientific
community, for its part, considers the British regulatory system too cumbersome and
130

ureaucratic. As we discuss in more detail in chapter 6.4, reproductive cloning in Britain is
prohibited, but research cloning is legal. Any research protocol involving nuclear transplantation
must obtain a license from the Human Fertilization and Embryology Authority, which closely
scrutinizes the rationale for conducting research on human embryos in general, and for research
cloning in particular. This provision alone is likely to make the HFEA unacceptable to the
American scientific community. Yet ironically, in October of 2004, the HFEA approved the first
research protocol involving nuclear transplantation. The decision was far from uncontroversial.
Pro-life groups vocally denounced it, but were eventually forced to recognize that the HFEA had
acted according to the laws of the country. As a result, a research group in Britain is now moving
forward with a cloning protocol backed by the full force of the law – despite, or perhaps thanks
to, a regulatory system considered by American observers to be too intrusive.
5.2.3 Legislative Initiatives at the State Level
Our discussion of state-level initiatives is not meant to be exhaustive. After examining
various state-level legislative initiatives, we have come to the conclusion that there is little to be
learned from the states either in the area of reproductive medicine or biomedical research. As
several commentators have recognized, few states have passed legislation concerning
reproductive technologies, and even fewer cases are relevant to the present discussion.
Of some interest is the approach taken by Louisiana to regulating reproductive medicine.
Louisiana, certainly, is the state that has passed the most comprehensive legislation in this area,
and also the most restrictive. Noteworthy in particular is the extensive legal protection afforded
to the embryo, defined as a “juridical person” enjoying most of the legal rights and protections
afforded to children. 39 More pertinent to the discussion is Louisiana reliance on the American
Society for Reproductive Medicine and the American College of Obstetricians and
Gynecologists (ACOG) to ensure that reproductive laboratories and facilities meet suitable
standards of quality and consistency. This is an important precedent: It demonstrates that, as for
other policy domains, it is both possible and sensible for regulators to rely on private standarddeveloping
organizations to achieve public goals. 40 The case of Pennsylvania is also worth
mentioning in this context, because it is to our knowledge the only state that has adopted
extensive record-keeping requirements. Both Louisiana’s and Pennsylvania’s experience in
regulating reproductive medicine could prove very valuable to federal regulators tasked with
implementing similar schemes at the federal level.
When it comes to the regulation of biomedical research, recent state-level initiatives closely
follow federal patterns. They are narrowly focused on cloning and stem cell research, and just
like the numerous federal bills introduced over the last few years, they either attempt to ban any
39
40
President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies,
p.52-53.
As we show in more detail in chapter 13.6, there are some good prima facie reasons for delegating certain
functions to the private sector, including economic efficiency, flexibility, and access to technical and medical
expertise.
131

kind of cloning or they limit the ban to reproductive human cloning but fail to provide adequate
safeguards for conducting research cloning. Among the states that have banned both
reproductive and research cloning are Arkansas, Iowa, North Dakota, South Dakota, and
Michigan. Many states have attempted to ban both kinds of cloning but have so far failed to pass
any legislation. Virginia has banned reproductive cloning, but excluded research cloning from its
ban. Rhode Island has adopted a similar measure, to expire in 2010. Some states, like Missouri,
have merely banned state funding of research cloning. New Jersey is the only state that has
passed legislation that explicitly bans reproductive cloning but legalizes research cloning.
Unfortunately, the New Jersey law, just like Senate Bill 303, while acknowledging the
controversial nature of this research, only requires research protocols to receive IRB approval,
and does not include any other safeguards against possible abuses. 41
California deserves a separate discussion. In 2003, the state of California banned
reproductive cloning but legalized research cloning and embryonic stem cell research. California
did go a step further, however. The state legislature required the California Department of Health
and Human Services to establish an anonymous registry of embryos available for research, and
specified in considerable detail the rules for disposing of these human embryos. The state
legislature, however, made the registry’s implementation dependent on the availability of private
funding. It also directed the state’s Health and Human Services Department to establish an
advisory board responsible for crafting guidelines for embryonic stem cell research. In the fall of
2003, then-Governor Gray Davis signed both bills into law. By any measure, this legislation was
by far the most sophisticated attempt at banning reproductive cloning while providing reasonable
safeguards to conducting research cloning.
With the 2004 passage of Proposition 71 (the “California Stem Cell Research and Cures
Act”), the situation has changed dramatically. Proposition 71 represents a radical departure from
pre-existing legislation in this area. It requires the state of California to raise $3 billion, to be
administered by a newly created California Institute for Regenerative Medicine (CIRM). An
“Independent Citizen’s Oversight Committee” should ensure that the research funds are spent in
conformance with the statute. Its label notwithstanding, the CIRM’s oversight committee
involves neither citizens nor independent individuals. Its 29 members are drawn from the
research institutions and biotech companies benefiting from the funding, and from various
disease advocacy groups that are strong promoters of this kind of research. The initiative goes so
far as to specify that no minority opinion can be issued unless 35 percent of the board votes in
favor; the likelihood that 11 of 29 members would have true independence from the scientific
community and the biotech industry is negligible, thus essentially muting any form of dissent.
Like its legislative predecessors, Proposition 71 explicitly embraces research cloning, but
makes no provisions for regulatory controls that would prevent, for example, a cloned embryo
from being implanted in a woman’s uterus. Disturbingly, the initiative specifically exempts
California researchers from existing rules prohibiting experiments on embryos beyond eight to
41
See Appendix G for an overview of state legislative initiatives.
132

12 days old, as well as safeguards for obtaining informed consent in human subject research. The
initiative carefully removes virtually all institutional constraints that would interfere with the
insiders doing what they want with the funds. Finally, the state legislature is prohibited from
amending the initiative for three years, and then only by a 70 percent margin, which makes it
highly unlikely that it will be able to pass any changes. 42
In sum, while the legislation passed by the California legislature in the fall of 2003 took
some preliminary but promising steps to create appropriate legal safeguards for conducting
cloning research, Proposition 71 was written in a way that all but ensures that the scientific
community will be able to conduct highly controversial research at the taxpayer expense free of
virtually any public oversight. Perhaps because the legislation was so poorly drafted, it has
already been challenged in the courts and faces potentially crippling delays as a series of litigants
challenge various aspects of the proposition.
5.3 Self-Regulatory Initiatives
5.3.1 Introduction
There is a tendency in many policy debates to consider regulatory interventions and selfregulatory
programs mutually exclusive. Typically, industry representatives perceive federal and
state regulations as burdensome and ineffective, and advocate self-regulation as a superior
alternative. Public interest groups, policy-makers, and many academics also subscribe to the
view that government regulation and industry self-regulation are mutually exclusive, but
interpret this observation in a diametrically opposed way. In the view of these critics, selfregulation
can be described as an elaborate public relation exercise meant to improve an
industry’s public image and to prevent regulatory interventions. In the critics’ view, cases of
credible self-regulation are simply too rare for self-regulation to be considered a credible
regulatory option. Neither one of these characterizations is empirically accurate. As we show
below, regulatory systems are almost always an amalgamation of legal requirements and private
standards. Effective and responsive regulatory systems often are based on self-regulatory
elements, an insight that will guide much of the discussion in chapter 13.6.
In the remainder of this section, we first provide several examples of the hybrid nature of
modern regulatory systems. We then examine in some detail the main components of the selfregulatory
system as it exists in the ART industry. As it will quickly become apparent, these selfregulatory
initiatives, while remarkable in their own right, all by themselves are incapable to
credibly adjudicate broad societal disputes produced by new reproductive technologies. Properly
integrated into a formal system of regulation, however, they could play a very important
supporting role.
42
The Center for Genetics and Society has monitored the implementation of Proposition 71 from the start. For a
detailed discussion see http://genetics-and-society.org/resources/cgs/20060118_cirm_press.html.
133

The federal government has been relying on the private sector to meet its numerous public
mandates in several ways. The Underwriters Laboratories (UL), for example, has long been
responsible for testing and certifying the safety of electric appliances and devices. The UL plays
a quasi-autonomous regulatory role, the credibility of which is ensured in part (but not
exclusively) by the tort system. UL is not an exceptional case, however. Just about every sector
of the economy has developed safety standards. Some of the most familiar examples include fire
safety codes developed by the National Fire Protection Association, health and safety standards
for cosmetics promulgated by the U.S. Pharmacopeia, and the innumerable standards developed
by American Society for Testing and Materials. 43
In other cases, the government sets broad public goals but allows the private sector to
determine how to achieve them. Emission trading systems are a case in point. The Environmental
Protection Agency (EPA) sets an overall environmental goal – for example, the total volume of
sulfur dioxide emissions produced by coal-burning electric plants – but leaves it to the market to
find the most cost-effective way to achieve this goal. Another example is Project XL, launched
by the EPA in 1995 as part of the Clinton administration’s efforts to improve government
services. 44 Under this program, industrial plants with multiple pollution sources can apply for a
single permit if they demonstrate that they can reduce their overall emission volume. More
prosaic perhaps but just as relevant is the case of the Fertility Clinic Success Rate and
Certification Act discussed in section 5.1.1 above. As the agency responsible for administering
FCSRCA, the CDC has delegated the responsibility for gathering ART success rates to a private
group, the Society for Assisted Reproductive Technology.
The federal government has a long record of adopting privately developed standards. One of
the most spectacular examples is the Occupational Safety and Health Administration’s wholesale
adoption of private health and safety standards soon after its creation. 45 Another example is the
Nuclear Regulatory Commission’s incorporation of its books of safety standards developed by
the Nuclear Energy Institute, an industry trade association. FCSRCA was in large part an
exercise in the codification of an already existing practice, namely the annual survey of success
rates conducted by SART. SART began gathering information about success rates on a voluntary
basis in 1989, and has been publishing the results in the journal Fertility and Sterility ever since.
FCSRCA improved the SART surveys in several ways – by providing a consistent definition of
success rate, by making reporting of success rates to the CDC mandatory, and more recently, by
43
44
45
Harry S. Gerla, "Federal Antitrust Law and Trade and Professional Association Standards and Certification,"
Dayton Law Review 19 (1994); Samuel Krislov, How Nations Choose Product Standards and Standards Change
Nations (Pittsburgh: University of Pittsburgh Press, 1997).
Dennis D. Hirsch, "Project XL and the Special Case: The EPA's Untold Success Story," Columbia Journal of
Environmental Law 26 (2001); Lawrence E. Susskind and Joshua Secunda, "The Risks and the Advantages of
Agency Discretion: Evidence from EPA's Project XL," UCLA Journal of Environmental Law and Policy 17
(1998).
That many of these standards were more effective at protecting the competitive position of their private
developers than at achieving their purported goal is a sobering lesson about the pitfalls of blind trust in the
virtues of the private enterprise.
134

conducting targeted inspections of fertility clinics aimed at verifying the accuracy of the
information provided.
FCSRCA demonstrates that, far from being mutually exclusive, the credibility and
effectiveness of self-regulatory programs can be improved through formal regulation. It also
shows that much federal regulation is based directly on self-regulatory standards. At the same
time, the preceding discussion also suggests that self-regulation, all by itself, is neither
sufficiently credible nor very effective, an observation that carries over to the ART industry, to
which we now turn.
5.3.2 Self-Regulation in the ART Industry
In this section, we describe in some detail the ART industry’s system of self-regulation. The
discussion has two main purposes. We show that self-regulation in this sector cannot simply be
considered a public relations scheme designed to prevent regulatory action. Self-regulation
consists of an extensive network of private organizations that has promulgated numerous
standards pertaining to medical practice, and has issued many ethical recommendations. To put it
bluntly, self-regulation in the ART industry should be taken seriously. However, while our
discussion will demonstrate that self-regulation is an incomplete system of governance, backed
by the power of the state, the ART industry system of self-regulation could become both a
credible and an effective system of regulation.
American Society for Reproductive Medicine. The ASRM is the leading professional group
representing the industry interests at the national level. ASRM has approximately 9,000
members, 25 percent of which are international. Its members include not only reproductive
physicians, but also scientists, nurses, and other specialists whom, taken together, cover OB-
GYN, urology, psychiatry, andrology, and embryology. Each major professional specialty in the
industry is organized into a separate professional society. There are three major professional
groups – the Society for Reproductive Endocrinology and Infertility (SREI), the Society of
Reproductive Surgeons (SRS), and the Society of Male Reproduction and Urology (SMRU).
The ASRM offers services typical of any professional association: It lobbies federal and
state representatives on behalf of its members; it offers professional education and certification;
it has a well-established and extensive record of developing standards and guidelines pertaining
to the practice of reproductive medicine; and it has developed health and safety standards and
operating procedures pertaining to embryo labs. Importantly, it also has adopted consensus
recommendations on numerous controversial ethical questions.
The governance structure of ASRM consists of an executive committee, three standing
committees, and 26 appointed committees. Two committees, the practice committee and the
ethics committee, are of particular relevance to the present discussion. Both are appointed
committees. According to Sandra Carson, former ASRM president, the ethics committee
135

includes ethicists, scientists, mental health care providers, lawyers, and members of the general
public. 46
Table 2 and Table 3 illustrate the scope of the ASRM system of self-regulation. As these
tables clearly demonstrate, over the years, ASRM has adopted guidelines and recommendations
on many issues raised by the practice of reproductive medicine. Remarkably, these
recommendations are often quite specific. For example, ASRM discourages pre-implantation
genetic diagnosis for elective sex selection; it also does not recommend post-menopausal
pregnancies through oocyte donation, and it is strongly opposed to reproductive cloning. On
other, critical issues such as the number of embryos to be transferred during IVF, ASRM has
adopted a more flexible position: It recommends transferring two embryos in favorable cases,
four embryos in the case of “average” prognosis, and five embryos for women with a “poor”
prognosis.
Guidelines
Year of publication
Position Statement on West Nile Virus 2005
Ovarian Tissue and Oocyte Cryopreservation 2004
Position Statement on Donor Suitability of Recipients of
2004
Smallpox Vaccine
Estrogen and Progestogen Therapy in Postmenopausal
2004
Women
Round Spermatid Nucleus Injection (ROSNI) 2003
Clomiphene Citrate Use in Women 2003
Salpingectomy for Hydrosalpinx Prior to IVF 2001 (reviewed 2003)
Table 2: Recent guidelines published by ASRM/SART. 47
The recommendations on the number of embryos to be transferred provide an excellent
illustration of the strengths and weaknesses of self-regulation. ASRM could have adopted a rigid,
universal rule as did the British legislation. For example, it could have recommended that no
more than two embryos be transferred, in any case. Instead, ASRM in this case opted for
flexibility. Flexibility generally protects the ART practitioners’ prerogative to take what is
thought to be the most appropriate course of action – certainly a desirable feature. In this case,
however, professional autonomy tends to operate in favor of the prospective parents and against
the interests of future children. As discussed in Appendix C, a high number of simultaneously
transferred embryos are responsible for most twins and higher-order pregnancies. Higher-order
pregnancies are the single most important factor affecting the health of newborn babies – they
are associated with serious health problems and are extremely costly. 48 For these reasons, many
46
47
48
Sandra Carson, Biotechnology and Public Policy: Professional Self-Regulation (Session 5, President's Council
on Bioethics Meeting, March 7, 2003 [cited September 16, 2005]); available from
http://www.bioethics.gov/transcripts/march03/session5.html.
See Appendix E for a comprehensive list of published guidelines.
L. Garceau et al., "Economic Implications of Assisted Reproductive Techniques: A Systematic Review," Human
Reproduction 17, no. 12 (2002), p.3104-05; C Jones and R. Ward, "Cost-Minimization Analysis of One-, Two-,
136

countries have imposed strict limits on the number of embryos that can legally be transferred. In
this case at least, an inflexible rule that protect the health of ART children would seem preferable
to a flexible approach that preserves professional autonomy and furthers the prospective parents’
interests.
Opinion
Date of Publication
Fertility treatment when the prognosis is very poor or futile 2004
Child-rearing ability and the provision of fertility services 2004
Informing offspring of their conception by gamete donation 2004
Family members as gamete donors and surrogates 2003 (reviewed 2004)
Donating spare embryos for embryonic stem-cell research 2002 (reviewed 2004)
Table 3: Ethical opinions recently published by ASRM/SART. 49
A crucial limitation of the ASRM system of self-regulation is the absence of any formal
system of monitoring and compliance assurance. The ASRM does not monitor adherence to its
recommendations, nor has it ever considered doing so. In this regard, ASRM is not unique. Most
self-regulatory systems do not have formal mechanisms of oversight. There are two reasons for
professional groups’ reluctance to adopt systems of compliance assurance. In the United States,
trade and professional groups are very concerned that by taking enforcement action, they might
violate anti-trust legislation. Judicial decisions in this area indicate that the reluctance to interfere
with private business practices is indeed justified. 50 The second reason for this reluctance is
organizational. Since the membership to a trade or professional group is usually voluntary, these
groups have virtually no authority to ensure compliance with their guidelines; a member can
easily avoid private regulatory strictures by leaving the association.
American College of Obstetricians and Gynecologists. Just like the ASRM, ACOG – the
largest gynecology and obstetrics professional association in the United States – has issued
several ethical opinions on questions ranging from surrogacy to embryo research. 51 And just like
the ASRM ethical guidelines, ACOG opinions are meant to inform, not to constrain medical
practice. Accordingly, ACOG does not monitor compliance assurance nor has it ever considered
sanctioning violations, except for highly visible cases where inaction could seriously undermine
the association’s credibility.
49
50
51
and Three-Embryo Transfers in IVF," in Triplet Pregnancies and Their Consequences, ed. Keith Louis G. and
Blickstein Isaac (London: Parthenon Publishing Group, 2002).
See Appendix F for a complete list of published ethical recommendations and links to the full-text articles.
Jack R. Bierig, "Whatever Happened to Professional Self-Regulation?," American Bar Association Journal 69
(1983); Gerla, "Federal Antitrust Law and Trade and Professional Association Standards and Certification.";
Robert Heidt, "Industry Self-Regulation and the Useless Concept of 'Group Boycott'," Vanderbilt Law Review
39, no. 6 (1986); Thomas A. Hemphill, "Self-Regulation Industry Behavior: Antitrust Limitations and Trade
Association Codes of Conduct," Journal of Business Ethics 11 (1992); Murray S. Monroe, "Trade and
Professional Associations: An Overview of Horizontal Restraints," University of Dayton Law Review 9, no. 3
(1984).
See http://www.acog.org/from%5Fhome/publications/ethics/.
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Society for Assisted Reproductive Technology. ASRM’s sister society, SART comprises
most of the nation’s ART programs. According to the 2002 CDC report on ART success rates in
the United States, there are 428 (reporting and non-reporting) ART programs. SART has a wellestablished
history of self-regulation. In 1989, it started gathering data about success rates, which
has been published every year since in the journal Fertility and Sterility. With the 1992 passage
of FCSRCA, the CDC signed a memorandum of understanding that effectively delegated to
SART the responsibility for conducting the annual survey of ART success rates. As of 1997,
SART has been conducting random validation inspections to verify the accuracy of the reported
data. In 2002, according to the CDC, SART inspected 30 of 391 reporting clinics. Discrepancies
between reported data and medical records were quite limited, mostly below 1 percent. 52
Reproductive Laboratory Accreditation Program. This program was developed by the
College of American Pathologists in cooperation with ASRM and SART. The CAP has long
played an important role in ensuring high standards of safety and quality at clinical laboratories
around the country. Clinical laboratories are subject to the requirements of the Clinical
Laboratory Improvement Amendments of 1988. The administering agency, the Center for
Medicare and Medicaid Services, has contracted with third parties such as the CAP to perform
tasks such as auditing and certification of clinical laboratories. The CAP does not merely
perform compliance assurance; it has developed a full-fledged Laboratory Accreditation Program
that meets or exceeds CLIA requirements. In 1992, in cooperation with ASRM, the CAP
designed an accreditation program for embryo laboratories, the Reproductive Laboratory
Accreditation Program (RLAP).
A comparison of the FCSRCA model program and RLAP shows that FCSRCA has adopted
and expanded most of the features of the CAP program. For example, RLAP establishes detailed
professional prerequisites for the position of director and for the laboratory personnel; it also
includes safety provisions, and describes the main components of a system of quality assurance
and discusses the modality of certification and inspection. 53 Certification is valid for two years,
and is renewable subject to inspection. Reproductive labs are required to audit themselves on a
regular basis. Far less clear is whether CAP inspectors have actual enforcement authority. RLAP
does not include sanctions of any kind, nor does it establish a schedule for correcting infractions
or require RLAP inspectors to perform follow-up audits. In 1998, SART made RLAP
accreditation mandatory for all its members. As a result, RLAP has achieved a very high level of
certification. In 2002, the most recent year for which CDC data is available, 72 percent of all
reporting ART programs were CAP/ASRM accredited. 54
52
53
54
Centers for Disease Control and Prevention, "2002 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," p.469-70.
College of American Pathologists, "Reproductive Laboratory Accreditation Program – Standards for
Accreditation," (Northfield, IL: 2004).
Specifically, of 403 reporting ART clinics in 2002, 289 were CAP/ASRM accredited. Cf. U.S. Department of
Health and Human Services (Centers for Disease Control and Prevention), "2002 Assisted Reproductive
Technology Success Rates. National Summary and Fertility Clinic Reports," (Atlanta, GA: 2004), Appendix C.
138

As for other programs of self-regulation, it is extremely difficult for an external observer to
determine whether RLAP is being properly implemented by ART clinics. Like any other trade
association, SART does not consider itself a policing organization and does not impose fines or
penalties. It emphasizes a collaborative approach to compliance; it considers violations the result
of inadequate training rather than malfeasance, and encourages members with a poor compliance
record to undergo additional training. 55 SART does have some authority over its members – it
can exclude members found in violation of RLAP requirements. Industry officials have testified
that over the last few years, SART has excluded more than 30 members, albeit mainly for failing
to report to the national success rate registry. SART members have up to one year to remediate
problems found during a RLAP inspection. Failure to correct problems can also trigger
expulsion. 56
SARS and ASRM, while certainly the most important, are not the only components of the
industry system of self-governance. Several other professional and trade associations have
developed their own systems of professional accreditation, and some of them have made
accreditation conditional upon on-site inspection.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The JCAHO
may be regarded as an alternative to CAP. It is the largest accreditation organization in the health
care sector and certifies nearly 16,000 health care organizations. JCAHO accredits a broad range
of facilities offering laboratory services, including freestanding clinical laboratories and embryo
laboratories. Its accreditation process is focused on health and quality, and covers surveillance,
prevention, and control of infections, management of information and human resources,
management of the laboratory environment, and quality control, among other things. 57
JCAHO is governed by a 29-member board of commissioners, which is broadly
representative of the health care sector and includes nurses, physicians, consumers, medical
directors, administrators, providers, employers, a labor representative, health plan providers,
quality experts, ethicists, a health insurance administrator, and educators. 58 The accreditation is
limited to two years (for clinical laboratories), and is renewable subject to a survey. According to
the 2001 CDC survey of ART success rates, 25 percent of reporting ART clinics are JCAHO
certified, and many of them have both CAP and JCAHO accreditation.
CAP and JCAHO provide a very similar service. Neither one of these organizations offer
ethical opinions, of course, yet both could play a very important role in monitoring and ensuring
compliance with government-mandated standards. In addition, they could greatly facilitate
consulting with ART practitioners on controversial public policy issues. A similar mediating
function could also be performed by professional organizations involved in the accreditation of
various reproductive medicine professions, such as the American Association of Bioanalysts, the
55
56
57
58
Carson, Biotechnology and Public Policy: Professional Self-Regulation ([cited September 16, 2005]).
Ibid.([cited September 16, 2005).
See http://www.jointcommission.org/AboutUs/joint_commission_facts.htm.
Ibid.
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Reproductive Endocrinology Subspecialty Board of the Society for Reproductive Endocrinology
and Infertility, the American Board of Obstetrics and Gynecology, and the American College of
Obstetricians and Gynecologists.
A promising approach to self-governance was the National Advisory Board on Ethics in
Reproduction (NABER). NABER was created in 1991 by ACOG and ASRM. It then became
independently incorporated. Before being disbanded in 1998 for lack of funding, it was regarded
as broadly representative of various industry interests. Over the course if its existence, NABER
published several highly regarded opinions on controversial biomedical developments. NABER
is a perfect illustration of the precarious existence many bodies of self-governance are
condemned to. Created by leading industry representatives out of concerns for the industry’s
public image, it quickly became apparent that, absent a credible threat by the Congress to
regulate the ART industry, NABER did not have the necessary authority to function as an
impartial arbiter on ethical controversies of national import. Not surprisingly, the ART industry
opposed NABER’s role as an independent regulator; in 1998, the organization simply ran out of
funds. 59
National Coalition for Oversight of Assisted Reproductive Technologies (NCOART). The
National Coalition for Oversight of Assisted Reproductive Technologies is a little-known but
potentially quite important institution of self-governance. Established in 1997 as a SART
oversight committee, NCOART is a genuine example of a bridging institution 60 – it includes
representatives of all industry interests, patient groups, and the government. NCOART has a
well-defined governance structure that consists of two SART representatives (one clinical and
one laboratory representative), an ASRM official, and a representative of RESOLVE, a leading
national patient group. The committee chair rotates every two years between SART and
RESOLVE. In addition to these voting members, NCOART includes liaison members
representing the CDC, the FDA, and the Federal Trade Commission (FTC). Significantly,
NCOART has the authority to spawn working groups; in addition to representatives of the
aforementioned organizations, working group members can come from the American
Association of Tissue Banks, the American Bar Association, and the American Fertility
Association.
Like other bridging institutions, NCOART does not regulate in the legal sense of the term.
Rather, its main goal is to identify “issues” and to develop “recommendations” on any topic of
paramount importance to the industry. While certainly not a regulatory body, NCOART could be
instrumental in identifying possible sources of common concern, in promoting communication
59
60
See Andrea Kalfoglou, "Looking Back, Looking Forward: The Legacy of the National Advisory Board on Ethics
in Reproduction (NABER)," Women's Health Issues 10, no. 3 (2000). for an in-depth discussion of the NABER
experience.
Franco L. Furger, "Accountability and Self-Governance Systems: The Case of the Maritime Industry," Law &
Policy 19, no. 4 (1997); Franco L. Furger, "Global Markets, New Games, New Rules: The Challenge of
International Private Governance," in Rules and Networks. The Legal Culture of Global Business Transactions,
ed. Richard P. Appelbaum, William L.F. Felstiner, and Volkmar Gessner (Portland, Oregon: Hart Publishing,
2001).
140

and dialogue among all relevant industry segments, and in facilitating the development of
consensual positions on many policy questions. Compared to other industry bodies of
governance, such as ASRM and SART, NCOART authority seems modest. At the same time, the
broad range of different interests represented within NCORT would make it an ideal candidate
for advising a future regulatory agency. Regulators in turn could consider strengthening
NCOART authority by delegating to it the responsibility for implementing monitoring and
compliance assurance functions.
5.3.3 Self-Regulation of Medical Research
Scientists, just like their counterparts in the legal and medical professions, have long
advocated and jealously protected their prerogative to be as free from governmental interference
as possible, and the government has generally obliged. The rationale for granting scientists
considerable latitude is straightforward: Science and technology are the engines of innovation on
which the prosperity of industrialized nations is based. Excessive restrictions on the scientific
enterprise could undermine both the prosperity and the competitiveness of nations. This is one of
the reasons why top scientists invariably advocate self-regulation in response to calls for direct
regulatory interventions. Another is, of course, a general sense of uniqueness and even
superiority toward members of the general public and political leaders. 61 What exactly scientists
mean by self-regulation is often unclear, but one precedent seems to loom large in this debate –
the Recombinant DNA Advisory Commission, or RAC.
To many scientists, the RAC is proof that the scientific community is quite effective at
regulating itself, if necessary. Unfortunately, the scientists’ faith in the RAC model is largely
misplaced. The effectiveness of the RAC in dealing with the challenges raised by new
recombinant DNA technologies can be attributed to contingent factors. As we show below,
absent these highly idiosyncratic factors, the self-regulation of science is very likely to fail.
As new and exciting techniques for cutting DNA molecules at specific locations and for
inserting fragments from other DNA molecules were announced at the 1973 Gordon Conference
– techniques that became known as recombinant DNA technologies – leading molecular
biologists began to worry about possible public health risks. The spectrum of a hitherto unknown
and dangerous strain of bacteria prompted leading scientists to call for a moratorium, one the
scientific community followed, albeit grudgingly so. The leaders in the field also called for a
conference to examine the risks associated with this new technology. The now famous Asilomar
Conference in 1975 took place with the notable (though not welcomed) participation of the news
media. One of the main concerns of the conference became how to ensure the safety of the newly
developed recombinant DNA molecules. The conference participants crafted a set of provisional
61
The Workshop on “Guidelines for Conducting Embryonic Stem Cell Research,” organized the U.S. National
Academies in the fall of 2004, is only the most recent illustration of the scientific community’s reluctance to
accept societal restrictions. Informal conversations with leading scientists at this workshop invariably have
shown that scientists are indeed quite skeptical of any federal intervention, and would much prefer a selfregulatory
approach.
141

safety guidelines aimed at ranking potential risks and defining appropriate safety procedures and
requirements. These recommendations were to be adopted and expanded by the newly created
Recombinant DNA Advisory Committee, established by the NIH in late 1974 and whose first
meeting took place in early 1975, immediately after the Asilomar Conference. Producing a final
version of the recommendations proved more difficult than anticipated. It took the RAC well
over a year, until June of 1976, to finally release this document. It is a testimony to the perceived
seriousness of the threats posed to public health by recombinant DNA technologies that the
private sector decided to follow the RAC guidelines and to voluntarily submit to the RAC its
research protocols for review.
In its early days, it appears that this system of semi-voluntary oversight was indeed quite
effective in reviewing research protocols involving rDNA molecules. Soon, however, the RAC
found itself exposed to considerable pressure by the scientific community to take a less cautious
approach in reviewing research protocols. Many scientists felt that rDNA technologies did not
pose significant risks and that the RAC was burdening them with unnecessary restrictions. As
recombinant DNA technology reached commercial viability, biotech companies began to express
concern about the open nature of the RAC review process, a process that in their view was not
sufficiently protective of their intellectual property. As the RAC played an increasingly marginal
role in reviewing rDNA protocols, it began focusing on gene therapy trials. The new emphasis
on human subjects prompted a revision of the guidelines and required significant changes to the
composition of the commission. Medical ethicists and lawyers replaced representatives of public
interest groups, mainly environmental groups. To date, the RAC remains involved mainly in the
review of gene therapy trials. 62
This (very much abridged) version of the RAC history seems to suggest that a selfregulatory
body could indeed supervise novel and potentially threatening research activities.
Arguably, the scientific community recognized from the beginning that rDNA technology posed
a potentially serious treat to public health and took appropriate measures to prevent a disastrous
outcome. In this sense, self-regulation as embodied by the RAC has succeeded in protecting
public health without creating cumbersome and inflexible regulations. By contrast, a legislative
response probably would have slowed down research considerably, with few or no additional
benefits to public health and to the research community. This, in a nutshell, is the position taken
in 1997 by two prominent scientists, Paul Berg and Maxine Singer, who warned against
legislative overreaction after Scottish scientists announced the cloning of a sheep. 63
Paul Berg’s and Maxine Singer’s concerns for unexpected negative consequences that
rushed legislative initiatives could have on the research enterprise are justified. Far less
62
63
A more detailed account of the RAC history can be found in Barry R. Furrow, "Governing Science: Public Risks
and Private Remedies," University of Pennsylvania Law Review 131 (1983); Norman L. Rave, "Interagency
Conflict and Administrative Accountability: Regulating the Release of Recombinant Organisms," Georgetown
Law Review 77 (1989); Charles Weiner, "Is Self-Regulation Enough Today? Evaluating the Recombinant DNA
Controversy," Health Matrix: Journal of Law-Medicine 9 (1999).
Paul Berg and Maxine Singer, "Regulating Human Cloning," Science 282, no. 5388 (1998).
142

justifiable is the assumption that in the case of modern biomedical research, the adoption of a
system of oversight inspired by the RAC would be equally effective. In the 1970s, scientists’
cooperative behavior was fueled in large measure by a genuine fear of a public health disaster. It
was the existence of a perceived collective threat that prompted the scientific community to
voluntarily accept significant constraints to their research freedom. As soon as this threat
subsided, scientists began pressuring the RAC for a more expeditious and less strict review
process. For its part, the biotech industry quickly lost interest in submitting rDNA research
protocols to the RAC. In sum, both the RAC’s effectiveness and authority were predicated on the
existence of a serious external threat. Absent this threat, the RAC quickly lost much of its moral
authority.
This sequence of events is by no means unique. In the late nineteenth century, it was the
rapidly deteriorating public image of the legal profession in Chicago and New York that
prompted these two legal communities to create local bar associations and to adopt ethical
guidelines. 64 The adoption by many sectors of the chemical industry of extensive safety and
environmental management programs ultimately can be attributed to the devastating impact that
the disastrous gas leak in Bhopal, India, had on that industry’s public image. The efforts
undertaken by the nuclear power industry to improve nuclear power plant safety above and
beyond federal standards are a consequence of the Three Mile Island accident. 65
The
international maritime industry has an extensive system of self-regulation whose adoption was
prompted in part out of concern for the industry’s deteriorating public image. 66 This body of
literature demonstrates not only that trade and professional associations adopt programs of selfregulation
mostly (but not exclusively) in reaction to a collective external threat; it also shows
that the effectiveness of these measures crucially depends on the sustained presence of a threat.
Absent this threat, a private body of governance quickly looses its authority.
The RAC is an inadequate model of governance for another reason as well. Two core
functions of a contemporary self-regulatory body are to ensure that a broad range of ethical
concerns be heard and that competing ethical claims be adjudicated. Preventing ethical debates
from turning into an exceedingly narrow discussion of mostly procedural questions would
require broadening the participation in this deliberative body to social scientists and to
representatives of the general public. During its entire history, the RAC has rarely attempted to
broaden the scope of its ethical inquiries. In its early days, it was simply a body of scientists
responsible for examining largely scientific issues. In its late incarnation, the RAC did include
bioethicists on its gene therapy subcommittee, but the focus of its ethical inquiry remained
64
65
66
Jerome E. Carlin, Lawyers' Ethics: A Survey of the New York City Bar (New York: Sage, 1966); William T.
Gallagher, "Ideologies of Professionalism and the Politics of Self-Regulation in the California State Bar,"
Pepperdine Law Review 22 (1995).
Joseph V. Rees, Hostages of Each Other: The Transformation of Nuclear Safety since Three Mile Island
(Chicago: University of Chicago Press, 1994).
Furger, "Accountability and Self-Governance Systems: The Case of the Maritime Industry."
143

elatively mundane. 67 For example, the RAC has always refused to explicitly condemn germ-line
genetic engineering, focusing instead on traditional bioethical concerns such as informed consent
and safety. In sum, a scientific body of self-governance as exemplified by the RAC is largely
incompatible with a broad ethical analysis. In plain terms, the main reason why the RAC in its
early days was regarded as a legitimate body of self-regulation was the absence of any
significant disagreement between the scientific community and the public about the need to
carefully monitor rDNA research. In the case of modern biomedical research, scientists and the
public are only partially in agreement on what constitutes acceptable research protocols. For this
reason, attempts by an RAC-like body to unilaterally resolve these controversies would not be
regarded by the public as legitimate.
Could the RAC be redesigned to become a credible and effective system of governance?
Technically, yes. A redesigned RAC would have to consider a much broader range of views. The
inclusion of a few representatives of public interest groups on this body is probably a necessary
first step, though certainly not a sufficient one. As our discussion of public attitudes toward new
biomedical technologies in chapter 8 shows, it is often incorrect to assume that public interest
groups accurately reflect the views of the general public. Nor are professional ethicists always or
necessarily in the best position to articulate critical ethical issues. Recent studies of patients’
moral reasoning have shown that the ethical arguments for and against new medical technologies
are much broader and often deeper than those offered by professional ethicists. 68
Rules of representation would have to be changed as well. Currently, the RAC charter
defines representation in functional terms, thus assuring that scientific and technical expertise is
adequately represented on the committee. Scientific competence is certainly an important
requirement, but we doubt that it should have a dominant role in the appointment process. The
appointment rules would have to be revised, as well. At present, the NIH director is responsible
for all appointments to the RAC. This may be acceptable for an obscure body of oversight that
operates essentially like a club, but it would clearly be difficult to justify this rule for a decisionmaking
body with broad regulatory authority. Finally, the RAC tends to develop its
recommendations in an informal way. To our knowledge, no specific rules of decision-making
exist. In the past, the chair of the subcommittee on gene therapy made an effort to craft a
consensus; other subcommittee may have been governed by different informal rules. 69 How
conflicts on the gene therapy subcommittee were resolved when a consensus could not be crafted
is unclear, but obviously this is an issue that cannot be left unresolved.
An RAC redesigned according to these criteria can no longer be described as a system of
self-regulation. It would certainly not be considered as such by the scientific community. But it
could become a respected body of governance if it succeeded in projecting an image of fairness
and impartiality.
67
68
69
Weiner, "Is Self-Regulation Enough Today? Evaluating the Recombinant DNA Controversy."
Leach Sculley, Rippberger, and Rehmann-Sutter, "Non-Professional Evaluation of Gene Therapy Ethics."
Interview with Leroy Walters, October 29, 2002.
144

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148

6 International Legislative and Regulatory Approaches
In this chapter, we take a detailed look at legislative initiatives in four countries: Italy,
Australia, Canada, and Britain. Each case provides a distinctive perspective on possible
approaches to the regulation of reproductive technologies and biomedical research. Italy
exemplifies a legislative approach to controversial biomedical developments that, while favored
by some in the United States, in our view would be costly at best and counterproductive at worst.
The Italian legislation goes well beyond simply targeting deeply troubling practices such as
reproductive cloning and the creation of human embryos solely for research purposes. The scope
of its prohibitions is very broad and its bans are sweeping. Not surprisingly, the Italian approach
has triggered a considerable amount of controversy, and we present it here as an illustration of
how not to approach controversial ethical dilemmas in the United States. Australia, by contrast,
has passed legislation that seems to enjoy the support of all relevant constituencies and of the
general public. Its approach to regulating controversial biomedical developments is restrictive –
from an American perspective, perhaps too restrictive – but it also recognizes the importance of
providing a legally protected space to controversial biomedical research. Finally, Canada and
Britain provide an illustration of our claim that similar regulatory infrastructures are compatible
with different ethical concerns. Both countries emphasize the need to closely monitor the field of
reproductive medicine and biomedical research through a specialized regulatory entity, yet
Britain is considerably more liberal in its regulatory stance than Canada. Britain is also the only
country with many years of experience in regulating controversial reproductive technologies.
None of the legislative approaches examined in this chapter provides a template that could
mechanically be used to implement a new regulatory structure in the American context. With the
exception of Italy, each of these approaches does, however, provide important insights into how
a U.S. system of regulation could be implemented. To facilitate this task, we have also examined
legislative and regulatory approaches in 13 industrialized countries. Our analysis shows that
there is virtually no agreement among these countries on what constitute the most appropriate
legislative responses to new biomedical dilemmas, the notable exception being reproductive
cloning. On the other end, there is considerable agreement on which reproductive practices and
research protocols should be regulated. 1 For each of these practices, a majority of the reviewed
countries has either adopted specific legislative measures or crafted regulation. Only one country
– the United States – has taken little or no action. This observation underscores the need for the
U.S. Congress to pay closer attention to medical and scientific developments in the area of
reproductive medicine and biomedical research.
1
In Appendix H, we have identified 10 activities pertaining to reproductive medicine and biomedical research that
in recent times have been targeted for legislative or regulatory intervention in 13 OECD countries.
149

6.1 Italy – from the “Wild West” to “Politburo”?
On February 10, 2004, the Italian Chamber of Representatives passed a comprehensive bill
titled “Norme in materia di procreazione medicalmente assistita” (“Norms concerning medically
assisted procreation”). The bill, already passed by the Italian Senate in December of 2003, is now
law. 2 We have chosen to examine in some depth the Italian case for one main reason: The new
legislation provides an excellent illustration of the possible negative consequences of a laissezfaire
approach to reproductive medicine, followed by a late and excessive legislative reaction. To
put it simply, the longer a legislative body delays crafting a response to new scientific and
medical developments, the likelier it becomes that legislators will overreact.
Until the passage of bill n.40, Italy exercised only minimal oversight over reproductive
medicine and research. Not coincidentally, among ART practitioners and ART patients, Italy
was known as the “Wild West” of reproductive medicine. The new law has changed all this. In
terms of access restrictions to ART technologies, the types of reproductive technologies
available to patients, and the ends that justify the recourse to assisted reproductive technologies,
the Italian legislation is one of if not the most restrictive legislative frameworks worldwide.
Hence the term “politburo” used by an Italian columnist to describe the new approach to
regulating reproductive medicine.
The costs of this legislative overreaction are likely to be significant, and they are not only
economic in nature. In the present case, the negative consequences of the new law will be felt by
research institutions, by patients, and by ART practitioners. Scientists will find themselves
incapable of conducting research that largely is considered legitimate in many other liberal
democracies. Patients will be deprived of important reproductive services, and the industry likely
will suffer considerable economic losses.
The law, though it does not explicitly discuss guiding principles, is informed by clear ethical
standards. ART technologies can be used exclusively for the treatment of medically diagnosed
infertility, and are not a means for individuals to meet their reproductive desires. Accordingly,
IVF is considered a medical technology of last resort intended to help heterosexual couples have
a baby. The protection of embryos has priority over the demands of non-traditional couples,
singles, research institutions, and in some cases, over the interests of the couple. In this sense, the
Italian law embodies very specific views of sexuality, of the family, and of the moral status of
the embryo – views that are quite close to traditional Catholic teachings on these issues.
The law consists of 18 fairly straightforward articles. Unlike most other legislative
approaches in the area of ART and biomedical research, the Italian statute is comprehensive. It
limits access to ART technologies, it describes which ART procedures can be used and how, and
it spells out the rationale for resorting to ART treatments. It also sets clear legislative boundaries
to what researchers are entitled to do in this area. In addition, the legislation requires the
implementation of a licensing scheme for all ART clinics, to be administered by the Italian
2
Legge 19 febbraio 2004, n. 40, available at http://www.parlamento.it/parlam/leggi/04040l.htm (Medically
Assisted Reproduction Law).
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Health Ministry, and sets aside funds for conducting scientific research on the causes of
infertility.
Taking a closer look at the law, article 5 establishes that only stable, adult, heterosexual
couples, married or otherwise, have the right to receive ART treatments. In addition, both
spouses must be alive. However, the access to reproductive treatments is not unconditional.
Traditional couples have access to ART treatments only after they have demonstrated that their
infertility cannot be cured by any other means. Demonstration of infertility requires medical
examination and appropriate documentation. 3
As for the means available to couples that qualify for an ART treatment, the statute contains
several provisions. Gamete donation by a third party is prohibited. 4 Since only the couple’s own
gametes can be used for reproductive purpose, no provision is necessary to regulate the donation,
import, or export of gametes and embryos. Performing IVF is subject to constraints. Only three
embryos can be created for any one cycle, and all of them must be transferred. 5 In an effort to
prevent the accumulation of excess embryos, the long-term cryopreservation of embryos is not
allowed, 6
nor is their destruction. Embryo cryopreservation is permitted only for medical
reasons, and only for a limited period of time, in any case until the embryo is transferred. 7
“Selective reduction” is prohibited, with some very limited exceptions. 8
Since every in vitro embryo must be transferred and no embryo can be destroyed, any
technique that leads to the destruction of an embryo is prohibited. This means that techniques of
genetic screening such as pre-implantation genetic diagnosis are not allowed for any reason,
including therapeutic treatments. Also banned is any eugenic application – i.e., any change in the
genome of gametes or embryos not intended directly to benefit the latter. 9 Research on embryos
is allowed only to benefit the health and development of the embryos themselves. 10
Consistent with the narrow focus on procreation, the law leaves very little room for research
involving reproductive tissues. Somatic cell nuclear transfer of any kind is prohibited. 11 Since
embryos can only be created for procreative reasons and cannot be destroyed, the donation of
embryos for research purposes is excluded. The law also explicitly prohibits the creation of
embryos solely for research purposes. 12 The creation of human-animal chimeras or hybrids is
3
4
5
6
7
8
9
10
11
12
See Article 4, Section 1.
See Article 4, Section 3.
See Article 14, Section 2.
See Article 14, Section 1.
See Article 14, Section 3.
See Article 14, Section 4.
See Article 13, section 3b.
See Article 13, section 2.
See Article 13, Section 3c.
See Article 13, Section 3a.
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also prohibited. 13 The law actively supports and promotes research on the causes of infertility,
including medical research on human gametes. 14
As for regulatory measures, the law requires the administering agency, namely the Health
Ministry, to establish a registry of all ART clinics. Also, ART programs are required to report
the number of created embryos and babies born through ART on an annual basis. 15 In addition,
ART clinics must provide the Health Ministry with the data necessary to monitor the health and
well-being of babies born through ART. Unfortunately, this article is crafted in such general
terms as to prevent an evaluation of the Italian approach to health monitoring. The law is much
more specific in terms of the administrative and criminal sanctions imposed on violators. For
example, an ART practitioner can be fined up to 600,000 euros (approximately $730,000) for
using gametes extraneous to the couple. Trade in gametes or embryos can be punished by up to
two years in prison, and attempts at reproductive cloning carry a sentence of up to 20 years in
prison and fines up to a million Euros (approximately $1,218,000).
The Italian approach to new reproductive technologies is an excellent example of how not to
legislate the field of reproductive science and medicine. As the preceding discussion
demonstrates, many legislative provisions in this law seem guided by a desire to ensure better
protection for ART children and for embryos. As we have argued in chapter 3, the well-being of
ART children and the respect for human embryos are both important moral goods worthy of
legislative attention. However, in our view the Italian statute achieves these goals by sacrificing
several other moral goods worthy of legal protection. Access to standard ART technologies, even
by heterosexual couples is severely limited, and promising new lines of medical research
(including but not limited to stem cell research) are sacrificed for the sake of a very specific
ethical perspective – an ethical perspective that may not be shared by a majority of the Italian
public. 16 The law also prevents prospective parents affected by genetic diseases from having
healthy children. In other words, it does not attempt to reconcile conflicting moral goods; it
simply imposes on Italian citizens what amounts to traditional Catholic precepts of morality.
The Italian law is problematic for other reasons as well. Its rigid approach to controversial
ethical questions makes it all but impossible to accommodate unanticipated future medical
developments. For example, medical research likely will make it possible in the not-too-distant
future to cryopreserve human oocytes. The cryopreservation of human eggs raises new and
important ethical questions, but it is not obvious to us that this technology should simply be
banned by legislative means. There may well be good medical and non-medical reasons for
13
14
15
16
See Article 13, Section 3d.
See Article 2 Sections 1 and 2.
See Article 11.
The failure of four referenda to revoke several provisions of this statute could be interpreted as an indication of
broad popular support for this new statute. However, the initiators made clear that theirs was not a fundamental
opposition to the regulation of reproductive medicine, per se. Rather, the referenda targeted specific prohibitions
of the new law deemed too broad – the use of human embryos for research, the cryopreservation of human
embryos, any form of pre-implantation genetic diagnosis, and ART procedures using donated gametes and
embryos – as well as the recognition of pre-embryos as legal entities with the same rights as human beings.
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allowing the cryopreservation of oocytes, at least in some cases. A sweeping ban on new medical
developments in our view is an ill-informed response to biomedical developments that cannot be
unambiguously condemned or unconditionally embraced.
6.2 Australia – Regulated Self-Regulation
6.2.1 Regulatory Precedents
A unique feature of the Australian system of government is its extensive reliance on selfregulation.
In the Australian context, self-regulation is not synonymous with lax regulation. The
Australian government codifies standards developed by the private sector and relies on trade
associations and other accredited third parties to ensure compliance. Procedures of compliance
assurance are no different from those adopted by government regulators in other countries, and
include inspections and various forms of sanctions. 17 The Australian ART industry provides an
excellent illustration of this approach. Australia, with approximately 20 million inhabitants, has
34 ART programs – almost twice as many per million inhabitants as the United States. By all
accounts, the Australian ART industry is very dynamic, on both the clinical and the research
fronts. The industry began regulating itself in 1987, when the Fertility Society of Australia
established the Reproductive Technology Accreditation Committee (RTAC). 18 The committee
produced a set of guidelines, the “Code of Practice for Centres Using Assisted Reproductive
Technology” (or “Code of Practice” for short), which was revised in April of 2002 and can be
regarded as a comprehensive set of binding recommendations for the operation of an ART
program in Australia. Its adherence is monitored and enforced by the RTAC.
In 1996, the Code of Practice was supplemented by the “Ethical Guidelines on the Use of
Assisted Reproductive Technology in Clinical Practice and Research” (or “Guidelines”),
published by the Australian Health Ethics Committee (AHEC) and updated in September of
2004. The AHEC is a principal committee of the National Health and Medical Research Council
(NHMRC), the Australian equivalent of the NIH, which was established under the NHMRC Act
of 1992. The Guidelines address numerous ethical questions not specifically discussed in the
Code of Practice, and not included in two statutes to be examined below, the Prohibition of
Human Cloning Act of 2002 (PHCA) and the Research Involving Human Embryos Act of 2002
(RIHEA). They are reminiscent of many guidelines developed by the American Society for
Reproductive Medicine, differing only in that they, unlike their American counterparts, are being
enforced.
The ethical standards espoused in the Australian Guidelines are indicative of a rather
conservative approach to the access and use of ART technologies, but they are certainly not as
rigid as their Italian counterpart. For example, the Australian Guidelines ban the use of sex-
17
18
See, for example, Toni Makkai and John Braithwaite, "Reintegrative Shaming and Compliance with Regulatory
Standards," Criminology 32 (1994).
See http://www.fsa.au.com/rtac/.
153

selection technologies, but only for non-therapeutic uses. They deem the commercial trade of
human gametes and embryos unacceptable, but allow the donation of such tissues. They
proscribe surrogacy as a commercial service, recognize that it remains a controversial practice
even for non-commercial reasons, and refer to state-level laws and regulations for additional
guidance. As for pre-implantation genetic diagnosis, they proscribe its use for elective sex
selection but allow it to prevent or reduce the chance of inheriting a serious genetic condition.
The Guidelines do not provide any guidance on other unconventional reproductive technologies
such as ooplasm transfer, embryo splitting, or reproductive cloning. Nor do they address the
creation of embryos and chimeras or genetic engineering. These issues are dealt with by the two
new statutes mentioned earlier, the PHCA and the RIHEA.
By the end of 2002, the Australian Parliament had passed both the PHCA and the RIHEA,
and did so in less than two years, apparently without major societal traumas. The two laws
complement each other: The PHCA identifies ethically unacceptable and therefore prohibited
practices in the ART industry, whereas the RIHEA outlines a regulatory system for conducting
research on human embryos, including but not limited to stem cell research. The actual
regulation of the ART industry is covered by the Code of Practice and by the Guidelines.
The PHCA and the RIHEA reflect a genuine effort by the Australian authority to balance
ethical concerns and freedom of research. The centerpiece of this balancing act is the Embryo
Research Licensing Committee (ERLC), a principal committee of the NHMRC responsible for
overseeing research protocols involving human embryos. The ERLC is modeled after the British
Human Fertilization and Embryology Authority, but differs from the latter in some important
respects. Unlike the HFEA, the ERLC oversees exclusively research activities, not the ART
industry proper. Appointment and operational rules also differ, as do the criteria for approving
and rejecting research proposals.
6.2.2 The Prohibition of Human Cloning Act of 2002
The stated purpose of the PHCA is to identify in a clear and unambiguous fashion
reproductive practices and technologies deemed unethical or otherwise unacceptable. 19 PHCA
does so by distinguishing between cloning 20 and prohibited activities. 21 Cloning a human embryo
for any purpose is prohibited. This means that Australia, unlike Britain but like Canada, has
banned both reproductive and research cloning. PHCA speaks of the “human embryo clone” and
defines this term as the “genetic copy” of another living or dead human being, excluding
“copies” created by the fertilization of an egg by a sperm, thus ensuring that twins are not
inadvertently declared clones.
In Section 8(2), the legislators clarify the definition of “genetic copy.” For an embryo to be a
genetic copy, it is sufficient for the genes in the nucleus of a cell to be copied; it is not necessary
19
20
21
See Section 3.
See Division 1.
See Division 2.
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that the cloned embryo have an identical copy of the genome of the original cell. This means that
cloning could not legally be performed on the grounds that cloned embryos have different
mitochondrial DNA and therefore are not genetic copies. Section 8(4) establishes that “embryo
splitting” – the process by which an embryo at a very early stage is split into two embryos – does
produce a human embryo clone and is therefore also banned. The PHCA prohibits the
implantation of cloned embryos in a human body, 22
and the import or export of cloned
embryos. 23 It also preempts the argument that cloning an embryo is not punishable because the
embryo in question would not have been viable, an argument that in the United States enjoys
some popularity. 24 In sum, Australia has closed all doors on the creation and use of cloned
human embryos.
The creation of human embryos is otherwise permitted but severely restricted. Embryos can
be created, but exclusively for reproductive purposes. 25 The PHCA forbids the creation of human
embryos by means other than the union of a human oocyte and human sperm. 26 It also prohibits
retrieving a viable human embryo from the body of a woman. 27 This procedure, known as
“embryo flushing,” is common in animal husbandry, but it has yet to be used in humans. The
PHCA makes it illegal to implant a human embryo in an animal, 28 and finally, it prohibits the
import and export of human embryos, 29 as well as the trade of embryos, human eggs, and human
sperm. 30 There are a few important exceptions to these prohibitions. In particular, neither embryo
nor stem cell research are covered by these bans, but both are strictly regulated. Terms and
conditions for conducting this type of research are laid out in RIHEA (see the next section).
Furthermore, the PHCA revised explanatory memorandum clarifies that screening embryos for
medical purposes, as for certain uses of PGD, remains legal.
With regard to reproductive technologies in Australia, the PHCA prohibits the creation of
human embryos with genetic material from more than two persons. 31 The revised explanatory
memorandum makes clear that Section 15 is intended to ban reproductive techniques such as
ooplasm transfer. This seems in keeping with the FDA suspension of this procedure in the United
States out of concern that it may not be safe. Another preventive measure is Section 16, which
bans the development of a human embryo outside the body of a woman for more than 14 days.
While it may be difficult to see the need for this prohibition at this time, our discussion of new
22
23
24
25
26
27
28
29
30
31
See Section 10.
See Section 11.
See Section 12.
See Section 14.
See Section 13.
See Section 19.
See Section 21.
See Section 22.
See Section 23.
See Section 15.
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eproductive technologies in section 4.5.4 has shown that in the not too-distant future, it may
indeed be possible to grow human embryos for extended periods of time outside the body of a
woman.
Like Canada, Britain, and most other OECD countries, the Australian legislation bans
genetic engineering, defined as a heritable alteration of the human genome. 32 PHCA deals
extensively with chimerism, as well, precisely defining what constitutes a chimeric animal and
how chimeric animals differ from hybrids and transgenic embryos. It is worthwhile delving into
some of these technicalities, as these definitional questions are of some import to our discussion.
PHCA Section 8(1) defines chimeric embryos as human embryos “in which a cell, or any
component of a cell, of an animal” has been introduced. 33 It appears that Australian legislators
were concerned about being outpaced by scientific progress, as they empowered regulators to
introduce additional definition of chimeric embryos, if necessary. The definition of a hybrid
embryo consists of four distinct categories: (a) an embryo created by fertilizing a human egg
with an animal sperm, (b) an embryo created by fertilizing an animal egg with human sperm, (c)
a human egg in which the nucleus of an animal cell has been inserted, and (d) an animal egg in
which the nucleus of a human cell has been introduced. Most importantly, the legislators have
allowed the regulators to introduce new definitions of hybrid embryos as necessary. Section 20
of PHCA makes it an offense punishable by up to 10 years in prison to create a chimeric embryo
or a hybrid embryo, as defined above.
In keeping with well-established laboratory practices, PHCA does not prohibit the creation
of transgenic embryos, defined as animal embryos in which human genes or fractions thereof
have been introduced, nor does it address the case of an animal embryo in which human cells
have been introduced. The PHCA revised explanatory memorandum describes these embryos as
instances of genetically manipulated organisms, a somewhat misleading terminology in our
opinion. This case is dealt with in a separate Act, the Gene Technology Act of 2000, which is
beyond the scope of the present report.
6.2.3 The Research Involving Human Embryos Act of 2002
The main purpose of the RIHEA, defined in Section 3, is to “…address concerns, including
ethical concerns, about scientific developments in relation to human reproduction and the
utilization of human embryos by regulating activities that involve the use of certain human
embryos created by assisted reproductive technology.” If the proposed research could damage or
destroy the embryo, research on human embryos is permitted only on excess embryos, and only
on those created prior to April 5, 2002. 34 This clause is more flexible than President Bush’s 2001
directive on human stem cell research. It allows the creation of new stem cell lines if these are
32
33
34
See Section 18.
Note that the terms “introduce” and “fertilize” are not synonymous. The former indicates a process by which an
some extraneous cells are mixed to the cell of an existing embryo.
See Paragraph 21(3)(b).
156

derived from embryos created before the April 2002 cutoff. In addition, paragraph 21(3)(b) was
repealed on April 5, 2005, thus allowing legislators to revisit the policy and update it, if
necessary. The moratorium has not been extended, thus allowing Australian researchers to derive
new stem cell lines using embryos created after April 5, 2002. 35
As mentioned above, Australia regulates human embryo research by means of a licensing
system overseen by the Embryo Research Licensing Committee, located within the NHMRC.
The ERLC has the authority to grant licenses for conducting embryo research and to monitor
research activities, licensed or not. In addition, it must maintain a public database of licensed
research projects. Its operations must be reviewed on a regular basis, and an activity report must
be submitted to both houses of the Australian Parliament.
The ERLC could be described as a hybrid between the British Human Fertilisation and
Embryology Authority and the U.S. Recombinant DNA Advisory Committee. Like the RAC, the
ERLC operates within the NHMRC. 36 Like the HFEA, the ERLC licenses all research activities
involving human embryos, not just publicly funded projects. And as with the HFEA, ERLC
members include representatives of the scientific community, the general public, and other
constituencies. Unlike the RAC, however, the ERLC has extensive monitoring and enforcement
powers backed by administrative and criminal sanctions.
The Australian approach to defining the composition of the ERLC departs significantly from
the British model. While the British HFEA is an idiosyncratic mix of corporatism and direct
popular representation, the Australian ERLC takes a clear corporatist approach. Sections 13
through 19 govern its establishment and operation. Section 16 establishes the committee’s
composition as follows:
(a) A member of the Australian Health Ethics Committee
(b) An expert in research ethics
(c) A person with expertise in a relevant area of research
(d) An ART expert
(e) A legal expert
(f) A representative of a consumer organization specialized in disability and disease
(g) A representative of a consumer and patient group focused on assisted reproductive
medicine
(h) An expert in the regulation of ART
(i) An embryologist
35
36
No Need for More Stem Cell Embryos (Sydney Morning Herald, March 29, 2005 [cited September 22, 2005]);
available from http://www.smh.com.au/news/National/No-need-for-more-stem-cell-embryos-
MPs/2005/03/29/1111862384922.html?oneclick=true.
It should be noted that in recent times, the British government has extracted the licensing of scientific projects
involving human embryos from the HFEA and entrusted this activity to a new regulatory body within the
National Health Service (NHS), the British equivalent of the NIH.
157

Neither the RIHEA nor its explanatory memorandum shed any light on which criteria were
behind this choice of experts. Most of the choices may be regarded as both obvious and
necessary. Appointing an ART expert, a legal expert, an expert in research ethics, a scientist, an
embryologist, and representatives of consumers and patients groups seem rather straightforward
choices. On the other hand, taken together, these choices produce a committee that is unique in
its structure. Unlike the HFEA, the ERLC is a committee of experts with no pretension of
including and/or consulting with the general public. Public views are not excluded from this
committee, but are limited to those societal groups most directly affected by research in this area
– i.e., to representatives of infertility patients and advocates of disabled persons. Individuals who
do not represent the medical profession or the research community and who are likely to
represent the views of the public are a clear minority. Depending on how the slots are filled, they
range between two and three out of nine members. Given the often rather self-interested nature
of organized groups, and the generally sympathetic approach displayed by the bioethics
profession toward the research community, this number could conceivably shrink to zero.
The technocratic approach taken by the Australian legislation in establishing the
composition of the ERLC can partly be explained by the committee’s charge. The ERLC is
responsible exclusively for approving research protocols on human embryos, not for untangling
difficult ethical dilemmas created by new reproductive technologies. In this sense, the
committee’s scope is relatively narrow and may not require extensive public input as required,
for example, for the promulgation of new ethical guidelines by the RTAC or the Human
Research Ethics Committee (HREC), which is similar to an institutional review board.
The Australian appointment process ensures that only broadly acceptable candidates will be
appointed. The appointment process is not governed by rigid administrative rules, nor are
appointments simply the result of an arbitrary choice made by the responsible minister. The
RIHEA assigns the minister the responsibility for making the actual appointments, but viable
candidates can be suggested only by a predefined list of organized interest groups and by the
states (Paragraph 16(3)(a)). In addition, the minister must “consult, and have regard to the views
expressed by, the States on the proposed appointment.” 37 How exactly this clause is being
interpreted in practice is not entirely clear, but it appears that the purpose of this consultation
process is to ensure that the appointed candidate is supported by all relevant political
constituencies. In other words, the states must not only be consulted, but should also be
represented. Sub-clause 16(5) requires that the committee chair only be appointed with a
majority of states agreeing, while sub-clause 16(6) instructs the minister as to the “desirability of
ensuring that the Committee as a whole comprises members from different States.” The
combination of formal and informal appointment rules seems to be designed to produce
consensus candidates. This approach can be relatively slow, but it guarantees that most
constituencies will regard the committee as a whole as a credible and trustworthy institution of
government.
37
See Paragraph 16(3)(b).
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RIHEA Sections 20 through 28 govern the issuance, change, and revocation of licenses. Of
particular interest to the present discussion are the conditions for obtaining a research license. 38
Some of these criteria are purely procedural; others are of a more substantive nature. The
procedural requirements include obtaining informed consent from the donors of excess
embryos, 39 and approval by the HREC in accordance with the NHRMC National Statement on
Ethical Conduct in Research Involving Humans. 40
In examining the merits of a research
proposal, RIHEA Section 21(4) requires (a) the committee to examine whether the number of
embryos to be used in the proposed research is commensurate to the research goals, and (b)
whether the proposed research is likely to advance scientific knowledge or improve medical
technologies and treatments that could not be achieved by other means. In addition, if the
research protocol involves the damage or destruction of human embryos, the applicant can use
only excess embryos created prior to April 5, 2002. Sub-clause 21(40(b) provides considerable
room for interpretation, and it is by no means clear how the ERLC members may resolve the
uncertainties that any attempt at assessing possible benefits and relative merits of different
medical research protocols inevitably will produce. Neither the RIHEA nor the accompanying
explanatory memorandum touches on this question. Surprisingly to us, the RIHEA does not
include any guidance on how the ERLC should resolve internal disagreement, or on what the role
the committee chair should play in this process.
The RIHEA also addresses conflicts between demands for transparency and commercial
expectations of confidentiality, conflicts that in the past have severely constrained the ability of
the U.S. RAC to review research protocols submitted by private companies. 41 The act does
require the ERLC to maintain a publicly accessible online database of granted licenses, but the
information required to be included in this database is minimal. It includes the applicant’s name,
a short description of the proposed research, the number of excess embryos whose use has been
authorized by the license, and the period of time during which the license is valid, but explicitly
excludes any commercially sensitive information. These provisions seem to suggest that the
review process is not open to the public. The RIHEA does not delve into questions of
transparency and public access to the review process. Whether a closed review process will
undermine the public confidence in this new institution of government remains to be seen.
RIHEA Sections 33 through 41 lay out the rules that govern monitoring activities. As with
the Canadian legislation described below, these sections leave many implementation details
unspecified. For example, the RIHEA does not state whether it is possible and/or necessary to
38
39
40
41
See Section 21.
See Paragraph 21(3)(i). Section 9 defines an excess embryo not only as an embryo that is not needed by the
woman for whom it was created, but also as an embryo no longer needed by her spouse (if any) (Paragraph
9(1)(b)).
The statement is available at http://www.nhmrc.gov.au/publications/synopses/e35syn.htm. The criteria, both
procedural and substantive, laid out by this document are not too different from the Common Rule or the FDA
regulations governing the establishment of operation of an institutional review board.
See Sections 29 and 30.
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inspect all licensees, or how often should they be inspected. Implementation questions are to be
addressed in future regulations. As for administrative and criminal penalties, the penalties
imposed by Australia, compared to Italy and Canada, are severe. Violating a provision of
Division 1 of the PHCA is punishable by up to 15 years in prison; other violations of the PHCA
call for up to 10 years. Criminal penalties in the RIHEA are not as severe, but could still land a
scientist in prison for up to five years.
6.3 Canada: Groping Toward a New Regulatory Structure
The Canadian response to the ethical dilemmas raised by new reproductive technologies has
been more than 10 years in the making. In the early 1990s, the Royal Commission on New
Reproductive Technologies on behalf of the Canadian government spearheaded a broad national
conversation on the risks and benefits of new options in reproductive medicine. It organized
numerous town hall meetings around the country, listened carefully to the views and opinions of
the general public, and summarized this experience in a highly regarded report, “Proceed with
Care,” published in 1993. The report was the basis for several legislative proposals, the last of
which – Bill C-6, the Assisted Human Reproduction Act respecting assisted human reproduction
and related research – was finally passed on February 11, 2004, by the Canadian House of
Commons.
An important reason for examining the Canadian statute in some detail is its regulatory
stance. The Assisted Human Reproduction Act (AHRA) not only distinguishes between
acceptable and unacceptable reproductive practices, it also establishes a new regulatory
institution responsible for regulating reproductive medicine. The Canadian case is interesting for
another reason as well: It is similar to the approach taken by Britain. The Canadian statute shares
with the British approach several key features, including the adoption of a licensing scheme and
the creation of a board of directors responsible for managing the new agency. But the Canadian
AHRA also differs from the British legislation in that it takes a much more restrictive approach
to several controversial reproductive and research techniques: It is more restrictive toward the
use of sex-selection technologies, it does not allow the creation of embryos solely for research
purposes, and it bans research cloning (which the British HFEA has legalized).
6.3.1 The Assisted Human Reproduction Act of 2004
The AHRA expounds what may be called a transitional morality, meaning a mix of ethical
norms informed by traditionalist moral sensibilities and contemporary notions of individual
moral autonomy. It prohibits all forms of human cloning, for research or reproductive purposes.
In addition, it explicitly proscribes the commercial trade in human gametes and embryos. In this,
it is quite similar to the position taken by the Australian legislators. On the other hand, it does not
prohibit surrogacy or other forms of assisted reproduction that require the use of extraneous
gametes. It also bans discrimination on the basis of sexual orientation and marital status, thus
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guaranteeing access to procreative technologies to gay and lesbian couples and to singles. In this
sense, the AHRA seems to accurately reflect prevailing Canadian moral sensibilities. 42
The AHRA takes what may be described as a principled approach to regulating reproductive
technologies and biomedical research. In this, the Canadian statute stands alone; neither the
British nor the Australian legislation nor any other legislative approach, to our knowledge, has
attempted to infer legislative prohibitions and to distinguish between banned and regulated
activities from a set of fairly general ethical principles. The seven principles enumerated in
Section 2 of the AHRA are worth quoting in some detail:
(a) The health and well-being of children born through the application of assisted human
reproductive technologies must be given priority in all decisions respecting their use;
(b) The benefits of assisted human reproductive technologies and related research for
individuals, for families, and for society in general can be most effectively secured by
taking appropriate measures for the protection and promotion of human health, safety,
dignity, and rights in the use of these technologies and in related research;
(c) While all persons are affected by these technologies, women more than men are directly
and significantly affected by their application, and the health and well-being of women
must be protected in the application of these technologies;
(d) The principle of free and informed consent must be promoted and applied as a
fundamental condition of the use of human reproductive technologies;
(e) Persons who seek to undergo assisted reproduction procedures must not be discriminated
against, including on the basis of their sexual orientation or marital status;
(f) Trade in the reproductive capabilities of women and men and the exploitation of
children, women, and men for commercial ends raise health and ethical concerns that
justify their prohibition; and
(g) Human individuality and diversity, and the integrity of the human genome, must be
preserved and protected.
These principles are remarkable for several reasons. They explicitly acknowledge the need
to protect those most directly affected by reproductive procedures, namely the ART children and
women who undergo these treatments (principles (a) and (c)). They subordinate the benefits of
reproductive technologies and biomedical research to the protection of human health, safety,
dignity, and the rights of those affected by these technologies and the public in general (principle
(b)). And they resolve controversies over differential access to reproductive technologies
42
Not everybody would agree with this statement. For example, it has been argued that the Canadian public is
actually not opposed to research cloning, and that by passing Bill C-6, the Parliament simply ignored the voice of
the public. Cf. Timothy Caulfield, "Politics, Prohibitions and the Lost Public Perspective: A Comment on Bill C-
56: The Assisted Human Reproduction Act," Alberta Law Review 40 (2002). Caulfield’s comments refer to an
earlier version of the bill, but most of his arguments apply to Bill C-6 as well.
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(principle (e)). 43 Canada affords equal access to ART technologies to any (presumably adult)
individual independent of sexual orientation and marital status. Accordingly, couples –
heterosexual or not – as well as singles are granted equal access to ART technologies.
A deductive approach to ethical controversies is not without problems however, especially
for the regulators charged with implementing the provisions of the AHRA. For example,
principle (a) is clearly intended to protect the health and well-being of children. As a matter of
principle, very few would disagree that the health and well-being of children is a moral good
worthy of protection, yet any attempt to give the terms “health” and “well-being” a precise
operational meaning is likely to be controversial. Principle (b) identifies human dignity and
human rights as two moral goods deserving protection, but leaves entirely unspecified the notion
of human dignity, and does not bother to identify which human rights should be protected.
Again, it would be only too easy to fault regulators for not adequately protecting human rights,
or for taking too expansive a view of human dignity for that matter. Furthermore, it is quite
possible that some of these principles may inspire conflicting regulatory interventions.
That guiding principles leave considerable room for interpretation does not justify
dismissing a deductive approach to modern ethical dilemmas as irrelevant or impracticable. It is,
however, a good reason for establishing specific rules and institutions for addressing these
interpretive ambiguities. In this regard, the AHRA leaves much to be desired, as it does not
include any provisions as to how regulators may go about resolving the ambiguities that a
principled approach inevitably will produce.
The principles themselves are only in minimal part derived from a consistent ethical
framework, and they seem to reflect the outcome of a political compromise. An American
observer might regard them as politically liberal, for example, when they afford gay and lesbian
couples equal access to reproductive technologies. On the other end, the principles prohibit the
commercial trade of human gametes and embryos, a measure many Americans would find too
restrictive. Being the result of a political compromise, these principles ignore some important
issues. For example, the distinction between therapeutic and enhancing applications of new
reproductive technologies has not been formalized, though it seems to inform several provisions
of this act. At the same time, the fact that these principles represent a political compromise
suggests that they will likely enjoy broad public support.
Prohibited Activities
AHRA Sections 5 through 9 enumerate proscribed reproductive procedures and research
activities. Taken together, these prohibitions suggest a restrictive approach to reproductive
medicine; the act prohibits many reproductive treatments now common in the United States.
These prohibitions are remarkable for two main reasons. First, they apply to certain procreative
ends, not to the specific technological means to achieve them. While scientific and medical
43
Principle (e) does not completely resolve this thorny issue. For example, it is not entirely clear whether this
principle would afford a woman the right to become impregnated with the sperm of her deceased husband.
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progress over time may provide new means, they will not undermine the corresponding
prohibitions. Second, the prohibitions are worded in such a way as to ensure that reproductive
technologies are used exclusively for reproductive purposes narrowly defined, though as we
show below, the intent to reproduce does not justify the use of each and every reproductive
technology.
The centerpiece of these prohibitions is Section 5. Section 5(1)(a) bans any kind of cloning,
including research cloning, but does so not by specifically prohibiting somatic cell nuclear
transfer. Rather, it defines cloning in functional terms. Thus, this section simply proscribes the
creation of “a human clone, by using any technique.” Consistent with its focus on human
reproduction, Section 5 bans the creation of embryos for any purpose other then procreation,
medical training, or the improvement of reproductive technologies. 44
Medical and clinical
research on human embryos remains legal, though it may be difficult, as a matter of practice, to
determine whether a research protocol involving human embryos is indeed designed to improve
the safety and efficacy of existing reproductive technologies. This distinction becomes
particularly problematic when research protocols are designed to explore questions impinging
only indirectly on actual medical practice. 45
Reproductive intent alone does not justify resorting to any and every reproductive
technology. Accordingly, Section 5 prohibits several reproductive procedures. For example, it
bans any technique that could lead to the creation of embryos from fetuses or from embryonic
stem cells. 46 This prohibition is a direct response to the announcement made in 2003 by an Israeli
research group that it had successfully retrieved viable oocytes from aborted fetuses, and to other
experiments in mice showing that it may be possible to derive sperm-like cells and oocytes from
stem cells (see chapter 4 for details). In keeping with a narrow understanding of reproduction,
Section 5 also proscribes the use of sex-selection technologies except for preventing sex-linked
diseases. 47 As with other prohibitions discussed in this section, this ban does not refer to a
specific sex-selection technology; it simply proscribes the use of any and all technological means
for elective sex selection. Also proscribed are all forms of genetic engineering that would
produce an inheritable genetic modification. 48 Presumably this prohibition extends to ooplasm
transfer, as this procedure indeed produces an inheritable genetic modification by passing on
mitochondrial DNA from a third party. Furthermore, innovative reproductive approaches that
involve the use of animal tissues, such as co-culture, are also prohibited. 49 In keeping with
44
45
46
47
48
49
See Section 5(1)(b).
The AHRA does not ban stem cell research, however. Section 5(1)(b) only bans the creation of in vitro embryos
for any purpose other than human reproduction. The act does not explicitly require the transfer of all in vitro
embryos into a woman’s uterus. This introduces the possibility that existing, cryopreserved embryos can be
donated for research, a solution that is reminiscent of the Australian approach to legalizing stem cell research.
See Section 5(1)(c).
See Section 5(1)(e).
See Section 5(1)(f).
See Section 5(1)(h).
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traditional views of reproduction, Sections 6 through 9 place numerous restrictions on the use of
third party gametes and embryos and on surrogacy services. The commercial trade of gametes
and embryos is proscribed, as are commercial offerings of surrogacy services, but gametes and
embryos can be donated, and surrogacy may be provided on a non-commercial basis.
Sections 5(1)(i) and 5(1)(j) ban the creation of chimeras and hybrids, respectively. Section
5(1)(i) only bans the creation of a human chimera (i.e., one created by inserting non-human cells
into a human embryos), but the converse procedure is legal, in keeping with common scientific
practice. By contrast, Section 5(1)(j) bans any form of hybrid (i.e., fertilizing a human oocyte
with non-human sperm, or fertilizing a non-human oocyte with human sperm), but also somatic
cell nuclear transplantation using human and non-human cells.
Surprisingly, Sections 5 through 9 do not address the legality of pre-implantation genetic
diagnosis, explicitly or implicitly. Section 5(1)(b) forbids the creation of embryos for any
reasons other than reproductive purposes. PGD requires the creation of several embryos for the
stated purpose of selecting a few with specific characteristics. Those not meeting certain criteria
are by definition not used for reproductive purposes, making PGD, in principle at least, illegal
under the AHRA. However, Health Canada has made clear that under the AHRA, PGD is a
regulated activity, not a prohibited one. 50
Performing PGD will be controlled by a set of
guidelines for which Health Canada was seeking public feedback at the time of this writing. 51
Regulated Activities
In AHRA terminology, regulated activities are referred to as “controlled” activities and are
described in Sections 10 through 19. Sections 10 through 13 sketch the architecture of the
Canadian system of licensing. Section 10(1) requires that any persons in the business of altering,
manipulating, or treating human reproductive tissues for the purpose of creating an embryo be
licensed. Also licensed must be any persons involved in altering, manipulating, or treating in
vitro embryos, 52
and any persons involved in storing, handling, transferring, importing, or
exporting reproductive materials and in vitro embryos. 53
A license is required to produce
transgenic animals. 54 Facilities must also be licensed. 55 Finally, reimbursement for transporting
and donating gametes and embryos and for surrogacy services is also subject to regulation. 56
Compared to the British licensing scheme, the Canadian approach is less demanding.
Licenses are granted to perform regulated reproductive activities in toto, not for specific
reproductive treatments, as is the case in Britain. At present, licenses have unlimited validity,
50
51
52
53
54
55
56
Health Canada is the Federal department responsible for protecting and improving pubic health in Canada.
See http://www.hc-sc.gc.ca/ahc-asc/public-consult/col/pgd-dgp/pgd-dgp_e.html.
See Section 10(2).
See Section 10(3).
See Section 11.
See Section 13.
See Section 12.
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whereas in Britain they must be renewed periodically. The Canadian approach to licensing,
unlike its British counterpart, does not distinguish between licenses to perform ART procedures
and licenses to store and distribute gametes and embryos. The Canadian approach to the
licensing of reproductive medicine is of course much stricter than its U.S. counterpart, in which
reproductive endocrinologists may be (but often are not required to be) specifically licensed to
perform ART procedures on a state-by-state basis, and where no such licensing requirements
exist at the federal level.
AHRA Sections 14 through 19 establish what may be called a system of health monitoring.
A key concept of this system is “health reporting information,” a term that in the act identifies
what information ART practitioners must report to federal regulators. Health reporting
information is a comprehensive concept that refers mainly to individuals. Individuals affected by
reporting requirements fall into two categories. In the first, the AHRA includes donors of
gametes and embryos, persons who have undergone an ART treatment (namely, the patients),
and persons conceived through ART (i.e., the ART children proper). 57 Information regarding
these individuals includes biographical, medical, and legal elements. The second category
consists of individuals responsible for the custody of gametes and embryos.
The AHRA stops short of requiring the implementation of a comprehensive tracking system
that includes both affected individuals and reproductive tissues. The regulatory agency is
required to establish and maintain a personal health information registry. However, the reporting
requirements are limited to individuals directly affected by ART procedures – i.e., donors of
reproductive tissues, patients, and ART children. 58 It appears that the act does not attempt to
track the history of each and every in vitro embryo. Section 15(3)(1) does, however, mandate
that regulators be notified when in vitro embryos are transferred between licensees. Reproductive
tissues are not affected by this requirement. Section 18 defines the purposes of these reporting
requirements, calling for regulators to use health reporting information for enforcement and for
public health purposes.
The AHRA specifies in some detail the rules governing the collection, access, and disclosure
of health reporting information. A licensee is not allowed to accept donated gametes or embryos
without obtaining the relevant health reporting information. 59 Conversely, the licensee is not
allowed to disclose health reporting information without written consent of the individual whose
information would be disclosed. 60 In addition, a person is entitled to obtain access to his or her
own health reporting information, and to request that any corrections be made to his or her health
reporting information. 61 Unfortunately, at the time of this writing, the regulations to implement
these provisions have not yet been finalized. The types of information to be regarded as critical
57
58
59
60
61
See Section 3 – definitions.
See Section 17.
See Section 14.
See Section 15.
See Section 16.
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y the Canadian authorities and the specific data that must be reported to regulators remain to be
determined.
The Assisted Human Reproduction Agency of Canada
Sections 21 through 39 establish a new regulatory agency, the Assisted Human
Reproduction Agency of Canada (AHRAC). Section 22 sets forth two objectives for the agency
– “to protect and promote the health and safety, and the human dignity and human rights, of
Canadians” and to “foster the application of ethical principles” in the practice of human
reproduction. The AHRAC bears some similarities to the British HFEA. It is governed by a
board of directors consisting of 13 members (at the most), including the chairperson and the
president. Appointments are for three-year terms and are renewable. The Canadian Governor in
Council appoints both the board members and the chairperson. 62 The AHRAC is managed by a
president, who is also appointed by the Governor in Council, for a term of five years, and can be
reappointed.
Unlike the British Human Fertilisation and Embryology Act, the Canadian AHRA does not
specify in any detail the rules that should inform the appointment of the board members, the
chairperson, or the president. Nor does the AHRA touch on the composition of the board –
whether it should be constituted as a body of specialists (as in the Australian case), or whether it
should be inclusive of all societal views, above and beyond the views represented by organized
interest groups (as in the British case). It only precludes individuals directly affected by AHRAC
decisions from becoming board members.
Canada takes a rather different approach than Britain in promulgating new rules and
regulations. Technically, the AHRAC does not have any authority to autonomously craft new
regulations; that responsibility falls to the Canadian minister of health. Yet it would be wrong to
conclude that the AHRAC is simply an administrative arm of the cabinet. Section 30(a)
stipulates that one of the board’s responsibilities is to advise “the Minister on assisted human
reproduction and other matters to which this Act applies, or on any matter referred to the Agency
by the Minister.” So while the formal authority for promulgating new regulations and revolving
controversial issues rests with the minister of health, the minister’s decisions may be heavily
influenced by the AHRAC, especially if the agency recommendations are based on a broad
process of public consultation. Thus, while from a legal standpoint the agency has very limited
regulatory authority, its influence on the regulatory process is likely to be significant.
The AHRA considerably restricts the authority of the executive to promulgate new
regulations. Section 66 requires the minister of health to submit new regulations for approval to
both houses of Parliament, a measure considered unusual by Canadian commentators. And
Section 70 requires that the act be reviewed by the overseeing parliamentary committees every
62
In Canada, the “Governor in Council” is the governor general acting on the advice of the federal cabinet (in other
words, the government executive). The cabinet is made up of the prime minister and members of parliament, and
sometimes senators, chosen by the prime minister. Each member of cabinet is assigned a portfolio of
responsibilities, usually the subject matter of a government department.
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three instead of the usual five years. Both provisions seem to reflect the highly contentious
nature of the act and the Parliament’s desire to maintain a tight control over the AHRAC.
The minister of health retains some administrative discretion in that he has the power to
promulgate so-called policy directions. The AHRA explicitly maintains that policy directions are
not statutory instruments – i.e., that they are not regulations subject to parliamentary approval. 63
Policy directions are meant to provide broad guidance in the implementation of the statute, and
should not intrude on specific administrative decisions. The issuance of policy directions is the
Canadian way of attenuating the tension between the desire to avoid politicizing administrative
procedures and the need to provide guidance to regulatory agencies.
In sum, compared to the HFEA, the Canadian AHRAC has a rather limited formal
regulatory authority. Regulation is the province of the minister of health, and not of the agency.
And unlike the U.S. Congress, which controls the administrative system mainly by indirect
means, the Canadian Parliament retains direct control over the regulatory process. In this sense,
the Canadian AHRAC and the British HFEA, while formally similar, have vastly different
authority. Nevertheless, the AHRAC is not entirely inconsequential, as it retains considerable
(albeit indirect) influence over the regulatory process by playing a crucial mediating role
between societal interests and the health ministry.
Among the AHRAC’s main operational responsibilities are monitoring and evaluating
clinical developments in reproductive medicine, 64
gathering and analyzing health reporting
information, 65 and informing and educating the public. 66 A central task for the agency is of
course the licensing of individuals, organizations, and facilities. 67 Another important agency
responsibility is taking measures to “prevent, reduce, or mitigate” threats to human health and
safety that may result from regulated activities. 68 In spite of this deceptively simple statutory
language, the implementation of this provision is likely to prove both complex and costly. Few
countries have implemented a system of surveillance that meets these requirements. In the
United States, surveillance is limited largely to measuring success rates on a clinic-by-clinic
basis. Britain comes closest to implementing a similarly comprehensive system, but as of this
writing, Health Canada has not made public any implementation details.
The AHRA requires that the AHRAC not only oversee the ART industry, but also that it
review research protocols involving human embryos. Since the AHRA mainly governs the use of
ART technologies and deals only tangentially with research on human reproductive tissues, this
area of medical research is regulated by a separate document, the “Human Pluripotent Stem Cell
Research Guidelines.” The AHRA, however, does contain two provisions relevant to conducting
63
64
65
66
67
68
See Section 25(3).
See Section 24(1)(c).
See Section 24(1)(e).
See Section 24(1)(f).
See Section 40.
See Section 44.
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esearch on human embryos. It requires written and informed consent from the gamete or
embryo donors (s. 40(3.1). And, crucially, Section 40(2) provides that scientists must satisfy the
agency that the proposed research goals cannot be achieved by any means other than using
human embryos. How this process is supposed to be implemented is an unresolved matter. In
particular, it is unclear whether the review process should be conducted exclusively by members
of the scientific community, or whether the review panel should also include representatives of
organized interest groups or even of the general public. Also unclear is whether and to what
extent proponents of rejected proposals should have access to judicial review.
Some scientists may find this requirement too intrusive, or even consider it an unacceptable
infringement on their scientific autonomy and professional independence. However, as a matter
of practice, this approach is neither exceptional nor unreasonable. The British HFEA has been
approving research protocols on human embryos in a similar fashion for many years. By
distinguishing between the ends of a proposed research protocol and the means to achieve these
ends, the Canadian AHRA protects a key aspect of research freedom while introducing a
measure of accountability.
Finally, a significant portion of the AHRA is dedicated to inspection and enforcement
procedures and to enumerating sanctions. 69 The order of magnitude of the fines imposed for
many violations is similar to other cases discussed in this chapter. For example, violators of
proscribed activities may be fined up to 500,000 Canadian dollars and may be imprisoned for up
to 10 years.
6.4 The Human Fertilisation and Embryology Act – Blueprint for Action or a Case of
British Peculiarity?
6.4.1 Introduction
Britain recognized earlier than any other OECD country that scientific developments in
genetics and reproductive medicine would call for the creation of new regulatory institutions. In
1990, the British Parliament passed the Human Fertilisation and Embryology Act (the HFE
Act). 70 The passage of the HFE Act was the culmination of a protracted public debate initiated
by the 1998 publication of the Warnock Report on the social, ethical, and legal challenges raised
by new reproductive technologies and biomedical research. 71 The report recognized that human
embryos are entitled to “some protection” under the law, consistent with the view that they are
neither simply clumps of human cells nor entitled to full human status. The report acknowledged
that in modern, pluralistic societies, reaching a consensus on ethical controversies is a very
difficult task, and recommended the creation of a regulatory institution specifically designed to
69
70
71
See Sections 45-59 and 60-64, respectively.
The full text of the HFE Act is available at http://www.opsi.gov.uk/acts/acts1990/Ukpga_19900037_en_1.htm.
Report of the Committee of Inquiry into Human Fertilisation and Embryology, Cm 9314, July 1984, also known
as the Warnock report.
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address ethical controversies – the Human Fertilisation and Embryology Authority. The HFEA
was charged with monitoring scientific and medical advances, and is responsible for licensing
any activity that involves the in vitro creation of human embryos, the storage and donation of
gametes and embryos, and medical research involving human embryos. It is also charged with
enforcing the provisions of the HFE Act and its regulations.
The HFE Act, based in large measure on the recommendations of the Warnock report, has
stood the test of time. To date, Britain is the only country with extensive experience in the
regulation of both reproductive medicine and biomedical research. The British experience in this
area, therefore, is of considerable interest to any government confronted with the task of
designing a regulatory structure for reproductive medicine and biomedical research.
In its 15 years of existence, the HFE Act has rarely been updated. For this reason, in 2004,
the British government announced that it planned to review the act and to conduct a public
consultation on this matter in 2005. 72 That it has remained largely untouched for such a long
period of time is itself an indication of broad public support for this approach to resolving
societal controversies produced by advances in reproductive medicine. The HFEA may not be
able to craft a consensus on each and every ethical controversy, and its policies have often been
criticized alternatively by pro-life groups, scientists, and the ART industry, but few have
questioned the legitimacy of the HFEA as a regulatory institution.
The special position occupied by the HFEA in the British system of government is itself an
expression of mild distrust in the ability of traditional administrative bodies to regulate
biomedicine. 73 The HFEA enjoys a measure of regulatory discretion unknown to other British
ministries. 74 The Parliament’s decision to shield the HFEA from traditional mechanisms of
oversight can be explained partly by the desire to protect this regulatory body against the
vagaries of interest group politics. It would seem only appropriate that a regulatory body charged
with resolving highly controversial moral dilemmas not be perceived as being captured by the
one or the other political constituency. While in other regulatory contexts the competition for
power and influence among politicians and organized interest groups can be described as normal
and even healthy, in the present case, the perception that the HFEA might cater to the interests of
a specific political constituency would ipso facto undermine its moral authority as a regulatory
body. In this sense, the partial regulatory autonomy enjoyed by the HFEA reflects the
Parliament’s intention to minimize regulatory capture.
72
73
74
See http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedConsultationsArticle/fs/en?CONTENT_ID
=4123863&chk=zy5dcI.
Note that for brevity, we at times use the term “biomedicine” to mean reproductive medicine and biomedical
research.
The HFE Act delegates responsibility for promulgating the necessary regulations to the ministry of health.
Regulations crafted by this ministry are subject to parliamentary review, as is the case for any other ministry.
The HFEA does not have the authority to autonomously craft regulations. However, the agency does have the
authority to formulate and enforce its own policies. HFEA policies, unlike regulations, are not subject to
parliamentary review. In this sense, the HFEA enjoys considerably more regulatory discretion than its Canadian
and Australian counterparts.
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This argument is not likely to convince American commentators of administrative law who
may describe the HFEA as a classic example of an “unaccountable” regulatory institution.
Formally, the HFEA may be less accountable than other regulatory institutions, but in practice,
its policies can hardly be described as “arbitrary and capricious.” The HFEA, mindful of its
unique position, traditionally has taken accountability seriously. An extensive process of public
consultation always precedes the adoption of controversial new policies. Among the subjects
selected by the HFEA for consultation are sex-selection and screening technologies, gamete and
embryo donation, and pre-implantation genetic diagnosis. 75 Through the appointment process,
the government can affect, at least in general terms, the future direction of the agency. Moreover,
the HFE Act requires the HFEA to prepare an annual report for the minister of health. The
reports are submitted to both houses of the Parliament for review. 76 Finally, HFEA policies are
subject to judicial review. In sum, while the HFEA enjoys more regulatory discretion than other
administrative entities, it cannot be described as an unaccountable regulatory institution in the
sense attributed to this term by U.S. scholars of administrative law.
6.4.2 The HFE Act
Any human embryo created outside the human body falls under the jurisdiction of the HFE
Act. This means that certain types of ART treatments that do not require the creation of an in
vitro embryo are not subject to the act’s provisions. Artificial insemination is an example; the
sale of fresh sperm is another.
Like other statutes discussed in this chapter, the HFE Act distinguishes between prohibited
and regulated activities. Prohibitions contemplated by the act are broadly consistent with
activities banned by statutes passed in other countries. Section 3 identifies prohibited activities
pertaining to the use of embryos, and Section 4 does the same for gametes. More specifically,
Section 3(2)(a) and (b) prohibits transferring a non-human embryo or any non-human gametes to
a woman’s uterus. Section 3(3)(a) also prohibits storing or using an embryo after the appearance
of the primitive streak, but in any case no later than 14 days. Section 3(3)(b) prohibits
transferring a human embryo to an animal, and Section 3(3)(d) was intended to prohibit any form
of cloning, though at the time cloning technologies did not yet exist. Section 12 prohibits, with
some qualifications, the commercial trade of embryos and gametes. Finally, Schedule 2, Section
(1)(4) prohibits the genetic modification of embryos.
Activities not explicitly prohibited by the HFE Act are regulated. The act regulates the
artificial creation of embryos, the storage of gametes and embryos, and the use of embryos for
research purposes by requiring ART practitioners and researchers to obtain a license for each of
these three types of activities. 77 This means that research on human embryos, either privately or
publicly funded, it legal under the act. In addition to the donation of human gametes and
75
76
77
See http://www.hfea.gov.uk/AboutHFEA/Consultations.
See Sections 7(1), (2) and (3) of the Act.
See Sections 3(1)(a) and (b) and Section 11.
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embryos, 78 the act regulates the creation of human-animal hybrids. 79 This is not as grotesque as it
seems. Human-animal hybrids are created to test human gametes in animals, a well-established
practice in reproductive medicine. The HFE Act is silent on the creation and use of chimeric
embryos (embryos consisting of both human and animal cells). As part of a recently launched
consultation on the revision of the HFE Act, the British department of health has solicited
comments on the creation of human-animal hybrid or chimeric embryos for research purposes. 80
A unique feature of the HFE Act is the absence of any reference to specific reproductive
procedures, and with one exception (reproductive cloning), it has never been amended to include
any such reference. For the last 15 years, it has been the HFEA’s task to craft policies designed
to distinguish between permissible and impermissible uses of reproductive technologies. In part,
this is due to fact that at the time the legislation was enacted, there were few if any controversial
reproductive technologies. According to HFEA officials, the generic structure of the HFE Act
was regarded by legislators as one if its main strengths. The act was designed to give the HFEA
authority to promulgate new policies in response to new scientific and medical developments in a
timely manner. This the HFEA has done with effectiveness. Among the most recent initiatives
are a public consultation on the use of PGD in 2002, another public consultation in 2002-2003 on
sex-selection technologies, and in 2004 a review of its policy on donated gametes and embryos. 81
6.4.3 The Human Fertilisation and Embryology Authority
The HFE Act defines the statutory functions of the Human Fertilisation and Embryology
Authority as follows:
• Review information about human embryos and any subsequent development of such
embryos, and the provision of treatment services and activities governed by the HFE Act.
The HFEA should also advise the secretary of state on relevant developments in
treatments and research. 82
• Promote its services and the services offered by the licensees to the public. 83
• Provide relevant advice and information to patients, donors, and clinics in the UK. 84
• Produce a code of practice which gives guidelines to infertility clinics about the proper
conduct of licensed activities. 85
78
79
80
81
82
83
84
See Art. 4(1)(b).
See Art. 4(1)(c).
The consultation documents can be found at http://www.dh.gov.uk/Consultations/ClosedConsultations/ClosedCo
nsultationsArticle/fs/en?CONTENT_ID=4123863&chk=zy5dcI.
See http://www.hfea.gov.uk/AboutHFEA/HFEAPolicy for additional information about these consultations
processes.
See Art. 8(a).
See Art. 8(b).
See Art. 8(c).
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• Maintain a formal register of information about donors, treatments, and children born as a
result of those treatments. 86
To discharge these functions, the HFEA has the authority to establish additional, specialized
committees. As of this writing, seven committees exist – the Regulation Committee, the
Scientific and Clinical Advances Group, the Ethics and Law Committee, the Organization and
Finance Committee, the Information Management Program Board, the Audit Committee, and the
License Committee. 87 The first three committees discharge the core HFEA functions. Members
of any of these committees are also members of the HFEA proper. Committees can establish
specialized subcommittees. Participation in a subcommittee is not restricted to HFEA members.
Outside members can be appointed to subcommittees, but HFEA members must remain in the
majority. 88
The HFE Act specifies in considerable detail the composition, responsibilities, and
procedures governing the Human Fertilisation and Embryology Authority. The HFEA, unlike its
Australian counterpart, is not designed to be exclusively a technocratic body of governance. The
Act tries to strike a balance between two partially conflicting goals, technical competence,
including scientific, medical, legal and ethical expertise, and legitimacy. A regulatory body
consisting exclusively of technical specialists obviously would be highly competent, but the
general public may view the policies promulgated by this body with suspicion. On the other end,
a regulatory body dominated by laypersons would most likely be regarded as legitimate, but its
technical competence would be very limited.
Currently, the HFEA has 18 members, including the chairperson and the deputy. Schedule 1
of the Act (“The Authority: Supplementary Provisions”) does not specify the size of this board;
that decision is left to the “Secretary of State for Health”, i.e. the health minister. It does,
however, offer considerable guidance regarding its composition. Article 4(2) of Schedule 1
requires that the views of both men and women be “adequately represented.” As of this writing,
the HFEA consists of exactly nine women and nine men. Article 4(3) establishes that three
categories of individuals are not eligible for the positions of chairperson or deputy chairperson:
(a) medical practitioners, (b) individuals involved in “keeping or using gametes or embryos
outside the body,” and (c) individuals with an interest in the funding of research on keeping or
using gametes or embryos. The health minister must also ensure that medical and ART
practitioners (categories (a) and (b)) are represented by at least one person on the board. Finally
and most importantly, the health minister must ensure that at least one-third but less than half of
HFEA members represent the medical profession, the ART industry, and the research
community (categories (a), (b), and (c)).
85
86
87
88
See Art. 25. The sixth edition of the code is available at http://www.hfea.gov.uk/HFEAPublications/CodeofPract
ice.
See Art. 31.
See http://www.hfea.gov.uk/AboutHFEA/OrganisationalStructure.
See Sections 9(1) – 9(6).
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This provision has important consequences. It severely limits the health minister’s ability to
appoint medical and scientific specialists. More specifically, it forces the minister to select
individuals who do not represent the medical profession, the ART industry, or the scientific
community. In this narrow but important sense, the health minister must appoint a majority of
individuals that in some sense represent the general public. This is a very unusual approach to
filling important administrative positions, and as such deserves some scrutiny.
It is the health minister’s responsibility to appoint a qualified individual to the HFEA.
Schedule 1 does not include any appointment rules. The HFEA simply conducts a nationwide
public search open to any qualified British citizen. The health minister selects new HFEA
members from the pool of qualified individuals. The appointment is for a three-year term. A
member of the HFEA can be reappointed, but not for consecutive terms. What constitutes a
suitable candidate and what rules inform the appointment process are not entirely clear. It
appears that the health minister enjoys considerable discretion in appointing new board
members. In this regard, the HFEA is no exception. In the recent past, appointments to boards of
“executive and advisory non-departmental public bodies” such as the HFEA have generated
considerable discomfort in the general public. In response to the charge that appointments to
these bodies often appear to be arbitrary and capricious, the British Government established an
Office of the Commissioner for Public Appointments charged with developing a code of practice
intended to increase the legitimacy and credibility of these appointments. 89 On its Web site, the
HFEA states that its members are appointed in accordance with guidance from the
Commissioner for Public Appointments, but the guidelines are rather generic and offer little
insight into how members are actually selected. Conversations with HFEA officials have
confirmed that the appointment process remains very much a discretionary activity of the health
minister, as nominees do not need to be confirmed by the Parliament and no specific guidelines
exist for the selection of suitable candidates.
In our view, the appointment process remains the weakest element of the British approach to
regulating reproductive medicine and medical technologies. To appreciate the limits of current
appointment rules, one should try to identify those HFEA members that do not represent the
fertility industry, the medical profession, or the scientific community. The HFEA Web site
provides a list of current members complete with short biographical abstracts, but it does not
supply any information about the slot occupied by each member. 90 There are seven members
who are obviously not representing the three main constituencies – the chairperson (a consumer
group advocate), a reverend, the UK’s financial Ombudsman, a broadcast journalist, a finance
and business professional, a very senior career politician, and a senior editor. These are
accomplished senior individuals, all of whom can be expected to appreciate the complexities
involved in regulating reproductive medicine and medical research. However, they can hardly be
regarded as typical representatives of the general public.
89
90
See http://www.ocpa.gov.uk/the_code_of_practice/index.asp.
See http://www.hfea.gov.uk/AboutHFEA/HFEAMembers.
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The remaining three positions reserved to laypersons are occupied by a representative of an
infertility group, a professor of medical law, and a professor of philosophy and ethics. These are
certainly highly qualified individuals, but one could legitimately wonder to what extent they may
be viewed as representatives of the general public. An unsympathetic reading of these
appointments could easily come to the conclusion that the HFEA lay members are neither lay nor
representative of the general public. Infertility groups, far from playing a mediating role between
the public and the ART industry, often are focused exclusively on their narrow interest. Whether
a professor specialized in medical law is more likely to take a broad public view of bioethical
dilemmas is an open question. As for the philosophy professor, it is difficult to imagine a profile
more distant from common conceptions of a layperson.
It is certainly not our intention to disparage the integrity and the professionalism of the
HFEA board members. What this short discussion shows is how problematic the notion of a
layperson can be. As it is now constituted, the HFEA is not too dissimilar from any other
technical advisory board – impressive in terms of the scope and depth of medical and scientific
expertise but hardly inclusive of lay views. These shortcomings notwithstanding, it must be
emphasized that HFEA appointments have rarely been controversial. Perhaps the British are less
distrustful of public officials than the American public.
It would have been interesting to examine in some detail the rules governing the HFEA
decision-making process. Unfortunately, we were unable to identify any. Schedule 1 leaves it to
the HFEA to constitute itself as it sees fit, but the HFEA has never spelled out these rules. It is
plausible to assume that the HFEA devotes a considerable amount of time to deliberating
controversial ethical questions – in other words, that it operates in a deliberative fashion.
Whether deliberation, on balance, leads to consensual positions or whether this regulatory body
remains divided most of the time is unclear. Asked about this issue, HFEA officials have
generally been evasive, a reaction suggesting that the decision-making process is not informed
by clear and unambiguous rules, that conflicts may be common, and that their resolution may
depend on a vote or on an executive decision by the chairperson.
6.4.4 Licensing
The HFE Act specifies both general requirements 91 and specific criteria for obtaining a
treatment, 92 a storage license, 93 and a research license. 94 Additional licensing requirements are
introduced in Schedules 2 and 3. Article 12 lays out the basic provisions for obtaining a license,
including record-keeping requirements, the right of the HFEA to inspect a licensed facility, and
the obligation of a licensed facility to provide records to the HFEA upon request.
91
92
93
94
See Art. 12.
See Art. 13.
See Art. 14.
See Art. 15.
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Schedule 2, Article 1 enumerates the activities a treatment license authorizes a licensee to
conduct – creating human embryos, 95 keeping embryos, 96 using gametes, 97 testing embryos
before implantation, 98 placing an embryo in a woman, 99 and mixing human sperm with animal
eggs (to test the viability of the sperm). 100 The validity of a treatment license is limited to five
years.
Article 13 spells out the requirements for obtaining a treatment license, and specifies the
record-keeping requirements 101 – it requires protecting the integrity of personal records 102 and
taking into account the welfare of the prospective child when considering treatment; 103
it
mandates counseling for the woman and/or the couple prior to treatment; 104 and it demands that
procedures be put in place for determining the identify of gametes and embryo donors. 105
Of some interest to an American audience is Article 13(5). As mentioned above, this Article
13 sanctions the principle that the welfare of ART children is be taken explicitly into account
when considering the pros and cons of a reproductive treatment. What exactly constitutes
“welfare” is defined more precisely in the code of practice discussed below. 106 For example, the
HFEA considers protecting the well-being of future children incompatible with single women
and lesbian couples seeking reproductive services. This policy has been very controversial from
the beginning, but it has remained in place. Whether it will survive the ongoing review process
remains to be seen.
Licensing requirements for the storage of gametes and embryos are relatively straightforward:
They simply require that storage be performed by licensed persons only, and that
reproductive materials be supplied or transferred only to individuals in possession of a license for
storage or treatment. Gametes can be stored for up to 10 years, embryos for five years.
More interesting to the present discussion are the provisions of Schedule 2, Article 3
concerning the granting of research licenses. Britain has been able to solve the conflict between
the scientists’ desire to protect the freedom of research and public demands for increased
accountability in controversial areas of medical research. Article 3 explicitly authorizes
conducting research on human embryos, but it severely restricts the scope for conducting this
95
96
97
98
99
See (1)(1)(a).
See (1)(1)(b).
See (1)(1)(c).
See (1)(1)(d).
See (1)(1)(e).
100
See (1)(1)(f).
101
See Art. 13(2).
102
See Art. 13(4).
103
See Art. 13(5).
104
See Art. 13(6).
105
See Art. 13(7).
106
See Articles 25 and 26.
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type of research. The HFEA is required by the HFE Act to ensure that the proposed research
meets any of the following criteria: 107
• It promotes advances in the treatment of infertility
• It increases knowledge about the causes of congenital disease
• It increases knowledge about the causes of miscarriages
• It aims to develop more effective methods of contraception
• It aims at developing methods for detecting gene or chromosomal abnormalities in embryos
• Other such purposes as may be specified in regulations
In November of 2000, following the recommendations of a report by the Chief Medical
Officer’s Expert Advisory Group titled “Stem Cell Research: Medical Progress with
Responsibility,” 108 the Parliament passed new regulations known as the Human Fertilisation and
Embryology (Research Purposes) Regulations 2001. 109 The new regulations, effective January
31, 2001, allow the HFEA the grant a research license for the following additional activities:
• Research involving embryos for the purpose of increasing knowledge about the development
of embryos
• Increasing knowledge about the development of disease
• Enabling any such knowledge to be applied in developing treatment for serious disease
These regulations are meant to legalize research cloning – to allow the creation of embryos
by somatic cell nuclear transfer for research purposes. Following the passage of the Human
Fertilisation and Embryology (Research Purposes) Regulations 2001, several members of
Parliament grew concerned that these new regulations would open the door to reproductive
cloning. To prevent this possibility, in the same year, the Parliament explicitly banned human
reproductive cloning. 110
Based on our conversations with HFEA staff, obtaining a license to conduct research on
human embryos is no easy task. For example, the HFEA requires applicants to demonstrate that
their research goals cannot be achieved without sacrificing human embryos. By imposing this
requirement, the HFEA, for all intents and purposes, separates (scientific) means and ends. The
HFEA does not question the ends (the research goals), but it probes whether the means are
commensurate with these goals. The HFE Act also establishes specific rules for appealing a
107
See Art. 3(2).
108
See http://www.dh.gov.uk/AboutUs/MinistersAndDepartmentLeaders/ChiefMedicalOfficer/ProgressOnPolicy/P
rogressBrowsableDocument/fs/en?CONTENT_ID=4108203&MULTIPAGE_ID=5123869&chk=JCM
yhP.
109
See http://www.opsi.gov.uk/si/si2001/20010188.htm.
110
See http://www.opsi.gov.uk/acts/acts2001/20010023.htm.
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decision by the licensing committee. 111 Researchers whose applications have been turned down
can first request to give an oral presentation to this committee. If the licensing committee persists
in refusing to grant a license, researchers can appeal to the HFEA. Finally, researchers can
challenge the decision by appealing to the High Court.
American scientists may find the British approach to granting research licenses too
restrictive. They may believe that the HFE Act excessively limits research freedom by granting
too much discretion to the HFEA, leading to “capricious and arbitrary” decisions. They may also
perceive this approach to be too bureaucratic and cumbersome. Others commentators may find
the utilitarian orientation underlying granting research licenses unacceptable. Still others may be
disturbed by the notion that the government is involved in the business of sanctioning the
destruction of human embryos.
To all those who oppose conducting research on human embryos, the British approach will
remain unacceptable. To other critics, however, this approach also has some attractive features. It
greatly reduces the need for scrutiny by universities and hospitals, a considerable burden
according to some scientists. It establishes clear and consistent criteria for conducting embryo
research, and it ensures equal treatment for publicly and privately funded research. Importantly,
the utilitarian approach to evaluating research proposals ensures that the researchers must justify
their methodological choices in some detail. In sum, the British approach to granting research
licenses protects the freedom of research while satisfying public demands for holding scientists
accountable.
6.4.5 The Code of Practice
Under the HFE Act, the HFEA has a statutory duty to prepare a Code of Practice. The Code
of Practice provides considerable guidance to licensees (ART clinics, research institutions, and
gametes and embryo banks) and to patients concerning the proper implementation of the act
itself. It is in this area that the HFEA regulatory autonomy manifests itself. The HFEA uses the
code to promulgate specific policies on a wide range of reproductive practices and ethical
questions. The sixth edition of the Code of Practice, published in 2003, covers most aspects of
the HFE Act. 112 New to this edition are Sections 14 (on pre-implantation genetic testing), 15 (on
witnessing clinical and laboratory procedures), and 16 (on intra-cytoplasmic sperm injection).
The legal status of the Code of Practice is somewhat ambiguous; its provisions do not have the
force of law, but licensees are well-advised to take its recommendations seriously, as
disregarding its provisions may have serious negative consequences. 113
111
See Articles 20 and 21.
112
These include staff, facilities, and administrative procedures, welfare of the child, assessing and screening
potential donors, information, consent, counseling, use of gametes and embryos, storage and handling of gametes
and embryos, research, records, confidentiality, complaints, pre-implantation genetic testing, witnessing clinical
and laboratory procedures, and intra-cytoplasmic sperm injection.
113
Article 25(5) states: “A failure on the part of any person to observe any provision of the Code shall not of itself
render the person liable to any proceedings, but: (a) a License Committee shall, in considering whether there has
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The relevance of the Code of Practice can hardly be overemphasized. It makes it much
easier for licensees to comply with the HFE Act by reducing legal uncertainty. It also
demonstrates how a regulatory body can promote the adoption of best practices without crafting
rigid rules and regulations. The code accomplishes this through the HFEA system of monitoring
and compliance assurance. Clinics are audited on a regular basis, typically yearly. Inspections are
unannounced, and violations can lead to suspension of the license. In this regard, the HFEA’s
approach to compliance assurance is no different than any other enforcement system. However,
many inspections are conducted not by HFEA officials but ART professionals themselves,
typically colleagues at other ART clinics. This measure was taken not to increase economic
efficiency or to reduce personnel costs, but to promote reciprocal learning and the adoption of
best practices. According to HFEA officials, this approach has proven very successful in
ensuring that clinics become aware of potential areas of concern, and has indeed promoted the
adoption of best practices among ART practitioners. 114 The HFEA capitalizes on this process by
carefully scrutinizing audit results and by using this information to improve existing policies and
practices.
6.5 Summary and Conclusions
Our review of legislative initiatives at the international level provides several lessons. Most
industrialized countries and many developing nations have responded to the ethical dilemmas
raised by reproductive medicine and biomedical research not only by appointing ethics
commissions, but also by passing new legislation. As Appendix H demonstrates, there is a
remarkable agreement among legislative bodies around the world on which reproductive
practices and scientific developments may call for governmental interventions. These include
embryo research, reproductive cloning, research cloning, stem cell research, pre-implantation
genetic diagnosis, the creation of chimeric animals, the creation of hybrids, germ-line genetic
modifications, surrogacy, and the trade or sale of gametes and embryos. The United States is the
exception, having refrained to adopting any specific measures for most of these developments.
Among the countries included in our survey, there is little agreement on how to respond to
new developments in biomedicine. Most countries have banned reproductive cloning. In other
respects, however, important differences remain. Interestingly, prevailing religious and cultural
orientations seem to be weak predictors of legislative choices. Spain, for example, has much
more liberal stem cell research legislation than France or Italy. Important differences exist
been a failure to comply with the conditions of a license and, in particular, conditions requiring anything to be
“proper” or “suitable,” take account of any relevant provision of the Code, and (b) a License Committee may, in
considering, where it has power to do so, whether or not to vary or revoke a license, take into account any
observance or failure to observe the provisions of the Code.
114
This practice is not as uncommon as one might think. In many industrial sectors that have adopted voluntary
environmental and safety codes, “compliance” is often ensured through an analogous mechanism. For example,
in the United States, the National Paint and Coatings Association, an organization that has adopted a
comprehensive and mandatory system of environmental management known as “Coating Care,” relies on
reciprocal audits to monitor compliance and promote the adoption of best practices.
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among Scandinavian countries; Sweden has embraced stem cell research and research cloning,
whereas Norway has adopted a much more cautious and restrictive approach. Similar differences
exist among Asian countries. These diverging legislative paths suggest that it would be
premature to envisage comprehensive international treaties in this area save for a ban on human
reproductive cloning.
Relatively few countries have adopted a regulatory approach or have created new regulatory
institutions. This may reflect important differences in national administrative systems and in
legal traditions, not to mention imperfect knowledge of these systems on our part. It appears that
in many cases, existing ministries have been given the authority to craft regulations in the area of
reproductive medicine and biomedical research. Switzerland is a case in point. The Australian,
Canadian, and British cases demonstrate that the delegation of legislative authority is a realistic
but not unproblematic legislative response. How these regulatory bodies can preserve their moral
authority without being perceived as unaccountable institutions is a question that has not yet
received an entirely satisfactory answer.
It has also become clear that neither the British HFEA nor its Australian and Canadian
cousins offer a template for building an analogous regulatory institution in the United States. The
HFEA decision-making process is probably too informal and not sufficiently transparent for the
U.S. public. Nor is an 18-member regulatory body likely to garner much support. The Australian
approach is more considerate of regional differences and could therefore be considered a better
fit, but it also reflects Australian peculiarities that would make it unsuitable to the U.S.
administrative context. Finally, the Canadian approach, though promising in many ways, is still
being implemented and cannot be properly evaluated. In short, while these three countries have
demonstrated the soundness and viability of a regulatory approach to reproductive medicine and
biomedical research, their respective approaches cannot easily be adapted to the U.S.
administrative and legal system.
179

180

6.6 Bibliography
Caulfield, Timothy. "Politics, Prohibitions and the Lost Public Perspective: A Comment on Bill
C-56: The Assisted Human Reproduction Act." Alberta Law Review 40 (2002): 451-62.
Makkai, Toni, and John Braithwaite. "Reintegrative Shaming and Compliance with Regulatory
Standards." Criminology 32 (1994): 361-85.
No Need for More Stem Cell Embryos Sydney Morning Herald, March 29, 2005 [cited
September 22, 2005]. Available from http://www.smh.com.au/news/National/No-needfor-more-stem-cell-embryos-MPs/2005/03/29/1111862384922.html?oneclick=true.
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182

7 Constitutional Constraints?
7.1 Traditional Reproductive Technologies versus Technologies of Reproductive Control
Many Americans regard procreative decisions as a quintessentially private choice. This is
especially true of prospective parents, advocacy groups, and ART professionals. Widely held
beliefs in the area of reproductive medicine tend to translate into the presumption that
procreative choices should receive constitutional protection against government interventions.
Rules and regulations promulgated by a new regulatory entity are therefore likely to trigger
judicial review. In light of this possibility, it is worthwhile exploring in some detail what legal
reasoning may warrant granting or denying constitutional protection to procreative choices
involving the use of assisted reproductive technologies.
No matter what a regulatory intervention in the area of reproductive medicine is designed to
achieve, one of its most likely effects is to limit the access to these technologies and in some
cases to nullify some individuals’ desires to have a progeny. There is little doubt that laws and
regulations are indeed likely to restrict the access to assisted reproductive technologies, at least
in part, but their constitutional import varies considerably depending on the type of restriction
and reproductive technology involved and the likely impact on prospective parents. Making the
access to in vitro fertilization excessively difficult may be a much more problematic proposition
than banning reproductive cloning, for example. How regulatory interventions may be ranked in
terms of their constitutional import is the subject of this chapter.
Since Louise Brown was born more than 25 years ago, the number of available reproductive
technologies has expanded greatly. Assisted reproductive technologies nowadays include IVF,
GIFT (gamete intrafallopian transfer), ZIFT (zygote intrafallopian transfer), IUIs (intrauterine
insemination with washed sperm), intravaginal culture, oocyte and sperm donation, and
micromanipulations such as ICSI (intracytoplasmic sperm injection), among others. 1
The
ultimate purpose of all these medical procedures is identical: They are designed to help couples
and individuals to start a family. None of these technologies was designed to meet specific
parental desires other than to have a child. For this reason, in the following discussion we speak
of traditional assisted reproductive technologies. 2
In a different category are assisted reproductive technologies designed not merely to
facilitate procreation but to customize it. Customization may mean different things, ranging from
selecting an embryo free of a particular genetic disease to giving birth to a baby for the purpose
1
2
A partial discussion of these procedures can be found in Centers for Disease Control and Prevention, "2002
Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports," p.3.
We have introduced this category and discussed some of the ethical issues raised by these types of procreative
technologies in chapter 4.
183

of saving the life of an older sibling. Pre-implantation genetic diagnosis is commonly used in
both cases. Customization may also mean fulfilling a desire for a girl or a boy, a desire whose
fulfillment technologies such as MicroSort are making both possible and affordable. A more
problematic illustration of customized conception has been provided by a couple of deaf
individuals that wished to have a deaf child. 3
This category also comprises any ART that
facilitates selecting embryos for higher traits, a fairly remote possibility at this time but one that,
given the speed of scientific progress, should not be underestimated. 4 In this chapter, we refer to
procreative technologies that facilitate meeting specific parental desires as technologies of
customization.
The distinction between technologies of customization and traditional assisted reproductive
technologies is crucial. 5 The former are not designed primarily to overcome a physiological
condition (infertility) that impairs the procreative capacity of an individual, man or woman.
Rather, these technologies expand the prospective parents’ ability to control the procreative
process itself. Unlike regulatory interventions in the area of traditional ARTs, laws and
regulations pertaining to technologies of reproductive control have a much more limited impact
on prospective parents. They may restrict the range of available procreative options but do not
constraint the ability to procreate per se. In other words, interventions in this area target specific
reproductive goals, for example elective sex selection, but do not in any way question the
legitimacy of an individual or a couple’s desire to start a family.
Laws and regulations in the area of traditional assisted reproduction are more likely to
impinge upon a basic desire to have a progeny; these interventions, in addition to making the
access to traditional ARTs somewhat more difficult and costly, are also likely to limit the range
of available reproductive options, possibly making it impossible for certain couples and
individuals to fulfill their reproductive dreams. Consider, for example, a ban on the free trade of
oocytes. Prohibiting commercial practices in this area is likely to reduce the availability of
oocytes and make it impossible for some couples to have a progeny. Older women in particular
may discover that the scarcity of oocytes tends to put them at a disadvantage.
Marital status and the type of intimate relationships involved in a procreative project
represent a second dimension of our discussion. ART services are no longer requested only by
traditional families (i.e., by married heterosexual couples). Single individuals, both women and
men, unmarried couples, as well as homosexual couples of both sexes are increasingly seeking
out the services of the ART industry. Laws and regulations in the area of reproductive medicine
3
4
5
Spriggs, "Lesbian Couple Create a Child Who Is Deaf Like Them."
In a recent review of the scientific literature in this area, the Genetics and Public Policy Institute suggests that
targeted genetic modifications may become possible much earlier that anticipated just a few years ago Baruch et
al., "Human Germline Genetic Modification: Issues and Options for Policymakers."
In chapter 4, we introduced a somewhat finer classificatory grid. Consistency would require that we use the same
classificatory scheme in this chapter. However, doing so would have made our discussion exceedingly lengthy
and complex. To keep this chapter from becoming unwieldy, we have decided to focus on the distinction that is
in our view is of fundamental importance – the distinction between therapeutic uses and technologies of
reproductive customization.
184

are likely to limit the number of reproductive options available to some of these couples and
individuals, or to make the access to them more difficult. For example, regulations governing
access to sperm banks may stifle a single woman’s desire to have a baby. Surrogacy laws may
prevent a single man or a homosexual couple from having a genetically related child. To the
extent that laws and regulations restrict access to reproductive options for certain couples and
individuals, they are also likely to be reviewed by the courts.
The combination of different reproductive technologies and diverse family relationships and
reproductive goals gives rise to a bewildering array of distinctive situations. Examining each and
every possible combination is well beyond the scope of the present discussion. Here, we limit
ourselves to examining two sets of fairly homogenous cases, regulatory interventions targeted at
traditional assisted reproductive technologies and regulations limiting the availability of
technologies of customization. 6
The distinction between regulatory interventions targeted at traditional assisted reproductive
technologies and interventions limiting the access to technologies of customization is informed
by the view that each type of intervention impinges on qualitatively different individual choices,
and calls upon different standards of state justifications. Government interventions in traditional
forms of assisted reproduction may be more problematic than regulations designed to restrict the
access to technologies of customization. Treating different procreative projects differently
already suggests that a broadly defined fundamental right of procreation may not exist, if this
right is supposed to protect access to ARTs independently of their purpose, of the technological
means envisaged, and of the individuals involved. This is an important point worth emphasizing.
It is certainly not our intention to deny individuals an opportunity to procreate. At the same time,
we believe it would be wrong for the courts to discover a broad new class of fundamental rights.
As we show below, neither the U.S. Constitution nor case law provides an especially strong
justification for recognizing a broad class of new fundamental reproductive rights. The public
and its elected representatives should have the opportunity to extensively debate the relative
merits of protecting individual liberties vs. honoring majoritarian societal values as expressed by
federal and state laws and regulations, before the Supreme Court is called upon to adjudicate
societal controversies. A Supreme Court ruling recognizing the existence of a broadly construed
6
Like any classificatory scheme, the distinction between these two classes of assisted reproductive technologies is
not always unambiguous. For example, is egg donation for women in their 40s and 50s an instance of a
traditional assisted reproductive treatment or a case of reproductive control? One could argue that age is not a
medical condition, and therefore that egg donation in this case should be considered a technology of reproductive
control. On the other end, this treatment can hardly be described as a technology of customization, so perhaps it
should be considered a more or less traditional instance of assisted reproductive treatment. That it may not
always be possible to unambiguously characterize each and every case as either an instance of assisted
reproductive treatment or as an example of customized conception is not a specific limitation of our
classificatory scheme, but simply an illustration of the conventional nature of any system of classification.
Barnes, "On the Conventional Character of Knowledge and Cognition."; Barnes, Bloor, and Henry, Scientific
Knowledge: A Sociological Analysis; Bloor, Wittgenstein, Rules and Institutions.
185

procreative right, unlikely as it is, would preclude any such debate, and would likely be regarded
by the public and the Congress as undemocratic. 7
7.2 Questions of Constitutional Interpretation
7.2.1 Selecting a Level of Generality
In deciding whether a right qualifies as fundamental, the Court applies what has become
known as the “substantive due process” doctrine. The term stems from the interpretation of the
due process clause of the Fifth and Fourteenth Amendments. The Court has long held the view
that due process consists of both a procedural and a substantive component. Substantive due
process is indispensable to protect certain fundamental rights from lawfully being taken by the
state. The due process clause then requires not only that the state follow certain rules and
procedures in taking away a “person’s life, freedom, or property,” but also that it provide a
rational justification for doing so. Unfortunately, it is not entirely clear how the Court applies
this doctrine.
Substantive due process remains an extremely controversial legal doctrine. 8 During the socalled
Lochner era, the Court made extensive use of substantive due process to invalidate state
laws restricting economic activities. 9 With Griswold v. Connecticut (1965), the Court sanctioned
a fundamental right to privacy partly on substantive due process grounds that laid the basis
during the 1970s and 1980s for an expansive interpretation of privacy rights. It is not too difficult
to appreciate the reasons for the controversial nature of this legal doctrine: It affords the Court an
extremely powerful tool of political intervention. How the Court should go about determining
whether an asserted liberty interest is fundamental is not entirely clear. Two distinctive
approaches can be identified, one based mainly on case law and the other on societal traditions.
We examine each in turn.
Crucial to the determination whether an asserted fundamental right is consistent with early
rulings is the selection of what constitutional scholars refer to as the appropriate “level of
generality.” 10 This concept can best be explained with an example. Consider the case of a couple
7
8
9
10
In passing, we should mention that this is not an issue of conservative versus liberal politics. To our knowledge,
only the United States among modern democracies has introduced a right to terminate a pregnancy by judicial
means. Every other country that has legalized abortion has done so through the legislative process.
James W. Ely, "The Oxymoron Reconsidered: Myth and Reality in the Origins of Substantive Due Process,"
Constitutional Commentary 16 (1999); John Harrison, "Substantive Due Process and the Constitutional Text,"
Virginia Law Review 83 (1997); Stephen A. Newman, "Human Cloning and the Substantive Due Process
Riddle," Southern California Interdisciplinary Law Journal 8 (1998).
See 198 U.S. 45 (1905). The Court found a New York law limiting the number of hours a baker could work each
week unconstitutional on the grounds that it was a violation of substantive due process and called it an
“unreasonable, unnecessary, and arbitrary interference with the right and liberty of the individual to contract.”
Bruce Ackerman, "Levels of Generality in Constitutional Interpretation: Liberating Abstraction," University of
Chicago Law Review 59 (1992); Frank H. Easterbrook, "Presidential Review," Case Western Reserve Law
Review 40 (1990); Laurence H. Tribe and Michael C. Dorf, "Levels of Generality in the Definition of Rights,"
University of Chicago Law Review 57 (1990).
186

that has been denied access to pre-implantation genetic diagnosis for a non-therapeutic use –
elective sex selection, for example. The couple decides to challenge this regulation in court on
the grounds that the federal statute banning elective sex selection violates its right to privacy.
How is the Court to determine whether the couple has a legitimate liberty interest in this matter,
and if so what criteria should inform the Court decision as to whether this interest constitutes a
fundamental right? The latter question is often at the center of cases involving reproductive
rights. Surprisingly (to us at least), no coherent methodology exists to determine whether an
asserted right should be considered fundamental.
The Court can seek guidance, first of all, in the Constitution itself. A narrow reading of the
case under consideration would lead to the (obvious) conclusion that the Constitution offers no
guidance whatsoever on the use of PGD for elective sex selection. Absent any guidance at this
extremely low level of generality, the Court could select a somewhat higher level of generality. It
could do so by scrutinizing its own judicial record. The Court could consult opinions involving
the use of other reproductive technologies of customization, of which PGD for elective sex
selection is an example. Once again, the Court would not be able to find any relevant precedents.
The justices could select an even higher level of generality by turning to cases pertaining to the
use of assisted reproductive technologies in general. Unable to find relevant precedents, the
Court could simply review cases involving procreative rights narrowly defined, or even
procreative rights in general (in other words, rights to procreate or not to procreate).
Unsatisfied with an interpretation of case law based on reproductive rights, the Court could
explore an altogether different line of reasoning involving privacy rights. These rulings, not
coincidentally, include (but are not limited to) several rulings pertaining to reproduction. Should
the Court determine that PGD for elective sex selection really revolves around privacy rights, it
would explore which activities in the past have been deemed private, and whether the case under
consideration may be described as another instance of a private activity the government can only
infringe by meeting a strict scrutiny test. 11 But the Court could also determine that neither its
rulings on reproductive rights nor those pertaining to privacy really shed much light on the
present case and decide to explore an altogether different line of reasoning.
To say that selecting the most appropriate level of generality is a task fraught with
difficulties is an understatement. As our brief discussion demonstrates, it may be possible to
select more than one line of Court rulings consistent with the case under review. Worse, the
Court may find that cases raising seemingly analogous questions have received rather different
answers. That under these circumstances the Court is far more likely to “discover” new
fundamental rights is not entirely surprising. For this reason, in recent times, the Court has
resorted to what a commentator has labeled “due process traditionalism.” 12 In banning physician-
11
12
The Court applies the “strict scrutiny” test to government intervention in matters deemed fundamental. In
principle at least, the government is not prevented from infringing upon a fundamental right, but the intervention
in this case must be motivated by a “compelling state interest.” In addition, the state must demonstrate that the
proposed intervention is a necessary and narrowly drawn means to pursue a compelling state interest.
Cass Sunstein, "Is There a Constitutional Right to Clone?," Hastings Law Journal 53 (2002), p.989.
187

assisted suicide, the Court has established that practices protected by substantive due process
must meet two specific requirements: (a) that they be “deeply rooted in this Nation’s history and
tradition” and “implicit in the concept of ordered liberty,” such that “neither liberty nor justice
would exist if they were sacrificed,” and (b) that there be a “careful description” of the liberty
interest being asserted. 13 An asserted right, then, is deemed fundamental if there exist specific,
longstanding societal traditions that uphold it.
The most articulate advocate of this approach has been Antonin Scalia. In Michael v. Gerald
(1989), the Court was called upon to determine whether a natural father had visitation rights to a
child conceived with a women married to another man. The Court found that protecting the
integrity of the family trumped the father’s interest in visiting with his child. 14 Justice Brennan,
dissenting, argued that the Court should have focused on “parenthood” rather than on the right of
natural fathers, per se. In a now-famous footnote, Justice Scalia replied that the Court in its
ruling had selected the most specific level of generality at which a relevant tradition protects or
denies protection to an asserted right. 15 Had the Court majority followed Justice Brennan and
selected the much broader category of parenthood, perhaps the father’s interest in maintaining
and developing a close relationship with his child would have been recognized. But because a
societal tradition with regard to the rights of the natural father of a child adulterously conceived
existed, it was not necessary for the Court to select the much higher level of generality implied
by the concept of “parenthood.”
Several Court cases have been decided by invoking historical traditions at the lowest
possible level of generality. For example, in Moore v. East Cleveland (1977), the Court
determined that a woman had a right to live with her two grandsons in one apartment even
though a local ordinance limited occupancy of a dwelling unit to members of a single family. In
finding against the city of Cleveland, the Court noted that “Our decisions establish that the
Constitution protects the sanctity of the family precisely because the institution of the family is
13
14
15
See 521 U.S. 702, 721 (1997).
Note the ambiguity built into this argument: The “family” to be protected in this case is implicitly defined in
legal terms, whereas the relationship between the father and his child is reduced to a mere matter of “visitation
rights.”
Justice Scalia formulated his reply to Justice Brennan as follows:
We do not understand why, having rejected our focus upon the societal tradition regarding the
natural father’s rights vis-à-vis a child whose mother is married to another man, Justice Brennan
would choose to focus instead upon “parenthood.” Why should the relevant category not be even
more general – perhaps “family relationships”; or “personal relationships”; or even “emotional
attachments in general”? Though the dissent has no basis for the level of generality it would select,
we do: We refer to the most specific level at which a relevant tradition protecting, or denying
protection to, the asserted right can be identified. If, for example, there were no societal tradition,
either way, regarding the rights of the natural father of a child adulterously conceived, we would
have to consult, and (if possible) reason from, the traditions regarding natural fathers in general.
But there is such a more specific tradition, and it unqualifiedly denies protection to such a parent.
491 U.S. 110, footnote 6, emphasis added.
188

deeply rooted in this Nation’s history and tradition.” 16
In Snyder v. Commonwealth of
Massachusetts (1934), a case involving procedural matters in a criminal trial, the Court found
that “The commonwealth of Massachusetts is free to regulate the procedure of its courts in
accordance with its own conception of policy and fairness, unless in so doing it offends some
principle of justice so rooted in the traditions and conscience of our people as to be ranked as
fundamental.” 17 And in Washington v. Glucksberg (1997), the Court ruled that bans on assisted
suicide are deeply rooted in the nation’s history. 18
Due process traditionalism offers what at first may be regarded as an impartial methodology
for selecting the most appropriate level of generality, a way out of interpretational ambiguity and
constitutional arbitrariness. Unfortunately, specificity does not necessarily eliminate
interpretative ambiguity. If in Michael v. Gerald the Court were unable to identify a specific
societal tradition for the rights of fathers of children adulterously conceived, it might have tried
to identify a societal tradition regarding the rights of natural parents (instead of fathers) of
children adulterously conceived. Arguably, this level of generality is just as specific as Justice
Scalia’s suggestion that the rights of natural fathers in general by consulted, but it is clearly
distinct. 19 Justice Scalia’s proposal cannot resolve this fundamental ambiguity without appealing
to rules and criteria external to the Constitution.
Historical traditions have a disciplining effect on the Court; they force the justices to
exercise considerable self-restraint in granting fundamental new rights not explicitly recognized
by the Constitution. Does this mean that the Court should not recognize new fundamental rights
absent a relevant tradition? Hardly. In Loving v. Virginia (1967), for example, the Court struck
down a Virginia law that prohibited interracial marriage. It did so not by identifying a specific
societal tradition, which obviously did not exist, but by invoking substantive due process. In this
case at least, the absence of a specific historical tradition would have been a problematic
justification for upholding a state prohibition of interracial marriage. Several other reasons exist
for considering with some skepticism traditions as the sole source of constitutional legitimacy. 20
Where does this discussion lead us? One obvious conclusion imposes itself. There is little
hope to identify a method of constitutional interpretation that avoids injecting in the legal
reasoning moral values, personal orientations, and political preferences. 21
This observation
should not be taken as a demonstration that constitutional law is dominated by arbitrariness and
political considerations. Selecting a level of generality may not be a problem solvable by
universally accepted rules; this does not mean that the selection process is necessarily arbitrary,
16
17
18
19
20
21
See Moore v. East Cleveland, 431 U.S. 494, 503.
See Snyder v. Commonwealth of Massachusetts, 291 U.S. 97, 105.
See 521 U.S. 702, (1997).
For a detailed discussed, see Tribe and Dorf, "Levels of Generality in the Definition of Rights," p.1090-91.
For a discussion, see Newman, "Human Cloning and the Substantive Due Process Riddle."
For a classic examination of this claim, see John Hart Ely, "On Discovering Fundamental Values," Harvard Law
Review 92, no. 1 (1977).
189

or that there are an infinite number of possible interpretations. One simply has to recognize that
in this as in many other areas of the law, professional and political judgment is inevitable.
7.2.2 From Levels of Generality to Principled Interpretation
The choice of the “appropriate” level of generality may also be described as the choice of a
general principle of interpretation. The best-known and most general formulation of this problem
has been offered by the late Ludwig Wittgenstein. In a much discussed passage of the
“Philosophical Investigations,” Wittgenstein asked what is the correct continuation of the
number series “1, 2, 3, 4, … ” One obvious answer is “5, 6, 7, 8, … ” but this is not the only
correct answer. Arguably “4, 3, 2, 1” is also a correct continuation, and so is “1, 2, 3, 4, 1, 2, 3, 4,
… .” What about “!, @, #, $, …”? At first, few would be inclined to consider this a correct
continuation of the original number series. But a perceptive reader may recognize that the latter
series obtains from the original one simply by hitting the “shift” key of a QWERTY keyboard, so
perhaps “!, @, #, $, …” should also be considered a correct continuation of the original number
series.
While there may be several correct continuations of this number series, their number is not
infinite and they all display internal coherence. Which continuation is considered to be the
correct one depends in large measure on the societal context in which this determination is made.
In a primary school class, the first answer is the one most likely to be chosen. By contrast, a
group of computer geeks may find the last solution much more natural. The point here is simply
that there are several correct answers to this question. Which rule is thought to generate the
correct number series is a question that can be answered only in the context of prevailing norms,
values, and orientations.
In the next two sections, we discuss two opposite approaches to selecting a level of
generality, one illustrated by the Supreme Court in Bowers v. Hardwick (1986), the other by the
concept of presumptive procreative liberty as advocated by Professor John A. Robertson and
other libertarians. Both provide an illustration of a principled approach to the discussion of
procreative liberties. Neither one of them, in our view, provides a suitable template for
adjudicating future disputes over the access to assisted reproductive technologies.
7.2.3 An Idiosyncratic Approach to Constitutional Interpretation
In Bowers v. Hardwick, the Court was called upon to rule on the constitutionality of a
Georgia statute that criminalizes sodomy. 22
This case provides an excellent illustration of
constitutional interpretation at an exceedingly low level of generality. The actual ruling in this
case is less interesting than the methodology used by the Court to reach its conclusions. The
Court asked whether “the Federal Constitution confers a fundamental right upon homosexuals to
22
See 478 U.S. 186 (1986). It should be mentioned that this ruling was recently reversed. In Lawrence v. Texas,
the Court found that the right to privacy does indeed extend to homosexual sex.
190

engage in sodomy […].” 23 By a five-to-four majority, the Court answered this question in the
negative.
A crucial element of the Court ruling was its interpretation of case law. After noting that
Pierce v. Society of Sisters (1925) and Meyer v. Nebraska (1923) were cases dealing with “child
rearing and education,” that Prince v. Massachusetts (1944) focused on “family relationship,”
Skinner v. Oklahoma (1942) on “procreation,” and Loving v. Virginia on marriage, that
Griswold v. Connecticut and Eisenstadt v. Baird (1972) were concerned with the use of
contraceptives, and that Roe. v. Wade (1973) concerned abortion, the Court concluded that none
of these opinions bore any resemblance to an asserted fundamental right to engage in acts of
sodomy.
The Court opinion makes clear that the justices interpreted their own record in a very
narrow, almost literal way. There is no particularly compelling reason for interpreting case law
literally other than in so doing, any continuity between earlier Court rulings and the present case
vanishes. Every case appears to be unique and disconnected from other cases – including the
case under consideration. At this particular level of generality, the Court was quite correct to
proclaim that cases pertaining to child rearing and education, family relationships, marriage,
procreation, contraceptives, and abortion bear little resemblance to homosexual sodomy. 24
Absent relevant precedents, the Court turned to societal traditions as a possible source of
constitutional guidance. The Court, however, concluded that homosexual sodomy is neither part
of the concept of ordered liberty nor a fundamental aspect of the nation’s traditions. 25 Sodomy,
in other words, cannot be considered a practice “deeply rooted in this Nation’s history and
tradition.”
The legal reasoning used in Bowers v. Hardwick is of some relevance to cases involving
reproductive rights. At a very low level of generality, assisted reproductive technologies bear no
resemblance to any other Court ruling. The only case involving positive procreative rights,
Skinner v. Oklahoma, pertains to the natural ability of a man to procreate; it says nothing about
the rights of a couple to access assisted reproductive technologies, or technologies of
customization for that matter. 26
The Court could have determined that Bowers v. Hardwick was to be decided on privacy
grounds. At this (higher) level of generality, several Court rulings exist. “Marital privacy” may
not be relevant in this case, but perhaps “intimate associations” are. We are not claiming that the
ruling necessarily would have been different had the Court selected a higher level of generality.
23
24
25
26
See 478 U.S. 186, 190.
The Court acknowledged that in the past, it often has granted fundamental status to rights not explicitly
contained in the Constitution by interpreting the due process clauses of the fifth and fourteenth amendments
substantively rather than procedurally, but it quickly resolved this tension by noting that deciding a case on
substantive due process grounds involves much more than “the imposition of the Justices’ own choice of values
on the states and the federal government. See 478 U.S. 186, 191.
See 478 U.S. 186, 191-192.
Nor could the Court offer any guidance on this matter, because it ruled on this case in 1942.
191

What is obvious is that the Court simply decided to ignore these and other rationales offered in
earlier rulings, opting instead for a literal interpretation of the case law.
We believe that the approach taken by the Court in Bowers v. Hardwick does not provide a
suitable template for cases involving assisted reproductive technologies. By selecting the lowest
possible level of generality, the Court would make sure that no new reproductive rights could
ever be recognized. We are not arguing that they should. As pointed out earlier, it seems to us
that societal and political debates should precede Supreme Court rulings on matters as delicate as
procreative rights. But to treat each new case pertaining to reproductive technologies as a unique
situation unrelated to past Court reasoning seems to us an abdication of the Court’s
responsibilities.
7.2.4 Robertson’s Concept of “Presumptive Procreative Liberty”
The constitutional protection that Robertson and other libertarian scholars would like to
afford to ARTs is predicated on interpreting case law at a very high level of generality –
precisely the opposite of the approach taken by the Court in Bowers v. Hardwick. 27 Robertson’s
concept of presumptive procreative liberty is based on a key assumption: Even though the
Constitution does not explicitly recognize a procreative right, the Supreme Court is likely to
recognize “coital reproduction” as a fundamental right deserving constitutional protection, at
least for married couples. Robertson then infers from this narrow definition of procreative liberty
that access to most, if not all, kinds of assisted reproductive technologies should be considered a
liberty protected by the Fourteenth Amendment.
There are two rationales for Robertson’s assumption, an early and a more recent one. In the
1980s, Robertson took the absence of any Court opinion on matters concerning procreative
liberty as a strong indication that this right was taken for granted. 28 More recently, Robertson has
justified the presumption of a right to coital reproduction by pointing to several Court rulings.
These include Meyer v. Nebraska (which affirmed the right to “marry, establish a home, and
bring up children”); Skinner v. Oklahoma (which asserted procreation as among “the basic civil
rights of man”); Stanley v. Illinois (1972) (that “the rights to conceive and raise one’s children
have been deemed ‘essential,’ ‘basic civil rights of man’ and […] far more precious than
property rights”); and the much quoted Eisenstadt v. Baird (“If the right of privacy means
anything, it is the right of the individual, married or single, to be free of unwarranted
governmental intrusion into matters so fundamentally affecting a person as the decision whether
27
28
John A. Robertson, Children of Choice: Freedom and the New Reproductive Technologies (Princeton: Princeton
University Press, 1994); John A. Robertson, "Embryos, Families, and Procreative Liberty: The Legal Structure
of the New Reproduction," California Law Review 59 (1986); John A. Robertson, "Procreative Liberty in the Era
of Genomics," American Journal of Law and Medicine 29 (2003).
Robertson, "Embryos, Families, and Procreative Liberty: The Legal Structure of the New Reproduction."
192

to bear or beget a child.”). 29 Legal scholars generally seem to agree that the Court is likely grant
fundamental status to coital reproduction, at least for married persons. 30
Robertson, then, distinguishes between procreative means and ends. Various ARTs, both old
and new, are simply the technological means to achieve the all-important procreative end.
Accordingly, presumptive procreative liberty includes both coital and “non-coital” procreative
techniques, such as sperm, egg, and embryo donation and even surrogacy. ARTs ranging from
traditional IVF to ICSI should also be protected, as should more recent techniques such as preimplantation
genetic diagnosis and reproductive cloning, if the technique in question is the only
way to achieve reproduction. Robertson goes so far as to argue that there might even be a
constitutionally protected right to genetically engineer babies. 31
How can such sweeping generalizations be justified? Robertson grounds his concept of
presumptive procreative liberty on evolutionary biology. In his view, parental desires are not
preferences shaped in large measure by social expectations, but biological instincts produced by
evolutionary pressure. Evolutionary biology then explains not only why parents have procreative
desires, but also why parents may wish to have a baby of a certain sex or with certain traits. For
example, beauty is explained in terms of a desire for healthy children. Stamina and strength are
key requisites for effectively protecting the familial unit. 32
Assisted reproductive technologies do not simply help prospective parents fulfill their
procreative dreams; they help them implement evolutionarily successful procreative strategies.
Since evolutionary biology seems to provide an a posteriori rationalization of each and every
procreative whim, it is not difficult for Robertson to conclude that access to both old and new
reproductive technologies should be granted not only to married couples, but also to unmarried
couples, single individuals, and homosexual couples – in short, to anyone.
Does evolutionary biology provide an adequate account of why some parents may prefer a
first-born male over a female, or why other parents would want to have a child taller than
average? More generally, can parental desires for children with any of what contemporary
America considers desirable traits be adequately explained by evolutionary biology? The short
answer to this question is no. Evolutionary biology may account for a deeply felt urge to
procreate, but just as it does not explain why people may prefer one brand of toothpaste over
another, it does not provide an adequate account of prospective parents’ preferences for certain
physical and cognitive traits. Parental desires for a successful progeny can perhaps be described
as the outcome of natural selection, but natural selection alone does not inform contemporary
notions of “success” or the “good life.” Evolutionary biology is an inadequate basis for
29
30
31
32
Robertson, "Procreative Liberty in the Era of Genomics," p.452-54.
Carl H. Coleman, "Religious Values and Legal Dilemmas in Bioethics: Assisted Reproductive Technologies and
the Constitution," Fordham Urban Law Journal 30 (2002), p.61; Ann MacLean Massie, "Regulating Choice: A
Constitutional Law Response to Professor John A. Robertson's "Children of Choice"," Washington and Lee Law
Review 52 (1995), p.150-51.
Robertson, "Procreative Liberty in the Era of Genomics," p.453-54.
Ibid., p.8-10.
193

generalizing from a strong but generic urge to reproduce to specific uses of assisted reproductive
technologies.
7.3 A Different Perspective
The Court has ruled repeatedly on matters pertaining both to reproduction and to privacy.
These cases have been quoted so often by the Court itself and by commentators as to warrant a
brief review. They are discussed in more detail in Appendix I. The only case specifically dealing
with a positive right to procreation is Skinner v. Oklahoma, 33 a case involving a compulsory
sterilization law, not procreative liberty per se. It focused on whether it is constitutional for the
state to deprive a man of his capacity to procreate. The Court found that the Oklahoma statute
was unconstitutional, but it did so by virtue of equal protection, not on substantive due process
grounds. In dictum, however, the Court noted, “We are dealing here with legislation which
involves one of the basic civil rights of man. Marriage and procreation are fundamental to the
very existence and survival of the race.” 34
In Meyer v. Nebraska, the Court found that families have the right to determine what
constitutes the best education for their children. Pierce v. Society of Sisters involved the parental
rights to send children to a school of their choice, including a private school, a right the Court
affirmed. That the education of children is considered an aspect of family life worthy of
constitutional protection was reaffirmed in Prince v. Massachusetts and again in Stanley v.
Illinois. 35 Also pertinent to this discussion is the right to marry, as sanctioned, for example, in
Loving v. Virginia. 36
Cases specifically focused on negative reproductive rights (i.e., on the right not to
reproduce) also might be relevant to the present discussion. Griswold v. Connecticut famously
established the right of married couples to use contraceptives by identifying the realm of “marital
privacy” as an area the state cannot enter. 37 Eisenstadt v. Baird extended this right to unmarried
couples, 38 and Carey v. Population Services International (1977) afforded the same right to
young adults 16 years of age and older, 39 whereas Roe v. Wade sanctioned a woman’s right to
terminate a pregnancy, 40 a right reaffirmed in Planned Parenthood of Southeastern Pennsylvania
v. Casey (1992). 41
33
34
35
36
37
38
39
40
41
See 316 U.S. 535 (1942).
See 316 U.S. 535, 541 (1942).
See 321 U.S. 158, 166 (1944); 405 U.S. 645 (1972).
See 388 U.S. 1, 8 (1967).
See 381 U.S. 479 (1965).
See 405 U.S. 438 (1972).
See 431 U.S. 678 (1977).
See 410 U.S. 113 (1973).
See 505 U.S. 833 (1992).
194

The emphasis placed by the Court on matters concerning the family, the education of
children, and contraception and abortion suggests that a state intervention intruding upon natural
procreation may have to meet or exceed a strict scrutiny standard. Natural procreation involves
several values central to Court jurisprudence, including privacy, bodily integrity, marital
intimacy, and integrity of the family unit. These values would be threatened at least in part by a
state intervention in this area. For this reason, some commentators believe that natural
procreation is likely to fall within the realm of the constitutionally protected private sphere. 42
Recognizing that the desire to procreate is central to family life does not necessarily afford
constitutional protection to each and every type of assisted reproductive technology. While a
state intervention in natural procreation likely would trigger strict scrutiny, regulations restricting
the availability of ART services are unlikely to raise the same constitutional concerns. The Court
may well recognize the centrality of reproduction to family life and personal identity, but avoid
extending constitutional protection to each and every assisted reproductive technology,
especially when the state has a “compelling interest” in regulating an ART. One such compelling
interest is the health and well-being of ART children.
Whether an outright ban of an ART procedure would be declared unconstitutional depends,
of course, on the state interests involved, and is a question that cannot be answered in general
terms. What is clear is that the Court is very unlikely to generalize broadly from a presumptive
right to natural procreation. The jurisprudence of religious freedom provides a useful illustration.
Religious freedom, just like freedom of speech, is explicitly recognized as a constitutionally
protected liberty. Yet the Court has ruled time and again that certain practices motivated by
religious beliefs do not enjoy constitutional protection. Obviously, freedom of religion requires
that both freedom of belief and freedom to practice a religion be protected, but the protection
afforded to religious practices is far less comprehensive than the absolute protection enjoyed by
religious beliefs. The Court has recognized that state interests may override practices dictated by
religious beliefs, as for example when it upheld universal immunization requirements and
antipolygamy laws against religiously motivated objections. And it might do so without holding
these laws to a strict scrutiny standard of review. These precedents demonstrate that the health
and well-being of children can override parental desires, even if these enjoy constitutional
protection.
Our discussion so far has simply underscored the fact that the Court is extremely unlikely to
recognize broadly defined procreative rights. We have not shown how the Court might reason in
these cases. Societal traditions, at a very low level of generality, might provide some guidance.
Michael v. Gerald is an example, as is Washington v. Glucksberg, a case in which the Court
found that our traditions are wholly incompatible with a right to assisted suicide. Resorting to
societal traditions will obviously invalidate any claims to new procreative rights. There simply
42
Coleman, "Religious Values and Legal Dilemmas in Bioethics: Assisted Reproductive Technologies and the
Constitution."; Massie, "Regulating Choice: A Constitutional Law Response to Professor John A. Robertson's
"Children of Choice"."; Radhika Rao, "Reconceiving Privacy: Relationships and Reproductive Technology,"
UCLA Law Review 45 (1998).
195

are not any societal traditions that may guide the Court on matters as novel as access to specific
assisted reproductive technologies. More importantly, it is not entirely clear why the Court
should focus on societal traditions rather than on its own record. Case law pertaining to
reproductive rights and privacy rights may be just as relevant to cases involving assisted
reproductive technologies as societal traditions.
There is one major difficulty in defining “reproductive rights” as the most appropriate level
of generality. “Reproductive rights” cases generally focus on the right not to reproduce – i.e.,
they are cases involving the use of contraceptives or the access to abortion services. Whether
negative reproductive rights can be generalized to include positive procreative rights is not
entirely clear. People have a right to decide whether to interrupt a pregnancy and to use
contraceptives, but that does not necessarily imply that they also have a right to choose any
technological means to procreate. To put it in starker terms, the use of contraceptives and the
access to abortive procedures uncouple procreative choices and recreational sex; Negative
reproductive rights cases sanction a right to recreational sex. By contrast, restricting the access to
assisted reproductive technologies pertains to the implementation of a positive procreative
decision, so to speak.
Restrictions in this area may not prevent a couple or an individual from having a baby; they
may simply make the access to a suitable ART procedure more difficult and/or more costly to
come by. Regulatory interventions that merely increase the burden of access to an assisted
reproductive technology are less likely to raise constitutional concerns: Restrictions to the
availability of ART services may be acceptable if they do not represent an undue burden for the
couple. 43 In some cases, however, a banned ART treatment may well be the only realistic option
to have a child. But even when a ban would prevent some couples and individuals from pursuing
their reproductive projects, it is not obvious that the ban by itself would create a serious
constitutional concern, especially if the state can offer compelling reasons for the ban. 44
An alternative to procreative rights could be “freedom of intimate association.” It has been
suggested that privacy-related Court cases could consistently be interpreted as extending
constitutional protection to activities and choices made in the context of intimate associations. 45
For example, the right to marry protects the desire of two individuals to form a family against
state intrusion rather than the right of each individual to marry. Neither one of the individuals
involved would be able to exercise this right without their partner’s consent. The right to raise
children is a familial right – a relational right, so to speak, not an individual right. The right to
use contraceptives presupposes two consenting individuals. As soon as conflicts arise between
the partners to an intimate association, the state has a legitimate role to play.
43
44
45
Coleman, "Religious Values and Legal Dilemmas in Bioethics: Assisted Reproductive Technologies and the
Constitution."
Sunstein, "Is There a Constitutional Right to Clone?," p.993-94.
Rao, "Reconceiving Privacy: Relationships and Reproductive Technology."
196

Selecting “freedom of intimate association” as the most appropriate level of generality does
seem to provide a fairly consistent reading of privacy-related rulings. If used to interpret ARTrelated
cases, it would draw some sharp cutoff points. Reproductive technologies that involve
one or more commercial transactions, as in the case of sperm, egg, and embryo donation as well
as surrogacy, are unlikely to be granted constitutional protection. In these cases, procreation may
involve up to three individuals external to a familial relationship – a sperm donor, an egg donor,
and a gestational mother. A fertility clinic is also involved, and perhaps a sperm bank as well. In
all these cases, the procreative act is not performed in the context of an intimate relationship. The
fact that procreation involves several individuals external to an intimate relationship greatly
undermines the intimate nature of the procreative project. A Court relying on this interpretative
principle is unlikely to extend constitutional protection to these forms of assisted reproduction.
Whether the concept of “intimate association” would extend to traditional ARTs, is not
entirely clear. As long as a couple requires ART services merely to mix their own gametes, one
could argue that procreation takes place in the context of an intimate association. In this case, the
ART specialist plays merely a facilitating role in an otherwise intimate project. Obviously, the
act itself is not intimate, but the Court in Paris Adult Theater I v. Slaton (1973) found that “the
constitutionally protected privacy of family, marriage, motherhood, procreation, and child rearing
is not just concerned with a particular place, but with a protected intimate relationship. Such
protected privacy extends to the doctor’s office, the hospital, the hotel room, or as otherwise
required to safeguard the right to intimacy involved.” 46 Whether the Court would be inclined to
define a procreative act facilitated by an ART specialist and performed at a reproductive clinic as
private is not entirely clear.
Less problematic is the application of this interpretative principle to cases of customized
conception. One may legitimately wonder whether technologies of customization really preserve
the intimate nature of a reproductive project. Customization of conception changes the
relationship between prospective parents and medical personnel. ART practitioners in this case
no longer play a facilitating role: They are not simply in the business of removing physiological
obstacles to natural procreation. One might say that they are tasked with “designing” a baby
according to parental specifications. Admittedly, this statement amounts to an exaggeration, but
only a slight one –moreover, one that is becoming more accurate by the day. Technologies of
reproductive customization redefine the very meaning of procreation by “outsourcing,” in part or
entirely, the process to ART specialists. Some may speak of a “joint venture,” but “intimate
association” is certainly not the attribute that comes to mind in considering this process. Where
exactly a reproductive choice stops being an intimate project and becomes a technological
enterprise is not altogether clear. What seems fairly obvious is that the Court would not treat
traditional ARTs and technologies of customization as equal.
One may wonder whether the concept of intimate association should be further
circumscribed to include activities taking place within the confines of the home, consistent with
46
See 413 U.S. 49 (1973) at 66 n.13.
197

the First Amendment’s protection of peaceful assembly and the Fourth Amendment’s protection
of the home. 47 At this relatively low level of generalization, natural reproduction is likely to be
considered a fundamental right, access to traditional ARTs would be somewhat less likely to
receive constitutional protection, and technologies of customization would be very unlikely to
warrant protection by the Court. Roe v. Wade would present a difficulty, of course, and so would
other rulings in which the Court reaffirmed certain rights to privacy as extending beyond the
private home. On the other end, by this reading, Bowers v. Hardwick would deserve to be reexamined.
Indeed, the Court, in Lawrence v. Texas (2003), reversed this earlier ruling.
The New York State Task Force on Life and the Law has identified several additional values
that are likely to affect a Court ruling on matters pertaining to assisted reproduction. Among
them are bodily integrity, marital intimacy, the importance of being a parent a raising a child,
genetic relatedness, religious aspects of the decision to procreate, and a woman’s interest in
gestation and giving birth. The task force concluded that procreative choices involving most or
all of the values listed above are more likely to be afforded constitutional protection than cases in
which only one of these values is involved. 48
Much depends, of course, on the justifications invoked by the government for banning or
restricting access to ART treatments. One can anticipate at least some of these arguments by
reviewing the legal reasoning offered for banning reproductive cloning. The arguments most
likely to survive a rational review or strict review test are those centered on potential harm to
ART children. Professor Robertson has argued that possible harm to ART children should not
trump procreative liberties because children born through ARTs do not really have any other
choice but to live with the limitations imposed by their parents and ARTs, the only alternative
being not having been born in the first place. 49 We very much doubt that the Court would find
this argument compelling. Pushed to its ultimate consequences, this reasoning would relieve the
ART industry of any duty of care. Preventing human suffering, then, is an obvious argument not
only against ART procedures such as human reproductive cloning, but also against other
innovative reproductive treatments that have not been demonstrated to be safe and effective. In
the latter cases, the evidence showing physical harm, while maybe more limited, would certainly
be sufficient to meet at least a rational review standard.
Technologies of reproductive customization could also undermine the individuality of the
child-to-be. It has been argued that because individuals are shaped as much by their genes as by
their environment, this argument is not likely to withstand a rational review, let alone strict
scrutiny. This argument is not convincing. That individual experience and the social environment
47
48
49
Tribe and Dorf, "Levels of Generality in the Definition of Rights," p.1108.
New York State Task Force on Life and the Law, "Assisted Reproductive Technologies. Analysis and
Recommendations for Public Policy," (New York, NY: 1998), p.144-46. See also Coleman, "Religious Values
and Legal Dilemmas in Bioethics: Assisted Reproductive Technologies and the Constitution."
Robertson, Children of Choice: Freedom and the New Reproductive Technologies, p.75. See also John A.
Robertson, "Liberalism and the Limits of Procreative Liberty: A Response to My Critics," Washington and Lee
Law Review 52 (1995), p.250-52.
198

contribute to shaping individuality does not invalidate the argument that being born as a means
to an end rather than as an end in itself could jeopardize the development of a sense of individual
identity. Whether the Court would consider this argument compelling depends, of course, on the
specific ART involved.
Also relevant to the present discussion is the argument that a customized baby would suffer
psychological harm. In the case of reproductive cloning, it may be detrimental for a child to be
confronted daily with an older replica of him or herself – to be able to learn at an early stage how
one is likely to develop, primarily physically, but to some extent psychologically as well. A child
in this situation could easily come to the conclusion that his or her life is pre-ordained, a state of
mind that certainly does not promote healthy mental development. This argument is particularly
relevant in cases pertaining to reproductive customization. For example, some parents may wish
to endow their children with the genetic assets of a top athlete like Michael Jordan, a Hollywood
star like Julia Roberts, or a celebrated musician such as Yo-Yo Ma. 50 In all these cases, the
children may be treated as means to some parental ends, and not as ends in themselves. Whether
the Court would apply a rational review test or the much more demanding standard of strict
scrutiny is anyone’s guess. What can be said is that the state interests invoked in the cases
discussed above would most likely withstand rational review, and perhaps strict scrutiny as well.
In the last section of this chapter, we turn to survey data on the relative importance of
biological procreation and genetic relatedness versus adoption. This data is of considerable
interest to the present discussion for two reasons. It puts in perspective many assumptions about
the centrality of biological procreation and genetic relatedness. And the reduced importance of
genetic relatedness to the procreative experience may induce the Court to hold state interventions
to a rational test rather than to strict scrutiny.
7.4 Procreative Drive or Familial Desires?
The concept of presumptive reproductive freedom is predicated on the assumption that
biological reproduction is a fundamental element of any person’s biography and sense of
identity. This observation is probably accurate in general form, but it sheds little light on the
relative importance of various forms of biological procreation compared to other forms of
reproduction – non-biological reproduction such as adoption in particular. Adoption is a
particularly interesting case because it is both a well-established practice in all Western countries
and is heavily regulated. A recently conducted survey provides several important insights into
this question.
The hypothesis to be explored in this section is simply stated: If biological reproduction is as
central to an individual’s sense of identity as commonly assumed, then adoption should be the
50
Admittedly, these are not technologies available today. But as pointed out in chapter 4, genetic engineering –
defined as the ability to purposefully modify the human genome – has made considerable progress over the last
few years. For a discussion, see Baruch et al., "Human Germline Genetic Modification: Issues and Options for
Policymakers."
199

least preferable among all forms of reproduction (biological as well as non-biological). More
specifically, ART treatments that afford at least partial biological relatedness should be
preferable to adoption. To explore this hypothesis, we used survey data gathered by RESOLVE,
a leading national advocate for infertility patients. 51 The survey was conducted in late 2002 and
included three samples: 976 RESOLVE members ages 18 to 45, 231 members of the Harris
Interactive Chronic Illness Panel, and a representative sample of the U.S. population consisting
of 1,034 adults, also ages 18 to 45. The U.S. sample is representative for sex, age, race and
ethnicity, education, region, and income. The survey was designed mainly to elicit both the
interest and level of information about embryo adoption and embryo donation. It also contained
several questions directly pertinent to the present discussion.
A first, startling result emerging from this survey is that biological relatedness is far less
important than one might assume. Respondents were asked to determine which reproductive
option they would be extremely or very likely to consider if they were unable to have children.
As Table 4 demonstrates, adoption is the preferred choice for infertile couples and individuals by
very large margins. Adoption – i.e., non-biological reproduction – is preferable even to partial
biological relatedness as provided by egg and sperm donation.
% Likely to Consider
U.S. Harris Chronic RESOLVE
Population Illness Panel Members
Adopting a child 66 71 74
Using donated embryos 27 35 34
Using donor egg 23 32 42
Using donor sperm 19 30 39
Surrogacy 13 16 20
Table 4: Relative importance of biological versus non-biological parenthood.
Interestingly, in all three samples, embryo donation is preferred to surrogacy by a factor of
two. Considering that surrogacy could actually ensure complete biological relatedness, the strong
preference for donated embryos suggests that the experience of giving birth is at least as
important if not more so than biological relatedness. Unfortunately, no data is available on the
relative importance of ART treatments that would ensure complete biological relatedness.
Nevertheless, these remain rather surprising results. They suggest that the urge to reproduce
biologically is perhaps not as consuming as industry representatives and advocates for the
infertile seem to believe.
One could argue that these are largely hypothetical answers produced by speculative
questions, and that actual behavior would tell a different story. To test this hypothesis, we looked
at actual birth rates versus adoption rates of very young children. According to the Census
Bureau, in 2000 (the most recent year for which data is available), 1.3 percent of all children one
51
RESOLVE: The National Infertility Association, "Embryo Donation Research: Select Findings," (Bethesda,
MD: 2003).
200

year of age or younger living in a U.S. household, or 41,795 children, had been adopted. 52 In the
same year, according the CDC National Summary and Fertility Clinic Report, 35,025 babies, or
1.1 percent of all children one year of age and younger, were born through ARTs. 53 This means
that in 2000, the number of very young children adopted exceeded the number of babies born
through ARTs by 19.3 percent. If it had been possible to compare the number of adopted small
children to children born through one of the three ART treatments listed in Table 4, this
difference would have been even larger.
There may be several reasons for this difference. It is safe to assume that ART treatments
that ensure full biological relatedness would be preferable to adoption, but it turns out that
adoption is not a measure of last resort. Asked about the reproductive options they had actually
considered, respondents with a history of infertility and those with a partner suffering from
infertility offered answers consistent with the above findings. As Table 5, Table 6, and Table 7
demonstrate, survey respondents in each panel considered adoption far more often than all other
available ART treatments.
Reproductive Method
% that considered
each step
Adoption 41
Embryo donation 2
Surrogacy 2
Donor egg 3
Donor sperm 2
Table 5: U.S. population.
The data provides strong evidence that once a couple is incapable of reproducing naturally,
ART treatments that merely offer biological relatedness are of almost no importance compared
to adoption. This is an important finding worth emphasizing. Biological reproduction seems to
derive its profound meaning from the union of the parents’ egg and sperm. If, for whatever
reason, either the prospective father or the prospective mother cannot contribute his or her
gamete, biological relatedness loses much of its appeal. In this sense, the term “biologically
related children” is misleading. It merges forms of reproduction that are not at all
commensurable.
Reproductive Method
% that considered
each step
Adoption 60
Embryo donation 13
52
53
U.S. Census Bureau, "Adopted Children and Stepchildren: 2000," (Washington, D.C.: U.S. Department of
Commerce, 2003), p.7. The Census Bureau does not provide data about adoption rates of younger children.
Centers for Disease Control and Prevention, "2000 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," (Atlanta, GA: National Center for Chronic Disease Prevention and
Health Promotion, Division of Reproductive Health, 2002), p.11.
201

Surrogacy 16
Donor egg 14
Donor sperm 14
Table 6: Harris Interactive Chronic Illness Panel.
The data also suggests that the quest for reproduction is only partially grounded in biology.
Access to reproductive technologies that deliver only biological relatedness may well be of
secondary importance compared to ART treatments that provide a reasonable chance to produce
full biological descendents. Pregnancy and biological relatedness are only two and perhaps not
the most important aspects of parenthood. In short, adoption is far more important than any ART
treatment involving extraneous gametes or donated embryos.
Reproductive Method
% that considered
each step
Adoption 70
Embryo donation 21
Surrogacy 17
Donor egg 30
Donor sperm 13
Table 7: RESOLVE members.
One could argue that different levels of knowledge and information may explain the
popularity of adoption over certain kinds of ART treatment. Adoption is almost as old as
humanity itself, whereas embryo donation is a new option for which little information is
available. The empirical evidence suggests that knowledge and information do not significantly
affect reproductive preferences. The RESOLVE survey includes questions designed to determine
whether members of the three samples had received adequate information about various
reproductive options (Table 8). It is safe to assume that RESOLVE members are the most
knowledgeable of the three samples included in the survey. Among the members of this panel, an
almost identical percentage had not received sufficient information about adoption, donor egg,
and donor sperm (24 percent, 26 percent, 25 percent, respectively). In other words, for each of
the reproductive technologies under consideration, RESOLVE members were provided with an
inadequate but very similar amount of information. This means that their preference for adoption
cannot be explained in terms of information differentials. As for members of the Harris Chronic
Illness Panel and the general population sample, they generally were better informed about
adoption than about egg and sperm donation.
Table 8 suggests that information does have an impact on preferences, but not a differential
one. Members of the RESOLVE panel, clearly the most knowledgeable of the three samples, are
much more likely than members of U.S. population sample to consider egg or sperm donation as
viable reproductive options. However, they are also more likely to consider adoption – 70
percent versus 41 percent of the general population. Thus, differences in knowledge and
202

information do not provide an adequate explanation for the far greater popularity of adoption
over egg and sperm donation.
% who indicated they did not have enough information
about option to make an informed decision
U.S.
Population
Harris Chronic
Illness Panel
RESOLVE
Members
Pursued an Adoption 37 28 24
Donor Egg 53 40 26
Donor Sperm 55 30 25
Table 8: Levels of information.
If information does not explain the strong preference for adoption, perhaps cost differentials
do. The costs associated with adoption can vary considerably depending on the agency and the
origin of the child. According to the National Adoption Information Clearinghouse, an office
within the U.S. Department of Health and Human Services, a domestic public agency could
charge anywhere between zero and $2,500 for foster care adoption, whereas reliance on a
domestic private adoption agency could cost between $5,000 and $40,000 or more. 54
By
comparison, the American Society for Reproductive Medicine recommends compensating an egg
donor with up to $4,000 for one egg and a sperm donor with $100. These are recommended
prices; the market price for a donated egg is often much higher. The costs of ART services are
charged separately and are significant; they range from $8,000 to $25,000 per cycle, depending
on the reproductive services provided, the reputation of the ART program, and its location.
Based on the available data, it appears that cost differences are not large enough to explain a
strong preference for adoption.
An additional consideration is red tape. Adopting a child in the United States is a lengthy
and bureaucratic process that can last several years. By comparison, an ART treatment is a fairly
straightforward, transparent, and predictable procedure. Thus, neither the relative costs of ART
treatments versus adoption procedures nor differences in transaction costs explains the
preference for adoption displayed by the members of the three panels.
One could also argue that the strong preference for adoption documented in Table 4 through
Table 7 may be explained by relative differences in the availability of these services throughout
the country. A back-of-the-envelop analysis shows that availability differentials cannot account
for the popularity of adoption. According to the most recent data on success rates published by
the CDC, there are more than 400 fertility programs in the United States. Over the last 25 years,
the number of ART programs has been increasing steadily. On the other end, an online search of
the Gale Encyclopedia of Associations reveals that in 2005, there were less than 200
organizations devoted to adoption issues, many of which provide lobbying rather then actual
adoption services. Thus, differential availability of reproductive services would favor egg and
sperm donation over adoption.
54
For additional information, visit http://naic.acf.hhs.gov/pubs/s_cost/s_costb.cfm (accessed April 26, 2004).
203

To recap, the survey data shows a strong preference for adoption over ART treatments
providing only partial genetic relatedness. It appears that in making procreative choices,
biological relatedness is not as important as commonly assumed. On the other end, given the
importance attached to adoption and its roots in the “history and traditions of this country,” one
could argue that adoption should be considered a fundamental right deserving of constitutional
protection. If this were the case, the Supreme Court would likely require any state regulation
limiting access to adoption services to pass a strict scrutiny test, a test not many regulations are
likely to survive. Instead, every state has laws regulating key aspects of the adoption process,
including data collection, payments, and parentage. 55
The data also suggests a broader point: Procreative decisions are based on several
considerations, only one of which is genetic relatedness. Other values – such as the importance
of being parents and raising children, the experience associated with pregnancy and childbirth,
and procreation in the context of a familial unit – are central aspects of a procreative choice, and
can be as important or more important than genetic relatedness. Perhaps not coincidentally, many
of the Court precedents discussed in this chapter pertain precisely to these aspects. They also
overlap with the considerations identified by the New York State Task Force on Life and the
Law as crucial to any Court ruling pertaining to reproductive medicine. Taken together, these
observations suggest that the Court is very unlikely not only to extend constitutional protection
to technologies of procreative customization, but also to deny fundamental status to several,
more traditional ART treatments.
55
Lori B. Andrews and Nanette Elster, "Adoption, Reproductive Technologies, and Genetic Information," Health
Matrix: Journal of Law-Medicine 8 (1998).
204

7.5 Bibliography
Ackerman, Bruce. "Levels of Generality in Constitutional Interpretation: Liberating
Abstraction." University of Chicago Law Review 59 (1992): 317-48.
Andrews, Lori B., and Nanette Elster. "Adoption, Reproductive Technologies, and Genetic
Information." Health Matrix: Journal of Law-Medicine 8 (1998): 125-51.
Barnes, Barry. "On the Conventional Character of Knowledge and Cognition." In Science
Observed. Perspectives on the Social Study of Science, edited by Karin Knorr-Cetina and
Michael Mulkay, 19-51. London: Sage Publications, 1983.
Barnes, Barry, David Bloor, and John Henry. Scientific Knowledge: A Sociological Analysis.
Chicago, IL: University of Chicago Press, 1996.
Baruch, Susannah, Audrey Huang, Daryl Pritchard, Andrea Kalfoglou, Gail Javitt, Rick
Borchelt, Joan Scott, and Kathy Hudson. "Human Germline Genetic Modification: Issues
and Options for Policymakers." Washington, D.C.: Genetics and Public Policy Center,
2005.
Bloor, David. Wittgenstein, Rules and Institutions. London: Routledge, 1997.
Centers for Disease Control and Prevention. "2000 Assisted Reproductive Technology Success
Rates: National Summary and Fertility Clinic Reports." Atlanta, GA: National Center for
Chronic Disease Prevention and Health Promotion, Division of Reproductive Health,
2002.
———. "2002 Assisted Reproductive Technology Success Rates: National Summary and
Fertility Clinic Reports." Atlanta, GA: National Center for Chronic Disease Prevention
and Health Promotion, Division of Reproductive Health, 2004.
Coleman, Carl H. "Religious Values and Legal Dilemmas in Bioethics: Assisted Reproductive
Technologies and the Constitution." Fordham Urban Law Journal 30 (2002): 57-70.
Easterbrook, Frank H. "Presidential Review." Case Western Reserve Law Review 40 (1990):
905-29.
Ely, James W. "The Oxymoron Reconsidered: Myth and Reality in the Origins of Substantive
Due Process." Constitutional Commentary 16 (1999): 315-45.
Harrison, John. "Substantive Due Process and the Constitutional Text." Virginia Law Review 83
(1997): 493-558.
Hart Ely, John. "On Discovering Fundamental Values." Harvard Law Review 92, no. 1 (1977):
1-55.
Massie, Ann MacLean. "Regulating Choice: A Constitutional Law Response to Professor John
A. Robertson's "Children of Choice"." Washington and Lee Law Review 52 (1995): 135-
71.
New York State Task Force on Life and the Law. "Assisted Reproductive Technologies.
Analysis and Recommendations for Public Policy." New York, NY, 1998.
Newman, Stephen A. "Human Cloning and the Substantive Due Process Riddle." Southern
California Interdisciplinary Law Journal 8 (1998): 153-66.
Rao, Radhika. "Reconceiving Privacy: Relationships and Reproductive Technology." UCLA Law
Review 45 (1998): 1077-123.
RESOLVE: The National Infertility Association. "Embryo Donation Research: Select Findings."
Bethesda, MD, 2003.
205

Robertson, John A. Children of Choice: Freedom and the New Reproductive Technologies.
Princeton: Princeton University Press, 1994.
———. "Embryos, Families, and Procreative Liberty: The Legal Structure of the New
Reproduction." California Law Review 59 (1986): 942-1039.
———. "Liberalism and the Limits of Procreative Liberty: A Response to My Critics."
Washington and Lee Law Review 52 (1995): 233-67.
———. "Procreative Liberty in the Era of Genomics." American Journal of Law and Medicine
29 (2003): 439-87.
Spriggs, M. "Lesbian Couple Create a Child Who Is Deaf Like Them." Journal of Medical
Ethics 28 (2002): 283.
Sunstein, Cass. "Is There a Constitutional Right to Clone?" Hastings Law Journal 53 (2002):
987-1005.
Tribe, Laurence H., and Michael C. Dorf. "Levels of Generality in the Definition of Rights."
University of Chicago Law Review 57 (1990): 1057-108.
U.S. Census Bureau. "Adopted Children and Stepchildren: 2000." Washington, D.C.: U.S.
Department of Commerce, 2003.
206

8 Public Sentiments Toward New Reproductive Technologies and
Biomedical Research
8.1 Introduction
The main purpose of the following discussion is not to determine whether the public is
supportive or opposed to any one of the many controversial reproductive technologies the news
media have reported on in the last several years. The data does suggest some fairly general and
robust conclusions, but this is not the most important result. Far more consequential is the
observation that the general public is not as polarized as the heated debates between radical
supporters and opponents of new biomedical technologies indicate. This finding suggests that the
current political gridlock over biomedical research at the federal level does not accurately reflect
attitudes and political preferences among members of the general public. Our data analysis
shows that on many divisive issues, the public displays far more nuanced positions than the
Congress. In other cases, the general public displays considerable ambivalence; in still other
cases, we have found broad opposition. What we did not find was a strongly polarized public.
There are several possible reasons for these differences; they may reflect opposing cultural
and social values among Congressional representatives of different states. This, of course, is as it
should be in any representative democracy. However, this explanation only accounts for political
differences, not for a polarized Congress. Polarization tendencies in the House of
Representatives may also reflect misguided policies of Congressional redistricting. 1
These
policies clearly have contributed to exacerbating political conflicts, but have not caused the
current political stalemate over biomedical research. As we demonstrate in more detail in chapter
10, the main culprits in Congress’ inability to craft broadly acceptable legislative proposals are
interest groups. In the area of reproductive medicine and biomedical research, these groups wield
excessive power over the Congress, to the detriment of an unaffiliated public that tends to
display more moderate views.
This chapter is organized as follows: We first explore public attitudes toward science,
technology and medicine in general. We then examine in some detail public sentiments toward
reproductive cloning, research cloning (referred to by news media as “therapeutic” cloning” and
by scientific organizations as “somatic cell nuclear transfer”), stem cell research, and genetic
engineering, in this order. These issues have received considerable attention from the news
1
Redistricting practices in many cases have had the intended result – to send a larger number of African-
Americans to the Congress – but they have also contributed to producing an increasing number of conservative,
white Congressional districts. Congressional representatives of these districts have no need to cater to a broad
range of political interests. Their districts are simply too homogenous to require political moderation and the
search for compromise.
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media and from polling organizations. Attitudes toward other developments such as preimplantation
genetic diagnosis and sex-selection technologies have been polled less frequently,
and are therefore not included in our discussion.
Overall, we have gathered more than 120 survey questions. The data were obtained from
four online databases, 2 gleaned from news reports and through extensive online searches. The
large number of survey questions included in our discussion has forced us to organize the data in
a somewhat unusual way. Given the survey responses to the wording of each question, we would
have liked to include all the questions and the data directly in our discussion. However, this
would have made this chapter unwieldy and excessively long. For this reason, we have grouped
all the survey questions and the corresponding data in several Appendices. The survey questions
used in each of the following sections have been linked to a corresponding Appendix through
footnotes and a numeric index. Readers interested in scrutinizing the survey questions and
answers in more detail should consult these Appendices.
8.2 General Attitudes Toward Science and Technology
It is a well-known fact that Americans, unlike Europeans and Canadians, are generally very
optimistic about the role of science and technology in society. Our data clearly supports this
observation. In 2002, a full 90 percent of respondents agreed strongly or somewhat strongly with
the statement “Scientific research is essential for improving the quality of human life” (1). 3 In
2003, the proportion of those who strongly agreed with this statement had increased from 48
percent to 59 percent (1). And the percentage of respondents who agreed somewhat or strongly
with this observation in 2004 remained very high (92 percent) (1).
A general sense of optimism also emerges from the enthusiastic reaction in 2001, 2002,
2003, and 2004 to the question of whether developments in science have helped make society
better off; a whopping 86 percent of respondents shared this view, whereas less that 10 percent
disagreed (2). These strongly positive attitudes toward science and scientific progress translate
into significant support for public funding of research. In 2001, 41 percent of respondents to a
Pew Research Center for the People and the Press survey thought that the federal government
“should increase” spending on scientific research (110), and in 2002, 34 percent of the public
thought that the federal government was spending “too little” on scientific research (111). Not
surprisingly, the public generally feels quite positive about the overall impact of science on
society. In 2001, 47 percent of respondents thought that on balance, the benefits strongly have
outweighed the harmful effects, and another 25 percent thought that the benefits “slightly
2
3
The four databases are Polling the Nations (http://www.orspub.com/), The Gallup Organization
(http://www.gallup.com/), PollingReport (http://www.pollingreport.com/), and the Kaiser Family Foundation
Health Poll Search database (http://www.kaisernetwork.org/health_poll/hpoll_index.cfm).
In this chapter, the numbers in parentheses refer to the corresponding questions in Appendices J through P.
Questions, data, and sources used in this section are available in Appendix J: Attitudes toward Science and
Medical Research.
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outweighed” the harm. By contrast, only 3 percent believed that the harmful effects strongly
outweigh the benefits (112). Perhaps more telling is the response to the following question:
“Even if it brings no immediate benefits, scientific research which advances the frontiers of
knowledge is necessary and should be supported by the federal government. Do you strongly
agree, agree, disagree, or strongly disagree?” (34). In 2001, 19 percent strongly agreed and 62
percent agreed with this statement.
With regard to medical technologies, the overall picture remains very positive, with 57
percent of individuals strongly agreeing that “new technology used in medicine allows people to
live longer and better,” and 34 percent agreeing somewhat with this statement (4). These
numbers, obtained in 2002, changed only slightly in 2003, with 60 percent agreeing very
strongly and 31 percent agreeing somewhat with the same statement. Compared to other fields of
scientific inquiry, medical research has the best public image, with 27 percent of the general
public sharing the view that over the last 30 years, medicine has made the most positive
contribution to society, followed closely by the 24 percent who thought that information
technologies have made the most positive contribution (5).
The picture emerging from the data is clear: In the United States, public sentiments toward
science in general and medical research in particular remain very positive. However, policymakers
and scientific leaders should not interpret these responses as a demonstration of
unconditional support. The fact that the public generally is positively predisposed toward science
does not prevent it from expressing some concerns. Asked whether “scientific research these
days doesn’t pay enough attention to the moral values of societies,” in 2001, a surprising 28
percent strongly agreed (6). This figure did not changed significantly in 2002, with 29 percent
agreeing strongly with this expression of skepticism. Very similar figures emerged in 2003 (28
percent) and in 2004 (25 percent). That not all is well with science is also demonstrated by
reactions elicited by the statement “Scientific research has created as many problems for society
as it has solutions” (7). In 2001, 2002, and 2003, a solid minority of approximately 20 percent of
respondents strongly agreed, and between 36 and 40 percent somewhat agreed with this vote of
no confidence. The following question produced an even stronger expression of distrust: “The
temptations to make money from new technologies puts pressure on scientists to pursue research
ideas that violate ethical principles. Do you strongly agree, somewhat agree, somewhat disagree,
or strongly disagree?” In this case, 69 percent of respondents either strongly or somewhat agreed
with this statement (95). These feelings of discomfort should not be dismissed simply because
they are generic expressions of distrust. The survey data introduced below show that generic
expressions of support or distrust provide a useful framework within which the public is likely to
make more specific distinctions.
8.3 Reproductive Cloning
The general public has been polled on reproductive cloning at least since 1993. The surveys
reviewed in this section were conducted in 1993, 1997, 1998, 2000, 2001, 2002, and 2003.
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Before diving into the data, the meaning of the term “reproductive cloning” should be clarified.
In this section and throughout this report, “reproductive cloning” is synonymous with somatic
cell nuclear transplantation for the purpose of creating a child. In other words, reproductive
cloning can be described as a new kind of reproductive technology. 4 The data presented in this
section is organized both chronologically and thematically. Chronologically, roughly three
distinct phases can be distinguished: The first phase includes surveys conducted before 1997, the
second period covers the years 1997 and 1998, and the third phase ranges from 1998 to 2003.
(We were unable to find surveys of sufficient quality after 2003.) 1997 was of course the year the
world became acquainted with the first cloned mammal, Dolly the sheep. Surveys conducted
before 1997 are necessarily somewhat speculative. Public reactions during the 1997-1998 were
registered against the background of a historical announcement. Finally, surveys conducted since
1998 are likely to reflect more distanced public sentiments.
Thematically, we first examine a series of questions aimed at eliciting general sentiments
toward reproductive cloning. Unlike the surveys discussed in the second part of this section,
these questions do not include a specific rationale for performing reproductive cloning. They
simply aim to assess the public’s reaction to the very notion of reproductive cloning. 5 One of the
earliest surveys on this question dates back to 1993. A Time/CNN poll explored the public’s
sentiments about reproductive cloning in several ways. It asked whether cloning is a “good or
bad thing” (10); 75 percent found it is a bad thing, 14 percent thought it was a good thing. Other
questions designed to elicit a generic statement of approval or disapproval produced similar
results. For example, asked whether reproductive cloning is morally wrong, 58 percent agreed
(14). A somewhat higher percentage (63 percent) believed that reproductive cloning is against
God’s will (15). And very few respondents (7 percent) were interested in “cloning an embryo”
for reproductive purposes (12).
In the aftermath of the Dolly announcement, the percentage of respondents who rejected
reproductive cloning increased. Depending on how the question was framed, opposition ranged
from a relatively low 63 percent to an overwhelming 93 percent. For example, in 1997, 88
percent of respondents were strongly opposed to “cloning a human being” (18). Asked whether
cloning “is a good or a bad thing,” 62 percent of respondents agreed that it is indeed a bad thing,
while 22 percent believed it is “a good thing” (19). 86 percent of respondents found it
“unacceptable” to “make copies of humans” (17), whereas 74 percent thought it was “against
God’s will” to clone a human being (131), 89 percent thought that it was “morally unacceptable”
(110), 93 percent agreed that it was a “bad idea” (111), and 84 percent “opposed” creating an
“exact copy” of a human being (20).
Since 2000, generic attitudes toward reproductive cloning have remained largely unchanged.
In 2000, 73 percent of respondents thought that it was “bad for society,” while only 10 percent
4
5
Some commentators have pointed out, correctly in our view, that reproductive cloning is not as much a
technology of reproduction as it is a replication technique. Cf. Annas, "Human Cloning: A Choice or an Echo?."
To avoid confusion, in this report we use the former and more common interpretation.
For a complete list of questions, corresponding data, and sources, see Appendix K: Reproductive Cloning.
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thought that cloning human beings would be “good for society” (23). A question framed in moral
terms produced an 89 percent opposition (27). An overwhelming 85 percent rejected the notion
that scientists should be allowed to try to clone human beings (26). In sum, the general public
has been consistently opposed to this reproductive procedure by large or very large margins for
well over a decade.
One could predict that questions worded in more specific terms – i.e., questions that include
various rationales for performing this procedure – would produce a dramatically different
picture. To test this claim, we assembled several questions designed to assess the public’s
sentiments on a variety of possible applications of reproductive cloning. As for the more generic
formulations, the available data can be subdivided into three time periods: the pre-Dolly era, the
period of time immediately following the announcement of Dolly, and surveys conducted more
recently.
In 1993, two out of three possible applications of reproductive cloning produced very strong
opposition. For example, the notion that parents might want to have a “twin child” at a later point
in time, that is to say a genetic copy of a living child, was rejected by 78 percent of respondents
(11). The possibility of having a twin clone, i.e. of copying oneself, was rejected by an even
bigger majority – 86 percent (13). By contrast, the suggestion that cloning may be used to
produce a larger number of embryos to help a couple have a child through ART techniques was
more controversial, with 45 percent approving and 46 percent disapproving of this possibility
(9).
In the aftermath of the Dolly announcement, the public was frequently polled on possible
rationales for performing reproductive cloning. With one exception, offering specific
justifications did not increase the public’s support for this technology. Asked whether they would
want to clone themselves if they found out they had only one year to live, in 1997, 91 percent of
respondents answered no (16). Nor is the possibility of simply cloning oneself appealing to
many: 91 percent denied that they would want to clone themselves (120). In 1998, the suggestion
that parents might want to clone a deceased young child was rejected by 87 percent of
respondents (122). The view that reproductive cloning could be used to make babies that would
provide vital organs to save the lives of others was rejected by 78 percent of surveyed individuals
(123). Noteworthy in this case is that 19 percent of those surveyed actually approved of this
suggestion – a rather discouraging result, to put it mildly. To allow parents to have a “twin child”
at a later point in time was again rejected, this time by 86 percent of respondents (124). Only the
suggestion that reproductive cloning may be beneficial to infertile couples garnered slightly more
positive responses: In one poll, 33 percent of respondents approved, while 63 percent
disapproved (121). In another poll on the same subject, however, the rejection in 1998 compared
to 1997 was considerably higher, at 80 percent (22).
More recent polls on specific applications of reproductive cloning have produced a similar
result. In 2001, only 10 percent of respondents supported reproductive cloning to allow gay
couples to have genetically related children, while 86 percent rejected this suggestion (125).
Producing “genetically superior human beings” was rejected by 92 percent of polled individuals
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(126), and allowing parents to have a “twin child” at a later point in time was again rejected by a
large margin, this time 88 percent (127). In 2001, retrieving “vital organs” from babies for
therapeutic purposes was rejected by 68 percent of respondents, while an alarming 28 percent
found this proposal acceptable (128). While 76 percent of respondents did not think that helping
infertile couple is an acceptable use of reproductive cloning (130), 74 percent of polled
individuals thought nothing of cloning a person in order to save that person’s life (129). In sum,
no matter what the rationale for resorting to reproductive cloning, the public finds this procedure
unacceptable by very large margins and has done so at least since 1993.
Interestingly, opposition to reproductive cloning is not limited to the cloning of human
beings. In 2002, the suggestion that pets could be cloned garnered strong opposition – 92 percent
(25). The public seems to be opposed to cloning animals even when this procedure could keep a
species from becoming extinct, with 58 percent of respondents remaining opposed to the
procedure in this case (24). Even cloning farm animals, an almost common practice these days, is
opposed by 42 percent of the general public (29).
When it comes to imposing legal bans, the picture is more ambivalent. In 1993, 46 percent
of the public thought that reproductive cloning should be regulated rather than banned outright.
An identical percentage thought that it should be banned (41). A few years later, in 1998, the
suggestion that reproductive cloning should be banned (“Do you favor or oppose an outright ban
on the cloning of human beings?”) mustered significant (albeit not overwhelming) support – 58
percent (21). Wording the question in terms of “not allowing” rather than “banning” significantly
affected the response: In 2001, a much higher proportion of respondents (89 percent) believed
that reproductive cloning “should not be allowed” (27). A year later, respondents thought by a
very large margin (85 percent) that scientists should not be allowed to clone human beings (26).
On the other end, surveys conducted by Virginia Commonwealth University (VCU) in 2001,
2002, and 2003 seem to indicate that support for an outright ban is somewhat lower, at
approximately 65 percent (28). This result is contradicted by a well-crafted question that in 2003
elicited strong support for making reproductive cloning illegal (138). Quite possibly, this
somewhat ambivalent attitude toward banning reproductive cloning reflects a deep-seated
skepticism about government institutions and regulations.
8.4 Research Cloning
We define research cloning as somatic cell nuclear transplantation for research purposes.
While from a scientific standpoint research cloning and reproductive cloning are identical,
research cloning is not performed with reproductive goals in mind. With research cloning, we
shift to a topic considerably more controversial than reproductive cloning. The medical and
research community aggressively have promoted the view that research cloning is a crucial step
in the development of cures for many diseases; opponents, for their part, have pointed to the
hypothetical nature of this assertion and sharply criticized the destruction of human embryos for
research purposes.
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Over the last few years, organized interest groups have often polled the general public on
this subject. In the process, they have produced a considerable amount of survey data.
Unfortunately, in the case of research cloning (or therapeutic cloning, as the news media and
some research organizations prefer to call this procedure), survey questions of good quality are
often hard to come by. In many cases, interest groups conduct these surveys to produce data
supportive of their positions rather than to elicit genuine public sentiments. To compensate for
poor data quality, throughout our discussion, we take the distorting effects of certain types of
wording explicitly into account.
Our analysis shows that two criteria have a significant impact on public attitudes toward
research cloning: Does a survey question specifically mention that research cloning might lead to
new medical treatments, and is the public being informed that conducting research cloning
entails destroying human embryos? Research organizations and science advocacy groups tend to
ask questions that emphasize the benefits for the patients and the public in general, but rarely
mention the destruction of the embryo. Conservative and religious groups, on the other end,
generally downplay possible medical benefits but underscore the fact that embryos must be
sacrificed for the sake of medical research. A third set of questions may be considered neutral, in
the sense that neither specific benefits nor drawbacks are mentioned. These questions do,
however, mention that cloning is being conducted for research. A few survey questions include
references both to possible benefits of medical research and to the destruction of cloned embryos
for research purposes. It is this last category of questions that is most likely to produce accurate
responses.
We found three fairly neutral, generic questions aimed at eliciting public feelings about
research cloning as a research technique (33, 37, 38). 6 Two of these questions focus on the
legality of research cloning (as in, “Should researchers be allowed to clone human embryos for
medical research?”), while one (33) simply measures support for or opposition to research
cloning. In this baseline situation, there is no evidence that the public would support research
cloning. In two cases (33, 38), respondents opposed research cloning by a two-to-one margin,
and in one case (37), opponents and supporters were evenly split, with 47 percent favoring a ban
and 48 percent opposing it. In short, the public has significant reservations about research
cloning, even though the questions worded in generic terms are more likely to elicit responses
supportive of medical research.
Ten survey questions of various quality explicitly mention possible benefits of medical
research but do not make any reference to the destruction of embryos (150, 45, 44, 151, 152, 35,
36, 40, 153, 154). 7 One may think that emphasizing possible health benefits would produce
strong and consistent support for this new field of research. To our surprise, this turned out not to
be the case. In three cases (45, 44, 36), supporters and opponents were almost evenly split.
Respondents to the other three questions (35, 40, 151) remained opposed or strongly opposed to
6
7
Wording of the questions used in this section, data, and sources are available in Appendix L: Research Cloning.
The order in which the questions are listed reflects their sequence in the Appendix L.
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esearch cloning. Two questions (150, 152) produced a significant but not overwhelming
majority of responses in support of research cloning; finally, respondents to two questions (153,
154) were overwhelmingly supportive of this kind of research. Based on this data, it is fair to say
that the public is rather ambivalent about the wisdom of moving forward with research cloning.
We found one question (43) that was designed to elicit the legitimacy of performing medical
research that would destroy human embryos but that did not mention possible medical benefits:
“Should scientists be allowed to use human cloning to create a supply of human embryos to be
destroyed in medical research?” Not surprisingly, an overwhelming majority of respondents (80
percent) found this suggestion unacceptable.
What about questions forcing respondents to evaluate both the pros and cons of research
cloning? We found two questions making the relevant trade-offs fairly clear (30, 155). Both
questions also explained in some detail the technicalities of research cloning. One (30) explicitly
juxtaposed the destruction of the embryo with possible medical breakthroughs. The other (155)
did not mention the destruction of the embryo, but pointed to the risk that cloning technologies
might be misused for reproductive purposes. In both cases, the public rejected research cloning
by a two-to-one margin. (Both questions were asked in August 2001, and are therefore somewhat
dated.)
Based on this survey data, we can draw three main conclusions: First, the poor quality of
some survey questions notwithstanding, it is fair to say that there remains considerable
skepticism among members of the general public about the wisdom of moving forward with
research cloning. Second, public attitudes toward research cloning seem quite sensitive to
whether mention is made of both embryo destruction and possible medical benefits. Third, and
most importantly, the general public clearly distinguishes between reproductive and research
cloning. We are not suggesting that the public has a clear understanding of the medical and
scientific terminology. Our claim is simply that respondents, if provided with understandable
trade-offs, provided consistently different answers to questions pertaining to these two
procedures: They reject reproductive cloning by large margins, and remain ambivalent about
research cloning.
8.5 Stem Cell Research
Not surprisingly, the best survey data available is on stem cell research. Our discussion of
this topic is organized as follows: We first take in in-depth look at several survey questions
worded in general terms. These are questions simply aimed at measuring generic support for or
opposition to stem cell research, in which no mention is made of the destruction of embryos, and
possible research benefits are rarely mentioned. We then examine survey questions pertaining to
the moral status of the embryo. In the final part of this section, we turn our attention to the
willingness of the public to support federal funding for stem cell research.
An important observation emerging from this data is that the general public holds fairly
specific and differentiated views about stem cell research. The public generally regards stem cell
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esearch as desirable. Generic expressions of support do not translate into unconditional support,
however. The donation of excess embryos is regarded as a viable option, whereas the creation of
embryos solely for research purposes is rejected by significant margins.
We have identified six survey questions posed between 2001 and 2004 designed to measure
generic levels of approval or disapproval for stem cell research. This data suggests that the public
consistently is supportive of stem cell research, although not in overwhelming numbers. Of the
six questions, three produce significant support (52, 54, 60) while the public was evenly divided
in three other cases (50, 51, 53). 8 Of some interest to our discussion is one poll, conducted by the
Juvenile Diabetes Research Foundation, which found that even religious and conservative voters
show a significant degree of support for stem cell research, with 39 percent in favor of it and
only 33 percent opposed (50).
These preliminary results are broadly consistent with prevailing moral sentiments. We found
five survey questions designed to elicit moral approval or disapproval for stem cell research,
again in general terms (61, 62, 63, 66, 68). Far from eliciting more cautious responses, these
questions tended to produce more consistent and somewhat stronger support for stem cell
research. For example, 53 percent of respondents disagreed with the statement that “using
embryos for research comes too close to allowing scientists to play God,” while 40 percent
agreed (62). Less dramatic formulations, such as “allowing any medical research using stem cells
from human embryos should be forbidden because it is unethical and immoral” (63), produce
even stronger expressions of disagreement, with 60 percent of respondents rejecting this view
and only 32 percent showing approval (63).
The generally positive attitudes displayed by the public seem to be fuelled by very
pragmatic considerations. In 2001, 34 percent of respondents thought that stem cell research is
“wrong, but may be necessary.” The same percentage thought that this line of research is “not
wrong, and may be necessary” (66). In the same year, 60 percent of respondents believed that
“the embryo has the potential for life, but is not the same as life, because it cannot develop on its
own,” whereas only 36 percent chose the statement “the embryo is a human life that should be
given the same protection as all other human lives” (69). Whether supporters of stem cell
research consistently hold a view of the moral status of the embryo that lies somewhere between
a materialistic and a transcendental perspective is anyone’s guess, but it is fair to say that this
view is entirely compatible with the 68 percent of the public that found stem cell research
“necessary.” A third question provides additional, albeit indirect, evidence for the public’s
pragmatic attitude: Asked whether “stem cell research is an important step forward in finding a
cure or treatment for things like Parkinson’s disease and MS (multiple sclerosis)” or whether
“stem cell research will take the lives of innocent unborn children,” 52 percent of respondents
chose the former option, while only 30 percent selected the latter (64).
Generic expressions of support consistently translate into equally supportive attitudes
toward federal funding for stem cell research. Between 2001 and 2002, polling organizations
8
A complete list of survey questions used in this section is available in Appendix M: Stem Cell Research.
215

asked five times whether the public would support federal funding for stem cell research. These
questions were worded in general terms, with no reference to the origin of the embryos or the
specific research benefits. Each of the five questions examined here produced significant support
for federal funding of stem cell research. In three cases, supporters outweighed opponents by a
two-to-one margin (56, 57, 46); in the other two cases, support remained significant, though a
larger number of respondents were undecided (47, 55). In sum, a solid although not
overwhelming majority of the public is supportive of stem cell research, does not find it morally
objectionable, and would be favorable to federal funding for this new area of research.
The two-to-one margin in favor of stem cell research should not be interpreted as an
unconditional statement of support. Rather, it should be regarded as a baseline that is likely to
shift depending on the specific policy proposals. As we show below, attitudes toward stem cell
research change significantly if one examines whether embryos should be created solely for the
purpose of conducting stem cell research (“research embryos”), or whether stem cell research
should rely on excess embryos from fertility clinics.
The question that by far has received the greatest attention is whether the public would
support the use of donated excess embryos stored at fertility clinics. We have identified 13
survey questions that speak to this issue. The results are summarized in Table 9 and Table 10.
These questions, though at times worded very differently, share two attributes: They make
reference to the fact that to derive new stem cell lines, the embryo would have to be destroyed,
and they explicitly mention possible medical benefits from this new area of research. The
vocabulary used to alert the respondents to the fact that embryos are being destroyed varies.
Some questions simply state that embryos would have to be used; others point out explicitly that
embryos are being destroyed.
The implicit reference to the destruction of embryos could mislead some members of the
public and produce distorted response patterns. To identify possible distortions, we have grouped
the survey questions in two categories: In the top half of Table 9 and Table 10, we have listed
questions that explicitly mention the destruction of embryos; in the bottom half, we have
included formulations that merely suggest embryo destruction. Surprisingly, the data do not
show any appreciable difference in the response patterns. For this reason, we have decided to
ignore this issue.
Poll Support Oppose Intensity
CNN/USA Today/Gallup 1 (Q83) 55 40 +
Ipsos Reid (Q84) 75 20 ++
CNN/USA Today/Gallup 2 (Q86) 55 39 +
Washington Post/ABC News (Q87) 63 33 ++
Harris Interactive 1 (Q81) 61 21 ++
Harris Interactive 2 (Q82) 72 21 ++
Gallup (Q88) 77 18 ++
Table 9: Attitudes toward the use of excess embryos for stem cell research in 2001.
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To the extent possible, we have aggregated the original data so as to allow a comparison
across questions. The last column in Table 9 and Table 10 is a measure of the intensity of
support. Intensity in this case is a somewhat subjective measure; we consider a two-to-one or
higher margin an indication of strong support (++), and anything less as indicative of moderate
support (+). In nine out of 13 cases, the public was very much in favor of using excess embryos
for research purposes; in three cases, respondents were supportive, but by a lesser margin; and in
one case, the public was almost evenly split between supporters and opponents. In sum, the
general public is overwhelmingly supportive of conducting stem cell research on excess
embryos.
Poll Support Oppose Intensity
Results for America II (Q92) 72 25 ++
Results for America I (Q59) 73 24 ++
Juvenile Diabetes Research Foundation 2 (Q89) 56 36 +
Harris Interactive 1 (Q58) 72 13 ++
Harris Interactive 2 (Q96) 73 11 ++
Juvenile Diabetes Research Foundation 1 (Q90) 44 46 ~
Table 10: Attitudes toward the use of excess embryos for stem cell research in 2004-2005.
The last policy question to be examined in this section is whether the general public would
support federal funding for research on embryos created exclusively for research purposes. This
question may at first seem a bit speculative. According to a recently conducted study, there are
currently more than 400,000 embryos frozen at fertility clinics around the country. 9 However,
this same study points out that the actual number of embryos suitable for research purposes is far
smaller. If federal funding for embryonic stem cells comes through, it is quite possible that the
supply of excess embryos from fertility clinics will quickly be exhausted. At that point, the
question would arise as to whether it would be desirable and permissible to create embryos for
the sole purpose of conducting research, and whether the federal government should fund stem
cell research that relies on embryos created exclusively for research purposes. 10
On this question, the general public would be far less supportive of scientists’ demands. In
2001, a slight majority of respondents (53 percent) was opposed to allowing the creation of
human embryos exclusively for research purposes, while only 38 percent supported this
proposition (70). In 2002, the strong opposition to creating embryos for research purposes had
subsided somewhat. A carefully worded Gallup question on this matter found that a majority (49
percent) of the public remained opposed to it, while a strong minority (46 percent) supported it
(71). One survey question is insufficient to draw a firm conclusion, of course, but it appears that
9
10
David Hoffman et al., "Cryopreserved Embryos in the United States and Their Availability for Research,"
Fertility and Sterility 79, no. 5 (2003).
It should be remembered that the Dickey-Wicker Amendment currently prevents the federal government from
funding any kind of research on human embryos. This amendment to the Department of Health and Human
Services appropriation bill has been renewed by Congress every year since its enactment in 1996.
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the creation of embryos solely for research would encounter much fiercer opposition than federal
funding for stem cell research conducted on excess embryos.
8.6 Genetic Engineering
An area of scientific research that has received considerable attention by polling
organizations is what is loosely referred to as “genetic engineering.” This term is not always
well-defined, but the survey questions usually are worded well enough to allow a systematic
evaluation of public sentiments on this issue. Attitudes toward human genetic engineering
provide an excellent opportunity to verify whether the public distinguishes between therapeutic
and enhancing applications of biomedical research. In chapter 3, we suggested that this
distinction should be included as one of the main guiding ethical principles in any enabling
legislation. Whether the general public believes that this distinction is meaningful is therefore of
considerable import to our discussion.
We have identified 17 survey questions pertaining to genetic engineering for the years 1993,
1994, 1997, 1998, 2002, and 2003. 11 In these questions, pollsters took this term to mean a
technology that would allow prospective parents to select specific human characteristics, usually
higher traits such as intelligence and artistic talent but also height, hair, and eye color. Scientists
in this context speak of inheritable genetic modifications. That these options today are available
only in a very limited sense or not at all is rarely mentioned.
An interesting result emerging from this data is that the public has begun only relatively
recently to distinguish between therapeutic and enhancing applications of genetic engineering.
For example, a 1993 Time/CNN poll found that 52 percent of respondents “disapproved” of
screening embryos for inherited abnormalities (107). A year later, 67 percent of respondents to a
CBS News poll thought that “to make a ‘test-tube’ baby that is guaranteed to be free of certain
genetic diseases” was “going too far,” while only 26 percent thought it was a “good thing” (160).
A few years later, in 2003, a Virginia Commonwealth University survey produced a similar
result, with 54 percent of respondents believing that “changing a baby’s genetic characteristics to
reduce the risk of serious diseases” is “taking medical advances to far,” while a relatively low 41
percent thought that it was an “appropriate use” of this technology (105).
The VCU result is somewhat of an outlier, however. It appears that the general public
already had begun to distinguish between medical and enhancing applications of screening
technologies. Asked by a Time/CNN poll in 1998 whether they would choose to “rule out a
genetically transmitted fatal or crippling disease,” two-thirds of respondents declared that they
would (162). The same survey found that a whopping 88 percent rejected sex selection,
presumably for non-therapeutic uses (164), 86 percent would not choose height or weight (165),
and 89 percent would also not choose hair or eye color (166).
11
All survey questions and corresponding data are available in Appendix N: Genetic Engineering.
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Therapeutic and enhancing applications of biomedical technologies trigger distinct
reactions. In 2002, the Genetics and Public Policy Center tested how acceptable various forms of
genetic interventions were judged to be among members of the public (167). Respondents were
again strongly opposed to elective sex selection (68 percent to 28 percent), and rejected the
notion that a baby should be engineered to have “desirable characteristics such as high
intelligence and strength” (72 percent to 22 percent). On the other end, the same respondents
were very much supportive of using genetic interventions to ensure that “their baby does not
have a serious genetic disease” (74 percent to 22 percent), and that their baby “does not have a
tendency to develop a disease like cancer when he or she is an adult” (60 percent to 33 percent).
The participants in this survey also found, by a large margin (69 percent to 25 percent), that
screening an embryo for certain tissue characteristics in order to help an older sibling in need of
a transplant is acceptable.
The rejection of enhancing applications of screening technologies has remained very strong.
In the 2003 VCU survey, 94 percent of respondents found “changing a baby’s genetic
characteristics for cosmetic purposes” to be unacceptable (104), and in a 2003 CNN/USA Today
poll, 88 percent of respondents thought that the selection of traits such as intelligence or artistic
talent “should not be allowed” (169). The CNN/USA Today poll also phrased the same question
in personal terms, asking whether respondents themselves would actually make use of traitselection
technologies. In this case, 91 percent of respondents thought that babies should “be
born with whatever traits [they] would naturally have” (170).
Whether opposition to screening and enhancing technologies will remain high in the face of
scientific and medical progress remains to be seen. One survey question seems to suggest that it
might not, at least in some cases. In 2003, the VCU survey asked a representative sample of U.S.
citizens whether they would likely make use of genetic technologies that “slow down the aging
process” (106); 61 percent rejected this notion, but a non-trivial 37 percent stated that they would
be either very likely or likely to use it. This is another compelling reason to consider adopting
regulatory institutions with a mandate to structure a broad public debate on these matters.
8.7 Awareness and Familiarity
Critical commentators could dismiss our findings on the ground that the data from these
surveys reflects superficial reactions by an uninformed public to poorly worded questions. In a
general sense, this criticism may be warranted, but it is largely irrelevant in the present case for
several reasons. It would certainly be misleading to draw broad generalizations from a single
data point. Our conclusions, however, are not based on isolated observations but on a large
number of survey questions, worded in different ways and asked at different times. Conclusions
based on many survey questions are far more robust than inferences drawn from individual data
points; the distorting impact of poorly worded survey questions becomes negligible, and
underlying trends begin to appear. Thus, it would be very difficult to dismiss our findings for
reasons of data quality.
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Our conclusions could be criticized on other grounds. It is well known that members of the
general public display fairly low levels of scientific literacy. This would seem reason enough to
ignore public attitudes on matters involving complex scientific controversies. This is certainly
the case as far as general scientific literacy is concerned. Some of the data introduced below tend
to support this observation. But as we make clear in the remainder of this section, the
relationship between levels of scientific literacy and the credibility of survey answers is weak. In
the case of reproductive technologies and biomedical research, comparatively low levels of
scientific literacy do not undermine the credibility of our results.
In light of the difficulty in assessing levels of knowledgeability, pollsters often resort to
measuring “awareness.” 12 Awareness is certainly no substitute for knowledgeability, but it is not
entirely unrelated to it. Individuals with no knowledge whatsoever of a topic are very unlikely to
be “aware” of this topic. Conversely, respondents with a considerable interest in and knowledge
of an issue are obviously aware of it. The available data suggests that the general public is quite
aware of topics such as stem cell research and the cloning controversy. Moreover, the levels of
awareness have increased significantly since President Bush addressed the nation on stem cell
research in August of 2001. Between 2001 and 2004, the general public’s interest in medical
research has remained quite high. Almost 50 percent of respondents to the annual VCU survey
register a “strong interest” in medical news stories, whereas only 10 percent are “not at all” or
“not much” interested in this topic (135). As for awareness of the stem cell research controversy,
we found seven questions addressing this issue (76, 78, 134, 75, 132, 74, 73). Rigorous
comparisons are not always possible due to different scales, but it is fair to say that a large
majority of the general public has at least heard of or read something about stem cell research.
With regard to levels of scientific literacy, the picture at first seems somewhat troubling. In
March of 2004, the Juvenile Diabetes Research Foundation asked the following question: “How
well do you think you could explain this topic to a family member or friend – very well,
somewhat well, not very well, or not at all well?” Only 9 percent of respondents thought they
could explain this issue “very well.” A promising 37 percent thought they could at least explain
these matters “somewhat well.” On the other end, 20 percent replied that they would not be able
to explain the issues involved at all (77).
For its part, in 2002, 2003, and 2004, Virginia Commonwealth University asked about the
difference between “therapeutic” and “reproductive” cloning (139, 99, 100). The public’s
responses to this question are somewhat disheartening: Responses to the question in 2002 and
2003 were very similar; only a small minority (8 percent in 2003 and 11 percent 2002) declared
to be “very clear” about this distinction, whereas a significant minority (26 percent and 31
percent, respectively) was “somewhat clear.” Another 30 percent was “not very clear” (32
percent and 29 percent, respectively) or “not at all clear” (33 percent and 28 percent,
respectively) about the difference between reproductive and research cloning (100, 99). When
this question was asked again in the fall of 2004, the number of those “somewhat clear” or “very
12
See Appendix O for details.
220

clear” had remained at 34 percent (131). Roughly similar figures emerged when the public was
quizzed about medical discoveries (“How well informed are you about medical discoveries?”).
About 10 percent of respondents said that they were “very informed,” two-thirds thought they
were “somewhat informed,” and 25 percent thought they were “not very informed” (133). On the
other end, a 2001 Harris Interactive poll found that 78 percent of the people surveyed were able
to identify genes as “the basic unit of hereditary information,” and 50 percent were aware that
genes consist of DNA. About the same percentage (52 percent) knew that the genome is “an
organism’s complete set of hereditary information.” 13 A year later, the Genetics and Public
Policy Center discovered that the general public is not always clear on whether it was currently
possible to actually engineer babies (136, 137).
As troubling as these results may appear, they are not necessarily detrimental to the quality
and credibility of the survey data. Consider the most damning piece of evidence – the general
public does not seem to distinguish very well between reproductive and therapeutic cloning.
Should this data be interpreted to suggest that any conclusion based on this distinction should be
invalidated? We don’t think so. Consider how questions 99, 100, and 131 assess scientific
literacy. These questions measure knowledge of abstract scientific concepts. The general public
may not always be able to provide scholastic definitions of terms such as “reproductive cloning”
and “therapeutic cloning,” but this knowledge is not necessary to answer survey questions in a
coherent and informed manner. Questions designed to assess public attitudes toward various
applications of cloning technology often convey a fairly good sense of what these procedures
entail and of the trade-offs involved. A deep understanding of the technicalities involved is not
necessary to provide an informed answer. So, while the public may not always be able to provide
precise definitions of the relevant scientific concepts, it does not follow that survey questions
cannot articulate the relevant trade-offs and elicit reasonably informed answers. 14
Another important reason for the relative unimportance of scientific literacy is that the
controversies surrounding new biomedical technologies are themselves non-scientific. 15 Is an
advanced degree in genetics required to decide whether sex selection for elective purposes is
desirable? Is mastery of cell biology a condition for a meaningful participation in the debate
13
14
15
Harris Interactive, The Public Is Overwhelmingly Optimistic and Supportive of Genomics Research – However,
Knowledge and Understanding Remain Modest (Health Care News, June 18, 2001 [cited September 21, 2005]);
available from
http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2001Vol1_iss20.pdf.
At least in the case of the distinction between therapeutic and reproductive cloning, the reason for this situation
is quite clear: Pollsters have refrained from using these terms, except for assessing levels of knowledgeability.
The news media, while it has reported profusely on this topic, rarely have made clear this categorical distinction.
Scientific leaders, for their part, have actively tried to blur this distinction by advocating the exclusive use of the
term “somatic cell nuclear transfer.” Cf. Vogelstein, Alberts, and Shine, "Please Don't Call It Cloning."
Incidentally, this is not a unique feature of biomedicine. Consider for example the great outdoors. Does the
general public need to absorb geomorphology and be cognizant about electrical engineering to reject a proposal
aimed at flooding the Grand Canyon to produce electric energy? Certainly not. Should this rejection be
dismissed by the proponents of the project as an uninformed view that Congress should ignore? Most certainly
not.
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about embryonic stem cells? The answer to these questions is no. In all these cases, the public is
not called upon to adjudicate among competing scientific claims; rather, it is expected to make
an informed ethical choice. 16 Offering thought-through answers to some of these questions may
be very difficult, but scientific expertise does not necessarily facilitate this job, nor is it a
requisite to accomplish it. 17
8.8 The Culture Wars: A Myth?
The empirical evidence discussed in this chapter suggests that the general public holds rather
moderate views on new reproductive technologies and biomedical research. Reproductive
cloning is rejected by large margins, research cloning generates considerable ambivalence, and
stem cell research, under certain conditions, is viewed very favorably by significant majorities of
the public. Finally, genetic screening technologies such as pre-implantation genetic diagnosis
garner significant public support, but only for compelling medical reasons. These conclusions
may lead those who subscribe to the view that America is deeply divided to conclude that our
data must be inaccurate or that our analysis is flawed. According to this view, which is especially
popular among political commentators, America is roughly divided into “red” and “blue” states.
In a nutshell, red-state Americans are socially conservative and deeply religious and tend to vote
republican. By contrast, in blue states live Americans with liberal social views who are of
Democratic leaning and largely secular. This characterization is usually meant to identify a
political divide along cultural rather than the traditional economic lines, hence the term “culture
war.” 18
If this view of contemporary America is correct and the “culture war” is indeed raging, then
our survey data must be inaccurate: Deep societal divisions should certainly become apparent in
matters as controversial as cloning technologies and stem cell research. The culture war
hypothesis, then, would lead to the conclusion that the stalemate between scientific organizations
advocating unfettered biomedical research and conservative groups staunchly defending the
dignity of human life accurately reflects public sentiments on these issues, as does the legislative
paralysis that has characterized the Congress in this area in the last few years.
As fashionable as the concept of a culture war may be, it is seriously misleading. As some
commentators convincingly have argued, most Americans continue to hold moderate, centrist
views on many controversial questions. 19
On the all-absorbing debate about abortion, a
16
17
18
19
Jürgen Habermas, The Future of Human Nature (Cambridge, UK: Polity Press, 2003).
Note that our claim here is not that scientific literacy is always or necessarily irrelevant. Different public
controversies may call for different levels of scientific literacy. For example, in assessing the health and
environmental risks associated with genetically modified organisms (GMOs), scientific literacy may play a more
prominent role.
James Davison Hunter, Culture Wars: The Struggle to Define America (New York: Basic Books, 1991).
Morris P. Fiorina, Samuel J. Abrams, and Jeremy C. Pope, Culture War? The Myth of a Polarized America (New
York: Pearson Education, 2005); Alan Wolfe, One Nation, after All: What Middle-Class Americans Really Think
222

significant majority of Americans continue to support this right, but with considerable
ambivalence, suggesting that abortion should stay legal but should also be closely regulated. On
issues pertaining to gun control and gay marriage, the electorate is equally ambivalent, not
polarized. The data on stem cell research discussed in the remainder of this chapter tells a similar
story. Support for stem cell research is significant across political orientation, race, and gender,
and in large measure across religious lines as well. The allegedly deep divisions often are simply
an artifact of poorly worded survey questions rather than an expression of a culture war. The
general public, presented with policy alternatives that do reflect realistic options, tend to display
moderate, centrist views.
In the following discussion, we included only survey questions that pose an explicit tradeoff
between possible benefits from medical research on the one end and protection of human
embryos on the other. We excluded several recently conducted surveys showing overwhelming
support for or opposition to stem cell research that do not make this trade-off explicit. For
example, a recent poll conducted by the United States Conference of Catholic Bishops that
showed strong opposition to stem cell research was excluded because the questions asked in this
poll barely made any mention of possible medical benefits. Analogously, we excluded a 2004
National Annenberg Election Survey in which the benefits of research were explicitly mentioned
but the means by which stem cell lines are derived were not. 20 Six surveys were examined: one
conducted in June 2001 by ABCNews/Beliefnet (98); one conducted in August 2001 by
ABCNews/Washington Post (56); two identical surveys conducted by the Pew Research Center
in 2002 (49) and 2004 (109); one conducted by the Juvenile Diabetes Research Foundation in
2004 (89); and one conducted in 2004 by the Civil Society Institute.
The two ABCNews polls found that the general public supported federal funding of stem
cell research by a two-to-one margin. In these surveys, even religious and conservative voters
were mostly supportive of federal funding for this kind of research. 21
For example, white
evangelical Protestants, arguably the most conservative group in the general population, were
essentially split (50 percent versus 40 percent in the June poll and 47 percent versus 47 percent
in the August one). Catholics were supportive by a two-to-one margin (54 percent versus 35
percent in June and 65 percent versus 33 percent in August), and non-evangelical Protestants
were supportive by even larger margins (68 percent versus 19 percent and 77 percent versus 19
percent, respectively). Ideological orientation produced similar results: Conservative respondents
20
21
About: God, Country, Family, Racism, Welfare, Immigration, Homosexuality, Work, the Right, the Left, and
Each Other (New York: Viking, 1998).
In the former case, a large majority of respondents opposed federal funding for stem cell research; in the latter,
respondents supported it by large margins.
It should be noted that the relevant questions as they appear in Appendix P did not make the trade-off between
embryo protection and research benefit explicit. Instead, this information was provided in the preceding
question: “Sometimes fertility clinics produce extra fertilized eggs, also called embryos, that are not implanted in
a woman’s womb. These extra embryos either are discarded, or couples can donate them for use in medical
research, called stem cell research. Some people support stem cell research, saying it’s an important way to find
treatments for many diseases. Other people oppose stem cell research, saying it’s wrong to use any human
embryos for research purposes. What about you – do you support or oppose stem cell research?”
223

were essentially split (44 percent versus 44 percent and 53 percent versus 42 percent); moderates
were supportive by a two-to-one margin (63 percent versus 26 percent and 64 percent versus 32
percent); and an even larger percentage of liberal respondents (76 percent versus 14 percent and
75 percent versus 23 percent) were in favor of federal funding of stem cell research. A similar
but not identical pattern emerged from the two Pew Research Center polls (49, 109). In these two
surveys, white evangelical Protestants were less enthusiastic about supporting stem cell research,
with only 26 percent supporting it and 55 percent believing that protection of human embryos
takes precedence over medical research (the 2002 Pew survey). The 2004 Pew survey produced
somewhat higher support among the same group, at 33 percent. Response patterns in other
population groups are comparable to those produced by the two ABCNews polls.
Answers provided by white evangelical Protestants are the most sensitive to phrasing, but
contrary to what might be expected, more detailed information tends to produce stronger support
for medical research. The importance of providing detailed, specific information about the policy
trade-offs becomes especially apparent in a poll conducted in 2004 by the Juvenile Diabetes
Research Foundation among self-identified conservative voters (89). In this case, the actual
survey questions were preceded by an extensive explanation that included, among other things,
the fact that embryos would have to be destroyed and that there are more than 400,000 frozen
embryos at ART clinics around the country. In this case, support for stem cell research increases
to 56 percent, while opposition decreases to 36 percent. The dramatic impact of wording on
conservative voters’ attitudes toward stem cell research also was documented in a 2004 survey
conducted by the Civil Society Institute. 22 While the initial view of stem cell research among
evangelicals is quite negative (53 percent oppose it and only 34 percent support it), after being
provided with additional information, 23 negative sentiments turned positive, with 76 percent of
these respondents expressing their support.
The data we have just discussed provides additional support for our claim that a supposedly
deep divide among contemporary Americans often is the result of poor wording rather than an
expression of irreconcilable political differences. If offered adequate background information
and reasonable choices, most Americans tend to pick compromise solutions and shy away from
either extreme. This is true not only among self-declared moderate voters, but also among those
voters who, according to the culture war thesis, should strongly object to any use of human
embryos in medical research – namely, Catholics, conservative Republicans, and evangelicals.
Against this background, our claim that the political gridlock in Congress reflects in large
measure strongly polarized interest groups receives additional support. We discuss this issue in
22
23
Peter D. Hart Research Associates, "Voter's Views on Stem Cell Research," (Newton Centre, MA: Civil Society
Institute, 2004).
“Embryonic stem cells are special cells that can develop into every type of cell in the human body. The stem
cells are extracted from frozen embryos in fertility clinics, donated by couples that no longer want or need these
embryos. This process destroys the embryo. These stem cells can then reproduce on their own, creating what is
called a “line” of stem cells that many researchers can work with. Scientists believe that there is a good chance
that stem cells can be developed into cures or treatments for diseases such as cancer, Parkinson’s, Alzheimer’s,
juvenile diabetes, and spinal cord injuries.” Ibid., p.5.
224

some detail in chapter 10.1 Here, we simply note that support for stem cell research among the
religious and conservative voters is in stark contrast to the resolute opposition expressed by
advocacy groups such as the Christian Coalition, the United States Conference of Catholic
Bishops, the Southern Baptist Convention, and the Family Research Council. Similarly, there is
some evidence that scientific societies do not always accurately reflect the positions of their
members.
225

226

8.9 Bibliography
Annas, George J. "Human Cloning: A Choice or an Echo?" Dayton Law Review 23 (1998): 247-
75.
Fiorina, Morris P., Samuel J. Abrams, and Jeremy C. Pope. Culture War? The Myth of a
Polarized America. New York: Pearson Education, 2005.
Habermas, Jürgen. The Future of Human Nature. Cambridge, UK: Polity Press, 2003.
Harris Interactive. The Public Is Overwhelmingly Optimistic and Supportive of Genomics
Research – However, Knowledge and Understanding Remain Modest Health Care News,
June 18, 2001 [cited September 21, 2005]. Available from
http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2001
Vol1_iss20.pdf.
Hoffman, David, Gail L. Zellman, C. Christine Fair, Jacob F. Mayer, Joyce G. Zeitz, William E.
Gibbons, and Thomas G. Turner. "Cryopreserved Embryos in the United States and Their
Availability for Research." Fertility and Sterility 79, no. 5 (2003): 1063-59.
Hunter, James Davison. Culture Wars: The Struggle to Define America. New York: Basic
Books, 1991.
Peter D. Hart Research Associates. "Voter's Views on Stem Cell Research." Newton Centre,
MA: Civil Society Institute, 2004.
Vogelstein, Bert, Bruce Alberts, and Kenneth Shine. "Please Don't Call It Cloning." Science 295
(2002): 1237.
Wolfe, Alan. One Nation, after All: What Middle-Class Americans Really Think About: God,
Country, Family, Racism, Welfare, Immigration, Homosexuality, Work, the Right, the
Left, and Each Other. New York: Viking, 1998.
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228

9 Possible Societal Responses
In this chapter, we present an overview of the full range of regulatory responses to the
challenges posed by new biomedical technology, from doing nothing to changing the status quo to
the creation of a new institution along the lines of the HFEA in Britain. In each case, we will lay
out both pros and cons of each approach before presenting our recommended option. As we will
show below, none of the possible options are cost-free; each involves trade-offs, and each is
likely to have unforeseen consequences down the road.
9.1 Maintaining the Status Quo
Arguments Pro
There are several serious arguments for not intervening at this time. Advocates of
maintaining the status quo have argued that existing federal and state statutes combined with an
extensive system of industry self-regulation provide a regulatory framework that is more than
adequate to respond to whatever challenges might lie ahead. 1 This argument is largely based on
the assumption that at the present time, we are not facing a threat serious enough to justify
creating an entirely new regulatory system, whereas the establishment of a new regulatory
framework would have immediate and significant costs. Should a legislative intervention become
necessary, one could simply rely on existing regulatory powers. Existing statutes could be used
to bolster safeguards against ethically questionable practices, obviating the need for new
regulatory powers or new bureaucracies. For example, the FDA responded in a timely and
effective manner to attempts to clone human beings: It simply declared cloned human embryos a
“cellular product” subject to its statutory authority.
The costs of a regulatory intervention are familiar. New statutes and regulations often have
unanticipated and undesirable consequences; one consequence herein could be the moving
abroad of both researchers and biotech companies seeking a more favorable regulatory climate.
The United States remains the world leader in biomedical research, but adopting an extensive
regulatory system could hobble its own competitive advantages, as well as deny patients access
to the latest medical technologies. It is perhaps no accident that the first successful cloning of a
human embryo, a procedure scientists believe is crucial to developing new cures for hitherto
incurable diseases, has taken place in Korea and not in the United States. And it is no
1
David Adamson, "Regulation of Assisted Reproductive Technologies in the United States," Fertility and Sterility
78, no. 5 (2002); Judith F. Daar, "Regulating Reproductive Technologies: Panacea or Paper Tiger?," Houston
Law Review 34 (1997).
229

coincidence that U.S. scientists identified the hostile political climate as one of the main reasons
why this scientific breakthrough took place in Korea and not here.
Crucially, regulatory costs include the opportunity costs of research outcomes and products
that do not come into being or come into being at a slower pace as a result of regulation. In
addition, regulatory intervention would reduce the range of available ART treatments and
increase the costs of regulated ART services, as clinics would pass on to patients most if not all
their compliance costs. For example, banning reproductive cloning would make it impossible for
couples unable to procreate using their own gametes to have genetically related children,
arguably a matter of great significance for a great many people. 2 New regulations may also mean
that treatments themselves would become more bureaucratic and more costly. Other costs
include the direct cost to researchers and businesses of complying with new regulations, and the
costs to the U.S. government of running a new regulatory agency.
More generally, there are good reasons to protect the autonomy traditionally enjoyed by
science and medicine. The amazing scientific and technological advances witnessed over the last
200 years would not have materialized had the scientific and technical community not been
protected from major interferences by politics and the public. The prosperity of liberal
democracies depends to a considerable extent on the ability of their economies to innovate. This
ability could be compromised by unnecessary regulatory interventions.
As for possible harms, advocates of the status quo reject “slippery slope” arguments – the
view that the uncontrolled development of reproductive medicine and biomedical research is
likely to produced undesired outcomes. This argument, in their view, is a weak foundation on
which to ground public policy. Regulatory intervention is justified only when actual harm has
been demonstrated. As long as “symbolic” harm is the only demonstrable harm, it is premature
for the Congress to prohibit or regulate technologies that could serve a genuine public purpose. 3
The widely publicized cloning experiment conducted by Korean scientists in early 2004
deserves a separate discussion. It has become painfully obvious that the leading Korean scientist
violated several widely accepted ethical standards and systematically forged scientific data. But
it is also true that the peer review process was conducted in an unsatisfactory manner. What is
needed in this case is a bolstering of existing safeguards, not the creation of new ones.
Furthermore, the Korean experiment does not prove that we are on a slippery slope. The
experiment merely has demonstrated that human embryos can indeed be cloned; it has not shown
that the cloned embryos are free of the imprinting and epigenetic defects that have hampered
efforts in animal husbandry. As long as safe and effective cloning techniques are not available, it
is simply not possible to clone a human being, and therefore, no legislation is needed.
As for attempts to clone a human being by “rogue” scientists – the Zavoses and Antinoris of
the world – and by groups such as the Raelians, advocates of the status quo could point out that
2
3
Robertson, "Two Models of Human Cloning."
John A. Robertson, " 'Paying the Alligator': Precommitment in Law, Bioethics, and Constitutions," Texas Law
Review 81 (2003).
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Neither Zavos and Antinori nor the Raelians have ever produced any evidence for their claims.
By all accounts, these groups are not credible and can safely be ignored. It is certainly possible
that at some point someone will succeed in cloning a human being or in performing a procedure
regarded by the public as repugnant and objectionable. Until that time arrives, advocates of the
status quo do not see a reason to intervene.
Arguments Con
As our discussion of the current regulatory system in chapter 5 has shown, it is very unlikely
that the FDA, or any other federal agency for that matter, could rely exclusively on its current
statutory powers to untangle future ethical dilemmas. 4 The FDA de facto ban on reproductive
cloning, often quoted by advocates of the status quo as a demonstration that the federal
government, if necessary, can prevent harm caused by new biomedical technologies, provides a
clear illustration of these limits. The FDA simply asserted its authority over reproductive cloning
on the basis of its powers to regulate cellular tissues. The agency explained that any attempt to
create a human being through cloning techniques would require institutional review board
approval and submission of an investigational new drug (IND) application. It went on to explain
that it deemed reproductive cloning unsafe, and that applicants would be denied IND approval
until these safety concerns had been addressed. 5 As some commentators have noted, until a court
is called upon to review the FDA rationale for asserting its jurisdiction over this procedure,
reproductive cloning cannot legally be performed in the United States.
The FDA’s haphazard response to attempts to clone a human being can hardly be regarded
as a model of regulatory decision-making. As some legal scholars have noted, the FDA’s
4
5
For an in-depth examination of this question, see President's Council on Bioethics, Reproduction and
Responsibility: The Regulation of New Biotechnologies.
The whole story is considerably more convoluted. Following the cloning of Dolly the sheep in 1997 in Britain,
the U.S. news media reported that some U.S. scientists were contemplating offering cloning services to the
general public. In response to these reports, the FDA, in a “Dear colleague” letter to all institutional review
boards, simply asserted jurisdiction over reproductive cloning. The letter made clear that any attempt to create a
human being through cloning techniques would require IRB approval and the submission of an IND application.
The letter explained that the FDA deemed reproductive cloning unsafe, and that applicants would be denied IND
approval until these safety concerns had been addressed. On March 28, 2001, Kathy Zoon, then-director of the
FDA’s Center for Biologics Evaluation and Research (CBER), reiterated the FDA position on reproductive
cloning, and addressed the jurisdictional question during a hearing before the Subcommittee on Oversight and
Investigations of the House of Representatives. Zoon made clear that the FDA jurisdiction over reproductive
cloning was based on its authority to regulate “cellular products.” See Center for Drug Evaluation and Research,
"Endocrinologic and Metabolic Drugs Advisory Committee Meeting."; Stuart L. Nightingale, Dear Colleague
Letter (October 26, 1998 [cited September 18, 2005]); available from
http://www.fda.gov/oc/ohrt/irbs/irbletr.html; Opposition to Human Cloning Will 'Blow over,' Scientist Says
(CNN, January 7, 1998 [cited September 18, 2005]); available from
http://www.cnn.com/TECH/9801/07/cloning.folo/; Kathryn C. Zoon, Statement before the Subcommittee on
Oversight and Investigations Committee on Energy and Commerce United States House of Representatives
(March 28, 2001 [cited September 18, 2005]); available from http://www.fda.gov/ola/2001/humancloning.html.
231

assertion of jurisdiction in this case rests on weak legal grounds. 6 While human embryos do
indeed consist of “cellular products,” we doubt that this legal argument would survive judicial
scrutiny. In addition, health and safety concerns as the main rationale for regulatory interventions
are of limited practical relevance. Not every new reproductive procedure is likely to raise safety
concerns. MicroSort, which is designed to allow parents to choose the sex of a baby, does not
seem to raise major health and safety concerns, yet there are good reasons for regulating this new
reproductive technology. And not every questionable new use of an existing reproductive
treatment is unsafe. Tissue typing also seems quite safe, yet it remains a very controversial
application of pre-implantation genetic diagnosis.
Legal scholars might be able to show that in principle at least, the FDA statutory powers
may reach beyond safety and efficacy, but the relevance of these legal constructions is bound to
remain academic. Even assuming that by some obscure legal theory the FDA does have the
power the adjudicate contentious ethical questions – i.e., to regulate the use of new reproductive
technologies and biomedical research not exclusively in terms of safety and efficacy – it would
be unsuitable for this task. Specialists in public administration have pointed out that agencies are
often built around a traditional goal, and that when they are given new goals, they often have a
hard time adapting. New goals often require a radical shift in an agency culture, a shift that is
very unlikely to occur, tied as the agency is to dominant professional norms. 7 In the introductory
chapter, we mentioned the case of the Interstate Commerce Commission being given the job of
regulating trucking in addition to railroads, and how administrative law experts believe this to
have been a big mistake. In chapter 2, we have shown how poorly prepared the FDA was to
determine whether children of idiopathic short stature should be treated with synthetic human
growth hormone, by some considered a case of an enhancing rather than a therapeutic treatment.
The FDA’s ban on reproductive cloning could also be described as a usurpation of
Congressional authority. The agency disguised what amounted to a political decision as a safety
issue, thus depriving the Congress of its legislative prerogative on a matter of great import. In
short, the FDA approach to banning reproductive cloning can be compared to saving the Apollo
13 astronauts with a shoebox and duct tape – a workable but hardly generalizable approach. 8
As for the criticism that regulatory interventions may cause opportunity costs in the form of
slower scientific progress and forgone medical advances, this is certainly accurate, but it is an
observation too generic to justify legislative restraint. Opportunity costs may or may not be too
high, but there is simply no way to demonstrate that they would outweigh the benefits. While we
accept the fact that regulation can indeed entail opportunity costs, we do not believe that in the
6
7
8
Richard A. Merrill, "FDA Regulation of Human Cloning: Usurpation or Statesmanship?," Harvard Journal of
Law and Technology 15 (2001).
James Q. Wilson, Bureaucracy: What Government Agencies Do and Why They Do It (New York: Basic Books,
1989), Ch.6 and p.107-09.
The selective augmentation of statutory powers suffers from similar limitations. A limited expansion of the FDA,
CDC, and NIH statutory authority, just to name a few likely candidates, would do nothing to change their
regulatory culture or their core values, or to expand their expertise in addressing normative questions.
232

present case there is any specific reason to be particularly concerned about forgone opportunities.
To put it bluntly, we see no evidence that scientists’ hopes to develop new and revolutionary
cures are more credible or reliable than predictions made by scientists with respect to other
scientific developments.
Consider, for example, gene therapy. In the early 1990s, the medical community was
electrified by the prospect of developing a medical technology that would have made it possible
to treat incurable diseases. The technology consists of inserting foreign genes into the DNA of
diseased somatic cells in the hope that these genes would replace the diseased ones. Fifteen years
later, it has become apparent that these hopes were unrealistic. To date, clinical researchers have
conducted only a few trials; none of them has produced promising results, and in some cases,
trials have ended with fatal consequences for the patients. 9
In sum, while regulatory
interventions, almost by definition, are likely to be associated with opportunity costs, absent
specific evidence to the contrary, decision-makers should receive with a healthy dose of
skepticism scientists’ predictions about likely medical breakthroughs. 10
Opportunity costs must be weighed against known and unknown harms that regulatory
interventions are designed to prevent. Just like opportunities, it is quite difficult to reliably
predict the harmful consequences of any given scientific and medical development. How harm is
defined is clearly an important question we cannot explore in great detail here. Suffice to say that
“symbolic harm” is wholly inadequate category to convey the societal import of new biomedical
technologies.
Advocates of the status quo tend to forget that laissez-faire itself is bound to entail
significant costs. The failure to anticipate the need for new regulatory powers often invites
legislative and regulatory overreaction when the inevitable scandal, abuse, or disaster occurs.
Many bureaucratic excesses since the end of World War II can aptly be described as a vicious
cycle of protracted legislative inaction followed by a highly visible, catastrophic event and a
period of short but intense legislative activity. 11 These interventions are usually quite effective in
the sense that they do achieve their stated goals, but their costs rarely justify their benefits. These
are draconian interventions that often produce as much harm as good.
The Italian response to years of excesses in the ART industry precisely illustrates this point.
Another example comes from agricultural biotechnology. During the early 1990s, the U.S.
agricultural biotech industry, which had initially favored certain forms of regulation like the
labeling of genetically modified foods, changed policy and argued that no new regulations were
needed. After U.S. companies began marketing Bt corn and roundup-ready soybeans in Europe,
the BSE (Bovine Spongiform Encephalopathy) scandal broke in the United Kingdom,
convincing many European consumers that food safety regulators were not doing their job. Much
9
10
11
See http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml#status.
For a revealing discussion of failed scientific forecasts, see Victor S. Navasky and Christopher Cerf, The Experts
Speak: The Definitive Compendium of Authoritative Misinformation (New York: Pantheon Books, 1984).
Marc Eisner, Regulatory Policy in Transition (Baltimore, MD: John Hopkins University Press, 1993).
233

of the opposition to genetically modified organisms (GMOs) in Europe was irrational, but some
was based on a view that consumers had a right to decide for themselves whether or not to eat
genetically modified foods. By not supporting relatively modest forms of regulation like
labeling, U.S. biotech firms found themselves shut out of European markets as the EU imposed
its own strict safety rules on GMO products.
9.2 Targeted Legislative Intervention
Senate Bill 303, discussed in chapter 5.2.2, is a good example of a targeted legislative
intervention. It is reactive, not anticipatory, and it is narrow in scope, addressing merely one of
the many issues raised by new reproductive technologies and biomedical research. Finally, it
neither requires nor intends to delegate any legislative authority to a regulatory agency. 12 A ban
on all kinds of cloning, as illustrated by Senate Bill 245, the Human Cloning Prohibition Act of
2003, is another example of a targeted legislation intervention. H.R. 810, the most recent attempt
by the Congress to address the stem cell controversy, is yet another example. It legalizes federal
funding for donated, excess embryos, but says nothing about cloning or any other issue
pertaining to reproductive medicine or biomedical research. It charges the NIH with developing
appropriate guidelines, but does not delegate any real regulatory authority to this agency. When
we discuss the pros and cons of targeted legislative interventions, we have regulatory
interventions of this kind in mind.
The reason we are focusing our discussion on targeted legislative interventions is quite
simple: In the area of reproductive medicine and biomedical research this is the kind of
legislative response the Congress is most likely to adopt. In the current political climate, only
highly visible, persistent, and controversial issues such as stem cell research and cloning stand a
chance to receive Congressional attention. These are also issues of considerable interest to
influential interest groups – those groups that in the quest for Congressional re-election loom
large, both in financial and electoral terms.
Arguments Pro
There are both conceptual and pragmatic reasons for favoring targeted legislative
interventions. Advocates of targeted legislative interventions could argue that the reactive nature
and narrow scope of these legislative interventions match perfectly the extent of current
controversies over new reproductive technologies and medical research. They are an excellent
example of legislative incrementalism designed to minimize the risks associated with grand
legislative visions. Legislative incrementalism forces legislators to focus on well-defined
political problems and to avoid legislating issues that have not yet risen to the top of the national
political agenda. In this sense, targeted legislative interventions can be described as a
12
S. 303 delegates to IRBs the responsibility for approving research protocols involving the use of embryonic stem
cells, but only with regard to procedural, not substantive matters.
234

disciplining tool. Furthermore, by their very nature, targeted legislative interventions are costeffective;
their implementation does not require the creation of costly new bureaucratic
structures.
One could also argue that targeted legislative interventions are in fact the only acceptable
response to biomedical dilemmas. The Congress is the only political institution with both the
legitimacy and the authority to settle national controversies. It is the Congress’ responsibility to
provide ethical and legal guidance on issues such as stem cell research and cloning. Any
delegation of legislative authority to an administrative entity in this view would amount to a
violation of constitutional prerogatives.
From a pragmatic point of view, one could point out that targeted legislative interventions
stand a better chance of being passed by the Congress than grandiose legislative visions.
Polarization tendencies in Congress further exacerbate the tendency to craft narrow legislation –
bills designed to achieve precisely one goal and to do so exclusively by legislative means. 13
Arguments Con
The arguments in favor of legislative incrementalism are reasonable ones. One should be
wary of excessively ambitious legislative projects. Experience has amply demonstrated that
legislation often has unanticipated consequences that may exceed its benefits. Clearly, there is a
place for incrementalism in any legislative system. The view that it is Congress’ responsibility to
address ethical dilemmas of national import is also eminently sensible. We do not want unelected
officials to resolve ethical dilemmas of national import. But not every ethical dilemma is equally
important. As for other policy areas, there are many questions of implementation whose
delegation to a regulatory authority is not only unproblematic but also necessary. Forcing the
Congress to retain control over each and every implementation issue would produce an
immediate legislative paralysis. Congress’ responsibility is to identify ethical dilemmas that need
immediate legislative attention and delegate the resolution of the remaining ones to an
administrative entity.
The kind of targeted legislative interventions introduced in Congress over the last few years
would have been unable to take into account the views and attitudes of the general public. As we
have shown in chapter 8, mainstream Americans hold fairly nuanced views about biomedical
technologies. They are against reproductive cloning, but they are unsure about research cloning.
They do not want embryos to be created exclusively for research, but they find it acceptable to
use excess embryos for this purpose. Taking these views and other distinctions documented in
chapter 8 seriously would have required Congress to delegate at least some legislative authority
to an administrative agency. In this context, one could also speak of legislative failure.
13
The logic responsible for catapulting highly visible and controversial reproductive treatments and research
protocols into the political limelight is also the reason for Congressional disinterest in issues not widely
perceived by the public as being of sufficient ethical import, and whose resolution would require from
Congressional representatives a considerable investment of time and resources.
235

More generally, it is shortsighted to address the challenges raised by the convergence of
molecular biology, genetics, and reproductive medicine in a piecemeal fashion. Congress’
responsibility, in our view, is not only to provide legislative guidance on the issue of the day, but
also to reflect on whether it has the legislative and regulatory tools necessary to respond to
present and future societal controversies.
9.3 Self-Regulation
Arguments Pro
Representatives of the ART industry and scientific leaders have often argued that selfregulation
is preferable to direct regulatory interventions. Self-regulation is certainly an
important and often-overlooked element of many regulatory systems. It is neither a rare nor an
uncommon or insignificant phenomenon. It has played and continues to play an important role in
such disparate areas as fire safety, ocean transportation, cosmetics, electrical appliances, and
nuclear power safety – and, as shown in chapter 5.3, in the ART industry as well. 14
Advocates point out that self-regulation can address issues of public concern much more
effectively, more rapidly, and at a fraction of the cost than a regulatory intervention would
impose on the ART industry and on the scientific community. In this view, self-regulation is
preferable to direct regulatory intervention for several reasons: Industry members have
privileged access to crucial information not readily available to regulators, and industry members
are in a better position to spot and correct violations. Federal regulators, by contrast, would be
forced to implement a costly and often quite ineffective system of monitoring and compliance
assurance.
Contrary to common belief, self-regulatory systems do have specific mechanisms of
compliance assurance. These are generally not formalized, and therefore are not visible to an
external observer, but they can be quite effective nonetheless. The few empirical investigations
available on this question seem to support this view. In one study of self-regulatory practices
among lawyers in the New York metropolitan area, the author found that subtle but effective
mechanisms of reciprocal monitoring create what he called an “ethical climate.” 15
Similar
14
15
Furger, "Accountability and Self-Governance Systems: The Case of the Maritime Industry."; Jennifer Howard,
Jennifer Nash, and John Ehrenfeld, "Standard or Smokescreen? Implementation of a Voluntary Environmental
Code," California Management Review 42, no. 2 (2000); Andrew A. King and Michael J. Lenox, "Industry Self-
Regulation without Sanctions: The Chemical Industry's Responsible Care Program," Academy of Management
Journal 43, no. 4 (2000); Krislov, How Nations Choose Product Standards and Standards Change Nations;
Rees, Hostages of Each Other: The Transformation of Nuclear Safety since Three Mile Island.
Jerome E. Carlin, Lawyers on Their Own: A Study of Individual Practices (Rutgers University Press, New
Jersey, 1962); Carlin, Lawyers' Ethics: A Survey of the New York City Bar. See also Hubert J. O'Gorman,
Lawyers and Matrimonial Cases: A Case Study of Informal Pressures in Private Professional Practice (Glencoe,
IL: Free Press, 1963).
236

mechanisms of information monitoring and compliance assurance have been shown to exist
among physicians at U.S. hospitals. 16
As shown in chapter 5.3, the ART industry has developed an elaborate system of selfregulation
over the years. Industry representatives have repeatedly pointed out that the
professional and ethical standards developed by the American Society for Reproductive
Medicine and other professional societies are more than adequate for the task at hand. The
ASRM continues to monitor scientific developments in the field and to adopt specific
recommendations as necessary. Scientific leaders, for their part, have advocated self-regulation
as the best way to reassure an already wary public. How they intend to face controversial ethical
questions has been described in a recent publication by the National Academy of Sciences. 17
Finally, advocates of self-regulation submit that reproductive decisions and research
priorities are essentially private choices the government has no business regulating. In this view,
prospective parents and their doctors are in an excellent position to determine what is in the best
interest of the children. As for biomedical research, the argument here is simply that setting
research priorities is best left to members of the scientific community. The public, ever ignorant
and driven by emotional responses rather than by rational analysis, is simply not in a position to
assess the rationale for viewing certain research questions as worth pursuing. Nor are politicians,
for that matter.
Arguments Con
A measure of self-regulation is a necessary requirement of any effective and efficient
regulatory system. Federal regulators, indeed all regulators, depend to some degree on the
regulated community for critical knowledge and information. In some cases, monitoring and
compliance assurance rely heavily on private third parties. Our discussion of the Fertility Clinic
Success Rate and Certification Act of 1992 in chapter 5.1.1 makes this point. The active
participation of the Society for Assisted Reproductive Technology in gathering the data needed
by the CDC on ART success rates contributes to generating better data at a lower cost.
That self-regulation is an important ingredient of any regulatory system does not
demonstrate that self-regulation, by itself, may be considered a substitute for more formal
regulatory approaches. Self-regulation is a complement rather than a substitute for formal
regulation. For example, in the 1990s, the National Paint and Coating Association established
Coatings Care, 18 an ambitious program of environmental management. By all accounts, Coatings
Care has been instrumental in improving the industry’s public image and its relationship to the
EPA, and in reducing the likelihood of catastrophic accidents. The National Association of
Chemical Distributors had a very similar experience with its “Responsible Distribution
16
17
18
Eliot Freidson, Profession of Medicine. A Study of the Sociology of Applied Knowledge (New York: Harper &
Row, 1970), p.137-57.
Committee on Guidelines for Human Embryonic Stem Cell Research, Guidelines for Human Embryonic Stem
Cell Research (Washington, D.C.: National Academies Press, 2005).
See http://www.paint.org/cc/index.cfm.
237

Process.” 19 According to their initiators, these programs are designed to strengthen the regulatory
system, not to replace it.
Contrary to industry claims, trade associations can rarely be considered impartial arbiters of
societal disputes. The ART industry approach to resolving public controversies has little
credibility not because it has avoided addressing these issues, but because its guidelines and
recommendations tend to reflect the interests of the industry and its clients (in this case, the
prospective parents) to the detriment of children and the general public. In other cases,
recommendations are just that – hortatory statements of little practical significance. For example,
ASRM recommends transferring no more than three embryos. ASRM also discourages the use of
pre-implantation genetic diagnosis for elective sex selection. This language suggests that ART
practitioners are not really expected to follow these recommendations if prospective parents wish
otherwise.
As for compliance efforts, the balance of the evidence is not encouraging. As part of its
certification program, the ASRM mandates periodic audits, but violations are met with
considerable leniency, as laboratories are given up to one year to correct a violation. More
importantly, compliance with ethical guidelines is not part of the mandatory certification and
audit program. ASRM simply does not know whether and to what extent its ethical
recommendations are being followed. Industry officials believe that ethical and professional
guidelines have a strong normative power. Absent any systematic assessment of compliance
rates, this conviction is of little relevance.
A final reason for being skeptical about the role of self-regulatory efforts in the ART
industry is the absence of robust mechanisms of reciprocal learning. Twenty-five years after the
first “test-tube” baby was born, this field of medicine has barely begun to take seriously the
possibility that ART treatments may indeed be associated with higher health and safety risks.
Often, reproductive practitioners simply believe that ART techniques are safe. Since the industry
“doesn’t know what it doesn’t know,” it is unable to identify possible areas of concern and to
learn from its mistakes. Considerations of cost may prevent the ART industry from
implementing expensive long-term follow-up studies, but cost considerations cannot dispel the
impression, occasionally expressed by pediatricians, that the ART industry is focused
exclusively on producing pregnancies, with little consideration for health consequences.
9.4 Regulatory Responses
Arguments Con
There are several objections to a regulatory approach, of both a general and a specific
nature. The general objections are well-known. Over the last 30 years, public administration
researchers, economists, political scientists, and administrative law scholars have documented in
excruciating detail the distortions, aberrations, hidden costs, and negative unanticipated
19
See http://www.nacd.com/rdp/.
238

consequences brought about by ill-informed regulatory interventions. Health, safety, and
environmental regulations are often singled out for achieving policy goals at exorbitant costs, or
for failing to achieve their self-imposed targets. The AEI-Brookings Joint Center for Regulatory
Studies has produced a long series of case studies documenting these distortions. 20
Economists have also demonstrated that regulation in many cases seems to be designed to
benefit or protect the competitive position of incumbent firms to the detriment of other
competitors rather than to serve the public interest. Much of the literature on regulatory capture
is informed by this basic observation. 21 For example, complex regulatory requirements tend to
favor large companies with extensive technical and legal expertise, and with considerable
financial resources, to the disadvantage of smaller but nimbler competitors whose
competitiveness is threatened by these regulations. 22
One also could argue that the delegation of legislative authority to a regulatory agency is an
administrative expedient with questionable constitutional legitimacy, and should be envisaged
only in the most unproblematic of circumstances. For example, delegating the responsibility for
implementing the Congressional prerogative to tax U.S. citizens to a specialized agency is
largely unproblematic. The agency in question is simply carrying out a Congressional mandate; it
lacks the authority to pass new tax laws. It is an altogether different matter to charge a federal
bureaucracy with adjudicating deeply divisive, fundamental questions of life and death. In this
case, delegating legislative authority to an unaccountable federal bureaucracy is unacceptable.
Only the Congress has the constitutional mandate to provide legal guidance on questions of
national import.
One may also wonder why reproductive medicine is being singled out while other medical
specialties have not received nearly as much attention. The field of reproductive medicine is just
20
21
22
A non-representative selection of these studies includes Jason K. Burnett and Robert W. Hahn, "A Costly
Benefit: Economic Analysis Does Not Support EPA's New Arsenic Rule," Regulation 24, no. 3 (Fall 2001);
Robert W. Hahn and Jason K. Burnett, "The Epa’s Radon Rule: A Case Study in How Not to Regulate Risks,"
(Washington, D.C.: AEI-Brookings Joint Center for Regulatory Studies, 2001); Andrew N. Kleit, "Impacts of
Long-Range Increases in the Corporate Average Fuel Economy (Cafe) Standard " (Washington, D.C.: AEI-
Brookings Joint Center for Regulatory Studies, 2002); W. Kip Viscusi and James T. Hamilton, "Are Risk
Regulator Rational? Evidence from Hazardous Waste Cleanup Decisions," (Washington, D.C.: AEI-Brookings
Joint Center for Regulatory Studies, 1999).
Garry Becker, "A Theory of Competition among Pressure Groups for Political Influence," Quarterly Journal of
Economics 98, no. 3 (1983); Sam Peltzman, "The Economic Theory of Regulation after a Decade of
Deregulation," Brookings Papers on Economic Activity. Microeconomics 1989 (1989); Sam Peltzman, "Towards
a More General Theory of Regulation," Journal of Law and Economics 19 (1976); Richard A. Posner, "Taxation
by Regulation," Bell Journal of Economics and Management Science 2, no. 1 (1971); Richard A. Posner,
"Theories of Economic Regulation," Bell Journal of Economics and Management Science 5, no. 2 (1974);
George J. Stigler, "Free Riders and Collective Action: An Appendix to Theories of Economic Regulation," Bell
Journal of Economics and Management Science 5, no. 2 (1974); George J. Stigler, "The Theory of Economic
Regulation," Bell Journal of Economics and Management Science 2 (1971). An overview can be found in Robert
D. Tollison and Roger D. Congleton, eds., The Economic Analysis of Rent Seeking (Hants, UK: Aldershot,
1995).
Note that this is not a phenomenon limited to formal regulation, however. The complexity of some systems of
self-regulation can be ascribed to the same phenomenon.
239

another branch of medicine. ART practitioners simply rely on a specialized body of medical
knowledge to restore reproductive functions, functions necessary to fulfill a deep desire by
infertile couples to have a biological offspring. Other areas of medicine are also unregulated and
pose significant health and safety risks, yet they are only subject to professional oversight. For
example, laser-based eye surgery is now widely practiced, yet the FDA does not regulate this
activity, a surgical procedure beyond its statutory authority. 23 Nor is there a system in place to
monitor the long-term consequences of this relatively new approach to eyesight correction.
Arguments Pro
The critique that the modern administrative state may be on shaky constitutional grounds
may or may not be accurate, but this is largely a platonic question. For better or worse, the
administrative state is here to stay. The contemporary United States simply could not function
without regulatory agencies. The Congress itself could not fulfill its constitutional mandate
without the support of the regulatory machinery. Nor is the regulatory apparatus unaccountable.
Some agencies are more accountable than others, but it would be misleading to assume that
unelected federal officials are accountable to no one. As we show in chapters 11 and 12, several
options exist to hold a regulatory agency accountable for its action, including Congressional
oversight, Presidential appointing and removal powers, and judicial review, among others.
We readily acknowledge that regulation may at times be problematic. To recognize that
regulation can be costly, inefficient, and ineffective is, however, no demonstration that it is
unnecessary. Determining the costs and benefits of a new regulation is important, but is by no
means the only consideration governing whether a proposed new rule is necessary or desirable.
Economic efficiency has never been the only principle guiding the administrative state.
Economists are correct to characterize the maximization of economic efficiency as a social good
that should inform any rule-making process. Just as correct are political scientists and ethicists
when they note that economic efficiency is not the only possible social good. An agency could
determine that a proposed new rule would produce more (economic) costs than benefits and still
decide to move forward with the new rule. Conversely, a regulatory agency may decide that a net
benefit to society is an insufficient foundation for proposing new regulations. 24 The Nuremberg
Code provides an illustration. At least since the Nuremberg process, from which the Code
derives its name, the medical community has accepted the principle that an individual cannot be
23
The FDA does, of course, regulate the safety and efficacy of laser systems. It also provides an online information
resource for prospective patients. See http://www.fda.gov/cdrh/LASIK/default.htm.
24
A large literature exists on this topic. For an introduction, see, for example, Matthew D. Adler and Eric A.
Posner, "Rethinking Cost-Benefit Analysis," Yale Law Journal 109 (1999); Henry S. Richardson, "The Stupidity
of the Cost-Benefit Standard," Journal of Legal Studies 29 (2000); Amartya Sen, "The Discipline of Cost-
Benefit Analysis," Journal of Legal Studies 29 (2000).
240

harmed for the greater good of the community. Yet cost-benefit considerations would show that
on balance, experiments on individual patients produce more benefits than costs. 25
We also do not dispute the well-documented empirical observation that the regulatory
process may be distorted by undue political influence, and may produce outcomes that
systematically benefit a certain societal group to the detriment of the broader public interest.
Indeed, much of the discussion in chapters 8 and 5.2 shows just that. Yet this is clearly not an
argument against regulation per se, as the demonstration that administrative checks and balances
above and beyond the minimal requirements of the Administrative Procedure Act may be
necessary. The last part of this report is devoted precisely to this question – i.e., to how undue
political influence can be minimized at the regulatory level.
There are also positive arguments for a regulatory approach to the resolution of normative
controversies. Political and economic rationality dictates that Congressional representatives will
address only the most visible and divisive political issues. Legislators do not have the time or the
expertise to familiarize themselves with the scientific and ethical aspects of each and every
controversy that new reproductive treatments and biomedical research are likely to produce in
the future. Political logic suggests that members of Congress will prioritize their efforts, at least
in part, according to electoral payoffs. Obscure technical controversies are very unlikely to
produce significant benefits. 26 Absent a suitable regulatory authority, these issues are likely to
remain unresolved – or to be resolved either by the market or by organized interest groups.
It is also not accurate to claim that reproductive medicine is just another medical specialty.
To be sure, ART specialists are in the business of curing physiological afflictions. But unlike any
other medical discipline, reproductive medicine literally makes children. The ART field is
structured around the needs and desires of prospective parents; it is less well-organized to protect
the long-term interests of the children it produces. Medical practitioners argue that parents
always have the best interest of their children at heart. This is undoubtedly true for the vast
majority of parents. On the other hand, there are good reasons to believe that the interests of
parents and their children could and occasionally do diverge. The discussion in chapter 4
provided many illustrations of possible conflicts of interest between different generations.
Reproductive medicine also differs from other branches of medicine in that it can affect in a
subtle but important way societal values central to our understanding of equality and of political
rights. These unintended consequences have little to do with reproductive medicine, per se. They
have everything to do with contemporary notions of equality and tolerance – the very values on
which our democratic society is grounded. Consequences of this kind may or may not be of
broader import, but this determination needs to be made by the public and its political
representatives, and should not be left to the medical profession and their patients.
25
26
This is assuming, of course, that one could solve the frustrating problems created by the comparison of
interpersonal utilities.
David Epstein, "Administrative Procedures, Information, and Agency Discretion," American Journal of Political
Science 38, no. 3 (1994).
241

242

9.5 Bibliography
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Fertility and Sterility 78, no. 5 (2002): 932-42.
Adler, Matthew D., and Eric A. Posner. "Rethinking Cost-Benefit Analysis." Yale Law Journal
109 (1999): 165-247.
Becker, Garry. "A Theory of Competition among Pressure Groups for Political Influence."
Quarterly Journal of Economics 98, no. 3 (1983): 371-99.
Burnett, Jason K., and Robert W. Hahn. "A Costly Benefit: Economic Analysis Does Not
Support EPA's New Arsenic Rule." Regulation 24, no. 3 (Fall 2001): 44-49.
Carlin, Jerome E. Lawyers on Their Own: A Study of Individual Practices: Rutgers University
Press, New Jersey, 1962.
———. Lawyers' Ethics: A Survey of the New York City Bar. New York: Sage, 1966.
Center for Drug Evaluation and Research, Food and Drug Administration. "Endocrinologic and
Metabolic Drugs Advisory Committee Meeting." edited by Food and Drug
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Committee on Guidelines for Human Embryonic Stem Cell Research. Guidelines for Human
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Daar, Judith F. . "Regulating Reproductive Technologies: Panacea or Paper Tiger?" Houston
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Eisner, Marc. Regulatory Policy in Transition. Baltimore, MD: John Hopkins University Press,
1993.
Epstein, David. "Administrative Procedures, Information, and Agency Discretion." American
Journal of Political Science 38, no. 3 (1994): 697-722.
Freidson, Eliot. Profession of Medicine. A Study of the Sociology of Applied Knowledge. New
York: Harper & Row, 1970.
Furger, Franco L. "Accountability and Self-Governance Systems: The Case of the Maritime
Industry." Law & Policy 19, no. 4 (1997): 445-76.
Hahn, Robert W., and Jason K. Burnett. "The Epa’s Radon Rule: A Case Study in How Not to
Regulate Risks." Washington, D.C.: AEI-Brookings Joint Center for Regulatory Studies,
2001.
Howard, Jennifer, Jennifer Nash, and John Ehrenfeld. "Standard or Smokescreen?
Implementation of a Voluntary Environmental Code." California Management Review
42, no. 2 (2000): 63-82.
King, Andrew A., and Michael J. Lenox. "Industry Self-Regulation without Sanctions: The
Chemical Industry's Responsible Care Program." Academy of Management Journal 43,
no. 4 (2000): 698-716.
Kleit, Andrew N. "Impacts of Long-Range Increases in the Corporate Average Fuel Economy
(Cafe) Standard ". Washington, D.C.: AEI-Brookings Joint Center for Regulatory
Studies, 2002.
Krislov, Samuel. How Nations Choose Product Standards and Standards Change Nations.
Pittsburgh: University of Pittsburgh Press, 1997.
Merrill, Richard A. "FDA Regulation of Human Cloning: Usurpation or Statesmanship?"
Harvard Journal of Law and Technology 15 (2001): 85-148.
243

Navasky, Victor S., and Christopher Cerf. The Experts Speak: The Definitive Compendium of
Authoritative Misinformation. New York: Pantheon Books, 1984.
Nightingale, Stuart L. Dear Colleague Letter October 26, 1998 [cited September 18, 2005].
Available from http://www.fda.gov/oc/ohrt/irbs/irbletr.html.
O'Gorman, Hubert J. Lawyers and Matrimonial Cases: A Case Study of Informal Pressures in
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Opposition to Human Cloning Will 'Blow over,' Scientist Says CNN, January 7, 1998 [cited
September 18, 2005]. Available from http://www.cnn.com/TECH/9801/07/cloning.folo/.
Peltzman, Sam. "The Economic Theory of Regulation after a Decade of Deregulation."
Brookings Papers on Economic Activity. Microeconomics 1989 (1989): 1-41.
———. "Towards a More General Theory of Regulation." Journal of Law and Economics 19
(1976): 211-40.
Posner, Richard A. "Taxation by Regulation." Bell Journal of Economics and Management
Science 2, no. 1 (1971): 22-50.
———. "Theories of Economic Regulation." Bell Journal of Economics and Management
Science 5, no. 2 (1974): 335-58.
President's Council on Bioethics. Reproduction and Responsibility: The Regulation of New
Biotechnologies. Washington, D.C., 2004.
Rees, Joseph V. Hostages of Each Other: The Transformation of Nuclear Safety since Three
Mile Island. Chicago: University of Chicago Press, 1994.
Richardson, Henry S. "The Stupidity of the Cost-Benefit Standard." Journal of Legal Studies 29
(2000): 971-1003.
Robertson, John A. " 'Paying the Alligator': Precommitment in Law, Bioethics, and
Constitutions." Texas Law Review 81 (2003): 1729-49.
———. "Two Models of Human Cloning." Hofstra Law Review 27 (1999): 609-38.
Sen, Amartya. "The Discipline of Cost-Benefit Analysis." Journal of Legal Studies 29 (2000):
931-52.
Stigler, George J. "Free Riders and Collective Action: An Appendix to Theories of Economic
Regulation." Bell Journal of Economics and Management Science 5, no. 2 (1974): 359-
65.
———. "The Theory of Economic Regulation." Bell Journal of Economics and Management
Science 2 (1971).
Tollison, Robert D., and Roger D. Congleton, eds. The Economic Analysis of Rent Seeking.
Hants, UK: Aldershot, 1995.
Viscusi, W. Kip, and James T. Hamilton. "Are Risk Regulator Rational? Evidence from
Hazardous Waste Cleanup Decisions." Washington, D.C.: AEI-Brookings Joint Center
for Regulatory Studies, 1999.
Wilson, James Q. Bureaucracy: What Government Agencies Do and Why They Do It. New York:
Basic Books, 1989.
Zoon, Kathryn C. Statement before the Subcommittee on Oversight and Investigations
Committee on Energy and Commerce United States House of Representatives March 28,
2001 [cited September 18, 2005]. Available from
http://www.fda.gov/ola/2001/humancloning.html.
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10 Correcting Political and Regulatory Distortions
10.1 Reproductive Technologies: A case of political failure
In chapter 8, we suggested that the views held by the general public on several controversial
issues are at odds with the positions advocated by influential interest groups and Congressional
representatives. In this chapter, we explore in some detail possible reasons for this misalignment.
We argue that a sustained misalignment is a clear indication of “political failure,” a concept
central to the theory of public choice. Before examining the empirical evidence in support of our
claim, we briefly introduce this economic theory and discuss political failure in general terms. In
the final part of this chapter, we suggest possible remedies.
The term “political failure” was introduced in the early 1960s by political economists to
offset the then-popular concept of market failure. 1 Public choice scholars, as they came to be
known, pointed out that government interventions to correct market failures tend to make things
worse, either because the costs to society are bigger than the expected benefits, or because the
intervention winds up benefiting those who do not need the help of the government, or else
because the government intervention is designed to benefit specific population groups to the
detriment of broader societal interests. Central to the economic analysis of politics is the
assumption that political actors such as Congressional representatives, administrators, lobbyists,
and activists pursue their own self-interest. This view was and remains in stark contrast to the
notion that political action reflects a commitment to the common good.
Self-interested motives should not be narrowly construed. They may range from pursuing reelection
to accumulating power and prestige to charting a professional career and increasing
one’s status. Whatever form of self-interest is contemplated, the theory of public choice
identifies in self-interest the ultimate motivation for a political actor’s preferred course of action.
For example, Congressional representatives are mainly interested in accumulating power and
influence and ensuring their re-election, and only secondarily in getting richer. Money, of course,
is crucial in modern politics, but as a means to an end (for example, to get re-elected), not as an
end in itself. Interest groups, for their part, gravitate toward Congress and federal bureaucracies
1
In its most general form, this approach is generally identified with the 1962 publication of James M. Buchanan
and Gordon Tullock, The Calculus of Consent: Logical Foundations of Constitutional Democracy (Ann Arbor:
University of Michigan Press, 1962). For a non-technical introduction in this field, see James M. Buchanan,
"Public Choice: Politics without Romance," Policy 19, no. 3 (2003). A comprehensive discussion can be found
in Daniel A. Farber and Philip P. Frickey, "The Jurisprudence of Public Choice," Texas Law Review 65 (1987);
Dennis Mueller, Public Choice Iii (Cambridge, UK: Cambridge University Press, 2003). For a critical
examination, see Daniel A. Farber, "Democracy and Disgust: Reflections on Public Choice," Chicago-Kent Law
Review 65 (1989); Jerry L. Mashaw, "The Economics of Politics and the Understanding of Public Law,"
Chicago-Kent Law Review 65 (1989).
245

to extract benefits for their members or to prevent or mitigate costly laws and regulations. Even
positions advocated by public interest groups can be explained by selfish motives.
Perhaps surprisingly, such a simplistic and cynical view of modern politics has considerable
explanatory power. 2 A central finding emerging from this body of literature is that organized
interest groups tend to have an influence over legislatures and regulatory agencies
disproportionate to their actual political weight. Undue influence often translates into laws, rules,
and regulations that directly benefit these interest groups at the expense of broader societal
interests. Their influence reflects their financial support for election campaigns and their ability
to deliver important blocks of votes. To some extent, they also provide Congressional
representatives with valuable technical information. Administrators obviously do not depend on
generous campaign contributions to do their job, but their dependency on key political
constituencies is real nonetheless. Complex regulations often can only be implemented with the
help and cooperation of the groups directly affected by them. Regulators may depend on
obtaining technical and scientific information that is available exclusively to the regulated
communities. Good professional relationships with these groups are essential to administrators
operating in a charged political environment.
The general public does have a role to play in this scenario, but only as a political pawn.
Public choice assumes that it is rational for the public to be uninterested. Modern policy
decisions are complex; for an average citizen, the costs of forming his or her opinion far
outweigh the benefits. As a practical matter, it is much easier and convenient to orient one’s
opinion to the recommendations expressed by the interest group or political party of choice, or
simply yield to the bombardment of political messages. At the regulatory level, the public is
generally not heard, simply because many regulations are simply too obscure and complex to be
of any real interest to a broader audience. In the few instances where members of the general
public submit a large number of comments to a proposed new rule, this is generally the result of
mobilization efforts by an organized interest group rather than an expression of spontaneous
political interest.
From a public choice perspective, this depressing view of modern politics is no reason for
pessimism. Policy-making can be described as a competitive process, as a market for political
influence. And competitive markets are known for their benign effects. The operative term here
2
There has been a great deal of empirical analysis informed by this analytical perspective. Examples include
government protection of the dairy industry to the detriment of margarine producers: Geoffrey P. Miller, "Public
Choice at the Dawn of the Special Interest State: The Story of Butter and Margarine," California Law Review 77
(1989). Chronically inadequate health standards in the meat and poultry industry: Dion Casey, "Agency Capture:
The USDA's Struggle to Pass Food Safety Regulations," Kansas Journal of Law & Public Policy 7 (1998). The
persistent importance of agricultural subsidies in the European Union: Matthew Elliott and Allister Heath, "The
Failure of CAP Reform: A Public Choice Analysis," Economic Affairs 20, no. 2 (2000). The popularity of a
losing financial proposition such as the public financing of sport stadiums: Veronica Z. Kalich, "A Public Choice
Perspective on the Subsidization of Private Industry: A Case Study of Three Cities and Three Stadiums," Journal
of Urban Affairs 20, no. 2 (1998). The capture of social housing programs in the UK by their beneficiaries:
David Mullins, "From Regulatory Capture to Regulated Competition: An Interest Group Analysis of Housing
Associations in England," Housing Studies 12, no. 3 (1997).
246

is competitive – as long as the market for power and influence is competitive, there is no reason
for concern. Consistent with this market metaphor, politicians trade political influence for
economic and other resources. Conversely, political constituencies gain power and influence by
providing politicians with the resources – financial and otherwise – needed for their re-election.
The final outcome of this complex trading process is a supposedly optimal distribution of power
and influence.
Political markets can be assumed to be efficient only if the political “trading” process is
governed by a few basic rules. A key requirement is that all interest groups are adequately
represented in the political arena. To the extent that the ensemble of all views represented by
interest groups is a sufficiently accurate representation of the views held by society as a whole,
one could argue that it is immaterial whether the general public has had an opportunity to
participate in the policy-making process. If all existing views have had a fair opportunity to be
heard, the market for political influence is likely to produce an efficient outcome of sort.
Conversely, a policy-making process characterized by limited political participation is a clear
indication of political failure and is likely to produce a distorted outcome.
Are reproductive medicine and biomedical research two policy domains characterized by
significant political failures? We believe this question must be answered in the affirmative, but
not in the ordinary sense. With regard to cloning and stem cell research, it appears that no key
political constituency has been unable to participate or has not been heard, and there is no reason
to believe that in the future any of these groups is likely be excluded from the political arena. In
this sense, one cannot speak of political failure. On the other hand, these groups are clearly not
representative of broader public sentiments and certainly cannot be considered a good proxy of
the views expressed by the general public.
There are only two main political camps in this policy domain, and all interest groups
involved can unambiguously be assigned to one or the other of these camps. At the one end of
the spectrum, we find scientific societies such as the American Association for the Advancement
of Science, the Coalition for the Advancement of Medical Research (CAMR), the Federation of
American Societies for Experimental Biology, and their allies – mainly single-issue advocacy
and patient groups like the Juvenile Diabetes Research Foundation, the Parkinson’s Action
Network, and Cures Now. Also in this camp we find the ART industry, represented mainly by
the American Society for Reproductive Medicine and the Society for Assisted Reproductive
Technology. On the other side of the political divide is an uncomfortable coalition of religious
organizations, such as the United States Conference of Catholic Bishops and the Southern
Baptist Convention, socially conservative groups like the Family Research Council, and liberal
environmental groups.
AAAS, the premiere U.S. scientific organization, has advocated the ban on reproductive
cloning, but supports research cloning and embryonic stem cell research. AAAS favors a limited
form of “federal oversight” for this kind of research, but it is unclear what this position actually
247

entails. 3 CAMR, a very large and heterogeneous umbrella organization consisting of all major
scientific societies, professional groups, and major research universities, has advocated a similar
policy. 4 CAMR is more vocal in its support of biomedical research than AAAS. In 2004, it
explicitly rejected any suggestion that regulatory interventions may be necessary. 5 Since then
however CAMR has stopped offering specific position statements in favor of member-specific
position statements. 6 FASEB, another umbrella group comprising 22 scientific societies, is also
supportive of banning reproductive cloning, but supports research cloning and embryonic stem
cell research subject to “strict ethical oversight.” 7 What “strict ethical oversight” means and who
should promulgate these norms is unclear. At best, this statement suggests the possibility of
establishing a weak form of self-regulation; at worst, it is simply an abstract recognition of the
need to provide ethical guidance. Other scientific organizations, such as the Council of Scientific
Societies Presidents, have expressed very similar views. In sum, leading science advocacy
groups agree that reproductive cloning should be banned, but they show no or very limited
support for any other form of governmental or regulatory intervention. Interest groups
representing the reproductive industry, such as ASRM, RESOLVE, and the American Fertility
Association have taken a similar stance, condemning reproductive cloning but vocally rejecting
any suggestion that regulatory interventions in this area of medicine may be needed.
As for the organized opposition to new reproductive and biomedical research, there is
considerable agreement among these groups on the need to prevent any kind of research or
manipulation of human embryos that would produce their destruction. From these groups’
perspective, there simply is not any justification for destroying what has been called nascent
human life. For example, the United States Conference of Catholic Bishops has repeatedly stated
its resolute opposition to any kind of cloning and embryonic stem cell research, 8 calling research
cloning “a sign of moral regress” and stem cell research “not […] a wise investment.” The
Family Research Council also opposes any kind of research that would destroy human embryos. 9
On its Web site, under “Position Statements,” the Southern Baptist Convention, for its part,
summarily notes, “Procreation is a gift from God, a precious trust reserved for marriage. At the
3
4
5
6
7
8
9
The AAAS position on human cloning is available at http://www.aaas.org/news/releases/2002/Cloning.shtml.
AAAS explored various policy options at a recent workshop of research cloning. A summary can be downloaded
at http://www.aaas.org/news/releases/2003/0403cloning.shtml.
A complete list of all CAMR members is available at http://www.camradvocacy.org/members.aspx.
The original links to these statements have been removed from the CAMR web site.
See http://www.camradvocacy.org/statements.aspx.
Carrie Golash, FASEB Statement on Human Somatic Cell Nuclear Transplantation (SCNT) and Embryonic Stem
Cells (FASEB, February 12, 2004 [cited May 3, 2006]); available from
http://opa.faseb.org/pdf/nr_2x12x4_stem.pdf.
On research cloning, see, for example, http://www.usccb.org/comm/archives/2004/04-187.htm. The most recent
statement on stem cell research is available at http://www.usccb.org/comm/archives/2004/04-025.htm.
The Family Research Council has posted several detailed statements on this issue. See for example John C.
Harvey, Distinctly Human: The When, Where and How of Life's Beginnings (Family Research Council, April 25,
2002 [cited May 3, 2006]); available from http://www.frc.org/get.cfm?i=IS02D3.
248

moment of conception, a new being enters the universe, a human being, a being created in God's
image. This human being deserves our protection, whatever the circumstances of conception.” 10
Against this background, it comes as no surprise that these groups dismiss the possibility of
donating excess embryos to research, or the suggestion that there may be legitimate uses of preimplantation
genetic diagnosis.
These extremely polarized positions do not reflect the more nuanced sentiments expressed in
survey after survey by the general public. Our discussion in chapter 8 has shown that Americans
are far less polarized than the advocacy groups and their Congressional representatives. These
groups either completely reject or wholly approve research cloning while the general public
remains ambivalent. In the case of stem cell research, the chasm between organized interest
groups and the general public is more apparent. While the public is favorable by significant
margins to the federal funding of stem cell research if suitable regulatory safeguards are put in
place, the president has refused to update his restrictive policy, in large measure because of the
influence exercised by religious groups on Congress and the executive. The chasm between the
general public and advocacy groups is particularly striking among religious voters. Catholics
clearly disagree with the United States Conference of Catholic Bishops on stem cell research
policy. Even conservative, white Evangelicals display ambivalence rather than downright
rejection on this matter, in clear opposition to the positions taken by the Southern Baptist
Convention and the Family Research Council.
Gauging whether the scientists’ views on these matters are in line with scientific societies’
positions is a bit of a challenge. Unlike the general public, scientists have rarely been surveyed.
The data available shows that scientists, like their professional associations, support a ban on
human reproductive cloning. According to one survey, only 9 percent of U.S. scientists and only
3 percent of international scientists support reproductive cloning. By contrast, nine out of 10
researchers favor research cloning. 11 With regard to these two issues, scientists’ attitudes and
their societies’ positions do seem aligned. On the other end, only 59 percent of scientists in the
United States support using excess embryos from fertility clinics. Considering that the public
often favors this approach by higher margins, this figure seems to suggest a measure of hesitation
on the part of scientific community. 12 That scientists may harbor some ambivalence about using
human embryos for research purposes is confirmed by the observation that 46 percent of
respondents found the destruction of human embryos “problematic,” and a whopping 73 percent
is opposed to the creation of human embryos exclusively for research. 13
This data suggests two distinct conclusions. The voice of the scientific community, as
opposed to the positions advocated by leading scientific groups, is not sufficiently heard in
contemporary debates about reproductive and biomedical technologies. A broader participation
10
11
12
13
See http://www.sbc.net/aboutus/pssanctity.asp.
Isaac Rabino, "Stem Cell and Cloning Controversies," Genetic Engineering News 24, no. 4 (2004), p.6.
Ibid., p.7.
Ibid., p.9.
249

of scientists in these debates would likely put many positions advocated by scientific
organizations in perspective, and may show important differences between scientists and their
professional representatives. In addition, the data suggests that on several (but not all) hot-button
issues, the general public and scientists are largely in agreement. It is not entirely unrealistic to
imagine that a sustained dialogue between scientists and the public could actually produce an
acceptable political compromise even in those cases, like research cloning, where the public and
the scientists currently are at odds. A question that remains unanswered is whether scientists
would support in significant numbers a system of regulatory oversight. Anecdotal evidence
suggests that at this time, the scientific community may be very reluctant to accept additional
regulations, though reluctance in this case may be dictated largely by contingent political factors
and not by a fundamental rejection of societal demands.
The dominance of extreme political positions and the absence of more centrist views among
advocacy groups may be described as an instance of group polarization. 14 Within a group,
polarization refers to the often-observed phenomenon that deliberation among individuals with
similar views tends to radicalize their opinions. For example, after talking to each other,
individuals with a skeptical view of the United Nations may regard this international body as a
vehicle of conspiracy against the sovereignty of the United States. Environmentalists concerned
about global climate change, after debating the gravity of this phenomenon, may come to believe
that major environmental catastrophes are imminent. Pro-life groups are not simply concerned
about possible abuses of abortion procedures. In their view, embryos are indistinguishable from
full-grown individuals, and therefore abortion is tantamount to murder. Scientists, taken
individually, may feel that they are in a better position than the public to set research priorities. A
group of scientists discussing this matter may come to the conclusion that it is no one’s business
but theirs to make this determination.
Advocacy groups that tend to debate political priorities and weigh policy options in isolation
from each other are clearly exposed to the risk of polarization. The rather homogenous
membership of these groups (compared to the general public) further amplifies the tendency to
polarize. Another important factor contributing to polarization is the lack of accountability
typical of many advocacy groups. The group leadership rarely if ever consults with its members
as a means to broaden the legitimacy of their political strategies. Paradoxically, this is especially
true for public interest groups. Disgruntled members can and on occasion do vote with their
wallets – “exit” rather than “voice,” in Albert Hirschman’s terminology – but this is a rather
marginal phenomenon. The opposite is actually more common: Public interest groups, by
advocating radical agendas, manage to recruit many more members than they loose. A final
14
This phenomenon initially was documented by social psychologists. Cf. David G. Myers, "The Group
Polarization Phenomenon," Psychology Bulletin 83 (1976); David G. Myers and G.D. Bishop, "Enhancement of
Dominant Attitudes in Group Discussion," Journal of Personality and Social Psychology 20 (1971). In the recent
past, group polarization has begun to receive considerable attention by legal scholars. Cass Sunstein,
"Deliberative Trouble? Why Groups Go to Extremes," Yale Law Journal 110 (2000); Cass Sunstein, Why
Societies Need Dissent (Cambridge, MA: Harvard University Press, 2003).
250

contributing factor is strategic behavior. Each interest group might be willing to make political
concessions if it did not believe that its political opponents would interpret their willingness to
compromise as a sign of weakness that could in turn lead to additional demands. This is a classic
“slippery slope” argument whose importance has been documented in many political settings. 15
Our discussion has shown that in the area of reproductive medicine and biomedical research,
political distortions are significant. How to respond to these failures is a tricky question. The
theory of public choice in this case has little to offer; its main recommendation, to ensure that all
views are being heard, both does not apply to the present situation and is operationally empty. It
does not apply because all organized interest groups are already participating in the political
arena. It is operationally empty because the general public, as such, cannot simply be organized
into yet another interest group. How then could political failures and distortions in the area of
reproductive medicine and biomedical research be corrected? In the remainder of this chapter,
we discuss this question in some depth. We explore first what may be described as the
professionalization of bioethical dilemmas. We find that this approach should be rejected in
favor of a much broader process of decision-making. We then examine the role of administrative
options such as notice-and-comment as a means to broaden public input. We also assess the
experience made by federal agencies such as the EPA and the Department of Energy (DOE) in
their efforts to involve the general public in highly controversial policy decisions. We conclude
that while these initiatives have taught us a great deal about the pitfalls of efforts to involve the
public, none provides a template for implementing a process of public consultation that meets
our requirements.
10.2 A Problematic Start: The Professionalization of Ethical Dilemmas
It may be argued that parliaments were created at a time when political decisions were
relatively simple choices and did not require an understanding of scientific facts or an
appreciation of ethical questions. In this view, parliaments are not suitable institutions for sorting
out some of the deepest questions afflicting modern liberal democracies. What is needed is an
institutional setting in which competent and experienced individuals are given an opportunity to
untangle modern ethical intricacies in a deliberate fashion free of nefarious political influences.
Bioethics commissions can be described as a rough approximation of this ideal. According to
this view, the members of these commissions, typically a mix of scientists, ethicists, theologians,
and occasionally senior politicians, are in the best position to examine in a dispassionate way
contemporary bioethical dilemmas and propose broadly acceptable answers.
Most industrialized countries have created ethics advisory panels, but none of them has
given these bodies actual legislative powers. Britain is the only instance where a parliament,
distrusting its own inclinations, has created a regulatory body, the HFEA, designed to be largely
insulated from mundane political influences; but the role played by bioethicists in this body is
15
Volokh, "The Mechanisms of the Slippery Slope."
251

elatively modest. Canada and Australia recently have established similar regulatory bodies, but
their enabling legislation does not assign bioethicists a prominent role, and their composition
does not reflect efforts to professionalize broad societal conflicts.
It is undeniable that this strategy has a considerable appeal, most likely fueled by a deepseated
mistrust in the ability of modern democracies to resist their worst temptations. Even such
a fervent defender of representative democracy as Ralf Dahrendorf has come to the conclusion
that parliaments are ill-suited to resolving complex ethical dilemmas, and has recommended a
politically independent body of highly regarded individuals as a preferable alternative. 16
The professionalization of modern bioethical dilemmas would be a mistake for several
reasons. Bioethics, just like other disciplines in the social sciences and humanities, has seen the
development of numerous and conflicting theoretical perspectives. As a discipline, bioethics is
simply incapable of providing politicians with uncontroversial answers. For why should a
particular ethical paradigm be preferred to another? It is fair to say that no rules exist to select
one ethical paradigm from the plethora of available ethical positions. And a plethora it is. Even a
cursory examination of the bioethical literature brings to the light such perspectives as
principlism, specified principlism, casuistry, and narrative ethics, just to name a few. 17 The
plurality of approaches in bioethics is a testimony of the richness of this relatively new academic
field, but it also makes it impossible for bioethics to play a privileged role in policy-making.
A genuinely pluralistic ethics advisory board could play a useful role in contemporary public
debates about reproductive technologies and biomedical research provided that it does not
attempt to produce consensus positions on questions for which a consensus simply does not
exist. Making majority and minority recommendations available to policy-makers and ensuring
that the underlying assumptions informing these positions are made transparent would be much
more valuable than a thinly disguised consensus report. As we have argued in chapter 2, poor
policy choices are more likely to be induced by a dearth of ethical positions rather than by a
plurality thereof.
A second concern is the rapid transformation of the field of bioethics from a discipline
focused on broad substantive questions into a largely technical field preoccupied with
fundamental principles and with procedural considerations rather than outcomes. The shift of
professional bioethics toward technical, narrowly defined questions also has legitimized many
hitherto controversial biomedical developments. The currently dominant bioethical perspective
16
17
Ralf Dahrendorf, Dopo La Democrazia. Intervista a Cura Di Antonio Polito (Roma: Laterza, 2001).
Tom L. Beauchamp, "Reply to Strong on Principlism and Casuistry," Journal of Medicine and Philosophy 25,
no. 3 (2000); Bernard Gert, Charles M. Culver, and K. Danner Clouser, "Common Morality Versus Specified
Principlism: Reply to Richardson," Journal of Medicine and Philosophy 25, no. 3 (2000); Albert R. Jonsen,
"Strong on Specification," Journal of Medicine and Philosophy 25, no. 3 (2000); Henry S. Richardson,
"Specifying, Balancing, and Interpreting Bioethical Principles," Journal of Medicine and Philosophy 25, no. 3
(2000); Ana Smith Iltis, "Bioethics as Methodological Case Resolution: Specification, Specified Principlism and
Casuistry," Journal of Medicine and Philosophy 25, no. 3 (2000); Carson Strong, "Specified Principlism: What
Is It, and Does It Really Resolve Cases Better Than Casuistry?," Journal of Medicine and Philosophy 25, no. 3
(2000).
252

provides considerable ammunition to advocates of unfettered biomedical research, but is
incapable of accommodating the concerns expressed by other constituencies. 18
The professionalization of ethical dilemmas is reminiscent of the role played by probabilistic
risk assessment in public controversies over nuclear power plant safety in the 1970s. The narrow
focus on probabilities advocated by the engineering community and by the manufacturers of
nuclear technology contributed to transform what were momentous societal choices into mere
technical questions. In the process, probabilistic risk assessment reduced these choices to
questions much easier to manage by public administrators, and made concerns expressed by the
general public appear uninformed or downright irrational. 19
A third and final concern is the largely benign view of controversial medical developments
displayed by many bioethicists. Such an uncritically positive view of new biomedical research
casts considerable doubts on the ability of bioethics committees to credibly mediate among
conflicting societal interests. While bioethics advisory bodies do indeed understand themselves
as effective and competent mediators, 20 one may wonder whether the implicit support for many
controversial biomedical developments demonstrated by the discipline makes these advisory
bodies a suitable institution for crafting a broad societal consensus. Recent controversies over the
remuneration of bioethicists by private companies only reinforce this skepticism. 21
10.3 Elements of a Solution: Notice-and-Comment
Some could argue that the professionalization of ethical dilemmas is a bad idea, but that
there is need for novel mechanisms of public consultation. Section 553 of the Administrative
Procedure Act (APA) provides ample opportunities for anyone to comment on a proposed new
rule. In a nutshell, section 553 requires federal agencies to publish a proposed new rule in the
Federal Register. It then affords interested parties and the general public at least 30 days to
submit comments to the agency. The agency is required to respond in writing to all comments
and to take them into consideration in finalizing the proposed new rule.
Section 553, better known as notice-and-comment, would seem to provide a robust
mechanism for soliciting public input. As a matter of practice, however, this is not the case.
There are several important limitations to using notice-and-comment as a tool of public
consultation. The APA was passed short after the end of World War II in response to numerous
cases of what can only be described as arbitrary and capricious agency decisions. In the period
leading up to the passage of the APA, many federal agencies had a tendency to operate in a self-
18
19
20
21
Evans, Playing God? Human Genetic Engineering and the Rationalization of Public Bioethical Debate.
Thomas Dietz and Robert W. Rycroft, The Risk Professionals (New York: Russell Sage Foundation, 1987).
Susan E. Kelly, "Public Bioethics and Publics: Consensus, Boundaries, and Participation in Biomedical Policy,"
Science, Technology and Human Values 28, no. 3 (2003); Jonathan D. Moreno, Deciding Together. Bioethics
and Moral Consensus (New York: Oxford University Press, 1995).
Carl Elliott, "Six Problems with Pharma-Funded Bioethics," Studies in the History and Philosophy of Biological
and Biomedical Sciences 35 (2004).
253

ighteous manner, justifying their conduct with appeals to vacuous notions of “public interest.”
Section 553 was one of the measures envisaged by Congress to curb the worst administrative
excesses. 22
Today, notice-and-comment in agency rule-making is no longer regarded as an effective tool
to curb agency discretion, and it is certainly not considered an effective institution of public
consultation, for several reasons. Notice-and-comment takes place at a point in time when all
controversial issues surrounding a new rule have already been sorted out. By the time a proposed
new rule is announced in the Federal Register, all influential interest groups have already been
consulted. Public comments at this late stage in the rule-making process are very unlikely to have
a significant impact on key aspects of a proposed new rule. Nor are they likely to provide
fundamentally new insights. According to practitioners, the actual importance of notice-andcomment
lies in building the agency rule-making record for judicial review rather than as a tool
for public consultation. 23 Indeed, if an agency were to make significant changes to a proposed
new rule in response to public comments, the courts could require the agency to re-propose the
rule.
The reasons for this dramatic shift are complex, but they can be summarized fairly easily.
Starting in the 1970s, numerous judicial decisions over agency rule-making have produced what
is today known as the “hard look” doctrine. The very strict standards of judicial review embodied
in the hard look doctrine force regulators to justify in excruciating detail all technical and
scientific assumptions incorporated in a proposed new rule. These requirements have made rulemaking
an exceedingly cumbersome and complex process. In addition to assembling a very
detailed technical “preamble,” an agency will negotiate extensively but informally with all
affected parties before publishing a proposed new rule. Strict judicial review has also had a
chilling effect on the willingness of many federal agencies to promulgate new rules, an effect
described by some commentators as a process of “ossification.” 24 An in-depth discussion of this
claim is well beyond the scope of the present discussion. What seems indisputable is that the
“hard look” doctrine has forced agencies to negotiate extensively with organized interest groups,
and in the process has rendered notice-and-comment as a tool of public consultation largely
irrelevant.
As tool of public consultation, notice-and-comment is not merely ineffectual; in some cases,
it actually contributes to amplifying existing political distortions. While in principle anyone can
22
23
24
Robert L. Rabin, "Federal Regulation in Historical Perspective," Stanford Law Review 38 (1986).
Donald E. Elliott, "Re-Inventing Rulemaking," Duke Law Journal 41 (1992), p.1492-96.
William S. Jordan, "Ossification Revisited: Does Arbitrary and Capricious Review Significantly Interfere with
Agency Ability to Achieve Regulatory Goals through Informal Rulemaking?," Northwestern University Law
Review 94 (2000); Thomas O. McGarity, "Some Thoughts on 'Deossifying' the Rulemaking Process Duke,"
Duke Law Journal 41 (1992); Thomas O. McGarity, "The Courts and the Ossification of Rulemaking: A
Response to Professor Seidenfeld," Texas Law Review 75 (1997); Richard J. Pierce, "Rulemaking and the
Administrative Procedure Act," Tulsa Law Journal 32 (1996); Mark Seidenfeld, "Demystifying Deossification:
Rethinking Recent Proposals to Modify Judicial Review of Notice and Comment Rulemaking," Texas Law
Review 75 (1997).
254

submit public comments, it is usually well-organized groups that make the most effective use of
this avenue. When members of the general public make themselves heard, it is often the result of
an organized political campaign rather than a grass-roots response by concerned citizens. As a
matter of regulatory practice, this may not be a serious problem, as federal regulators have
become quite adept at spotting these manipulative maneuvers. But the fact remains that
regulators do not use and not do consider notice-and-comment an effective tool of public
involvement.
Having discredited notice-and-comment as an effective institution of public consultation, it
is worth noting that there have been a few instances of federal agencies making a strategic use of
this administrative tool to promote broader societal interests. 25
The term “broader societal
interests” in this context indicates a situation in which an agency is willing and able to pursue a
policy that is likely to be supported by a large majority of the general public but opposed by a
few well-organized interest groups. This characterization closely resembles our description of the
political landscape in the field of reproductive medicine and biomedical research, and is
therefore of some interest to our discussion. The agencies involved are the EPA, the FDA and the
Office of the Comptroller of the Currency (OCC), the federal agency responsible for regulating
the banking industry. In 1997, the EPA managed to promulgate new air standards designed to
reduce air pollution by ozone and particulate matters, against the vehement opposition of the
regulated interests, including automakers, coal producers, electric utilities, and oil companies. In
1996, the FDA issued a new rule governing the advertising, sale, and distribution of cigarettes
and smokeless tobacco. The proposed new rule restricted access to cigarette sales by minors,
limited tobacco advertising in the media, and prohibited the distribution of free tobacco samples
and non-tobacco promotional items, among other things. Finally, in the late 1990s, the OCC took
numerous bold steps to expand bank securities and insurance powers, naturally over the
opposition of powerful financial interests.
Common to these three federal agencies was a strategy designed to build broad public
support for their proposed new regulations. To achieve this goal, the agencies began to reach out
to the public at a very early stage of the rule-making process – that is, well before the proposed
new rules were officially announced in the Federal Register. The tools used for this purpose
varied somewhat from case to case; they ranged from convening public hearings, and organizing
conferences and town hall meetings to making informational materials available to the public,
among other things. The novelty in this case does not reside in the tools used, but in the
extensive efforts made by these agencies to reach the general public at a stage of the regulatory
process in which an agency usually negotiates exclusively with key interest groups.
An important reason for mobilizing the general public was to stimulate a large number of
supportive comments during the notice-and-comments phase. Extensive outreach strategies had a
second, important goal: to build the best possible case in support of the proposed new rules. By
25
Steven P. Croley, "Public Interested Regulation," Florida State University Law Review 28 (2000); Elizabeth
Garrett, "Interest Groups and Public Interested Regulation," Florida State University Law Review 28 (2000).
255

eaching out to the public, the agencies hoped to obtain additional information, new insights and
data that could strengthen the cases for their respective new rules, a goal that closely parallels
our call for the consideration of a much broader range of normative arguments in contemporary
bioethical debates. The agencies did not expect notice-and-comment to produce exclusively
supportive arguments, and organized interest groups did use notice-and-comment to register their
discontent. But as hoped for by the agencies, the number of favorable comments dwarfed the
negative reactions, thus strengthening the agencies’ positions.
Critics could argue that these agencies manipulated the rule-making process to achieve their
own bureaucratic goals, and that the process just described is a blatant case of “rogue” agency
behavior, of agency “drift.” This criticism is misleading. For one thing, the goals pursued by all
three agencies were indeed largely in the interest of the general public. Pursuing broader
objectives certainly has not benefited the leadership of these agencies. To the contrary, by
deciding to fight powerful business interests and their allies in Congress, these agencies took
significant risks. The agencies simply used the room afforded to them by the APA to discharge
their public mandate, and did so in the same way well-organized private groups routinely do to
pursue their own interests.
That the agencies succeeded in neutralizing the distorting effect of organized interest groups
demonstrates that regulators genuinely committed to pursuing broader societal interests can use
notice-and-comment to their advantage. Unfortunately, these are the proverbial exceptions to the
rule. Mounting an effective outreach campaign is a time-consuming and costly undertaking that
many agencies may not be able to undertake. The APA certainly does not mandate conducting
costly and time-consuming outreach campaigns. Deciding to fight large business interests and
Congress at the same time is not a decision many administrators are likely to make. Nor are
senior administrators inclined to risk a conflict with the president. In sum, notice-and-comment,
by itself, is of very limited value as a tool of public involvement. It can, however, become quite
useful in combination with other measures of public outreach.
10.4 Why Consult with the Public?
In section 10.1, we argued that untangling modern bioethical dilemmas will likely require
devising institutions of public consultation of a novel kind. We argued that the inclusion of the
general public in policy-making would prevent political failures, or at least mitigate political
distortions in a policy arena fraught with both. Another way to account for the importance of
adopting robust institutions of public consultation is to note that the quality of a policy and the
fairness of the decision-making process crucially depend on the range of views available to
decision-makers. Skeptics may agree with this general observation but observe that in the case of
biomedical dilemmas, the general public simply does not have the expertise to make substantial
contributions to the debate. In this section, we discuss a few examples that demonstrate the
opposite. Taken together, they suggest that professional views of ethical dilemmas represent only
256

a fairly limited spectrum of the pool of ethical arguments policy-makers should include in their
decision-making process.
The case of synthetic human growth hormone discussed in chapter 2 provides a first
(negative) illustration of the importance of making a broad pool of ethical arguments available to
decision-makers. In that case, the Endocrinologic and Metabolic Drugs Advisory Committee
decided to approve the use of human growth hormone for non-therapeutic uses based largely on
testimonies offered the pharmaceutical industry and patients. A few dissenting voices were
heard, but listening to critics was a formality rather than an important element of the decisionmaking
process. The narrow scope of the arguments presented to the committee suggested that
this advisory committee would have recommended including idiopathic shortness on the list of
FDA-approved indications for the use of human growth hormone. This is exactly what the
committee recommended.
A case study of patients’ evaluation of somatic gene therapy provides an illustration of the
discrepancy between laypersons’ and professionals’ perspectives on bioethical dilemmas. 26
Among bioethicists and medical professionals, gene therapy is generally viewed as a benign
biomedical development. Its potential benefits are substantial, while the risks are negligible;
issues of patient selections, informed consent, and confidentiality of personal data do not seem to
pose significant problems. The health care costs of this treatment remain very high and are
clearly regarded as source of concern. This, in a nutshell, is the professional take on gene therapy
trials. 27
Patients with disabilities draw a much more nuanced and problematic picture of this
potential cure. These patients expressed 11 distinct ethical concerns, many of which have not
played a significant role in mainstream bioethical debates. Among them are the relationship
between disability and personal identity and between genetic changes and personal identity.
Several patients found that their disabilities, for better or worse, had become part of their
identities, and that by removing these disabilities, something irreplaceable would be lost. The
possible impact of somatic gene therapy on attitudes toward disabilities was a second concern.
Some disabled individuals thought that society would be impoverished if certain disabilities were
to disappear. This is indeed a recurrent topic, especially among deaf persons, who often do not
consider themselves disabled but rather members of a distinctive subculture. Many prospective
patients were worried that society would impose what might be called eugenic pressure, a worry
that is either ignored or quickly dismissed by professional bioethicists. Some patients also were
concerned about the rationale offered by pharmaceutical companies and the medical
establishment for developing the treatment. 28 These individuals wondered whether gene therapy
26
27
28
Leach Sculley, Rippberger, and Rehmann-Sutter, "Non-Professional Evaluation of Gene Therapy Ethics."
LeRoy Walters and Julie Gage Palmer, The Ethics of Human Gene Therapy (Oxford: Oxford University Press,
1996).
Leach Sculley, Rippberger, and Rehmann-Sutter, "Non-Professional Evaluation of Gene Therapy Ethics,"
p.1417-18.
257

ultimately benefits more the patients or the pharmaceutical companies involved in its
development.
The researchers also surveyed a group of medical professionals. Not surprisingly, the study
found several important differences in how professionals and patients evaluated somatic gene
therapy. The professionals’ concerns revolved mainly around the safety and efficacy of this
treatment. The study showed that for these health care professionals, the notion that some
patients may not consider gene therapy a treatment at all was difficult to accept.
The example just discussed is not exceptional. Time and again, non-professional
assessments of bioethical dilemmas focus on substantive rather than procedural issues.
Laypersons question the ends as opposed to simply examining the means. They wonder whether
new cures such as gene therapy are another instance of a social problem being transformed by
the medical profession and the pharmaceutical industry into a medical condition. On the other
end, many of the traditional preoccupations of professional bioethicists, such as autonomy,
beneficence, non-malfeasance, and justice, are not or only marginally reflected in these patients’
concerns.
A third example of how professionals and laypersons may differ in their respective
assessments of ethical priorities is provided by a comparative study of genetic counseling. 29 A
group of citizens was assembled that was directly affected by genetic conditions, but with no
prior connections to advocacy groups. Included also were genetic counselors, medical
geneticists, and public health professionals. The study was designed to elicit and rank concerns
from each of these groups. The results were revealing. Among patients, respect and accuracy of
the information provided ranked first and second, respectively. By contrast, topics of
considerable interest to bioethicists, such as privacy, non-directive counseling, and informed
consent, were notably missing from the patients’ concerns.
Yet another telling illustration of the differences between professionals’ and laypersons’
approaches to ethical dilemmas is provided by coping strategies adopted by parents after learning
that they most likely will have a disabled child. A somewhat dated but suggestive qualitative
analysis of these parents’ strategies shows that parents do not decide to abort pregnancies (or to
keep babies, for that matter) based on statistical probabilities. Whether parents face a 20 percent
or a 70 percent chance of having a disabled child is not decisive. The prospective parents assess
first how their life might change if a disabled child entered their lives, and what it would be like
to care for this child. If they conclude that they will be able to cope with the challenge of raising
a disabled child, then they are likely to have the baby. If on the other hand they come to the
conclusion that they would not be able to care for the child, they are likely to interrupt the
pregnancy. And when they are unable to make a positive decision, they tend to let the fate
decide. 30 Compare this approach to professional norms. There is considerable anecdotal evidence
29
30
Dorothy C. Wertz and Robin Gregg, "Genetics Services in a Social, Ethical and Policy Context: A Collaboration
between Consumers and Providers," Journal of Medical Ethics 26 (2000).
Abby Lippman-Hand and Clarke F. Fraser, "Genetic Counseling: Parents’ Responses to Uncertainty," Birth
Defects: Original Article Series 15 (1979). A much more differentiated and more recent discussion of this issue
258

that medical personnel often encourage, in subtle but no less effective ways, prospective parents
to consider an abortion when an amniocentesis indicates a strong likelihood of a severe
disability. 31
Each of the examples discussed in this section makes a similar point: Bioethicists, medical
professionals, patients, and the public differ in important ways in how they approach modern
bioethical dilemmas. Moreover, these examples demonstrate that lay views widen the pool of
relevant ethical arguments in important ways. We are certainly not claiming that the public
always or necessarily offers superior ethical arguments. Our contention is simply that a broad
process of public consultation on difficult ethical dilemmas is likely to expand in significant
ways the pool of relevant ethical arguments. A large pool of ethical views is indispensable to
politicians and administrators responsible for crafting broadly acceptable responses to the
dilemmas created by new biomedical research. Conversely, regulatory institutions that by design
limit the pool of available ethical arguments are likely to exacerbate societal divisions.
10.5 Who Should Be Consulted?
Simply advocating a process of broad public consultation leaves an important question open:
Who exactly is “the public” in a public consultation? Administrators have often been faced with
this question, either because a statute requires them to solicit public input (more on this in
section 10.9), or because agency policy demands it, or else because failure in the past to include
one or the other constituency has led to a protracted and acrimonious process of decisionmaking.
As a matter of practice, then, many administrators operating in charged regulatory
environments, the EPA and the DOE being two examples, have found ways to translate abstract
demands of inclusiveness into viable administrative practices.
Central to administrative notions of inclusiveness is the concept of “stakeholders.”
Identifying critical stakeholders, from an administrative point of view, is far simpler than
involving the public in its entirety. Administrators do not need to seek out stakeholders; these
individuals and groups literally run into their offices to “inform” and to lobby them. These are
the stakeholders the agency ignores at its own risk. The public, on the other hand, must be
invited, motivated, and cajoled to participate in matters often perceived as distant and complex.
In more recent times, federal agencies have adopted more elaborate strategies designed to ensure
that all stakeholders, including those that traditionally have mistrusted the federal government,
participate in policy-making. These refinements, however, do not affect the view that the public,
as a matter of bureaucratic practice, can be equated to a group of loosely defined key
stakeholders.
31
can be found in Rayna Rapp, "Refusing Prenatal Diagnosis: The Meanings of Bioscience in a Multicultural
World," Science, Technology and Human Values 23, no. 1 (1998); Rayna Rapp, Testing Women, Testing the
Fetus: The Social Impact of Amniocentesis in America (New York: Routledge, 2000).
See Erikson, "Post-Diagnostic Abortion in Germany: Reproduction Gone Awry, Again?."; Michael J.
Malinowski, "Coming into Being: Law, Ethics and the Practice of Prenatal Genetic Screening," Hastings Law
Journal 45 (1994).
259

In many cases, these efforts are perfectly adequate. At the local level, participation by
various interest groups may be considered an adequate substitute for broad public participation;
participation in decision-making at the local level is less likely to suffer from political failures.
The empirical evidence suggests that agencies such the DOE and the EPA have become quite
adept at designing and running participatory processes. 32 Unfortunately, a pragmatic stance in
identifying stakeholder groups and in involving the public makes these otherwise remarkable
initiatives largely irrelevant.
Stakeholders are often defined as those groups that are substantially and negatively affected
by an agency policy. This definition is of considerable practical import, but it is far from
unproblematic. Consider the following hypothetical example: Let us assume that the Yosemite
Valley has not yet been made into a national park. Political pressure is mounting to get the
National Park Service to take action. The Park Service recognizes the urgency of moving
forward on this matter, but is concerned about opposition expressed by select interest groups. To
gauge public support for this measure, it initiates a broad process of public consultation. Central
to this process are negotiations with key stakeholders. What stakeholders is the National Park
Service likely to consult with? Surely, the agency would seek comments from tourist and travel
operators, logging companies, hunters’ societies, local communities, and Native American tribes,
among other groups. The Park Service would also want to consult with environmental and
conservationist groups, both at the local and national levels. Finally, the agency would also want
to solicit public comments from the general public.
Are these stakeholders all equally entitled to be heard? Do they all have “stakes,” and what
are these stakes? The first group of individuals and organizations identified by the agency clearly
meet the standard definition of stakeholder. These are societal groups who are likely to be
substantially and negatively affected by the proposal to protect the great outdoors. Their stakes
are obvious and undisputable; most of these groups would suffer economic losses; others would
be dramatically restricted in activities they once took for granted. In other words, these groups
would be harmed in the strong sense of this term.
Environmental and conservationist groups, for their part, certainly consider themselves
stakeholders on par with logging companies and the tourist industry. The Park Service, for its
part, would share this view. These groups can be expected to provide strong support for the
agency proposal to turn Yosemite Valley into a national park. As a practical matter, few would
dispute the view that conservationist groups should be considered stakeholders. By the standard
definition of this concept, however, this inference is not necessarily warranted. In which sense
would environmentalists and the public be negatively affected should the Park Service decide not
to move forward with its proposal? What kind of damage would these groups suffer? Clearly,
environmental groups would not suffer any economic losses, nor is the source of their livelihood
32
Thomas C. Beierle, "The Quality of Stakeholder-Based Decisions: Lessons from the Case Study Record,"
(Washington, D.C.: Resources for the Future, 2000); Judith A. Bradbury and Kristi M. Branch, "An Evaluation
of the Effectiveness of Local Site-Specific Advisory Boards for U.S. Department of Energy Environmental
Restoration Program," (Pacific Northwest National Laboratory, 1999).
260

affected by a negative decision. In this sense, environmental groups do not have a stake in this
decision, if “stake” is defined along the lines delineated by the Supreme Court in Lujan v.
Defenders of Wildlife (1992). 33
That this is not merely an academic question becomes apparent if the Park Service decided
that Yosemite Valley is not worth protecting after all. National environmental groups would
certainly challenge this decision in court. They could do so on the grounds that some of their
members have been harmed by the Park Service’s negative decision. These groups could claim
that their members have visited Yosemite Valley in the past and many of them plan to do so
again in the future. If the National Park Service failed to protect Yosemite, these Americans
would experience a considerable loss.
The Supreme Court has repeatedly ruled on similar cases in the past. Lujan v. Defenders of
Wildlife involved a decision by the Department of the Interior to provide partial funding for dam
projects in Sri Lanka and Egypt. Defenders of Wildlife, a U.S. non-profit organization, claimed
that the decision by the Department of the Interior would have threatened the habitat of several
endangered species under the Endangered Species Act. The Court determined that the fact that
an individual (in this case members of Defenders of Wildlife) had visited a pristine
environmental area in the past and had a vague intention to do so again in the future did not
prove that he or she would be injured by a failure to protect the area. 34 To claim standing, these
individuals would have to demonstrate specific plans to visit the area again in the near future,
and not merely that they have an abstract interest in the protection of the area and may visit it
again sometime in the not-too-distant future.
The example just discussed is far from hypothetical. The Endangered Species Act, for
example, requires public input in the listing of endangered species, the designation of critical
habitat, and the recovery plans for endangered species, among other things. 35 Yet exactly whose
input should be solicited to implement this act? It is quite easy for the administering agency, in
this case the U.S. Fish and Wildlife Service, to identify those parties that would be negatively
and substantially affected by expanding the list of endangered species. Property owners,
developers, timber companies, and small rural communities dependent on the timber industry for
their livelihood would all be threatened in an obvious and immediate way. Yet these are not the
only affected parties. The agency could determine that “interested and affected parties” should
include all parties with a substantial interest in endangered species, such as national
environmental groups, local activists, and biologists.
33
34
35
See 504 U.S. 555 (1992). In Lujan, the Court found that an individual has standing only if he or she can
demonstrate “actual or imminent injury” (504 U.S. 555, 567).
Bradford C. Mank, "Standing and Global Warming: Is Injury to All Injury to None?," Environmental Law 35
(2005), p.30.
Nancy Perkins Spyke, "Public Participation in Environmental Decisionmaking at the New Millenium:
Structuring New Spheres of Public Influence," Boston College Environmental Affairs Law Review 26 (1999),
p.286-87.
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The rationale for including stakeholders that are not negatively and significantly affected by
the decision to list (or not to) a species as endangered is murky. Is it legitimate for national
environmental organizations to intervene in what many would consider strictly local matters? Is
it enough for these organizations to declare themselves interested parties by virtue of their
interest and commitment to environmental causes? Good arguments can be made in favor of and
against their participation, the latter by virtue of the simple fact that these organizations are
intervening in highly localized political conflicts. But one could argue that the loss of a species
cannot be regarded simply as another instance of a local political controversy. As we have
argued earlier, the fact that the protecting Yosemite Valley directly affects only a very narrow
segment of the general public does not make protecting it a local issue. In addition, national
environmental groups bring resources and expertise to the table often not available to local
groups. In this sense, they contribute to enlarging the pool of possible arguments pro and con
listing a species as endangered, and may contribute to correcting a political failure.
The examples discussed in this section are representative of a wide range of political
controversies, including those triggered by advances in reproductive medicine and biomedical
research. Our “genetic heritage” and the great outdoors both are the products of billions of years
of natural evolution. And just as it is utterly foolish for anyone to suggest that the Yosemite
Valley or the Grand Canyon could be “improved,” so is it equally foolish for scientists to claim
that the human genome can be improved in more than a marginal sense. Both the magnificence
of the great outdoors and the beauty of the double helix inspire respect and awe. Yet respect for
the great outdoors and for our genetic heritage does not exclude enjoying these national
treasures, nor does it preclude scientific research. In the case of our national parks, we have
found acceptable ways to reconcile enjoying nature with the need to protect spectacular
landscapes against degradation and destruction. Americans are rightly proud of their great
outdoors. But it must be recognized that only national leaders inspired by an undiluted notion of
public interest made the protection of these national treasures possible.
Our discussion has shown that the concept of stakeholders solves as many problems as it
creates. While organized interest groups are a reality that no politician or administrator can
afford to ignore, reducing the concept of the public to a more or less arbitrary group of
stakeholders is a pragmatic approach with clear conceptual and operational limitations. For this
reason, in chapter 12, we propose mechanisms of public consultation explicitly designed to elicit
input both from organized interest groups and from individual citizens.
10.6 Scientific Literacy and Public Participation
Given the rather modest levels of scientific literacy in the general population, it may seem
implausible that modern bioethical controversies should be resolved by resorting to broad public
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consultations. 36 These doubts are understandable, but hardly justified. Many case studies have
shown that citizens who are given an opportunity to examine a technological controversy
develop an uncanny ability to “deconstruct” scientific claims, to uncover questionable tacit
assumptions, and to thoroughly probe the empirical evidence experts rely on for their claims.
They become, in other words, experts at questioning scientific authority. 37
The important
question is not whether the public meets some a priori, arbitrary level of scientific literacy, but if
members of the general public, given the opportunity, can familiarize themselves with a complex
scientific and technological controversy. The evidence suggests that this is indeed the case. 38
Consider the case of stem cell research. At first, it would appear that scientific literacy
would matter a great deal. Leading scientists have argued that embryos should be sacrificed for
the sake of developing cures for hitherto incurable diseases. While these scientists have
expressed considerable confidence that this line of research will deliver revolutionary new cures,
the President’s Council on Bioethics, in a recent assessment of the state of the art, was far less
sanguine about the availability of cures in the immediate future. 39 A minority of scientists is not
convinced that the development of embryonic stem cells can precisely be controlled, and
recommends instead focusing on the less flexible but perhaps more promising area of adult stem
cells. Assessing the credibility and accuracy of competing scientific claims offered by equally
competent and credible scientists then would seem to require precisely the kind of scientific
expertise that the general public does not have.
A background in science or biology would be useful but is not necessary to evaluate
conflicting scientific perspectives. To adjudicate among competing scientific claims is to take on
the role of an investigative reporter. What are required are general analytical skills and a
reasonable, general level of education rather than expertise in cell and developmental biology.
An understanding of how scientific institutions work would also be helpful. For example, no
special expertise is necessary to probe scientists’ belief that the development of embryonic stem
cells can actually be controlled. 40 The public could also question the reasons for scientists’
aggressive pursuit of cloning technologies; conducting cloning research has been justified by the
need to develop immunologically compatible organs, but a lay audience may come to the
conclusion that this is a rather weak rationale, considering that clinical applications are many
36
37
38
39
40
The National Science Foundation (NSF) periodically conducts scientific literacy surveys whose results are, in the
eyes of NSF officials, invariably a source of concern. See
http://www.nsf.gov/statistics/showsrvy.cfm?srvy_CatID=6&srvy_Seri=17.
Robert Futrell, "Technical Adversarialism and Participatory Collaboration in the U.S. Chemical Weapons
Disposal Program," Science, Technology and Human Values 28, no. 4 (2003).
Aaron Wildavsky, But Is It True? A Citizen's Guide to Environmental Health and Safety Issues (Cambridge,
MA: Harvard University Press, 1995).
President's Council on Bioethics, Applications of Human Stem Cells in Research and Medicine (2003 [cited
October 3, 2005]); available from http://www.bioethics.gov/background/sc_application.html.
By their own admission, and despite their best efforts, scientists so far have not been able to control how human
embryonic stem cells develop. But this ability is crucial, if any clinical application should come from this line of
research.
263

years away. Again, no scientific background is necessary to inquire about this issue. And by
asking this question, a lay audience is likely to learn a great deal about how scientists set their
research priorities and about the rationales for these choices. Effectively assessing the credibility
of scientific claims certainly is no easy task, but scientific literacy is unlikely to make this job
easier.
Finally, it is worth pointing out that the distinction between the scientifically illiterate public
and informed scientists is itself seriously misleading. In most cases, scientists are just as illiterate
about science as is the public. Knowledge production is so fragmented and specialized that
anyone outside any of the innumerable and often tiny scientific communities – they are so small
that one is tempted to call them cliques – is a scientific illiterate. For example, an average
biologist, just like anyone else without an advanced degree in physics, is very unlikely to know
what a Lorenz transformation is. Yet this is not an arcane piece of mathematics, but the
foundation of Einstein’s special theory of relativity – formulated and published in 1905 and often
taught in physics curricula at the high-school level. Lorenz transformations should not be
confused with the Lorenz effect, named after Edward Lorenz. In the 1960s, Lorenz famously
observed that a butterfly flapping its wings in Beijing could alter the weather in San Francisco.
Among experts of chaos theory and climatology, this story is a familiar one. Yet few persons
outside of these scientific communities are likely to have heard of this effect. Scientific
(il)literacy is a widespread phenomenon in industrialized societies, but is of very little help in
explaining opposition to scientific and technological developments.
10.7 Key Features of Institutions of Public Consultation
10.7.1 Deliberation: Vehicle of Consensus or Catalyst of Conflict?
We suggest that mechanisms of public consultation should always include a deliberative
phase. There are several good reasons for including deliberation in processes of public
consultation. Deliberation ensures that the participating citizens do not simply offer improvised
answers to complex questions they may never have pondered. Institutions of public consultation
should be designed specifically to elicit informed and reflected opinions. Deliberation ensures
that participants acquire a much deeper and differentiated understanding of the issues involved; it
is the process of familiarization that is likely to produce well-informed opinions. The outcome of
this process cannot easily be dismissed on the grounds that people are in no position to express
informed opinions. This is the feature that sharply distinguishes a traditional survey from a
consultative process.
Unlike opinion surveys, the views gathered through a process of public consultation are
stable, in that they are unlikely to change significantly over time. Deliberation should all but
eliminate the sensitivity of survey results to the wording of poll questions, a problem we have
repeatedly encountered in our discussion of survey data in chapter 8. In sum, by ensuring that the
public expresses its views only after having reflected for some time on various aspects of a
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ioethical dilemma, the credibility and robustness of a process of public consultation are
considerably enhanced.
By exposing all participants to a broad range of different views, beliefs, and values,
deliberation fosters a better understanding of opposing views. Importantly, exposure to different
opinions facilitates the crafting of political compromises. Alternatively, deliberation may help
participants identify innovative solutions that they were not aware of before engaging in face-toface
communication. Deliberation, in other words, can be described as a “discovery process.” 41
Scholars of deliberative democracy will readily recognize these arguments. Our concept of
deliberation bears some similarities with the notions of deliberation espoused by these scholars,
but it also differs in important ways. Advocates of deliberative democracy and their critics seem
to assume that deliberation is either disinterested or entirely self-interested. 42 Neither one of
these assumptions is empirically accurate. Participants in a process of public consultation do not
check their interests and predispositions at the door. Nor it is reasonable to assume that actual
deliberations are always or exclusively informed by opportunistic, self-interested norms. More
often than not, self-interest and what may be called public-mindedness coexist. This means that
deliberation has only a limited capacity to bring about consensus. Deliberation can move
conflicting parties toward a consensus, but there is no reason to assume that this will always or
necessarily be so. Some controversies may be more difficult to solve through deliberation than
others. Deliberation is no substitute for other mechanisms of decision-making, such as voting. In
this view, we differ from advocates of deliberative democracy, who assume, more or less
explicitly, that deliberation ultimately will move participants toward finding a consensus.
That deliberation does not necessarily produce consensus is demonstrated by our national
conversation about new biomedical research. Since President Bush announced his policy on stem
cell research in August of 2001, much has been said and written on national television and in the
news media about reproductive cloning, research cloning, and stem cell research. From a
quantitative perspective, the debate has been vigorous. Since we started monitoring the print
media in early 2003, we have gathered almost 3,000 news stories on these and closely related
topics. 43 Yet one cannot avoid the conclusion that this conversation has not contributed to
bringing opposing parties closer together. To the contrary, the existing positions seem to have
hardened, leaving no room for political compromise. What has been unfolding in the news media
is the discursive equivalent of a bullfight: Each side has persistently but unsuccessfully tried to
impose its fixed views on the other and on the nation as a whole.
41
42
43
This term is borrowed from Friedrich Hayek, who introduced it to describe market mechanisms. Friedrich A.
Hayek, "Der Wettbewerb Als Entdeckungsverfahren," in Kieler Vorträge (Kiel: 1968). That in Hayek’s concept
of the market face-to-face communication plays a crucial role is no coincidence.
Richard A. Posner, Law, Pragmatism, and Democracy (Cambridge, MA: Harvard University Press, 2003),
p.131-43. See also Amy Gutmann and Dennis Thompson, Democracy and Disagreement: Why Moral Conflict
Cannot Be Avoided in Politics, What Should Be Done About It. (Cambridge, MA: Belknap Press, 1996).
News stories are available online at http://www.biotechgov.org.
265

The view that deliberation can sharpen conflicts rather than mitigate them has a solid
empirical foundation. Social psychologists have long been aware that deliberation does not
always promote nuanced views, mutual understanding, and consensus among warring factions. It
would be a disaster if a process of public consultation intended to facilitate reconciliation
inadvertently contributed to sharpen societal divisions. In the remainder of this section, we
discuss three mechanisms that can undermine deliberative efforts. They are informational
cascades, reputational cascades, and a limited “arguments pool.” Taken together, they contribute
to what is known as “group polarization,” a phenomenon whose significance to politics and
policy-making has only recently been explored. 44
Informational cascades may be described as a social mechanism of opinion-building. The
need for orientation may arise with respect to widely different questions: How safe are nuclear
power plants? Is busing effective? Is the minimum wage a good or bad thing? How much would
it cost to send humans to Mars? In all these cases, individuals with limited knowledge and
expertise tend to take their cues from opinion leaders. Opinion leaders are not always or
necessarily highly reputable individuals with impeccable academic credentials. Children view
their parents as their frame of reference. For teenagers, it may be their peers, much to the dismay
of their parents. To political activists, it may be a charismatic leader. And if you are black, poor,
and living in a dilapidated urban environment, the opinion of your church leaders on the
minimum wage will carry considerable weight. Even judges and legal scholars are not immune
from informational cascades. 45
The more opinion leaders share a certain view of a controversial issue, the likelier it is that
other, less informed or less opinionated individuals will share a particular view of a controversial
question, and the more likely it becomes that even more people will hold this opinion, until the
entire population or a very large fraction thereof holds the same opinion, whether this view is
accurate or not. This, in a nutshell, is an informational cascade. Importantly, different population
groups may be affected by different informational cascades, producing homogeneous and nonoverlapping
distributions of attitudes toward controversial issues.
Reputational cascades are a second important mechanism of social influence. A selfexplanatory
term for this phenomenon is group conformity. Reputational cascades can play an
important role in small group deliberations. Individuals conform to a group’s opinion out of a
concern for their reputation, even though they may actually disagree with the group. The
mechanism at work here seems to be a deeply felt need to protect one’s public image and to
avoid ostracism by one’s peers or colleagues. Reputational cascades can work in the opposite
direction as well: They may induce individuals to make public statements that they privately do
not endorse. Reputational cascades are relevant only in those cases in which individuals are
44
45
Myers, "The Group Polarization Phenomenon."; Sunstein, "Deliberative Trouble? Why Groups Go to
Extremes."; Sunstein, Why Societies Need Dissent.
Sunstein, Why Societies Need Dissent. On cascades, see also Timur Kuran and Cass Sunstein, "Availability
Cascades and Risk Regulation," Stanford Law Review 51 (1999).
266

concerned about their public image. Individuals only mildly or not concerned about their
reputation are unlikely to feel compelled to comply with their group’s expectations.
Consider for example a scientist expressing the view that research cloning currently is not
critical to developing new medical treatments. This person is likely to be exposed to considerable
opprobrium by his colleagues, and his career could suffer greatly. Alternatively, consider an
evangelical Christian expressing some doubts about the wisdom of literally equating embryos to
human beings. It is fair to assume that this person would no longer be welcome in his or her
church. In these cases, reputational cascades shed considerable light on why we observe so much
conformity among the members of a social group, even though disagreement may be widespread.
Group polarization proper is the third and final phenomenon of import to institutional
design. The term itself is a bit of a misnomer, since it is not meant to suggest a process by which
a group breaks down into two distinct camps, or a phenomenon by which distinct groups shift
toward opposite views, although as we have seen in section 10.1, this can indeed be the case. In
its original meaning, group polarization identifies a rather puzzling phenomenon. After
deliberation, groups whose members hold similar views shift their opinions toward a more
extreme version of their initial positions. In other words, group polarization occurs when “an
initial tendency of individual group members toward a given direction is enhanced following
group deliberation.” 46 Group polarization is not synonymous with group radicalization. A group
of cautious individuals is very likely to become ever more cautious after deliberation. The
important point here is that deliberation tends to amplify the initial inclinations if a group
consists of individuals with similar views. In this case, deliberation contributes to shifting
individual views toward the extreme.
Group polarization is well-documented and is quite common in many deliberative settings.
For example, law professors sympathetic to affirmative action after deliberation are likely to
express a firmer support for this policy. Citizens somewhat favorable to gun control coming
together to discuss possible gun control measures in the aftermath of a nationally televised
shooting are likely to endorse stricter measures. And a group of women concerned about the
growing influence of feminism can be expected to develop a very strong opposition to feminism
as a result of deliberation. 47
A recently conducted study of jury deliberation offers a particularly convincing example of
group polarization. 48 To determine whether jury deliberation contributes to group polarization,
the study authors assembled more than 500 mock juries. The individuals were provided with
informational materials about a personal injury case and asked to rate the punishment on a scale
between 0 (no punishment) and 8. The participants were then randomly assigned to juries of six
46
47
48
Daniel J. Isenberg, "Group Polarization: A Critical Review and Meta-Analysis," Journal of Personality and
Social Psychology 50 (1986).
David G. Myers, "Discussion-Induced Attitude Polarization," Human Relations 28 (1975); Myers and Bishop,
"Enhancement of Dominant Attitudes in Group Discussion."
David Schkade, Cass R. Sunstein, and Daniel Kahneman, "Deliberating About Dollars: The Severity Shift,"
Columbia Law Journal 100 (2000).
267

members and instructed to reach consensus on the punishment. Common sense suggests that the
consensus rating should approximate the average of the views represented on each jury. The
actual results were quite different. Juries whose median pre-deliberation punishment rating was 4
or higher produced an even higher consensus rating. Conversely, juries whose pre-deliberation
rating was smaller than 4 shifted toward an even lower consensus rating. It appears that
deliberation amplifies a jury’s pre-deliberation tendency, whatever that tendency may be. 49
Fortunately, polarization is not an inevitable feature of group deliberation. Just as
deliberative groups under certain circumstances polarize, under other circumstances, they
depolarize. Producing “depolarization” is a surprisingly straightforward process. It merely
requires that opposing views within a group be represented in sufficiently high numbers. If this
structural condition is met, deliberation is very likely to move the participants closer to the
median view. Deliberation in this case produces the expected outcome – it fosters compromise,
and perhaps even a consensus. To the extent that minority views are represented in roughly equal
numbers, the evidence suggests that reputational cascades (or the tendency to conform to the
majority’s view) do not occur.
The data discussed in chapter 8 provides some evidence, albeit indirect, that even
individuals holding what seem to be unshakeable moral views may not be immune to
depolarization. Even religious and conservative voters normally opposed to abortion rights show
a measure of support for federal funding of embryonic stem cell research. Similar tendencies can
be observed in Congress, where a growing number of Republican leaders, including many
opposed to abortion, have expressed their support for a stronger role of the government in
supporting stem cell research. Although the evidence in this case is only anecdotal, it appears
that having a family member or a friend affected by a devastating disease may have prompted
many conservative voters and their Congressional representatives to reconsider their firm
opposition to stem cell research.
In short, deliberation as understood in this report increases the credibility of a process of
public consultation. It may also contribute to producing broadly acceptable political
compromises, but only if the consultative process is designed to prevent group polarization and
cascades. This can be accomplished by ensuring that the broadest possible range of societal
positions is heard, and that these views are represented in roughly equal numbers.
10.7.2 Other Features
In addition to deliberation, institutions of public consultation have other distinctive features.
Before diving into specifics, however, a qualification is in order. Throughout this report, we
frequently use the term “consultation” instead of the more common “participation.” The term
“public participation” has generated both considerable interest and considerable confusion, in
large measure because its advocates often fail to specify the role public participation should play
in the administrative and regulatory context. This becomes especially problematic at the federal
49
Sunstein, Why Societies Need Dissent, p.114.
268

level, where bureaucratic authority and technical expertise clash against popular expectations to
substantially affecting the decision-making process.
Public consultation as understood in this report is a tool to correct political failures and to
mitigate agency capture, not a means to subvert the federal system of governance. 50 Institutions
of public consultations are designed to strengthen the credibility of and trust in our system of
representative democracy. Views gathered through a process of public consultation should play
an important role in agency decision-making, but they should not mechanically translate into a
specific course of action. The relationship between Congress, the office of the president, the
administrative state, advocacy and interest groups, and the general public is a complex one that
cannot be reduced to simple normative expectations. 51
Target audience: Because this report is focused on federal regulatory institutions, references
to the general public always identify the entire U.S. population, i.e., a population of individual
citizens endowed with certain rights and obligations, as opposed to a population of stakeholders
such as trade groups, scientific societies, or religious organizations. Obviously, individual
citizens may represent specific social groups; their views are likely to reflect specific social,
ethnic, or racial backgrounds. But a process of public consultation is not designed to elicit groupspecific
views. Rather, it affords the public as a whole a chance to be heard. Accordingly, no
efforts are made to include group-specific views. This is not to say that these views are
unimportant, just that there are already plenty of opportunities for them to be heard in other
settings.
Representativeness: As a practical matter, it is impossible to envisage a mechanism of
public consultation that is literally inclusive of the entire U.S. population. As such, the public
participating in the consultative process should be a sample large enough to be representative of
the U.S. population with regard to the usual socio-demographic variables. We believe that this is
not only an acceptable compromise, but that in a sense, a randomly selected sample of the U.S.
population may even be superior to traditional voting. For example, a representative sample
ensures that the views of social groups unlikely to go to the polls are being included. It also
ensures that these views are not interpreted and misused by political entrepreneurs for their own
self-interested purposes.
Knowledgeability: A consultative process seeks to elicit informed opinions. This
requirement sets consultative processes apart from classic polls and shields them against the
common – and often justified – criticism that opinion surveys reflect uninformed views. By
making sure that the participating public has an opportunity to familiarize itself with complex
policy questions, an institution of public consultation takes on a role the news media are
expected to play but are increasingly unlikely to meet.
50
51
William F. Funk, "Regulatory Negotiation and the Subversion of the Public Interest," Duke Law Journal 46
(1997).
We discuss this question in more depth in chapter 11.
269

Deliberation: This requirement has already been discussed at length, so we can keep this
discussion short. An institution of public consultation is deliberative in the following sense: It
encourages mutual understanding among the members of the general public, and it encourages
crafting broadly acceptable political compromises (i.e., it promotes group depolarization). What
deliberation is not expected to produce is consensus or unanimity.
Balance: A mechanism of public consultation should be designed to facilitate the
articulation of all views. This means that each view should be equally represented independently
of its actual political weight. Balance is required to prevent deliberative groups from
polarizing. 52
10.8 Institutional Options
Evaluating institutions of public participation presents a challenge. There have been some
efforts in the literature to identify universal evaluative criteria, but these efforts have been
hampered by a lack of attention for the administrative and legal context in which participatory
initiatives take place. 53 These works have proposed both substantive and procedural criteria that
would make a process of public participation effective, but since effectiveness can only be
measured against a specific goal, and the goal is not always clearly defined, these criteria are of
little help to our discussion. For this reason, the mechanisms of public consultation examined in
the remainder of this section are evaluated largely against the constitutive attributes of an
institution of public consultation as we envisage it in this report.
The mechanisms of public consultation we discuss in the next two sections are the public
hearing and the consensus conference. Other institutions of public consultation exist, including
citizens’ panels, 54 citizens’ juries, 55 and focus groups. 56 We discuss only public hearings and
consensus conferences for two main reasons. Public hearings remain by far the administrators’
52
53
54
55
56
A careful reader may point out that this and the first attribute are mutually exclusive. A closer examination
shows that this is actually not the case. It is always possible, at least in principle, to assemble a representative
sample of the general population in which each view is shared by an equal number of citizens.
Gene Rowe and Lynn J. Frewer, "Public Participation Methods: A Framework for Evaluation," Science,
Technology and Human Values 25, no. 1 (2000); Thomas Webler, " 'Right' Discourse in Citizen Participation:
An Evaluative Yardstick," in Fairness and Competence in Citizen Participation: Evaluating Models for
Environmental Discourse, ed. Ortwin Renn, Thomas Webler, and Peter Wiedemann (Dordrecht, the Netherlands:
Kluwer Academic, 1995).
John S. Applegate, "Beyond the Usual Suspects: The Use of Citizens Advisory Boards in Environmental
Decisionmaking," Indiana Law Journal 73 (1998); Bradbury and Branch, "An Evaluation of the Effectiveness of
Local Site-Specific Advisory Boards for U.S. Department of Energy Environmental Restoration Program.";
Susan L. Santos and Caron Chess, "Evaluating Citizen Advisory Boards: The Importance of Theory and
Participant-Based Criteria and Practical Implications," Risk Analysis 23, no. 2 (2003).
David Dunkerley and Peter Glasner, "Empowering the Public? Citizens' Juries and the New Genetic
Technologies," Critical Public Health 8, no. 3 (1998); Wendy Kenyon, Ceara Nevin, and Nick Hanley,
"Enhancing Environmental Decision-Making Using Citizens’ Juries," Local Environment 8, no. 2 (2003); David
Price, "Choices without Reasons: Citizens' Juries and Policy Evaluation," Journal of Medical Ethics 26 (2000).
Gregor Dürrenberger, Hans Kastenholz, and Jeannette Behringer, "Integrated Assessment Focus Groups:
Bridging the Gap between Science and Policy?," Science and Public Policy 26, no. 5 (1999).
270

method of choice at all levels of government, and as such deserve to be closely scrutinized.
Consensus conferences, on the other end, are perhaps the most interesting and most promising
method of public participation developed in recent times. Other methods of public participation
either are not sufficiently distinct from consensus conferences to justify a separate discussion, or
are less innovative.
10.8.1 Public Hearings
Public hearings are the oldest and most common form of public participation. Over the last
40 years, administrators from the local to the federal level have routinely relied on public
hearings to test the public mood on any number of issues, ranging from room-tax collection in
Puerto Rico to the use of locomotive train horns at highway-rail crossings in Illinois and Ohio,
from open-flame mattress flammability standards in California to inner-city Brownfield cleanup
efforts by the EPA and the disposal of nuclear wastes at Yucca mountain in Nevada by the DOE.
A public hearing generally consists of an introductory presentation by the convening agency.
The presentation is meant to convey basic, factual information to the public. The presentation is
followed by a question-and-answer session. The Q&A session gives the public an opportunity to
ask for clarifications on technical matters, and is not intended to foster dialogue between agency
officials and the public. After the Q&A session, the public has a chance to make public
statements, followed by a response by the public officials. Administrative agencies often
reconfigure the basic structure of a public hearing depending on the circumstances, but the
elements just described are generally included.
Judged by the criteria laid out in the preceding section, public hearings are a poor
mechanism of public consultation. They do a poor job of conveying complex and controversial
technical information to the general public. Nor is the goal of a public hearing to adjudicate
among conflicting scientific claims. At a hearing, scientists tend to provide even prosaic
scientific information in an obscure technical language. 57 Deliberation as we have defined it in
this report is simply is not present. Q&A sessions are exactly what their name suggests – an
opportunity to clarify details, not a forum for discussing complex technical or policy questions.
Testimonies given by the public are not meant to be deliberative, and public officials do not treat
them as such. Statements and rebuttals are reminiscent of a jury trial rather than a deliberative
forum. The participants in a public hearing are anything but representative of the general public.
At the federal level at least, but often at lower administrative levels as well, only well-organized
advocacy groups have both the resources and the expertise to participate in a meaningful way.
Lay participants tend to be poorly informed and overwhelmed by technicalities, and are quickly
marginalized. In sum, public hearings disregard representativeness and knowledgeability, are not
deliberative, and tend to exacerbate political failures – hardly a sound foundation on which to
build new institutions of public consultation.
57
There is good reason for this: The use of scientific jargon insulates experts from public criticism and reinforces
their authority vis-à-vis the general public.
271

One may wonder why public hearings remain so popular among public administrators if
they are such a poor institution of public consultation. There are several good reasons for this
situation. Public agencies with a statutory mandate to solicit input from the public regard them as
a quick and cheap way to formally meet their administrative obligations. In addition, public
hearings can be manipulated to minimize challenges to the agency’s preferred policy option.
Since the agency controls the logistical aspects of the decision-making process, it can choose to
convene a public hearing when fundamental policy choices have already been made. If an
agency expects the proposed policy to trigger strong criticism, it can decide to exclude the most
controversial issues from the agenda. Alternatively, it can convene the hearing on a day and at a
time that is likely to make it difficult for critics to participate.
Hearings are popular among administrators also because they provide an opportunity to
strengthen their relationship with key political constituencies. Organized interest groups are
predictable, their positions don’t change abruptly, and they master the technical and legal
language necessary to communicate effectively with public administrators. By contrast,
laypersons are often viewed as unpredictable, irrational, and poorly informed. In addition, the
agency can credibly describe its effort to reach out to its core constituencies as an adequate
approach to soliciting public input. Well-organized interest groups, for their part, welcome
public hearings because they afford them an opportunity to restate their positions in a public
setting. Finally, public hearings are useful to the agency because they may warn of upcoming
legal challenges. Against this background, it should come as no surprise that the available
empirical evidence suggests that despite their popularity, public hearings have very little impact
on agency behavior. 58
10.8.2 Consensus Conferences
Consensus conferences have been described by some commentators as a promising
institutional mechanism for democratizing political choices involving controversial technological
developments. 59 In this section, we briefly examine the history of this participatory instrument
58
59
Barry Checkoway, "The Politics of Public Hearings," Journal of Applied Behavioral Science 17, no. 4 (1981);
Richard L. Cole and David A. Caputo, "The Public Hearing as an Effective Citizen Participation Mechanism: A
Case Study of the General Revenue Sharing Program," American Political Science Review 78, no. 2 (1984);
Carol Ebdon, "Beyond the Public Hearing: Citizen Participation in the Local Government Budget Process,"
Journal of Public Budgeting, Accounting and Financial Management 14, no. 2 (2002); Daniel J. Fiorino,
"Citizen Participation and Environmental Risk: A Survey of Institutional Mechanisms," Science, Technology and
Human Values 15, no. 2 (1990), p.230-31; Tom Lando, "The Public Hearing Process: A Tool for Citizen
Participation, or a Path toward Alienation?," National Civic Review 92, no. 1 (2003); Jeanne Nelson Ratliff, "The
Politics of Nuclear Waste: An Analysis of a Public Hearing on the Proposed Yucca Mountain Nuclear Waste
Repository," Communication Studies 48, no. 4 (1997); Rowe and Frewer, "Public Participation Methods: A
Framework for Evaluation," p.18.
Edna F. Einsiedel and Deborah K. Eastlick, "Consensus Conferences as Deliberative Democracy," Science
Communication 21, no. 4 (2000); David H. Guston, "Evaluating the First U.S. Consensus Conference: The
Impact of the Citizens’ Panel on Telecommunications and the Future of Democracy," Science, Technology and
Human Values 24, no. 4 (1999); Simon Joss, "Toward the Public Sphere – Reflections on the Development of
Participatory Technology Assessment," Bulletin of Science, Technology and Society 22, no. 3 (2002); Myung-Sik
272

and lay out its main elements. We then discuss whether this approach can be considered a
suitable mechanism of public consultation as defined in section 10.7.
Consensus conferences are nothing new. NIH has been using them in their original form
since the 1970s as a means to bridge the gap between medical research and clinical practice. 60 As
practiced by NIH, the goal of a consensus conference is to craft a consensus among leading
clinical researchers on the best available treatment for a medical condition. It is a collaborative
effort by clinical researchers to resolve a professional controversy over the merits of alternative
therapies. This seems an eminently sensible way to assist practitioners with no access to a
university hospital. 61
In the mid-1980s, the Danish Board of Technology, an institution inspired by the U.S.
Office of Technology Assessment, made the consensus conference concept into a tool for
consulting with the general public on new technological developments. 62 The Danish Board of
Technology is an independent organization wholly funded by the Danish parliament and
governed by a board of directors broadly representative of all major political constituencies. 63
The board has a twofold mission: to advise the parliament on controversial policy questions and
to stimulate a public debate on new technological developments. Since its creation, it has
convened numerous consensus conferences on topics ranging from food irradiation to gene
therapy and teleworking. The institutionalized position of the board, its independence, and its
credibility ensure that the Danish parliament not only takes consensus recommendations
seriously, but on occasion also adopts them. 64 The Danish example spurred numerous imitations.
The Swiss government adopted a similar approach when it created the Office of Technology
Assessment and gave it an advisory function. Like its Danish counterpart, this office has shown
considerable interest in consensus conferences, known as “publiforums.” 65 In addition, as of this
writing, Argentina, Australia, Canada, France, Germany, Israel, Japan, The Netherlands, New
Zealand, Norway, South Korea, and Switzerland all have conducted at least one consensus
60
61
62
63
64
65
Kim, "Cloning and Deliberation: Korean Consensus Conference," Developing World Bioethics 2, no. 2 (2002);
Derrick Purdue, "Experiments in the Governance of Biotechnology: A Case Study of the UK National
Consensus Conference," New Genetics and Society 18, no. 1 (1999).
A search in the New England Journal of Medicine produced more than 250 articles reporting on consensus
conferences.
Allan D. Sniderman, "Clinical Trials, Consensus Conferences, and Clinical Practice," Lancet 354; JoAnne
Zujewski and Edison T. Liu, "The 1998 St. Gallen's Consensus Conference: An Assessment," Journal of the
National Cancer Institute 90 (1998).
Simon Joss, "Danish Consensus Conferences as a Model of Participatory Technology Assessment: An Impact
Study of Consensus Conferences on Danish Parliament and Danish Public Debate," Science and Public Policy
25 (1998).
See http://www.tekno.dk/subpage.php3?page=forside.php3&language=uk for more information.
Joss, "Danish Consensus Conferences as a Model of Participatory Technology Assessment: An Impact Study of
Consensus Conferences on Danish Parliament and Danish Public Debate."
See http://www.ta-swiss.ch/framesets/projects-e.htm#publiforum for additional information.
273

conference. Denmark is the clear leader among these countries, with 19 conferences organized
since 1987. 66
Consensus conferences have a straightforward structure: A steering committee is tasked with
recruiting a panel of laypersons and selecting a group of experts representative of all societal
sectors (industry, science, and consumers groups, among others). The appointment rules vary,
but there is broad agreement among practitioners that the panel members should not have any
ties to the industry being scrutinized, should not represent an advocacy group, and should not
have strong views on the matter under consideration. In other words, they should not be
prejudiced in favor of or against a given technology, and should represent only themselves. A
panel generally consists of 12 to 20 citizens. Organizers often try to assemble a “balanced”
panel, i.e., a panel that is at least somewhat representative of the general public with respect to
key socio-demographic variables such as sex, age, education, and geographical origin.
Operationally, a consensus conference consists of three main stages. In the first stage, the
lay participants have an opportunity to absorb basic scientific facts and uncontroversial technical
details. The learning phase is followed by a deliberative phase, during which the panel has an
opportunity to engage the experts and probe conflicting answers. The deliberative stage is
usually conducted in the presence of a larger audience and representatives of the news media. In
the third and final stage, the panel is charged with preparing a consensus statement. This final
phase takes place behind closed doors.
By all accounts, consensus conferences have a significant impact on both lay participants
and the scientific experts. To lay participants, a consensus conference is a refreshing civic lesson.
Without exception, the participants describe their experience as exhausting but also as a
tremendous learning opportunity. For their part, experts are invariably surprised and impressed
by how quickly laypersons learn to identify weak aspects of a scientific rationale and to question
them in a competent way. Many of them develop a healthy respect for a lay audience’s ability to
probe highly technical issues.
Of more immediate interest to our discussion is the impact that deliberation may have on the
participants’ views and opinions. As much of the work on consensus conferences is descriptive
rather than analytical, answering this question is not entirely possible. Generally speaking, lay
participants take participation in a consensus conference very seriously. Discussions often are
informed by a genuinely disinterested perspective, while strategic behavior and self-interested
motives, if not entirely absent, tend to recede into the background. In this sense, deliberation
comes quite close to the Habermasian ideal of communicative action. On the other end, there is
considerable anecdotal evidence that consensus conferences rarely produce a genuine consensus,
and that consensus statements often are consensual only in name. Panelists have repeatedly
pointed out that these statements must be regarded as a precarious compromise designed to mask
sharply diverging views rather than a genuine expression of unanimity.
66
See http://www.loka.org/pages/worldpanels.htm for details.
274

There is also some evidence that on occasion, deliberation has contributed to polarize the
panelists. The first Canadian consensus conference on agricultural biotechnologies is a case in
point. 67 As part of their evaluation efforts, before the conference, participants were asked to
describe what images came to mind when they thought of agricultural biotechnology. According
to the organizers, the lay participants had a rather negative view of agricultural biotechnologies.
The skewed composition of the panel suggests that deliberation may have pushed the participants
to espouse more radical views. Unfortunately, this question was not asked again after the
conference, but there are some indications that the deliberative process did indeed exacerbate the
panel’s negative views of agricultural biotechnologies; news reports about the conference noted
that the panel consensus statement, while allowing that agricultural biotechnology could have
some benefits, had identified a long litany of concerns. 68
There is a simple explanation for the tendency displayed by some of these panels to polarize.
The organizers of these events make considerable efforts to assemble a “balanced” panel by
recruiting lay participants on the basis of the usual socio-demographic variables. For example,
they will ensure that the panel consists of an equal number of women and men, and that all ages
and education levels are represented. By contrast, it is not clear that pre-deliberation attitudes
toward specific policy options are systematically taken into account, or that a panel is balanced
not only with regard to key socio-demographic variables, but also with respect to predeliberation
views and opinions.
Their undeniable appeal notwithstanding, it is fair to say that consensus conferences have
not played a major role as mechanisms of public consultation, nor have they affected important
legislative or regulatory choices, perhaps with the exception of the Danish consensus
conferences. There are both implementation and conceptual reasons for this state of affairs. From
a practical standpoint, consensus conferences are not sufficiently focused on a specific policy
questions to have an impact on politicians and senior administrators. The first United Stated
consensus conference on new information technology provides an illustration. It took place just a
few months after the passage of a major bill, the 1996 Telecommunications Act, and could
therefore no longer affect the legislative choices. Even if it had taken place earlier, it would not
have affected the legislative process, for one simple reason: The lay panelists made a conscious
decision not to focus on specific policy questions, opting instead to examine a host of rather
generic issues. 69 The fact that the conference took place in Boston and not in Washington, D.C.,
certainly didn’t make it easier for these lay panelists to have a measurable impact on national
politics.
There are also more general reasons for the negligible role consensus conferences have
played in policy-making. Chief among them is their uncertain and precarious place in the
67
68
69
Einsiedel and Eastlick, "Consensus Conferences as Deliberative Democracy."
Ibid.
Guston, "Evaluating the First U.S. Consensus Conference: The Impact of the Citizens’ Panel on
Telecommunications and the Future of Democracy."
275

legislative and regulatory process. Consensus conferences are not initiated by regulators or the
legislative branch. Members of parliament and regulators therefore regard them with
considerable skepticism, as the first British consensus conference on agricultural biotechnology
demonstrated. At the end of the conference, Lord Howie of Troon, chair of the Lords Select
Committee on Biotechnology, after offering the obligatory laudatory remarks went on to explain
in no uncertain terms that the consensus conference report would have no influence on the
parliament. 70
Apparently, the organizers of the first German consensus conference on
reproductive technologies received a similarly frosty reaction from members of the German
parliament.
That legislators and bureaucrats are not willing to relinquish their authority is not surprising.
Consensus conferences may be perceived as an attempt to shift the center of political gravity
from elected representatives and government bureaucracies to the general public. They also
undermine well-established administrative norms. Yet it would be shortsighted to conclude that
the main reason for the failure of consensus conferences to influence national politics is the
(understandable) tendency of politicians and bureaucrats to protect their turf. Just as important is
the naïve understanding of the public, of democracy, and of democratic participation displayed
by advocates of participatory methods. One can hardly fault politicians for pointing out that that
unlike a lay panel, a parliament is a far better and more legitimate representation of the general
public.
An important lesson to be learned from consensus conferences is that size matters.
Organizers of consensus conferences often invest inordinate amounts of time and financial
resources to ensure “balance,” but invariably convene exceedingly small panels. For example,
organizers of the 2001 German consensus conference on reproductive medicine invested
approximately two years recruiting a panel of only 19 members. 71 Other organizers of consensus
conferences have managed to recruit panels of laypersons much faster by focusing on their
regions. The U.S. consensus conference on telecommunication and the Canadian consensus
conference on agricultural biotechnology took this approach. Yet promoters of consensus
conferences have never attempted to broaden participation beyond the usual dozen citizens.
In sum, consensus conferences can be considered deliberative as we understand this term.
They can also be said to rely on knowledgeable panelists. However, consensus conferences, like
most other tools of public participation, do not ensure representativeness, and while they may be
balanced in terms of key socio-demographic variables, they may be unbalanced with respect to
pre-deliberative views and opinions. In its present form, therefore, a consensus conference is not
a viable institutional option.
70
71
Purdue, "Experiments in the Governance of Biotechnology: A Case Study of the UK National Consensus
Conference," p.92.
Silke Schicktanz and Jörg Naumann, eds., Bürgerkonferenz: Streitfall Gendiagnostik. Ein Modellprojekt Der
Bürgerbeteiligung Am Bioethischen Diskurs (Dresden: Deutsches Hygiene-Museum, 2003) p.57-68.
276

10.9 Public Participation at the Federal Level
The post-World War II era has witnessed a continuous expansion of public participation
efforts in administrative decision-making. “Public participation” originates in the concept of selfgovernance,
a concept that, like accountability, is at the core of many American institutions of
government. Numerous instances of federal statutes include provisions for public involvement
above and beyond the requirements of the Administrative Procedure Act. Among these statutes
are the National Environmental Policy Act of 1969, the Resource Conservation and Recovery
Act of 1994, the Comprehensive Environmental Response, Compensation, and Liability Act of
1980, and the Endangered Species Act of 1973. Other statutes that mandate public participation
are the Clean Water Act of 1972 72 and the Federal Advisory Committee Act of 1972. 73 The
Onshore Oil and Gas Leasing Reform Act of 1987 requires public participation before issuing a
lease of public lands. 74 Agencies such as the EPA and the DOE have promulgated regulations
that mandate public involvement for a variety of federal statutes. For example, 40 C.F.R. 25.7
(1989) requires establishing citizen advisory groups under the Clean Water Act, the Resource
Conservation and Recovery Act, and the Safe Drinking Water Act.
Statutes requiring broader public participation in the rule-making process reflect mainly the
expectation that public involvement will increase confidence in federal agencies operating in
controversial regulatory environments and prevent conflicts and reduce litigation. For this
reason, federal regulators’ experience in implementing these provisions is of considerable
interest to our discussion. As we show in the remainder of this chapter, these expectations often
are not met, partly because Congress provides precious little guidance on how an agency should
implement these provisions, but also because these statutes do not address the inherent tension
between administrative prerogatives and public demands. Confronted with a host of difficult
implementation questions, an unpredictable, noisy, and uninformed public, and aggressive
interest groups, federal agencies have responded by adopting administrative strategies that
minimize public input by restricting the scope of public comments, by soliciting public input at a
late stage in the policy-making process, and by relying heavily on public hearings. In short,
statutory provisions mandating public involvement have often not produced the expected results.
In the next two sections, we elaborate on these themes by focusing on two statutes, the National
Environmental Policy Act (NEPA) and the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA).
72
73
74
See 33 U.S.C. 1251(e) (1994).
See 5 U.S.C. 1-15 (1972).
See 30 U.S.C.A. 226(f) (1986).
277

10.9.1 The National Environmental Policy Act of 1969
NEPA is often referred to as the father of all environmental statutes, the “Magna Carta” of
the environmental movement – and with good reason. 75 With NEPA, Congress enacted a very
ambitious statute that, among other things, was supposed to “encourage productive and enjoyable
harmony between man and his environment; to promote efforts which will prevent or eliminate
damage to the environment and biosphere and stimulate the health and welfare of man […].” 76
The centerpiece of these efforts is the environmental impact statement (EIS), a detailed
description of possible negative impacts on the environment. Section 102(C) of the statute
requires the agency to make the EIS, along with comments from other federal agencies with
relevant expertise, available to the general public for comments. Following the statute’s passage,
the Council on Environmental Quality (CEQ), the executive office administering NEPA,
promulgated numerous regulations that translated these rather generic requirements into specific
obligations.
NEPA does not establish specific performance standards. It achieves its main goal
procedurally by requiring federal agencies to develop methods and techniques to study the
impact of their endeavor on the natural environment and to make a “determination of
significance” thereof. In this, NEPA was a visionary statute, anticipating by more than 20 years
modern tools of environmental management such as the ISO14000 set of standards. NEPA also
fosters what could be described as a dialogue with the public: Agencies have an obligation to
inform the public about a project’s environmental impact by disseminating the EIS. The public,
for its part, is given an opportunity to improve on the quality of the analysis by submitting
comments.
There is no doubt that NEPA has been widely successful in broadening the decision-making
process beyond contractual stakeholders. Environmental groups quickly recognized that the
rhetoric of “public participation” would have shifted the center of political gravity from the
agencies and their closest clients to a much larger universe of advocacy groups, neighborhood
associations, ad hoc citizens’ coalitions, and just plain folks. Legislators had hoped that a more
inclusive process of decision-making would have increased the legitimacy of the final outcome
and reduced litigation. More than 35 years after the enactment of this statute, it has become clear
that NEPA, far from quelling public controversies over federal projects, has actually contributed
to amplifying them. The end result, according to some commentators, has been both
administrative paralysis and litigiousness.
The fact that consulting with the public has in some cases paralyzed the bureaucratic
machinery is not necessarily an indication of political failure. One could argue that injecting
public views and allowing environmental groups to comment on proposed projects actually has
contributed to correcting a political failure characterized by distorted planning processes in
75
76
Michael C. Blumm, "The National Environmental Policy Act at Twenty: A Preface," Environmental Law 20
(1990).
See P.L. 91-190, Section 2.
278

which only business and developers’ interests were effectively represented. Yet it is hard to
avoid the conclusion that over time, this welcome correction has degenerated into unjustifiable
administrative paralysis. 77
To appreciate the reasons for this state of affairs, a brief discussion of the rules of public
participation under NEPA is necessary. Per CEQ regulations, NEPA requires an agency to
prepare an EIS for all “major actions significantly affecting the quality of the human
environment.” It is the agency’s responsibility to determine whether the proposed action should
be considered “major” and whether its impact on the environment is “significant.” If the
proposed action is not deemed major, then it is not subject to NEPA’s provisions. If a project is
thought to be major but its impact is not “significant,” then the proposing agency needs only
prepare a much-less-demanding environmental statement focusing on whether the proposed
action may have a significant impact on the human environment. Whether a project is considered
significant is, once again, a determination made by the agency itself. 78
The 1978 CEQ regulations lay out in some detail the procedural rules governing the
preparation of an EIS. The first step is called “scoping.” During scoping, the agency determines
which issues should be considered and how they should be ranked. Scoping requires input from
other agencies as well as the general public. The public may provide comments in writing or at
meetings organized by the agency. Following scoping, the agency prepares a draft EIS, which it
makes available to the general public for comment. Interested parties must be given a minimum
of 45 days to respond.
CEQ regulations are more demanding than APA requirements in that they allow more time
for response; they also require the agency not only to announce the publication of the draft EIS
in the Federal Register, but also to actively solicit comments from “those persons or
organizations who may be interested or affected.” 79
This usually means announcing the
publication of the draft EIS in local papers and notification by mail. In addition, CEQ regulations
require the agency to hold public hearings on the draft EIS if there is “substantial environmental
controversy concerning the proposed action or substantial interest in holding the hearing […].” 80
After receiving comments from the public and from other agencies, the proposing agency
produces the final EIS. The public again has 30 days after publication of the final EIS to
comment before the agency makes it final determination, described in the “record of decision,”
or ROD. The ROD must, among other things, state the agency decision and the alternatives
77
78
79
80
As for example in the case of decision-making and the National Forest Service. Cf. Stark Ackerman,
"Observations on the Transformation of the Forest Service: The Effects of NEPA on Forest Service Decision
Making," Environmental Law 20 (1990), p.710.
William Murray Tabb, "The Role of Controversy in NEPA: Reconciling Public Veto with Public Participation in
Environmental Decisionmaking," William and Mary Environmental Law and Policy Review 21 (1997), p.185-92.
See 40 C.F.R. 1503.1(a)(4).
See 40 C.F.R. 1506.6(c).
279

considered in the process, identify the preferable alternatives from an environmental standpoint,
81 82
and discuss the criteria used to make the final determination.
This seems an eminently rational and transparent way to structure a complex decisionmaking
process, one with ample opportunity for all interested and affected parties to be heard.
Yet the (somewhat naïve) hope that a broader process of public involvement would produce
strong public support for bureaucratic decisions rarely has materialized. A case in point is the
U.S. Army Corps of Engineers, which in the late 1970s became a frequent target of
environmental groups’ discontent after NEPA provided a systematic opportunity to challenge the
Corps approach to waterway management. In a short time, the agency went from an organization
proud of its engineering accomplishments to a paralyzed bureaucracy incapable of meeting its
public mandate. 83
That broader public involvement produced more controversy is not entirely surprising given
the history of technocratic decision-making at many federal agencies. Public servants
traditionally have privileged technical expertise over processes of public consultation, in part
because of dominant professional norms, but also as a means to protect their power and
authority. By allowing the public to participate in a hitherto bureaucratic process of decisionmaking,
the cultural clash between administrative culture and pluralist impulses became visible.
Whereas agency representatives had traditionally emphasized and cultivated technical expertise,
representatives of interest groups and members of the general public espoused a pluralist view of
public policy, one in which every view is equally legitimate.
From a bureaucratic standpoint, public participation can be reduced to two basic steps: The
agency “informs” the public about its plans, and the public registers with the agency its
disagreement and discontent. To the extent that an agency relies on input provided by the public,
it does so to ensure that it has complied with its procedural requirements. An actual dialogue,
even in embryonic form, does not take place. On the one end, the agency deems the public
simply incapable of appreciating the technical complexities involved in preparing an EIS; on the
other, the public perceives the agency as incapable or unwilling to provide technical information
in a clear and transparent way.
Pluralism has profoundly affected not only how the general public and interest groups view
government bureaucracies, but also how public administrators interpret their mandate to involve
the public. In a sense, administrators unconsciously have absorbed the main tenets of public
choice theory – that citizens, like any other individuals in the political arena, are rational
individuals with fixed preferences exclusively interested in maximizing their private utility. In
81
82
83
Paul J. Culhane, "NEPA's Impacts on Federal Agencies, Anticipated and Unanticipated," Environmental Law 20
(1990), p.691-93; Jonathan Poisner, "A Civic Republican Perspective on the National Environmental Policy
Act's Process for Citizen Participation," Environmental Law 26 (1996), p.68-75.
See 40 C.F.R. 1505.2(a)-(c) (1995).
Daniel A. Mazmanian and Jeanne Nienaber, Can Organizations Change? Environmental Protection, Citizen
Participation and the Corps of Engineers (Washington, D.C.: Brookings Institution, 1979).
280

this view of politics, there is no space for lofty concepts such as deliberation, reciprocal
understanding, and the pursuit of the public good.
This rather cynical view of public involvement has immediate practical consequences.
Public administrators, not expecting participatory processes to produce anything even remotely
resembling a consensus, are very unlikely to consider the impact of alternative institutions of
public participation on the quality of the participatory process. A pluralist view of public
participation is often a self-fulfilling prophecy: By assuming that participants have fixed
preferences and that no room for compromise exists, it ignores institutional options that may
reduce group polarization and may actually contribute to exacerbating the initial differences. Not
coincidentally, then, many federal agencies, while superficially complying with CEQ regulations
and court rulings, have used their administrative power to channel and restrict public
participation in myriad ways, further exacerbating the pathologies of a technocratic decisionmaking
process. 84
10.9.2 The Comprehensive Environmental Response, Compensation, and Liability Act of 1980
In 1976, recognizing the need to protect Americans from the health risks produced by
hazardous waste sites, Congress passed the Resources Conservation and Recovery Act
(RCRA). 85 RCRA is a prospective statute: It addresses future hazardous waste releases but
ignores the health risks created by pre-existing hazardous wastes. To reduce these risks and to
promote the cleanup of old industrial sites, Congress enacted the Comprehensive Environmental
Response, Compensation, and Liability Act in 1980. 86 CERCLA instructs the EPA to develop
plans for cleaning up the nation’s hazardous waste sites and imposes “several joint liabilities” on
responsible parties. What this means exactly has been the subject of much litigation, but the
original legislative intent is fairly clear: Past and present owners of a contaminated industrial site
are jointly responsible for the clean-up costs.
From the very beginning the relationship between the affected populations –(often poor,
African-American, or Latino communities) and the agency administering the statute (the EPA)
has been strained. In its original form, CERLCA provided very limited opportunities for these
populations to comment on EPA clean-up plans. 87
The agency’s credibility was severely
undermined when several studies in the 1980s showed that the EPA was apparently much more
solicitous in cleaning up hazardous waste sites located in white neighborhoods than those in the
84
85
86
87
Perkins Spyke, "Public Participation in Environmental Decisionmaking at the New Millenium: Structuring New
Spheres of Public Influence," p.277-80; Tabb, "The Role of Controversy in NEPA: Reconciling Public Veto with
Public Participation in Environmental Decisionmaking," p.177-86.
See 42 U.S.C. 6901-6999k (1988).
See 42 U.S.C. 9601-9675 (1994).
Adam N. Bram, "Public Participation Provisions Need Not Contribute to Environmental Injustice," Temple
Political and Civil Rights Law Review 5 (1996), p.161.
281

vicinity of black residential areas. 88 The preparation of the clean-up plan, a key element of the
statute, quickly became a major source of concern for the affected populations and the focal
point of the confrontation between the EPA and local environmental groups. One EPA official
reportedly characterized the relationship between the agency and minority populations as one in
which the EPA initiates remediation action with “negative trust.”
The Superfund Amendments Reauthorization Act (SARA) of 1986 partly remedied this
disastrous situation. 89 Under SARA, the EPA must notify the affected populations of its plans to
remove hazardous wastes or remediate a site. SARA gives the EPA the authority to call public
hearings as a means to inform the public about the proposed clean-up plan. The plan must
describe the clean-up alternatives considered, identify the preferred option, and provide a
rationale for the agency’s choice. The EPA also must provide extensive information about the
plan itself; in other words, it must attach a description of the plan in non-technical language. The
public has 30 days (extensible to 60 days) to submit written comments. The EPA must respond
to any “significant comment” through a “responsiveness summary” and take into account any
new information it receives. The agency must then notify the public of any changes made to the
original clean-up plan. The responsiveness summary becomes part of the administrative record
and must also be made available to the public. To assist and facilitate the participatory process,
technical assistance grants (TAGs) are available. TAGs are meant to help local organizations to
educate themselves in highly complex technical matters such as analyzing technical reports and
clean-up plans. The public also has the right to judicial review of any regulation promulgated
under the statute. Finally, SARA authorizes citizen suits against the EPA for failure to perform
nondiscretionary duties. 90
The EPA did not wait for the Superfund Amendments Reauthorization Act of 1986 to
implement its own outreach measures. Its community relations program, adopted in 1981, was
designed to improve communication with the affected populations. Among the activities
included are the early-stage involvement of local community members in characterizing the site,
the identification of key community leaders and interested parties, the establishment of a location
for information depositories and public hearings, and the appointment of an EPA community
coordinator. The most recent description of the EPA’s approach to community involvement is
contained in two documents, the Superfund Community Involvement Handbook 91
and the
88
89
90
91
Vicki Been, "What's Fairness Got to Do with It? Environmental Justice and the Siting of Locally Undesirable
Land Uses," Cornell Law Review 78 (1993); United Church of Christ Commission for Racial Justice, Toxic
Waste and Race in the United States: A National Report on the Racial and Socioeconomic Characteristics of
Communities with Hazardous Waste Sites (New York: Public Access, 1987).
See Pub. Law. No. 99-499, 100 Stat. 1613 (1986).
Bram, "Public Participation Provisions Need Not Contribute to Environmental Injustice."; Ellison Folk, "Public
Participation in the Superfund Cleanup Process," Ecology Law Quarterly 18 (1991), p.193-95; Perkins Spyke,
"Public Participation in Environmental Decisionmaking at the New Millenium: Structuring New Spheres of
Public Influence," p.284-85.
See http://www.epa.gov/superfund/tools/cag/ci_handbook.pdf.
282

Superfund Community Involvement Toolkit. 92
As even a cursory examination of these
documents and the related online resources shows, the EPA has made enormous efforts to inform
and involve the affected populations.
There is no doubt that the EPA has become much more sophisticated and effective in
dealing with what continues to be a very delicate public controversy. In other respects, however,
the EPA has not been able to reconcile community demands with bureaucratic authority and
expectations from former property owners. Officially, the EPA has moved away from a strategy
based on “communication” and adopted an approach that emphasizes dialogue – what
practitioners describe as “two-way communication.” The Superfund Community Involvement
Handbook, published in 2002, includes among its “core values for public participation” the
expectation that “People should have a say in decisions about actions that affect their lives,” and
furthermore, that public participation “includes the promise that the public’s contribution will
influence the decision.” The handbook also requires that “[t]he public participation process
communicates the interests and meets the needs of all participants.” 93
One does not need to be a public administration specialist to recognize that these generic
declarations of intent, as laudable as they may be, provide precious little guidance to
administrators in the trenches. What does it mean from an administrative standpoint that the
community “should have a say”? Should community views simply be accepted on their face
value, even if the EPA has come to the conclusion that the option advocated by the community
would produce marginal health benefits whose costs could not be justified? What if the option
favored by the community from a public health perspective is inferior to the agency-preferred
alternative? If the EPA determines that it is politically preferable to endorse the community’s
preferred option, even if it is the less-than-optimal choice, how should the EPA justify its
decision to the responsible parties?
Left without appropriate regulatory guidance, program administrators could respond in one
of two ways. They could interpret their role as a purely informational one. In this role, the EPA’s
primary responsibility is simply to adequately inform the general public, and secondarily to
“listen” to the community’s concerns. The requirement to listen, in this case, is simply a
procedural obligation, and does not entail a duty to incorporate the community’s concerns into
the clean-up plan. This strategy is entirely compatible with the technocratic instincts of many
federal agencies, and has been the EPA’s preferred mode of operation for many years. 94 It allows
the agency to formally meet its statutory mandate, but also to preserve its authority.
Alternatively, program administrators could envisage extending the clean-up process until a
consensus among the affected population and the responsible parties is reached. This option is
unlikely to garner significant administrative support, however, for several reasons. By its nature,
92
93
94
See http://www.epa.gov/superfund/tools/.
See the Superfund Community Involvement Handbook, p.7.
See, for example, Folk, "Public Participation in the Superfund Cleanup Process." for a detailed account of the
EPA approach to public involvement.
283

it significantly constraints the agency’s ability to choose the clean-up plan it deems most
appropriate. In addition, a consensus solution is exposed to the risk of legal challenge by a
disgruntled affected or responsible party. Whether this argument would stand up in a court of law
depends on the details of the case. Our point here is simply that consensus solutions produced by
ad hoc coalitions consisting of representatives of the public and responsible parties may not be
regarded as acceptable by all parties involved.
In recent times, the EPA has been experimenting with community advisory groups (CAGs).
Their predecessors, community working groups, were one element of the EPA community
relations program, but they were rarely used and were generally regarded as a conduit for
efficiently conveying important information to the affected population rather than as a potentially
viable institution of public participation. The term “advisory” suggests a more rigorous and
perhaps a more dialogic approach to community relations. Convening an advisory panel is
subject to the provisions of the Federal Advisory Committee Act, 95 which, while far from
perfect, forces the convening agency to respect certain basic procedural rules, ensures some
degree of transparency, and calls for a broad representation. A recently conducted review of five
Superfund CAGs found, among other things, that CAGs are one of the most effective means of
promoting community involvement. Not surprisingly, the review also found that broadly
representative CAGs enjoy the confidence of the communities they represent, and are more
credible in the eyes of the EPA. The study emphasized the importance of appointing CAG
members without a specific agenda, possibly an indication of the distorting political influence of
interest groups at the local level. It went on to note that unlike public hearings, CAGs are wellsuited
to be institutional platforms of public deliberation and consensus finding. Finally, the
study noted that CAGs increase the influence of the affected populations on the clean-up process,
and contribute to establish a more constructive relationship between EPA officials and local
groups. 96
CAGs are certainly not the final word on institutions of public participation, but they once
again demonstrate the crucial importance of institutional design in meeting statutory goals. The
provisions of the Federal Advisory Committee Act are a weak protection against attempts to
limit the range of views represented on these committees. And CAGs operate in a purely
advisory mode. Yet nothing would prevent the EPA from strengthening the CAGs’ role by
imposing more stringent eligibility criteria. The agency could mandate appointing CAG
members through a local election. An election would almost guarantee that CAG members
would represent much broader sections of the local population, thus mitigating the risk of group
polarization. If interest group leaders were elected, they would represent the affected population
and not just a small group of activists. Increased legitimacy, in turn, would make the CAG a
much more credible partner in dealing with the EPA. Last but not least, broadly legitimate and
95
96
See chapter 2 for a discussion.
"Community Advisory Groups: Partners in Decisions at Hazardous Waste Sites, Case Studies," (Cincinnati, OH:
National Service Center for Environmental Publications, 1996).
284

more deliberative CAGs may produce more realistic recommendations and refrain from
excessive clean-up demands, a problem that has traditionally plagued remedial actions and has
been responsible for horrendous clean-up costs. 97
In this chapter, we have argued that reproductive medicine and biomedical research are
fraught with political failures. This term indicates a gap between the policies advocated by
organized interest groups and the attitudes displayed by the general public on key policy
questions. Considerable disagreement also exists between some organized interest groups and
their core constituencies. We have suggested that an institution of public consultation would
greatly reduce the negative consequences of political failure. Public consultation is nothing new
in the American system of government. Many statutes require the administering agencies to
“consult with the public.” Its long history notwithstanding, public participation remains a
precarious exercise that often produces the exact opposite of what it was designed to achieve –
broad public support for an agency policy. A mechanism of public consultation that is likely to
produce reliable results and prevent both political failures and regulatory capture must ensure
that the participating public is representative and balanced, that it is knowledgeable, and that the
process is deliberative. But a process of public consultation is only one (albeit important)
element of a new regulatory system. In the next chapter, we examine in some detail which
organizational forms may be suitable to regulate reproductive medicine and biomedical research.
97
Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation (Cambridge, MA: Harvard
University Press, 1993).
285

286

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11 Independent Agencies
11.1 Why an Independent Agency?
Any proposal to create a new regulatory institution for biomedical technologies must ensure
that regulators remain independent. Only a proposal for a genuinely independent agency stands a
chance to be supported by organized interest groups and by a majority in Congress. What exactly
“independence” means will be discussed in some detail below, but the basic gist of the argument
can easily be summarized: we consider an agency independent if none of the affected interest
groups believes that other interest groups exercise undue influence over the agency decisionmaking.
Agency independence as understood in this report is related to but distinct from the
concept of independent agency familiar to legal scholars and public administrators. As we will
show in more detail below, independent agencies as they exist throughout the federal
government are not adequately protected against regulatory capture and political manipulations
by Congress or the office of the president. They are, however, an important means to ensure
genuine independence.
A quick look at the current political landscape demonstrates the crucial importance of
agency independence. It is no exaggeration to say that in recent times, the scientific community
has been terrified by the prospect that research freedom could be encroached upon by
ideologues, religious zealots, and radical environmental groups advancing a deeply skeptical
view of modern science. On the opposite side, an alliance of religious and conservative
organizations is deeply concerned about unbridled reproductive medicine and what they see as
growing scientific arrogance. In this political climate, the science camp has come to view any
attempt to provide legal guidance in this area as the first step toward bigotry and intolerance.
Conservative and religious groups, for their part, resist a regulatory approach on the grounds that
it would provide a governmental stamp of approval to murderous procedures. Against this
background, a proposal that does not include appropriate measures to prevent undue political
interference would simply be ignored.
Supporters of unconstrained scientific research may find the concept of agency
independence very attractive; in the current political environment, an independent agency would
provide an effective protection against attempts by conservative and religious groups to unduly
interfere with science and medicine. Protecting science is, however, not what agency
independence is designed to achieve. The concept of an independent agency is neutral. One
could just as well imagine a future administration very supportive of biomedical research being
unable to significantly affect an independent agency constrained by a statute deemed too
restrictive. In this scenario, it is the scientific community that threatens to unduly influence the
regulatory independence. The concept of independence, if it means anything, denotes an
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agency’s ability to implement Congressional intent in accordance with broad public sentiments,
possibly against the wishes of organized interest groups of any kind.
The relevance of agency independence is not limited to the U.S. context. As shown in
chapter 6, countries such as Britain, Canada, and Australia have, to different extents and in
different ways, endorsed this general principle. The British experience certainly suggests that
agency independence as envisaged by the British Parliament is a feasible and effective
proposition. In the course of its relatively short history, the Human Fertilisation and Embryology
Authority has faced numerous challenges and the wisdom of its rules and policies has often been
contested, yet until very recently, its legitimacy as the premiere regulatory authority in matters
pertaining to reproductive medicine has not been challenged. 1 The much more recently created
Australian Embryo Research Licensing Committee has received its fair share of criticisms, but to
our knowledge its existence is not in danger.
Independent agencies are nothing new in our own administrative system. Since the
establishment of the first independent agency in 1887, the Interstate Commerce Commission,
Congress has created numerous independent agencies, including the Securities and Exchange
Commission and the National Labor Relations Board (both established during the New Deal),
and more recently the Consumer Product Safety Commission, the Nuclear Regulatory
Commission, the Commodity Futures Trading Commission, and the Federal Communications
Commission. This list is by no means exhaustive. The May 2005 Unified Agenda lists 17
independent agencies, but many more are likely to exist. 2
But what is an independent agency in the U.S. system of government? Surprisingly, no
universal legal definition of this term is available. Independent agencies can differ from each
other in significant ways. Legal scholars have identified several attributes shared by most
independent agencies. 3
Appointing the head of an independent agency is a presidential
prerogative. Appointments require confirmation by the Senate – the president appoints with the
“advice and consent” of the Senate. Unlike other heads of agency, however, the head of an
independent agency does not serve “at the pleasure of the President” – the president can only
remove him or her for “cause.” In the case of the Federal Trade Commission (FTC), for example,
the removal clause maintains that “any commissioner may be removed by the President for
1
2
3
This may be about to change however, as in early 2005, the House of Commons Science and Technology
Committee has initiated a broad review of the HFEA’s mandate. See Susan Bartlett Foote, "Independent
Agencies under Attack: A Skeptical View of the Importance of the Debate," Duke Law Journal 1988 (1988);
Science and Technology Committee House of Commons, "Inquiry into Human Reproductive Technologies and
the Law: Eighth Special Report of Session 2004-05," (London: The Stationary Office, 2005); James C. Miller,
"A Reflection on the Independence of Independent Agencies," Duke Law Journal 1988 (1988); Alan B.
Morrison, "How Independent Are Independent Regulatory Agencies?," Duke Law Journal 1988 (1988); Aulana
L. Peters, "Independent Agencies: Government's Scourge or Salvation?," Duke Law Journal 1988 (1988); Glen
O. Robinson, "Independent Agencies: Form and Substance in Executive Prerogative," Duke Law Journal 288
(1988).
See http://www.gpoaccess.gov/ua/browse0505.html.
For an in-depth discussion of independent agencies and their position in the U.S. system of government, see Paul
R. Verkuil, "The Purposes and Limits of Independent Agencies," Duke Law Journal 1988 (1988).
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inefficiency, neglect of duty, or malfeasance in office.” 4 Thus, in the U.S. system of government,
agency independence has a very narrow meaning: An agency enjoys a measure of independence
from the executive branch, and from the executive branch only. Congressional oversight, in its
various forms, is fully preserved.
Most independent agencies are constituted as commissions of various sizes, though in
principle at least, an independent agency could be governed by a single individual. To our
knowledge, currently no such agency exists. Most commissions, including the Federal Trade
Commission, the Nuclear Regulatory Commission, and the Securities and Exchange
Commission, have a five-member board; a few operate with only three commissioners, and one,
the Federal Reserve Board, is governed by seven board members.
Another typical attribute of independent agencies is stacked appointments for a fixed term of
office. Stacked appointments ensure that new commissioners are replaced at a slow pace, and
that the turnover remains low. The terms of office are often set so as not to coincide with the
presidential term. FTC commissioners, for example, serve for a five-year term. Members of the
Federal Reserve Board serve for an exceptionally long 14-year term. Other commissions operate
on a three-year basis. By limiting the appointment to only one term, commissioners have greater
room for maneuver; their reappointment obviously is not a consideration in their daily work.
Independent commissions are constituted as bipartisan administrative units. Neither party can be
represented by a clear majority – another indication of the Congressional will to insulate
independent agencies from excessive political influence.
Independent commissions tend to operate in a consensual way. Commissioners debate the
pros and cons of alternative courses of action, listen to expert testimony, and try to make
decisions by consensus rather than by majority vote. Decision by consensus is normally the
preferred option; decision by majority vote is regarded both as a recognition of the difficulty of
achieving a consensus within a reasonable period of time, and of the need to avoid administrative
paralysis.
A final, perhaps less common but important attribute of independent agencies is their
accumulation of authority in legislative, adjudicative, and prosecutorial matters. In plain text,
some independent agencies make rules, preside over legal disputes pertaining to the
commission’s regulatory scope, and in some cases also prosecute civil violations of the statutes
they administer. Not all independent agencies perform all three tasks, and some executive
agencies have been assigned at least two of these functions, so this is by no means an exclusive
characteristic of independent agencies, but it seems more common for independent agencies than
for executive agencies to accumulate powers. This is also the reason why some legal scholars
believe that this administrative construction violates the separation of powers doctrine and is
therefore unconstitutional.
But what is the rationale for Congress to create an independent agency? Traditionally,
Congress has established independent agencies to oversee specific industries or policy-making
4
See 15 U.S.C. § 41 (1982).
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areas that were thought to require extensive technical expertise. Moreover, in Congress’ view,
the exercise of technical judgment should not be hampered or distorted by political
considerations. Agency independence in this case is synonymous with technocratic decisionmaking:
Technical experts are in the best position to select the most appropriate course of action;
they do so by relying on science-based, objective criteria. Non-technical considerations are
regarded as an unacceptable distortion of the decision-making process. Examples include the
regulation of nuclear power plants (by the Nuclear Regulatory Commission), of financial
markets (by the Securities and Exchange Commission), or of product safety (by the Product
Safety Commission).
On closer examination, this rationale is anything but convincing. If technical expertise and
technocratic decision-making were of such paramount importance, then it is difficult to see why
the Food and Drug Administration is not an independent agency. On the other end, some would
argue that the extreme independence enjoyed by the Federal Reserve Board cannot be justified
on technical grounds alone. These observations suggest that the Congressional rationale for
establishing independent agencies is of dubious credibility. Whatever the officially stated reasons
for Congress to establish a new independent agency, its creation usually signals a Congressional
desire to increase control over the agency at the expense of the president’s ability to shape
agency policy. Agency independence, in this sense, is simply a (perhaps marginal) shift in the
relative ability of the executive and legislative branches of government to control a regulatory
body. It most definitively does not represent a significant net increase in the agency’s ability to
implement a policy agenda that conflicts with presidential wishes or Congressional preferences.
Furthermore, independent agencies, just like any other executive agency, are exposed to the
lobbying efforts of innumerable interest groups. So it is not at all clear that the creation of an
independent agency, notwithstanding many desirable attributes of this organizational form,
would help create an agency that could operate in a genuinely independent manner.
Some commentators have argued that independent agencies are more and not less exposed to
the dangers of factionalism and capture than agencies placed under the control of the president. 5
Reducing the president’s powers to shape agency policy could deprive the agency of a powerful
political advocate. Independence originally derived from an antiquated notion of the
administrative state. In this view, an agency implementation and interpretation of the law can and
should be guided exclusively by technical rationality. Accordingly, an agency should be
insulated from any external interventions that might distort this allegedly impartial process of
decision-making. The agency is supposed to pursue the public interest, and the means for
accomplishing this goal is technical rationality. This view of the administrative state was very in
vogue during the New Deal, but it lost much of its appeal soon after the end of World War II.
During those days, agency independence was often synonymous with regulatory capture and
factionalism. Independent agencies were more exposed to the dangers of factionalism and
5
James F. Blumstein, "Regulatory Review by the Executive Office of the President: An Overview and Policy
Analysis of Current Issues," Duke Law Journal 51 (2001); Easterbrook, "Presidential Review."; Lawrence
Lessig and Cass Sunstein, "The President and the Administration," Columbia Law Review 94 (1994).
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capture than executive agencies placed under the control of the president. It is in no small
measure because of “arbitrary and capricious” decisions by both independent and executive
agencies that the Congress in 1946 passed the Administrative Procedure Act.
In what sense, then, is an independent agency a concept worth pursuing? First, for symbolic
reasons. In the eyes of the general public, it simply would not be credible on the one end to call
for strong regulatory independence and on the other to reject the creation of an independent
agency. Proponents of an executive agency would find themselves in the uncomfortable position
of having to explain why an executive agency is actually more independent than an independent
agency. Establishing an independent agency is thus a first, necessary step to ensure genuine
independence.
Political symbolism is certainly not the only reason for favoring the creation of an
independent agency. This organizational form is a far better match for what may be described as
the two main tasks facing a regulatory agency responsible for overseeing reproductive medicine
and biomedical research – implementing the Congressional mandate and adjudicating societal
disputes – than an executive agency. Consider first how the agency would go about translating
Congressional expectations into actual regulations. Let’s assume for a moment that Congress has
included a set of ethical principles in the enabling statute as outlined in chapter 3. Ethical
principles, by definition, provide merely a general sense of direction. In all but the most trivial
cases, they are not capable of unambiguously resolving a specific ethical dilemma, in the sense
that with regard to a given medical technology or research protocol, there may be several
regulatory interpretations of the same ethical principle. For example, the principle that the
agency should favor therapeutic over enhancing technologies, applied to pre-implantation
genetic diagnosis, could produce startlingly different regulations depending on exactly how the
concept of therapy is defined, and on whether the prospective parents alone should benefit from
the treatment or the benefits should be extended to the blastocysts and the future child. If
Congress does not ban reproductive cloning, the agency would also have to determine whether
this procedure should be considered therapeutic or enhancing. Sex-selection technologies would
raise analogous interpretative problems. In all these cases, the agency would be called upon to
perform a task typical of a judicial body. 6
The agency would also be called upon to adjudicate disputes over new reproductive
treatments or controversial research protocols. For example, at some point regulators may be
forced to offer a legal opinion on whether the creation of so-called designer babies is compatible
with the protection of the well-being of future children, or whether this procedure should be
considered therapeutic in the first place. Some research protocols involving mixing human and
animal reproductive tissues are also likely to require adjudication by the agency.
6
Some could argue that performing judicial tasks reflects Congress’ failure to promulgate sufficiently specific
legislation. In this view, Congress should prevent this abuse of administrative power by passing more narrowly
crafted legislation. As discussed in chapter 9, this view simply flies in the face of current administrative realities.
In addition, requiring Congress to take on regulatory tasks would produce a rigid statutory framework incapable
of responding in a timely fashion to new medical and scientific developments.
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Small decision-making bodies such as independent agencies are particularly well-suited to
take on both interpretative and adjudicative tasks. Performing these tasks requires balanced
judgment, a systematic examination of all relevant arguments, and an overall commitment to
finding consensual solutions in a deliberative fashion. In other words, this independent agency
would operate more like a court than a traditional executive agency. Its core task would consist –
after listening to the views and positions of all affected parties and the general public – of
deciding factual questions in a deliberative manner by applying the ethical principles set forth in
the enabling legislation. Central to this decision-making body are not efficiency and
effectiveness, as in the case of an executive agency responsible for implementing a
Congressional mandate, but moral authority and procedural fairness, as expressed in the rationale
offered to justify a certain finding of fact. This is not to say that this agency would not have to
perform traditional executive tasks. We will discuss some of these tasks in chapter 13. Our claim
here is simply that this independent agency’s core task is mainly judicial. For this particular task,
a small deliberative body would be the organizational form of choice.
The judicial nature of this regulatory body provides a prima facie argument against
presidential powers of removal. It would be quite disturbing, inappropriate, and detrimental to
our modern notions of democracy if a president felt compelled to intervene on behalf of specific
political constituencies in an ongoing adjudicative procedure by removing commissioners
deemed hostile. No quasi-judicial regulatory body would be viewed as an authoritative and
independent arbiter if the president had the authority to remove a commissioner deemed hostile
to the interest of one or the other presidential constituencies. Agency independence, in this case,
is indeed crucially dependent on the president not having powers of removal.
The view that adjudicatory functions within the executive branch should be removed from
presidential oversight is certainly not new. As some commentators have pointed out, the
Founding Fathers placed considerable value on a unitary executive, but they also made clear that
other values could on occasion trump unitariness. 7 Arguably, the independence of adjudicative
functions was such a value. This is not all that surprising and quite consistent with contemporary
notions of the separation of powers. This is not to say that presidents would be deprived of broad
policy-making authority, or that they would loose the ability to ensure that the administrative
apparatus conforms to their political priorities. The president can do so effectively through the
appointment process, but also through the Office of Management and Budget (OMB) regulatory
review and through presidential directives. For example, Section 1 of President Clinton’s
Executive Order 12866 of September 30, 1993, requires that all federal agencies, in deciding
whether to regulate, take all costs and benefits into account. 8 Obviously, Executive Order 12866
7
8
Lessig and Sunstein, "The President and the Administration."; Cass Sunstein, "The Myth of the Unitary
Executive," American University Administrative Law Journal 7 (1993).
Executive Order 12866, 1993, “Statement of Regulatory Philosophy and Principles” states that (a) The
Regulatory Philosophy. Federal agencies should promulgate only such regulations as are required by law, are
necessary to interpret the law, or are made necessary by compelling public need, such as material failures of
private markets to protect or improve the health and safety of the public, the environment, or the well-being of
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does little to directly affect the outcome of rule-making. It does, however, provide a specific
policy framework within which any agency of the federal government, independent or executive,
involved in regulatory activities must operate. 9 Executive Order 12866 advances a view of the
regulatory state strongly informed by cost-benefit considerations. It goes almost without saying
that at least some of the ethical principles outlined in chapter 3 would produce rules that might
not pass a cost-benefit test. Whether these rules would be incompatible with Executive Order
12866 is an interesting question that we are not prepared to discuss here.
Skeptics could argue that adjudicative functions should not lie with an independent agency,
but rather be delegated to the judiciary. We believe that there are good reasons for keeping these
functions within the executive branch. An independent commission, unlike a panel of judges,
specializes in a specific and narrow aspect of the law, in this case a statute pertaining to
reproductive medicine and biomedical research. Over time, this regulatory institution would
develop considerable expertise in adjudicating difficult bioethical controversies; the quality of its
rulings, measured by their perceived fairness in the eyes of all affected parties and the general
public, would increase, and so would the agency’s efficiency is delivering a ruling.
The emphasis we have placed on agency independence could suggest inattention on our part
to questions of accountability. A judicial body should be shielded from political manipulations.
On the other end, there is a very real danger that a quasi-judicial body, as outlined in this report,
could quickly turn into an unaccountable bureaucracy with a tendency to produce “arbitrary and
capricious” opinions. Inadequate accountability would be just as corrosive as factionalism and
capture, and must be avoided. Our discussion could have suggested that there may be an
unavoidable trade-off between agency independence and accountability. This impression is
misleading. We believe that it is quite possible to ensure both agency independence and
accountability.
The president and Congress have various means at their disposal for ensuring accountability.
Congress can threaten to use the power of the purse to induce the agency to change its course, a
threat used quite effectively in the past. Presidents, for their part, through their power to facilitate
or impede future career moves, can exercise considerable influence on commissioners taking
positions incompatible with broad public sentiments. Judicial review is also a powerful check on
agency drift. These are all familiar checks and balances. With the exception of judicial review,
these oversight measures could themselves be regarded as “arbitrary and capricious.” For this
reason, we propose to ensure accountability by other means – i.e., through mechanisms of public
consultation. How a public consultation could be embedded in traditional rule-making and what
its impact would be on the legislative and executive branch is the topic of chapter 12. Here, we
would simply like to point out that mechanisms of public consultation are likely to obviate a
long-standing problem, namely that with the ability of either branch of government to maintain
9
the American people. In deciding whether and how to regulate, agencies should assess all costs and benefits of
available regulatory alternatives, including the alternative of not regulating. […]”
Note that this directive replaced a similar one originally signed by President Reagan, and that the current
president has left Executive Order 12866 in place.
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accountability also comes the very real risk of excessive or inappropriate interventions by the
office of the president or Congress. In sum, while advocates of a unitary executive may find it
disturbing that in our proposal the president would be deprived of his or her removal powers, we
believe that these powers are not necessary to protect the agency against capture, and that they
could actually threaten the credibility and authority of this quasi-judicial regulatory body.
11.2 Design Considerations
Having justified in some detail why an independent commission is preferable to an
executive agency with a single head, in this section we proceed to discuss several additional
benefits and a few possible drawbacks of the proposed organizational format, and to examine
specific implementation options.
A deliberative body of government is much better suited to resolving complex ethical
dilemmas than a single head of agency. Deliberation is likely to produce better reasoned and
therefore more legitimate rulings. A fair judgment also requires taking into account all
perspectives, and doing so in a balanced manner. A single head of agency is simply in no
position to meet all these requirements. Another reason for preferring the commission format to a
single head of agency is that the decision-making process would be more transparent. Opening
the commission meetings to the public would likely increase the quality of the arguments in
favor of and against any given policy. It would also shield the commissioners against the most
blatant attempts to manipulate the decision-making process. 10 This is not to say that private
conversations in this regulatory context have no useful role to play. To the contrary, a measure of
privacy is indispensable for commissioners to establish relationships of mutual trust. How
exactly conflicting demands for privacy and for public access should be reconciled is not a
question with a straightforward answer.
A commission, by its very nature, is less exposed to manipulative attempts by Congressional
representatives. The history of the administrative state clearly demonstrates that often it is
precisely Congressional representatives who advance the most parochial agendas on behalf of
their constituencies. A commission format dilutes administrative authority and makes it more
difficult for politicians to directly influence regulatory process. Finally, a deliberative approach
to resolving ethical dilemmas is particularly well-suited to reconciling different interests and
ethical positions. It also helps in crafting broadly acceptable political compromises. As shown in
chapter 10, a deliberative approach to ethical controversies does not guarantee consensus or
unanimity, and under certain circumstances deliberation may even sharpen the divisions among
commissioners. On the other end, it is difficult to imagine addressing any ethical dilemmas in a
non-deliberative fashion.
Having mentioned the benefits associated with a commission format, we should mention
some potentially significant disadvantages. Scholars of public administration have pointed out
10
Making the transcripts of public meetings available to the public, as is now common across the federal
government, would also have a positive educational impact on the general public.
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that independent commissions tend to attract second-rate candidates for office. An appointment
to a federal regulatory commission generally is not a sufficient enticement to attract top
administrative talent. This is especially the case when an independent commission’s work has
become somewhat of a routine. Independent agencies are also likely to be inefficient. 11 Some
commentators have pointed out that a deliberative approach to rule-making and the search for
consensus solutions make for slow decision-making.
These criticisms are accurate, but only in a narrow sense. The kinds of skills embodied in
ambitious, top-notch administrators would be of little use in the context of a deliberative body.
Making the most efficient use of bureaucratic resources to achieve a policy goal is not what the
resolution of complex ethical dilemmas requires. Not only would top administrators not be
attracted by this body, their appointment is unnecessary and would be counterproductive. Strong
personalities with an extensive business background are a poor choice for a quasi-judicial,
egalitarian, and deliberative body of government.
The quality and competence of prospective commissioners is not likely to degrade over time
for the simple reason that medical and scientific progress will keep the agency’s work from
becoming routine. As the case of the British Human Fertilisation and Embryology Authority
demonstrates, in its 14 years history, that agency rarely has formulated a policy that did not
generate considerable public controversy. And while it is certainly true that in certain regulatory
contexts – as in the case of product safety, for example – the commission format most likely has
been the primary reason for an unacceptably slow pace of decision-making, 12 one may wonder
whether in the case of nuclear power safety slow decision-making is such a bad thing. Efficiency
is only one of several competing goals in designing a system of governance. A head of agency
most likely would resolve ethical dilemmas in a more expeditious way, but protracted judicial
review would more than compensate for increased efficiency at the regulatory stage. One simply
has to accept the fact that deliberative bodies are not designed to operate in an efficient manner,
and that producing fair and just rules in this case takes precedence over bureaucratic efficiency.
What criteria, then, should inform the design of this commission? At the international level,
there seems to be a growing consensus that a regulatory body in the area of reproductive
medicine and biomedical research should be composed of representatives of specific
constituencies. The British have been the first to adopt this approach. As discussed in chapter 6,
the HFEA governing body consists of 18 persons. In addition to representatives of the fertility
industry and the medical community, this body includes a majority of what may be called
laypersons, i.e., individuals who do not represent a clearly identifiable interest group. This was
11
12
Commentators seem to agree that independent agencies are an inefficient form of government, yet there is
precious little evidence of actual inefficiency, if by evidence we mean a systematic, comparative analysis of
decision-making within different types of government organizations. It is true that during the New Deal, the
Golden Age of independent agencies, regulatory capture and organizational dysfunction were of almost Biblical
proportions, as documented, for example, in James M. Landis, The Administrative Process (New Haven: Yale
University Press, 1938). modern independent agencies do not bear much resemblance to their ancestors.
Elliot Klayman, "Standard Setting under the Consumer Product Safety Amendments of 1981 – a Shift in
Regulatory Philosophy," George Washington Law Review 51 (1982).
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and remains the British solution to the problem of capture by factional interests. Perhaps inspired
by the British precedent, the Australian and Canadian governments have also established
regulatory bodies structured in functional terms, though in these latter two cases, it appears that
preventing regulatory capture was not of paramount importance in allocating the available slots.
We believe that an independent agency for regulating reproductive medicine and research in
the United States should not be thought of and designed as a representative body of key political
interests. Attempts to ensure representation would likely produce a large regulatory body
consisting of many narrow and mutually exclusive interests. Affected constituencies are illdefined
societal groupings with a tendency to proliferate. For example, it may not be sufficient to
ensure that the interests of prospective parents are adequately represented, because at some point,
lesbians and homosexual associations may feel that their constituents’ interests are sufficiently
distinct from those of traditional couples as to deserve separate representation. This distinction,
in turn, may encourage singles to claim their own separate seat at the regulatory table. The ART
industry and the scientific communities are likely to suffer from the same fragmentation
tendencies. As a general rule, the more homogeneous a political constituency becomes, the more
specific and narrow its interests, and the more difficult it is for its representatives to accept
political compromises, let alone produce consensual solutions. This is not to say that factional
interests should be ignored, but merely that these groups should have an opportunity to be heard
in a different setting. 13
Independent commissions are generally quite small. With very few exceptions, U.S.
independent agencies consist of only three to five commissioners (the Federal Reserve Board
being a noteworthy exception). Bureaucratic efficiency would require keeping the number of
commissioners small, but in this case, efficiency is neither the only nor the most important
design consideration, nor is size as detrimental to efficiency as commentators tend to believe.
The British and Australian regulatory bodies in the area of biomedicine are considerably larger.
The HFEA is governed by an 18-member body, as stated above, while the Australian Embryo
Research Licensing Committee consists of nine members. Whether the size of the HFEA
governing committee has had a negative impact on the ability of the British regulators to oversee
reproductive medicine in an efficient way is an interesting but also very difficult question to
answer. Anecdotal evidence suggests that in controversial and highly visible cases, the HFEA
indeed proceeded at a glacial pace. If one examines the HFEA decision-making record over its
entire existence, however, it is difficult to depict this agency as a paragon of bureaucratic
inefficiency. So while to U.S. commentators an 18-member independent commission may seem
exceedingly large, experience demonstrates that a regulatory body of this size is quite capable of
meeting its public mandate.
Another reason for not attaching too much importance to the size of a regulatory body is
that, in the case of the HFEA, for example, the slow pace of decision-making was not as much a
13
Establishing specific commission positions may also be interpreted as an unconstitutional limitation on the
presidential prerogative to appoint executive officers.
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eflection of the committee size as a conscious choice by the HFEA to resolve deep divisions
among its members by consensus rather than by majority vote. Conclusive evidence is not
available, given the British penchant to conduct business in a rather informal manner, but
anecdotal evidence suggests that the HFEA often has strived to find consensual answers to the
ethical dilemmas. Taking a vote would of course make the decision-making process considerably
more efficient, but efficiency would have been achieved at the cost of legitimacy.
One important reason for not envisaging a large commission is that a smaller commission
has a better chance to produce a genuine consensus. Yet small size has its own problems. Small
bodies are exposed to the risks of individual idiosyncrasies and perverse group dynamics in a
way that larger bodies are not. Some commissioners may become too influential; others may
become irrelevant. By contrast, the larger the group, the less idiosyncratic it is likely to become.
The influence of individual members becomes smaller the larger the body is. In addition,
members of a very small regulatory body may quickly become trapped in mechanical reactions
and argumentative frameworks that would make it very difficult for this board ever to achieve
consensus. For this reason alone, the periodic renewal of commission members may be crucial to
maintaining the commission’s ability to regulate. 14
Absent empirically validated rules for
determining the optimal size of a small regulatory body such as the one envisaged in this chapter,
we believe that a commission of seven to nine members represents a reasonable compromise
between the pros and cons of large versus small decision-making bodies.
Consensual solutions to complex ethical dilemmas contribute to increasing the legitimacy of
a controversial regulatory body in a way that a majority vote does not, though it is not entirely
obvious why this is so. Perhaps a consensual response to difficult ethical dilemmas reinforces the
regulators’ moral authority in the eyes of the general public. To the extent that all affected parties
and the public regard this regulatory body as genuinely independent, consensual solutions would
certainly make controversial policies more acceptable to the loosing factions. For this reason,
organizational design should privilege structures and procedures that favor consensus solutions.
Very little consolidated knowledge is available on how to promote achieving a consensus.
Deliberation, as often noted in this report, certainly is an important contributing factor, but its
importance should not be overemphasized. Just as important in this context is the actual
composition of the regulatory body with regard to the commissioners’ views and ethical
inclinations. Commissioners with weak preferences are preferable to candidates with very strong
views if finding consensus is indeed of paramount importance. Against this background,
appointing professional bioethicists or individuals with considerable ethical expertise may be
counterproductive. The appointment of what may be described as thoughtful generalists would
promote a deliberative process that starts from genuine ambivalent positions and fluid
preferences rather than from clearly articulated interests. The appointment of generalists all but
ensures that these individuals would not have strong allegiances to any particular constituency.
Just as important is ensuring that no particular view is overrepresented. In practice, this
14
In this regard, see Moreno, Deciding Together. Bioethics and Moral Consensus, ch.8.
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equirement is very difficult to implement, as the agency is called upon to regulate disparate
issues likely to produce different distributions of individual positions.
An obvious way to ensure consensus is for the Congress to mandate consensual decisionmaking
in the enabling legislation. This extreme measure would ensure that the agency will
promulgate only broadly supported rules and regulations, but it would also mean that as a matter
of practice, this regulatory agency will produce very little legal guidance. And consensus, in
many cases, may simply reflect a political compromise and not a genuine common view
achieved in a deliberative manner. Consensus through compromise may be an acceptable
alternative to genuine consensus when the commissioners have clear and strong preferences. In
this case, deliberation will contribute to clarifying the commissioners’ positions, but it is unlikely
to cause the commissioners to change their ethical preferences. This outcome may not be
satisfactory to advocates of deliberative democracy, but it may well be the only available option
short of deciding by majority vote – an alternative that, considering its corrosive impact on the
moral authority of a regulatory body, is far less attractive. 15
In the world of politics, it is unrealistic to expect that even the best-intentioned and
thoughtful commission would always produce a consensus. One possible alternative to making
choices either by consensus or by majority voting is to invest the chairperson with the authority
to decide on a case-by-case basis whether an ongoing rule-making process is likely to produce a
consensus. Should he or she determine that a consensus could be achieved, he or she may decide
to invest more time in deliberation; otherwise, he would simply call for a vote. Alternatively, the
enabling legislation could provide for a fixed, maximum period of deliberation, say three
months, followed by a vote. Depending on the issue under consideration, a simple majority could
suffice; in more divisive cases, a supermajority may be required.
If designed according to the criteria discussed in this report, a regulatory commission is
much more likely to promulgate consensus policies than the preceding discussion indicates. The
commission’s deliberations would take place at an advanced stage of the rule-making process. At
that stage, the commissioners would be able to review the range of positions advocated by a wide
range of affected and interested parties, as well as to gauge the public’s response to various
policy options emerging from a process of public consultation. As a practical matter, it may not
always be possible to conduct public consultation, and in some cases the consultation may not
produce an unambiguous outcome. But to the extent that a clear public inclination emerges, it
would dramatically reduce the potential for gridlock.
In discussing possible implementation options, we have privileged legitimacy, moral
authority, and consensus over efficiency, representativeness, and ethical expertise. These choices
15
There is no consensus on the actual value of deliberation in the regulatory and more generally in the political
context. In a recently published book, Judge Richard Posner has argued that deliberation is of little value to the
functioning of modern representative democracies. Cf. Posner, Law, Pragmatism, and Democracy. That the role
of deliberation is not as straightforward as sometimes assumed is not in dispute. But it would be difficult to
argue that deliberation has no impact, even on highly opinionated individuals. The change of heart displayed by
some solidly conservative Supreme Court justices seems to indicate that even highly competent and opinionated
individuals in a deliberative context may re-examine their views.
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should not be taken to suggest that the latter design considerations are unimportant, but only that
there are trade-offs in the design of an independent regulatory agency. In this sense, our
approach departs significantly from that of the British. In our view, representativeness is not
sufficiently important as to warrant explicit consideration in the design of our independent
commission. Nor is efficiency so important as to warrant reducing this independent agency to a
three-member body, though it is sufficiently important as to induce us to avoid recommending an
18-member panel. Finally, we believe that ensuring the legitimacy and credibility of this body
should have priority over its ethical and scientific expertise. This is not to say that
representativeness and ethical and scientific expertise should be neglected, but rather that
organized interest groups should have a chance to be heard in a different setting, and that the
commission should be granted access to ethical and scientific expertise by bureaucratic means.
11.2.1 The Advisory Board
Many of the limitations characterizing the British, Australian, and Canadian approaches to
regulating biomedicine can be traced to organizational trade-offs. It is simply not possible to
design a small deliberative body that is authoritative and legitimate and at the same time broadly
representative of all affected parties and knowledgeable in ethical, medical, and scientific
matters. For this reason, we propose to complement the independent commission with an
advisory board. As its name suggests, the board would not have regulatory authority. In essence,
its job would be to serve as an institutionalized communication platform between the
commissioners, the regulated community, and the general public.
The board would be designed to ensure representativeness and technical competence in all
relevant scientific fields and in bioethics. It would operate in a deliberative fashion, but would
not be required to produce consensus recommendations. Majority and minority positions would
not only be allowed but welcomed, for the reasons discussed in chapter 10. Finally, the board
would not be subject to size constraints to the same extent as the independent commission, and
could be considerably larger.
Representativeness requires elaboration. The advisory board would be representative of all
affected parties, but not as this term is normally understood. An affected party should not
necessarily be equated to any existing professional or trade association. Affected parties include
the ART industry, the scientific community, the biotech industry, and patients. Each sector
would receive a fixed and equal number of slots. Trade and professional associations and their
members would be responsible for selecting and nominating suitable candidates. For example,
the scientific community may decide that it wants to be represented by the American Association
for the Advancement of Science. In this case, AAAS would represent not only its own members,
but also the members of other scientific societies, such as the Federation of American Societies
for Experimental Biology or the American Society for Microbiology. Analogous choices would
have to be made by the ART industry and its various trade and professional associations.
There are good reasons for proposing such a broad concept of representativeness. As
repeatedly discussed in this report, the broader the sector represented by a member of this
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advisory board, the higher the chances that the advisory board will succeed in generating broadly
acceptable policy recommendations. To use the terminology developed in chapter 10, the less
homogenous the sector represented, the less likely it is that the advisory board will display
polarization tendencies.
Some commentators have observed that advisory panels, especially those meant to provide
scientific guidance, may have both a subtle and a disproportionate influence on regulatory
agencies. 16 How an ethical dilemma is framed and what language and metaphors are used to
describe the relevant ethical concerns are choices likely to affect how an independent
commission will resolve a controversy. This is why it is important that all societal perspectives
be represented on this panel, including those of laypersons. A layperson is an individual who
does not represent the interests of the ART industry, patients, the scientific community, or the
biotech industry. Furthermore, this person is not immediately or substantially affected by
advances in reproductive medicine or biomedical research, and does not have financial interests
in the sectors subject to the commission’s regulatory authority.
There are at least four reasons for appointing a substantial number of laypersons to the
advisory board. Laypersons are likely to advocate a notion of harm not limited to economic costs
or to narrowly defined health risks. They would also prevent the advisory board from focusing
exclusively on procedural matters. In addition, a significant number of laypersons would
contribute to preventing or mitigating group polarization. To this end, it would not be sufficient,
as is common practice on many science advisory boards, to appoint only one layperson.
Depolarization can only take place if all relevant views are represented in roughly equal
numbers. A fourth and final reason for including laypersons on the advisory board is their
policing role. By virtue of its position between the independent commission and the affected
parties, the advisory panel could accumulate considerable power and influence. As for any other
broker, the role of this advisory board could be both beneficial and pernicious. On the one end, it
could actively promote collaboration, consensus, and compromise. Alternatively, it could
promote a political agenda of its own. 17 Absent independent board members, it is quite possible
for a societal sector to obtain support for a policy in its interest in return for the promise to return
the favor in the future.
How many laypersons should be appointed? Our discussion of group polarization suggests
that for laypersons to develop a genuinely independent voice, their weight on the commission
should be comparable to that of other societal interests. For this reason, we propose to appoint at
least as many laypersons as representatives of any one of the other societal sectors. If the
enabling legislation does not require the advisory board to produce consensus recommendations,
16
17
Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, MA: Harvard University
Press, 1990).
This is a somewhat unusual illustration of what may be called a “political entrepreneur.” As pointed out by
Ronald Burt, an entrepreneur is an individual (or an organization) that has identified two disconnected parties
who could each benefit from cooperation but are unable to do so by themselves. Ronald S. Burt, Structural
Holes. The Social Structure of Competition (Cambridge, MA: Harvard University Press, 1992).
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then an equal number of representatives for all societal sectors, including the general public,
would be acceptable. On the other hand, if recommendations on the advisory board are made by
majority vote, then the number of appointed laypersons should be much larger – and equal that
of all interested parties combined.
The advisory board would also work with the commission to implement and operate a
suitable system of monitoring and compliance assurance. This move has both obvious and
subtler benefits. By delegating monitoring functions to the advisory board, the commission
would be able to focus on its core task. Less intuitively, delegation of monitoring and
compliance assurance to third parties is likely to produce higher levels of compliance and, in the
long run, to increase the legitimacy of government regulation in the eyes of the regulated
community. We will return to this topic in chapter 13. 18
To prevent this advisory from becoming unaccountable to its constituencies, the enabling
legislation could require that board members be in close contact with their constituencies. The
importance of this measure can hardly be overemphasized. Absent any accountability
mechanism, board members would be free to advance a political agenda that may be entirely
detached from the constituencies they supposedly represent. As noted in chapter 8, little is
known about the attitudes of scientists, reproductive doctors, or biotech companies on a broad
range of contested policy questions. There is some evidence that these constituencies do not
always endorse their association’s positions. Whether, for example, scientists share the views
and positions of the AAAS or any one of the many scientific societies operating in Washington is
debatable. Some scientific societies do make some efforts to consult with their members on
important issues, but these are exceptional cases. It is quite possible that the associations’
positions in the area of reproductive medicine and biomedical technologies are aligned with their
members’ views; yet absent specific mechanisms of consultation, this question cannot be
answered.
This requirement would not be as unusual as it may seem. As a matter of practice, many
trade and professional organizations already consult with their members on various issues of
mutual interest. And one should remember that there are significant benefits to implementing this
measure. By adopting a robust mechanism of internal consultation, the legitimacy of the
positions represented on the advisory board would greatly be strengthened.
18
The delegation of monitoring and compliance assurance functions to private parties is a classic example of what
is sometime referred to as “collaborative governance.” Jody Freeman, "Collaborative Governance in the
Administrative State," UCLA Law Review 45 (1997); Jody Freeman, "The Private Role in Public Governance,"
New York University Law Review 75 (2000); Lester M. Salamon, Partners in Public Service: Government-
Nonprofit Relations in the Modern Welfare State (Baltimore, MD: Johns Hopkins University Press, 1995).
Collaborative governance describes an approach to government in which a government agency plays a prominent
role, but is by no means the only relevant actor in the implementation of public policies.
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11.2.2 The Advisory Board as a Board of Directors?
The appointment of representatives of the general public to a federal advisory board is
certainly unusual within government, but it would not be exceptional in the private sector. The
type of advisory board envisaged in this report is not too dissimilar from a board of directors. In
the United States, it is common practice to appoint independent board directors, but this
corporate role is relatively new. To appreciate its importance, it is instructive to revisit the
motivations for creating independent board members.
In the late 1970s, a string of highly visible corporate scandals prompted the business and
legal communities to reexamine the then-dominant approach to corporate governance. 19 At the
time, the debate was informed by the assumption that poor corporate governance was the direct
consequence of the sharp separation of ownership and control. In a nutshell, shareholders “own”
the corporation, but they have very little say in how it is managed. Conversely, management is
largely responsible for both strategic decisions and the day-to-day operations, but it has few if
any property rights in the firm. One of the main tasks of the board of directors, then, is to ensure
that the shareholders’ and senior management’s interests are aligned. This includes monitoring
strategic decisions and preventing opportunistic behavior by senior management – i.e.,
management choices designed primarily to benefit senior management to the detriment of the
company. 20
As a matter of practice, this laudable construction has been of limited effectiveness. Because
senior management often appoints the board members, and because those board members used to
be subordinates, their willingness to intervene in managerial decisions is limited. In other cases,
top individuals in management would simply appoint themselves to the board. Not surprisingly,
then, early studies found that boards of directors play a largely passive role in governing
corporations and are in no position to challenge senior management’s decisions. 21
A proposal that eventually garnered considerable support in both the legal and business
communities was the appointment of independent or outside board members. Independent
directors were meant to increase both the independence of the board of directors from top
management and the board’s ability to prevent opportunistic behavior. The notion of the
independent (or outside) director is itself broad, and can be interpreted in various ways.
Formally, an outside director is an individual who is not currently employed by the corporation
he or she is meant to oversee. Practically, this may include former employees, retired executives,
19
20
21
Stephen M. Bainbridge, "Independent Directors and the ALI Corporate Governance Project," George
Washington Law Review 61 (1993); Melvin A. Eisenberg, "Corporate Governance: The Board of Directors and
Internal Control," Cardozo Law Review 19 (1997); Roberta S. Karmel, "The Independent Corporate Board: A
Means to What End?," George Washington Law Review 52 (1984); Mark J. Loewenstein, "The SEC and the
Future of Corporate Governance," Alabama Law Review 45 (1994).
“Opportunistic behavior” indicates the pursuit by senior management of its own financial interests to the
detriment of shareholders’ best interests.
Myles L. Mace, Directors: Myth and Reality (Boston: Graduate School of Business Administration, Harvard
University, 1971); Lewis D. Solomon, "Restructuring the Corporate Board of Directors: Fond Hope: Faint
Promise?," Michigan Law Review 76, no. 4 (1978).
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or individuals who have been selected by the CEO because of their close personal ties to top
management. These individuals, while technically outsiders, do not meet any strong, substantive
notion of independence. 22
Other commentators have submitted that the outside director’s role is not simply one of
monitoring senior management on behalf of the shareholders, but of representing a broad range
of societal constituencies, including employees; representatives of women, minorities, and
environmental groups; key corporate customers; consumer groups; representatives of the
financial community; and large institutional investors. The inclusion of these stakeholders serves
several purposes, including obtaining access to information, reducing coordination costs,
facilitating access to capital, obtaining independent advice, providing a mechanism of early
warning, and, last but not least, protecting the corporation’s public image. 23
Over the last 20 years, the composition of U.S. boards of directors has shifted significantly
to reflect these demands. As of 1998, corporate boards of publicly traded corporations had on
average 11 directors, but only two inside directors, down from three inside directors in 1993 and
five in 1973. 24 Paradoxically, it is not entirely clear that the inclusion of outside directors has
improved corporate boards’ ability to prevent corporate misconduct. The empirical evidence in
this regard is mixed. 25 There are straightforward reasons for doubting the effectiveness of outside
directors, some of which we have already alluded to: Outside directors may be insiders in
disguise. They may lack either the expertise or the resources (or both) to closely and competently
monitor senior management. Crucially, they may not have access to the information necessary to
accurately assess the performance of senior management. Lastly, they may not be inclined
openly to challenge senior management and risk losing their positions on the board. 26
Perhaps paradoxically, independent board members are much more likely to meet the
expectations imposed on them in the regulatory context than in the business sector. Monitoring
the independent commission is a straightforward task, and concerns regarding the competence of
these board members are of secondary importance, because their responsibility would not entail
assessing complex technical matters. In short, the effectiveness of independent board members is
likely to be far greater in government than in the private sector.
11.2.3 Appointment Rules
Identifying suitable appointment criteria for independent board members presents a bit of a
challenge. There is certainly no dearth of organizations that would feel quite comfortable
22
23
24
25
26
Victor Brudney, "The Independent Director: Heavenly City or Potemkin Village?," Harvard Law Review 95, no.
3 (1982).
Lynne L. Dallas, "The Multiple Roles of Corporate Boards of Directors," San Diego Law Review 40 (2003),
p.796-800.
Ibid., p.787.
For a discussion see, Kathleen A. Farrell and David A. Whidbee, "The Consequences of Forced CEO Succession
for Outside Directors," Journal of Business 73, no. 4 (2000).
Brudney, "The Independent Director: Heavenly City or Potemkin Village?."
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suggesting candidates. They include religious organizations such as United States Conference of
Catholic Bishops and the Southern Baptist Convention, socially conservative organizations such
as the Family Research Council, and secular groups such as the Center for Genetics and Society.
Most of them would likely see themselves as legitimate representatives of the general public, or
at least as representing views not associated with the regulated community. Each of these groups
would inject a distinctive perspective into the debate and could be expected to oppose the ART
industry and the scientific community on many key issues. From a pluralist perspective, this
indeed would seem a natural way to select independent board members.
Our analysis of the current legislative stalemate in chapter 10 suggests that this would not be
a wise move. By mechanically appointing representatives of opposing interest groups, we would
simply replicate on a smaller scale the current political gridlock. Furthermore, including
constituencies on the advisory board that are not directly and negatively affected by regulatory
interventions could be problematic, if not downright arbitrary. In the current litigious climate, it
would be very difficult to justify why one particular organization should be preferred to an
equally credible group. Conceivably, one could envisage adopting the same procedure laid out
for appointing the representatives of affected parties: Interested organizations are responsible for
identifying broadly acceptable candidates for the available slots. In this case, however, we are
not dealing with a reasonably homogeneous organizational universe, and there is little chance
that these organizations would agree on common candidates. For these reasons, appointing
laypersons in the narrow sense of this term is a preferable option.
We propose that the head of an executive agency – for example, the head of the Department
of Health and Human Services – be charged with appointing independent board members. The
enabling legislation should provide considerable guidance as to what constitutes an independent
commissioner. This point should not be underestimated. Even a cursory examination of an
average advisory board charter would demonstrate that agency heads have a tendency to ignore
the Federal Advisory Committee Act’s calls for “fair and balanced” appointments, instead
simply filling these slots with political allies. Several desirable characteristics of an independent
advisory board member have already been identified: An independent board member should not
have strong ties to the ART or the biotech industries or to the scientific community. A financial
interest in the ART or biotech industries would most likely be regarded as prejudicial. A
biomedical scientist would also not qualify for a position as an independent board member,
though perhaps other natural scientists and in particular social scientists might. An independent
board member should not have close relatives affected by medical conditions that could be cured
by promoting certain types of research. 27 Most importantly, perhaps, these individuals should
bring with them the analytical skills and life experience necessary to navigate complex questions
at the intersection of ethics, science, and medicine.
27
We are certainly not suggesting that the patients’ interests should be ignored. We believe that their interests are
adequately represented by both patient groups and the scientific community.
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How should these individuals be identified? Standard random sampling techniques followed
by a standardized interview would produce a sizeable pool of suitable candidates. We believe
this approach is superior to the British approach in terms of procedural fairness, in that it would
not be subject to self-selection bias, and the selection criteria would be established in advance. In
order to further reduce possible sources of administrative drift, independent board members
could be selected at random from the pool of suitable candidates. In turn, this suggests that in
addition to the selection criteria discussed above, it may be necessary to ensure balance in terms
of regional representation and socio-demographic characteristics. Alternatively, the head of
agency could personally select independent board members based on a personal conversation.
Selection through a head of agency would probably identify better-suited candidates, but in the
current political climate, it is unlikely to be acceptable to all affected parties. The technocratic
alternative may not produce equally capable independent directors, but it is a practicable solution
and would not be regarded as biased. 28
28
The novel nature of this appointment process may require Congress to periodically revisit the enabling
legislation and update appointment rules and procedures based on past experience.
311

312

11.3 Bibliography
Bainbridge, Stephen M. "Independent Directors and the ALI Corporate Governance Project."
George Washington Law Review 61 (1993): 1034-83.
Bartlett Foote, Susan. "Independent Agencies under Attack: A Skeptical View of the Importance
of the Debate." Duke Law Journal 1988 (1988): 223-37.
Blumstein, James F. "Regulatory Review by the Executive Office of the President: An Overview
and Policy Analysis of Current Issues." Duke Law Journal 51 (2001): 851-99.
Brudney, Victor. "The Independent Director: Heavenly City or Potemkin Village?" Harvard Law
Review 95, no. 3 (1982): 597-659.
Burt, Ronald S. Structural Holes. The Social Structure of Competition. Cambridge, MA: Harvard
University Press, 1992.
Dallas, Lynne L. "The Multiple Roles of Corporate Boards of Directors." San Diego Law Review
40 (2003): 781-820.
Easterbrook, Frank H. "Presidential Review." Case Western Reserve Law Review 40 (1990):
905-29.
Eisenberg, Melvin A. "Corporate Governance: The Board of Directors and Internal Control."
Cardozo Law Review 19 (1997): 237-64.
Farrell, Kathleen A., and David A. Whidbee. "The Consequences of Forced CEO Succession for
Outside Directors." Journal of Business 73, no. 4 (2000): 597-627.
Freeman, Jody. "Collaborative Governance in the Administrative State." UCLA Law Review 45
(1997): 1-98.
———. "The Private Role in Public Governance." New York University Law Review 75 (2000):
543-675.
House of Commons, Science and Technology Committee. "Inquiry into Human Reproductive
Technologies and the Law: Eighth Special Report of Session 2004-05." London: The
Stationary Office, 2005.
Jasanoff, Sheila. The Fifth Branch: Science Advisers as Policymakers. Cambridge, MA: Harvard
University Press, 1990.
Karmel, Roberta S. "The Independent Corporate Board: A Means to What End?" George
Washington Law Review 52 (1984): 534-56.
Klayman, Elliot. "Standard Setting under the Consumer Product Safety Amendments of 1981 – a
Shift in Regulatory Philosophy." George Washington Law Review 51 (1982): 96-112.
Landis, James M. The Administrative Process. New Haven: Yale University Press, 1938.
Lessig, Lawrence, and Cass Sunstein. "The President and the Administration." Columbia Law
Review 94 (1994): 1-120.
Loewenstein, Mark J. "The SEC and the Future of Corporate Governance." Alabama Law
Review 45 (1994): 783-815.
Mace, Myles L. Directors: Myth and Reality. Boston: Graduate School of Business
Administration, Harvard University, 1971.
Miller, James C. "A Reflection on the Independence of Independent Agencies." Duke Law
Journal 1988 (1988): 297-99.
Moreno, Jonathan D. Deciding Together. Bioethics and Moral Consensus. New York: Oxford
University Press, 1995.
313

Morrison, Alan B. "How Independent Are Independent Regulatory Agencies?" Duke Law
Journal 1988 (1988): 252-56.
Peters, Aulana L. "Independent Agencies: Government's Scourge or Salvation?" Duke Law
Journal 1988 (1988): 286-96.
Posner, Richard A. Law, Pragmatism, and Democracy. Cambridge, MA: Harvard University
Press, 2003.
Robinson, Glen O. "Independent Agencies: Form and Substance in Executive Prerogative." Duke
Law Journal 288 (1988): 238-51.
Salamon, Lester M. Partners in Public Service: Government-Nonprofit Relations in the Modern
Welfare State. Baltimore, MD: Johns Hopkins University Press, 1995.
Solomon, Lewis D. "Restructuring the Corporate Board of Directors: Fond Hope: Faint
Promise?" Michigan Law Review 76, no. 4 (1978): 581-610.
Sunstein, Cass. "The Myth of the Unitary Executive." American University Administrative Law
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Verkuil, Paul R. "The Purposes and Limits of Independent Agencies." Duke Law Journal 1988
(1988): 257-79.
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12 Designing Mechanisms of Public Consultation
A key element of our regulatory proposal is an institutionalized mechanism of public
consultation. In chapter 10, we have argued that consulting with the public is necessary to
mitigate the distorting impact of interest group politics, while in chapter 11, we have shown that
an institution of public consultation is indispensable both to ensure agency independence and to
prevent factionalism. In the following discussion, we lay out in some detail how it may be
possible to implement institutions of public consultation that meet the requirements discussed in
section 10.7: The agency must ensure that the consulted public is a representative sample of the
general population, that the sample is balanced, that the consulted public is adequately informed,
and, last but not least, that the process is deliberative.
With regard to the implementation of mechanisms of public consultation, it is crucial that
the enabling legislation be sufficiently specific. First, the public should be consulted on any new
regulatory initiative. Second, Congress should specify in some detail what criteria a consultative
mechanism should meet. Third, Congress should mandate that the consultative process be
conducted at the early stages of the rule-making process, in parallel to traditional consultations
with organized interest groups, and in any case well before the announcement of a proposed new
rule. Fourth, the enabling statute should require that the outcomes of any process of public
consultation be published as soon as the consultation has been concluded, but in any case no later
than the publication of a proposed new rule. All materials related to the consultation process
must be made available to the general public.
In the remainder of this chapter, we explore two possible mechanisms of public consultation,
deliberative panels and the consultative college. These two institutions of public consultation are
reminiscent of James Fishkin’s “deliberative polls.” 1 Like Fishkin, we emphasize the role of
informed public opinion in policy-making. Our approach differs from Fishkin’s in that feasibility
considerations play a more prominent role in our discussion. Another important difference is the
role played by consultative processes in the administrative system. In our view, institutions of
public consultation should strengthen representative democracy, not be regarded as a possible
substitute. Accordingly, we articulate more precisely the role of institutions of public
consultation in the regulatory process.
1
James S. Fishkin, "Deliberative Polling and Public Consultation," in Deliberative Democracy in Theory and
Practice ( Turin: European Consortium for Political Research, 2002); James S. Fishkin, "The Televised
Deliberative Poll: An Experiment in Democracy," Annals of the American Academy of Political and Social
Science 546 (1996); James S. Fishkin and Chair Patterson-Bannister, "Virtual Democratic Possibilities:
Prospects for Internet Democracy" (paper presented at the Internet, Democracy and Public Goods, Belo
Horizonte, Brazil, November 6-10, 2000); Iain S. McLean, "Does Deliberation Induce Preference Structuration?
Evidence from Deliberative Opinion Polls" (paper presented at the American Political Science Association
Annual Meeting, Washington, D.C., August 30-September 4, 2000, 2000).
315

12.1 Deliberative Panels
Deliberative panels expand and refine the concepts of consensus conferences and citizens’
panels discussed in chapter 10. They address three important shortcomings of the latter two
institutions of public participation: The views expressed by participants in consensus conferences
and citizens’ panels carry very limited political weight, the size of these groups is too small to be
regarded as indicative of broad public sentiments, and they tend to produce polarized opinions.
Increasing the political weight of deliberative panels is a straightforward process. Instead of
convening just one panel, regulators should run numerous deliberative panels. As we show
below, convening a significant number of deliberative panels is both logistically feasible and
financially affordable. Surprisingly, proponents of participatory methods, to our knowledge, have
never entertained this possibility, an indication that there is a considerable room for
experimentation and innovation in this area.
Deliberative panels differ from consensus conferences and other participatory tools in that
they are not expected to produce a consensus. The purpose of convening a deliberative panel is
to identify and evaluate ethical concerns, and – depending on the issue under consideration – to
rank policy options from the most to the least desirable. This is in keeping with our conviction
that deliberation can provide clarification and an appreciation of complex ethical questions, but
cannot be expected to always move the participants toward consensual positions.
Preventing group polarization from distorting the final outcome presents a challenge. A
sample of the general public based on the usual socio-demographic variables is likely to produce
an uneven pre-deliberation distribution of existing views. This means that it may be difficult to
assemble a large number of small deliberative groups with an equal number of views in favor of
and against a regulatory proposal. As we have repeatedly pointed out in this report, deliberation
among members of an unbalanced group could reinforce a priori beliefs and induce group
polarization. Obviously, this is not a desirable outcome, if indeed this shift is caused exclusively
by a pre-deliberation bias. An institution of public consultation must be neutral with regard to the
possible final outcomes.
Fortunately, a straightforward solution to this problem exists. If we assume that the
participants’ attitudes are not extremely skewed, it is relatively easy to assemble two
representative samples of the general public, one consisting of individuals generally supportive
of and the other of citizens opposed to a given policy option. If the public holds views pro and
con in roughly equal proportions, or if the public has no strong opinions or else is ambivalent
about a new biomedical development, assembling balanced pre-deliberation panels is a
straightforward process. In these cases, it is particularly important that the consultation process
does not itself turn into a source of significant distortions by exacerbating polarization
tendencies.
Public consultation does not become superfluous if a large fraction of the general public
holds specific views. As we have argued in chapter 8, survey results often are exposed to the
criticism that they merely reflect superficial views held by uninformed citizens. A mechanism of
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public consultation is immune to this criticism. In this case, ensuring balance not only is far less
important, but it also could also be seen, with some justification, as an attempt by the regulators
to manipulate public opinion.
An alternative method to control for skewed pre-deliberation positions is to explicitly
include this information in the analysis. Assuming that a sufficiently large number of panels have
been convened, a statistical analysis will reveal the impact of the pre-deliberation bias on the
final outcome. This approach makes a fairly complicated sampling process unnecessary and is
less costly, but it may require a larger sample.
12.1.1 Questions of Implementation
Experience suggests that each deliberative panel should consist of no more than 10 to 12
participants. Larger groups would make it difficult to sustain genuine group discussions; smaller
groups would require convening a much larger number of panels and would make the logistics
too complex.
Participation in deliberative panels should not require citizens to commit a weekend or even
a full day, as has often been the case for consensus conferences. Depending on the complexity of
the issue under consideration, a few hours to one afternoon should be sufficient. In the summer
of 2004, the Genetics and Public Policy Center at Johns Hopkins University in Washington,
D.C., conducted six town-hall meetings, each lasting one afternoon, on the ethical dilemmas of
new reproductive technologies. Conversations with the center staff have shown that it is quite
possible to tackle complex ethical and policy question in one afternoon, including an initial
familiarization phase.
There are several ways to familiarize the participants with the scientific aspects of
reproductive medicine and biomedical research. The panelists could be required to participate in
a short training session. Typically, this would consist of watching an introductory video or
attending a presentation. Alternatively, the participants could receive print materials ahead of
time. A well-structured online resource could complement both print and video materials.
However, while availability of information alone is unlikely to motivate prospective participants
to thoroughly familiarize themselves with complex scientific and ethical questions, this would
only be a potential problem in select cases, as both the introductory session and the deliberation
phase itself would serve to clarify most technicalities. To help the panelists feel comfortable with
complex medical and scientific questions, a panel of experts representative of all relevant
positions (industry, academic scientists, regulatory scientists, advocacy groups, and so on) would
be available to answer questions about controversial scientific claims.
Making expert opinions available to a large number of deliberative panels presents a
logistical challenge. A nationwide public consultation requires that all regions of the country
have an opportunity to be heard. This means that deliberative panels would have to be convened
at different locations around the country. As a practical matter, it may not be possible to
assemble a group of nationally recognized experts at each location, nor is it feasible for one
panel of experts to participate in every group discussion. One way to reduce the logistical
317

complexity would be to convene deliberative panels at different locations at roughly the same
time. Information technologies (such as e-mail, online chat, voice-over-IP, and teleconferencing)
would enable deliberative panels at different locations to communicate with the experts. And
while it would obviously be impossible to assemble as many expert groups as deliberative
panels, it is quite reasonable to assume that the agency could at least assemble several such
panels.
Another distinctive attribute of deliberative panels is an Internet-based information
clearinghouse, which would serve as a repository for all the educational materials (brochures,
technical summaries, scientific publications, instructional videos, and so forth) and be made
available to all participants and to the general public. The clearinghouse would also keep track of
all questions put to the experts by the lay panelists and their answers. This feature would allow
lay participants to learn from each other, and would drastically reduce the volume of questions
the experts could expect to receive. Finally, the clearinghouse would serve as a repository for all
recorded conversations among participants in each deliberative panel. Unlike other sources of
information, recordings of actual deliberations would be made available to a general audience
only after the consultation process had been concluded, and only in anonymous form.
12.1.2 Considerations of Feasibility
Deliberative panels are not entirely new, of course. In the last 20 years, there have been
various efforts, mostly involving local matters, to engage the public in policy-making. We have
discussed some of these initiatives in chapter 10. The most suggestive precedent to our proposal,
however, is not a proposal aimed to enhance public participation, but a project designed to study
the impact of jury deliberation on monetary awards in personal injury cases. This project is
remarkable, among other things, because it demonstrates that it is quite possible to convene a
very large number of deliberative panels in a limited period of time. The study in question was
based on 500 mock juries, each consisting of six citizens, with a total participation of more than
3,000 individuals – an impressive number by any measure, and certainly more than adequate to
ensure representativeness in a process of public consultation. 2
Running 3,000 people through 500 mock juries turned out to be a surprisingly
straightforward task, partly because the organizers limited the time for deliberation to only 30
minutes. Each session lasted one-and-a-half hours. It took the study authors only five
consecutive weekends (consisting of a Friday, Saturday, and Sunday) to complete the study. On
each day, the group ran eight sessions, each including four simultaneous juries. Recruitment
started approximately three weeks before the first weekend. Assuming recruitment costs of $35
per person, financial incentives to participate in this effort of $100 per participant, and including
personnel costs, convening 500 mock juries would cost approximately $450,000 dollars.
These figures demonstrate that the logistics of organizing and running even a large number
of deliberative panels are not overly complex, that the time required for conducting a process of
2
Schkade, Sunstein, and Kahneman, "Deliberating About Dollars: The Severity Shift."
318

public consultation is modest, and that the cost is reasonable. In the case of a national
consultative process, the convening agency would have to run things somewhat differently. The
deliberative phase would have to be extended considerably. Regulators would have to budget for
expert participation, for moderators, and for the implementation and maintenance of the Webbased
clearinghouse. On the other end, the agency could assemble groups up to twice as large.
Furthermore, to ensure representativeness, a sample of approximately 1,000 participants would
suffice. Nevertheless, the overall costs for a consultative process are likely to exceed the above
figure. This sum is not negligible, to be sure, but well worth it if it contributed to crafting a
national consensus on highly controversial matters pertaining to reproductive medicine and
biomedical research.
As for the online clearinghouse, a few suggestive precedents exist. Our own Human
Biotechnology Governance Forum was intended to achieve similar goals, but constraints on
financial resources have prevented us from fully implementing it. 3
In its present form, the
Human Biotechnology Governance Forum includes almost 3,000 news stories on scientific and
policy developments, as well as dozens of commentaries and editorials. It also incorporates
analysis and resources sections, the former focused on scholarly analysis and the latter intended
as a tool for self-study. The Center for Genetics and Society Web site is probably the single best
source of information available in the area of reproductive medicine, but does not include an
interactive component. 4 The Geneforum, a non-profit initiative launched in Oregon in 1998,
promotes education and public dialogue on subjects broadly related to biotechnology. 5 None of
these online resources fully implement the information clearinghouse concept as envisioned here,
but taken together, they suggest that its implementation is within reach.
12.2 Consultative College
Deliberative panels are predicated on face-to-face deliberation. An emphasis on traditional
forms of small-group deliberation both is costly and increases logistical complex. Importantly, it
may force the agency to compromise on other design goals, such as the time available for
deliberation or the number of experts and the quality of expert opinions. For this reason, in this
section, we discuss an alternative mechanism of public consultation that retains deliberation
(though not face-to-face deliberation) but tries to reduce logistical complexity and cost through
the systematic use of information technologies. We call this approach a consultative college.
The consultative college is similar to deliberative panels in that it also strives to ensure
representativeness. Just like deliberative panels, it begins with a familiarization phase, continues
with a deliberation stage, and closes with participants ranking alternative policy options.
Deliberation takes place in small, balanced groups, as is the case for deliberative panels. Unlike
3
4
5
See http://www.biotechgov.org.
See http://www.genetics-and-society.org/index.asp.
See http://www.geneforum.org/.
319

deliberative panels, however, deliberation in a consultative college is mediated by information
technology. In other words, the deliberation in a consultative college renounces to face-to-face
communication.
There are several important benefits to relying on information technologies for the
deliberation phase. Geography in a country as large as the United States is no longer a
constraining factor. Participants can be consulted from the comfort of their living rooms. Experts
can receive and answer questions from anywhere. Public officials can monitor the entire process
from one location. Travel needs are reduced to a minimum. Informational and educational
materials can quickly and easily be made available to everyone.
The use information technology makes it possible to overcome otherwise severe time and
spatial constraints. A consultation process can be stretched over an extended period of time,
several weeks and perhaps even months, with minimal disruption for participants’ daily routines.
For example, college members could meet online once a week or once every other week over a
period of several weeks. This approach would make it considerably easier for the regulatory
agency to recruit participants. It would also make it possible to envisage a stable membership, if
necessary. Repeated participation in public consultation would further reduce overall operational
costs. Participants would have to receive a monetary compensation for their participation, but the
savings from a dramatically simplified recruitment process and from relying on a stable pool of
participants would more than offset these costs. Conceivably, over time, monetary rewards could
be reduced as participation in a consultation process could become a source of (some) prestige.
The consultation process follows a familiar plot: College members first familiarize
themselves with the therapeutic and scientific and aspects of the reproductive technology under
consideration. This is accomplished in the same way as for deliberative panels, i.e., by making
print and video materials available to college members and by implementing an information
clearinghouse. A panel of experts representing various interests and positions, convened by the
agency, stands by to take and answer questions. Questions and answers are saved in the
clearinghouse and made available to all members of the consultative college. In the final step, the
agency gathers, evaluates, and synthesizes the range of expressed concerns and attitudes toward
various policy options. This information forms the basis for crafting new rules and regulations.
As for the actual deliberative stage, college members rely on voice-based technology to
communicate with each other. Text-based communication is possible, but should be used as a
backup or as a tool for the moderator to get in touch privately with individual participants. The
popularity of Internet telephony demonstrates that it is becoming both technically feasible and
economical to use the Internet for voice-based communication. Our approach is not too
dissimilar from what survey organizations have been doing for years. As part of their business
portfolio, these organizations have assembled panels representative of the general U.S.
population. These panels are polled regularly by phone on any number of topics. In recent years,
polling organizations have begun using the Internet to enable online discussions among panel
members. In the summer of 2004, the Genetics and Public Policy Center relied on one of these
survey organizations to conduct an Internet-based deliberative poll similar to what we are
320

proposing here. More than 130 individuals participated in this project. Participants were assigned
to groups of approximately 12 to 15 persons. Online meetings took place on a weekly basis over
a period of two months. Each session lasted on average one-and-a-half hours. 6
The extensive use of information technologies gives the convening agency an unprecedented
ability to closely monitor the deliberative process and to quickly respond to unanticipated
problems. For example, the review of online deliberation may provide cues as to an inadequate
or insufficient understanding of technical and/or scientific matters among the college members.
In this case, the agency would be able to provide additional information to select participants
without embarrassing them in front of their colleagues. The agency would also be able to
selectively foster contributions from passive participants by establishing separate discussion
forums (“deliberative enclaves”) that would encourage these individuals to develop their own
views privately until they feel confident enough to share them with their original audience.
The enabling legislation would require the agency not only to publish the proposed new rule
in the Federal Register, but also to make the consultation process itself and all related materials
available to the general public. This could have an important side effect: By becoming a focal
point for individuals seeking reliable information on the medical and ethical aspects of a
regulatory proposal, the clearinghouse is likely trigger an informational cascade. 7 For example,
Catholics may find it helpful to examine the views expressed by fellow Catholics represented on
the college. Liberal voters may take a similar approach. To the extent that the views expressed by
members of a reference group are more nuanced and differentiated than those expressed by
corresponding organized groups, there is a chance that over time, the deliberative college would
contribute to reducing societal divisions. To use the terminology developed in chapter 10, the
college would contribute to depolarizing the public.
Conversations with representatives of the Genetics and Public Policy Center have shown
that the technical hurdles to running a process of online consultation remain significant. On the
other hand, the quality and reliability of information technologies is rapidly improving. The rapid
development of Internet telephony suggests that in the medium term, technology no longer will
play a constraining role. It is also becoming apparent that government agencies are beginning to
explore uses of information technology beyond traditional considerations of efficiency and
responsiveness. For example, in July of 2001, the EPA conducted a “National Dialogue on
Public Involvement in EPA Decisions,” which was intended to supplement notice-and-comment
through an online public consultation process. The initiative brought together 1,166 individuals
over a period of two weeks. The result was 1,261 messages posted by 320 people, with many
more reading the postings and the daily summaries. According to one commentator, the initiative
was a resounding success. 8 The same author also pointed out some predictable shortcomings.
6
7
8
Joan Scott, Genetics and Public Policy Center, personal communication.
See chapter 10 for a discussion of informational cascades and related concepts.
Thomas C. Beierle, "Democracy on-Line: An Evaluation of the National Dialogue on Public Involvement in
EPA Decisions," in RFF Report (Washington, D.C.: Resources for the Future, 2002). That this initiative was the
first of its kind speaks volumes about the real role of information technologies on administrative processes and
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Participation suffered from considerable self-selection bias, ethnic minorities were
underrepresented (in large measure due to limited access to technology), and time demands on
the agency staff were considerable. There is also considerable evidence that outside the United
States, especially in Europe, the role of information technologies is no longer seen simply as a
tool to improve government efficiency and cut costs. 9 In Britain, some commentators have
advocated experimenting with mechanisms of public engagement not too dissimilar from what
we have proposed here. 10 The British Parliament took an interest in this matter as it published the
“Sixth Report on Innovations in Citizen Participation in Government.” 11
The concept of the consultative college as espoused in this chapter does suffer from some
potentially important problems and limitations. Advocates of traditional forms of public
consultation may argue that online deliberation is an inadequate substitute for face-to-face
communication. 12 The evidence does not support this claim. It is certainly no secret that the
quality of deliberation in online, text-based forums is indeed very low. It is also quite common
for these forums to polarize in ways that can only be described as spectacular. But the poor
quality of online forum discussions has everything to do with the rules governing these online
forums, and very little to do with the medium itself. Carefully designed experiments to elicit
possible differences between face-to-face communication and voice-based deliberation have
found that online deliberation is just as valid an option as face-to-face communication. 13 Other,
in-depth studies have produced similar results. In a series of facilitated online deliberations
conducted in 2000 involving both randomly recruited participants and control groups,
researchers found that participation in online discussions can produce greater awareness of the
9
10
on rule-making. Federal agencies do of course rely extensively on information technologies, but technology is
mostly used to increase efficiency and cut costs. They do not have a significant impact on the practices of rulemaking.
Yet it is in this area, as one commentator points out, that information technologies could play a very
useful role. See Beth Simone Noveck, "Designing Deliberative Democracy in Cyberspace: The Role of the
Cyber-Lawyer," Boston University Journal of Science & Technology Law 9, no. 1-91 (2003); Beth Simone
Noveck, "The Electronic Revolution in Rulemaking," Emory Law Journal 53 (2004).
Dimitris Kyriakou, Special Issue: On E-Democracy (The IPTS Report 75, June, 2003 [cited September 6,
2005]); available from http://www.jrc.es/home/report/english/articles/vol75/welcome.htm; Malcolm Peltu and
Stephen Coleman, "A New Agenda for E-Democracy: Positions Papers for an Oxford Internet Institute
Symposium. In Association with with University of Maryland, Cisco and BT" (paper presented at the OII
Symposium, Oxford, May 7, 2004); Bart Van Oudenhove et al., "Report on Electronic Democracy Projects,
Legal Issues of Internet Voting and Users (i.e. Voters and Authorities Representatives) Requirement Analysis,"
(Consortium led by MATRA Systèmes & Information, 2001).
Stephen Coleman and John Gøtze, "Bowling Together: Online Public Engagement in Policy Deliberation,"
(London: BT Hansard Society, 2001).
11
The full report is available at
http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubadm/373/37303.htm. The government
response is available at
http://www.publications.parliament.uk/pa/cm200102/cmselect/cmpubadm/334/33403.htm.
12
Benjamin R. Barber, "The Uncertainty of Digital Politics," Harvard International Review 23, no. 1 (2001).
13
S. Iyengar, R.C. Luskin, and James S. Fishkin, "Facilitating Informed Public Opinion: Evidence from Face-to-
Face and on-Line Deliberation." (paper presented at the American Political Science Association Annual Meeting,
Philadelphia, PA, 2003).
322

underlying motives informing opposing views. Predictably, the researchers also found that
deliberation can produce polarization. 14
Representatives of the Genetics and Public Policy
Center, for their part, have pointed out that in their experience, participants in online
deliberations do engage each other in a respectful and constructive manner. They also noticed
that voice-based interactions foster a more frank dialogue than traditional face-to-face
communication.
Some commentators are likely to criticize our proposal for not being “open and transparent.”
Others may argue that ours is an elitist approach designed to exclude rather than to include the
public. We freely acknowledge that a process of public consultation as envisaged in this report is
not open to the general public and it is not entirely transparent; it is not supposed to be. The
legitimacy and credibility of mechanisms of public consultation as proposed in this report
depend crucially upon the regulators maintaining tight control over the process itself. “Opening”
the consultation process to a larger audience would obviously undermine any claim to
representativeness; it would disrupt the deliberative phase and expose the entire consultative
process to manipulation by organized interest groups. The proper way for the general public and
for interest groups to provide input is through notice-and-comment afforded to all citizens by the
Administrative Procedure Act. As for the claim that the proposed mechanisms of public
consultation exclude the public, this criticism is unfounded. No other process of public
consultation, to our knowledge, would afford the general public greater influence over the
regulatory process.
Two other, possibly important problems are access to information technology and literacy.
Extensive reliance on information technologies could prove a barrier for some, especially among
the poor and the uneducated. The “digital divide” is shrinking, however, as the cost of personal
computers has dropped significantly and continues to fall. The agency could remedy this
problem by lending or renting for a nominal fee a TV computer, just as some polling
organizations do. Literacy is a more serious problem. Even the best informational and
educational materials require basic readings and analytical skills. It may be unrealistic to expect
most participants to absorb lengthy policy briefs, even if they are designed with a lay audience in
mind. Educational videos may mitigate this problem, at least in part. Conceivably, the convening
agency could recruit volunteers willing to help struggling individuals overcome these barriers.
We realize that our discussion of online consultative tools does not provide satisfactory
answers to each and every implementation detail. Our aim here was not to offer an exhaustive
description of innovative mechanisms of public consultation. Rather, we wanted to demonstrate
that the time is ripe for experimenting with innovative forms of public consultation. We hope our
readers will find our discussion compelling enough to explore our proposal in more depth.
14
V. Price and J. Cappella, "Online Deliberation and Its Influence: The Electronic Dialogue Project in Campaign
2000," IT & Society 1 (2002); V. Price and J. Cappella, "Online Discussion, Civic Engagement, and Social
Trust," (Philadelphia: University of Pennsylvania, 2003).
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12.3 Public Consultation and Rule-Making
A question we have only peripherally explored in this report is the relationship between
consultative processes and agency discretion. In chapter 10, we have argued that a consultative
process does not compromise the agency prerogative to pursue a specific regulatory agenda. At
the same time, a proposed new rule flying in the face of broadly shared public sentiments would
be considered by some to be strong evidence of capricious and arbitrary agency behavior. In
what sense, then, does a structured process of public consultation contribute to preventing or
mitigating agency capture? How does a consultative process protect the independence – i.e., the
credibility – of this agency?
Consider the case of an agency succumbing to pressures from an interest group, a powerful
Congressional representative, or a senior White House official. Let’s assume that the agency has
conducted a consultative process and that the consultation has produced a clear and unambiguous
result. The agency is considering ignoring this outcome and is strongly tempted to follow the
recommendations of one or the other of its closest constituencies. This is an illustration of
political failure as defined in chapter 10: The agency is catering to parochial interests to the
detriment of broader public sentiments.
What considerations may affect the agency’s decision to ignore or to abide by the outcome
produced by the consultative process? As mentioned earlier, the enabling legislation requires the
agency to make the results of all consultations available to the general public well before the
agency publishes its proposed new rule in the Federal Register. The agency is perfectly aware of
the implications of the “hard look” doctrine for rule-making and, in particular, of the need to
provide a very detailed rationale for the assumptions informing a proposed new rule. The agency
is entitled to propose a policy inconsistent with the outcome of a public consultation, but it
would have to provide a well-reasoned explanation for this choice. To the extent that the agency
was indeed considering an alternative policy for no other reason than political expediency,
justifying a different choice may be extremely difficult. For this reason, the agency is likely to
resist the demands by special interest groups and their allies in Congress even if regulators
sympathize with these demands, or might have found it useful to cater to a powerful political
constituency as a means to pursue other bureaucratic goals, such as ensuring future agency
funding.
Now let’s assume that the agency believes it can get away with a decision to ignore the
outcome of a consultative process. Following the publication of the consultation results, the
public has an opportunity to provide feedback through notice-and-comment. While some
organized interest groups will certainly voice their support, the general public is likely to signal
its disagreement to the agency in significant numbers, and point to the inconsistency between the
consultation process and the proposed new rule. The Administrative Procedure Act requires the
agency to acknowledge each comment and to “consider” it in drafting the final rule. The agency
may try to finesse the inconsistencies brought about by its decision to overlook public
sentiments, but it also knows that its responses to the received comments become part of the
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administrative record and form the basis for judicial review. Knowing this, the agency will likely
resist the temptation to ignore the consultation results. 15
Critics may argue that even if an agency proposes a rule inconsistent with the outcome of a
consultation process, the public is unlikely voice its disagreement through notice-and-comment,
either because it won’t notice the agency’s disregard for public sentiments, or simply because it
won’t care. For this strategy to succeed, several fairly implausible requirements must be met.
Public consultation should be a low-key affair with little or no media visibility. This is very
unlikely, given the public nature of most bioethical controversies. Even if the media and the
general public are not paying attention, organized interests groups are. These groups will
immediately spot any inconsistency between consultation results and proposed new rule. In their
comments to the agency, they would demand that the agency provide a rationale for its choice.
These are also the groups most likely to challenge a new rule in court should they come to the
conclusion that the agency has no reason to disregard the outcome of a consultative process. For
these reasons, it would not be rational for the agency to assume that “bureaucratic drift” will go
unnoticed. 16
Our discussion so far was based on the assumption that a process of public consultation will
produce a clear and unambiguous outcome. This may not always be the case, however. A divided
public – i.e., a situation in which any given policy proposal is approved and disapproved by
roughly 50 percent of the public – would afford the agency considerably more discretion. Should
agency discretion be considered problematic? Does this amount to the breakdown of a central
mechanism of accountability? Most likely not. To the extent that the public is genuinely divided
and/or ambivalent about a new reproductive technology or a revolutionary line of research, the
agency could choose between two strategies. It could determine that it should move ahead and
propose a policy that more closely reflects the preferences of organized interest groups. This
would not be a case of agency capture, but of exercise of legitimate regulatory authority
constrained by the enabling statute and Congressional intent. Alternatively, the agency could
decide that it would be inappropriate to deprive the public of the opportunity to debate the pros
and cons of a new biomedical development, and simply propose a moratorium.
As a matter of practice, it is very unlikely that the agency, after consulting with the public,
will be left without guidance. It is certainly true that most people entering a consultative process
are unlikely to have strong, informed views about a new biomedical development. But the
empirical record suggests that citizens, if given an opportunity, are perfectly capable of
developing informed opinions. And while it is certainly possible that a given policy option will
15
16
It is worth noting that agency accountability is the result of both public consultation and notice-and-comment.
Absent notice-and-comment, the agency would face fewer incentives to abide by the outcome of a consultative
process. On the other hand, rule-making without public consultation would greatly diminish the effectiveness of
notice-and-comment as a mechanism of accountability.
The preceding discussion is based on the assumption that a rational choice model is an adequate representation
of agency behavior. It would certainly be possible to analyze agency behavior from a somewhat less cynical
standpoint, but a more sophisticated modeling exercise is very unlikely to affect our conclusions.
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divide the public, it is quite unlikely that the general public will be divided on each and every
available choice. As our discussion in chapter 8 has shown, more often than not, a divided public
reflects inadequate alternatives rather than underlying deep divisions.
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12.4 Bibliography
Barber, Benjamin R. "The Uncertainty of Digital Politics." Harvard International Review 23, no.
1 (2001): 42-47.
Beierle, Thomas C. "Democracy on-Line: An Evaluation of the National Dialogue on Public
Involvement in EPA Decisions." In RFF Report. Washington, D.C.: Resources for the
Future, 2002.
Coleman, Stephen, and John Gøtze. "Bowling Together: Online Public Engagement in Policy
Deliberation." London: BT Hansard Society, 2001.
Fishkin, James S. "Deliberative Polling and Public Consultation." In Deliberative Democracy in
Theory and Practice. Turin: European Consortium for Political Research, 2002.
———. "The Televised Deliberative Poll: An Experiment in Democracy." Annals of the
American Academy of Political and Social Science 546 (1996): 132-40.
Fishkin, James S., and Chair Patterson-Bannister. "Virtual Democratic Possibilities: Prospects
for Internet Democracy." Paper presented at the Internet, Democracy and Public Goods,
Belo Horizonte, Brazil, November 6-10, 2000.
Iyengar, S., R.C. Luskin, and James S. Fishkin. "Facilitating Informed Public Opinion: Evidence
from Face-to-Face and on-Line Deliberation." Paper presented at the American Political
Science Association Annual Meeting, Philadelphia, PA 2003.
Kyriakou, Dimitris. Special Issue: On E-Democracy The IPTS Report 75, June, 2003 [cited
September 6, 2005]. Available from
http://www.jrc.es/home/report/english/articles/vol75/welcome.htm.
McLean, Iain S. "Does Deliberation Induce Preference Structuration? Evidence from
Deliberative Opinion Polls." Paper presented at the American Political Science
Association Annual Meeting, Washington, D.C., August 30-September 4, 2000, 2000.
Noveck, Beth Simone. "Designing Deliberative Democracy in Cyberspace: The Role of the
Cyber-Lawyer." Boston University Journal of Science & Technology Law 9, no. 1-91
(2003).
———. "The Electronic Revolution in Rulemaking." Emory Law Journal 53 (2004): 433-518.
Peltu, Malcolm, and Stephen Coleman. "A New Agenda for E-Democracy: Positions Papers for
an Oxford Internet Institute Symposium. In Association with with University of
Maryland, Cisco and BT." Paper presented at the OII Symposium, Oxford, May 7, 2004.
Price, V., and J. Cappella. "Online Deliberation and Its Influence: The Electronic Dialogue
Project in Campaign 2000." IT & Society 1 (2002): 303-28.
———. "Online Discussion, Civic Engagement, and Social Trust." Philadelphia: University of
Pennsylvania, 2003.
Schkade, David, Cass R. Sunstein, and Daniel Kahneman. "Deliberating About Dollars: The
Severity Shift." Columbia Law Journal 100 (2000): 1139-75.
Van Oudenhove, Bart, Berry Schoenmakers, Sylvie Brunessaux, Karl Schlichting, and Tomas
Ohlin. "Report on Electronic Democracy Projects, Legal Issues of Internet Voting and
Users (i.e. Voters and Authorities Representatives) Requirement Analysis." Consortium
led by MATRA Systèmes & Information, 2001.
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13 Implementation Issues
Consistent with the scheme developed in chapter 4, in this chapter we discuss
implementation-related issues for each of the three areas of reproductive medicine (standard
reproductive treatments, innovative reproductive procedures, and technologies of reproductive
customization) and for biomedical research. We also discuss in some detail issues pertaining to
compliance assurance, and we conclude by offering some considerations of cost.
13.1 Monitoring and Information Gathering
One of the first challenges the newly created regulatory agency would face is the design and
implementation of a system of monitoring and information gathering. This system is
indispensable to discharging the agency’s statutory mandate and would serve several purposes.
First, it would allow the agency to identify and evaluate health and safety risks associated with
traditional ART procedures. As mentioned in chapter 4, this is possible today only in a very
limited sense. Second, a tracking system would facilitate identifying and monitoring ART clinics
performing innovative ART treatments, an area of reproductive medicine in need of closer
scrutiny. Third, information gathered through a system of monitoring would make it possible for
regulators to implement an effective mechanism of reciprocal learning within the ART industry –
and in so doing, would contribute to improving the quality and reliability of ART treatments.
Fourth, a comprehensive tracking system is crucial to ensuring compliance, not only in the ART
sector, but also in the biotech industry and in the scientific community. Finally, a system of
monitoring and information gathering would enable regulators to provide prospective parents
with up-to-date information on a wide range of infertility-related questions, and would help
improve our understanding of the causes of infertility.
A tracking system as proposed in this chapter would track the import, creation,
manipulation, storage, trade, and export of human reproductive tissues. Reproductive tissues
include human embryos, oocytes, and sperm. The term “creation” should be understood in the
broadest possible sense: It includes not only traditional practices, such as the in vitro mixing of
egg and sperm, but also laboratory practices that lead to the creation of viable oocytes and sperm
by artificial means, such as experiments involving human embryonic stem cells, for example. 1
Different reproductive tissues entail different record-keeping requirements. The import,
export, creation, use, and trade of embryos would receive the greatest regulatory attention,
followed by oocytes and by sperm. This ranking reflects the relative importance of ethical
concerns. We discuss these differences in more detail in the following sections.
1
Reporting requirements in this case are limited to fully functional reproductive tissues.
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Among the parties subject to record-keeping requirements are ART programs, embryo
laboratories, sperm banks, university hospitals, university labs, and research labs at biotech and
pharmaceutical companies. This list is not meant to be exhaustive. Should the preservation of
human oocytes become widely available, then oocytes banks would also be subject to regulatory
oversight. In other words, any establishment that retrieves, produces, stores, and trades in human
reproductive tissues would be subject to record-keeping and reporting requirements. The newly
established registration requirements promulgated by the FDA for establishments involved in the
trade, storage, and use of human tissues provide an excellent implementation basis. 2
The tracking system proposed in this chapter could be implemented in various ways. The
British HFEA, arguably the agency with most experience in this area, has adopted a fairly
intrusive system of monitoring that consists of both a licensing and a reporting system. In the
United States, it is the responsibility of the states to license the practice of medicine. For this
reason, it is very unlikely that Congress would support a federal system of medical licensing,
even a narrowly defined one. Furthermore, it is not entirely clear that additional licensing
requirements at the federal level are necessary to meet the new agency’s public mandate. On the
other end, a mandatory establishment registration coupled with specific reporting requirements
would satisfy most if not all regulatory demands.
A monitoring system that emphasizes the health and well-being of ART children and women
would entail much more than just tracking the use of reproductive tissues. It would require
gathering information concerning the ART children, their parents, the gamete donors (if the
gametes were donated), and the type of ART procedure performed, among other things. These
are not unreasonable requirements; Canadian regulators are in the process of implementing
similar requirements. The British HFEA has been operating a comprehensive system of
monitoring for years.
A statutory emphasis on the health and well-being of children could also mean that the
personal identity of gamete and embryo donors must be preserved. Currently, ART clinics
routinely destroy records that would allow ART children to identify gamete donors. It is a
practice that protects the interests of prospective parents and donors, possibly to the detriment of
ART children. Whether these children are ultimately better off knowing their biological parents
is a question for others to ponder, but it can no longer be assumed that this information should
simply be destroyed. That this requirement could significantly reduce the pool of available
gamete donors is a risk that would have to be weighed against other benefits.
Record-keeping would be subject to inspection, and violations would trigger civil and/or
criminal penalties, depending on the gravity of the violation. This is in marked contrast to current
practice. The CDC has no authority to enforce the reporting requirements established by the
Fertility Clinic Success Rate and Certification Act. Non-reporting, however, is rather modest,
roughly 10 percent or less. This figure suggests that while actual sanctions for non-compliance
are necessary, they would not have to be draconian. Furthermore, the implementation of a
2
See chapter 5 for a discussion.
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tracking and monitoring system would in part be delegated to third parties such as trade and
professional societies. We discuss compliance assurance in more depth in section 13.6.
13.1.1 Embryos
Procedures involving human embryos raise the most serious ethical concerns and would be
subject to the most stringent record-keeping requirements. The protracted controversy over the
use of human embryos for stem cell research suggests that the import, creation, storage, use,
manipulation, and export of human embryos should be carefully monitored. Developing and
testing innovative reproductive procedures would be far less controversial activities if they were
to be conducted with the blessing of the law. The view – shared by two-thirds of the American
public – that embryos are not simply just another mass of cells but cannot be equated to actual
human beings 3
underscores the importance of distinguishing between acceptable and
unacceptable uses of human embryos.
Subject to record-keeping requirements would be all establishments involved in the import,
storage, creation, use, trade, and export of human embryos, including ART programs, biotech
firms, and university laboratories. These categories are not meant to exhaust the variety of
establishments subject to record-keeping requirements. Any establishment more than marginally
involved in these activities would be subject to the same requirements. 4
The “creation” of embryos must be construed in the broadest possible way. Included in this
definition are not only embryos created in vitro for ART purposes, but also embryos created
through somatic cell nuclear transplantation or any other medical technology that may become
available in the future.
Record-keeping requirements vary considerably depending on the enabling statute.
Generally speaking, the more specific the statutory provisions, the more detailed the reporting
requirements are likely to be. For example, should reproductive cloning be banned and research
cloning legalized, regulators would have to adopt a record-keeping architecture that would
discourage attempts to misuse cloned embryos. Regulators may consider limiting the maximum
number of embryos that can be transferred to a woman’s uterus to two or three, a limitation
adopted by some European countries. They could grant researchers permission to conduct a
controversial but particularly promising experiment involving the destruction of embryos, but
require that only a small number of embryos be used. In all these cases, an architecture of recordkeeping
ensures that all parties operate in accordance with applicable rules and regulations. In
short, record-keeping requirements for embryos greatly facilitate monitoring and compliance
assurance efforts.
The nascent practice of “adopting” supernumerary embryos raises specific record-keeping
issues. Among them is the question of just how much information should adopting parents be
entitled to receive about a donated embryo. Many prospective parents are likely not only to
3
4
See chapter 8 for details.
The transportation of human reproductive tissue would not be subject to reporting requirements.
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demand in-depth health screening, a requirement that is now part of the new FDA human cellular
and tissue-based products rules; they may also feel entitled to select an embryo based on
extensive genetic testing information, and on detailed descriptions of the biological parents’
physical characteristics and on their academic and personal achievements, among other things.
“Informed choice” in this case would come dangerously close to private eugenics. Whether
Congress is prepared to restrict the amount of information donor organizations are allowed to
gather remains to be seen.
13.1.2 Oocytes
While the donation and manipulation of human oocytes do not raise ethical concerns as
substantial as those surrounding the use of human embryos, they nevertheless must be taken
seriously. The new FDA rules regulating human cellular and tissue-based products require that
oocyte donors be screened for a wide range of communicable diseases. In this area, no additional
requirements are necessary. Broadly speaking, oocytes are being donated for reproductive or
research purposes. Each case raises a distinctive set of issues.
The for-profit trade of human oocytes for reproductive purposes is gaining popularity among
affluent individuals. Oocytes from young, athletic, good-looking women with impeccable
academic credentials are in high demand. In a few instances, these oocytes have been sold for as
much as $200,000. The average price for oocytes is much lower, ranging roughly between
$5,000 and $10,000. 5 High prices correlate strongly with parental desires. Prospective parents
may wish to select oocytes based on a wide range of characteristics, ranging from good health
and good looks to academic achievement. Accordingly, oocytes “donated” by students with high
SAT scores or by super models fetch premium prices. This is more surprising, considering that
this kind of eugenic selection is very unlikely to be effective. In any case, until oocyte
cryopreservation is fully developed, oocyte donation will remain a fairly limited phenomenon.
Oocyte donation for reproductive purposes does not require extensive record-keeping.
Preventing the spread of infectious diseases may entail preserving the identity of egg donors for
an extended period of time. Donor identity may also have to be preserved if Congress decides
that the well-being of ART children includes being able to meet their biological mothers.
Donating oocytes for research requires closer scrutiny. Should research cloning show
promise, biomedical research would become a very important “buyer” of oocytes. That in this
area abuses are indeed possible has recently been illustrated by Dr. Hwang Woo-Suk, the Korean
researcher who in 2004 successfully cloned several human embryos. Dr. Hwang recently
resigned amid allegation that he had pressured his female staffers to “donate” their oocytes, and
5
The American Society for Reproductive Medicine has recognized the problematic nature of unregulated oocyte
donation and has adopted guidelines that discourage the sale of oocytes but allow reimbursement for medical and
other expenses up to approximately $4,200. Cf. Ethics Committee of the American Society for Reproductive
Medicine, "Financial Incentives in Recruitment of Oocyte Donor," Fertility and Sterility 74, no. 2 (2000), p.219.
332

that he had falsified some of the data used for his seminal publications. 6 At a minimum, then,
investigators would have to demonstrate compliance with rules of informed consent. Ensuring
traceability may also be necessary, as research could produce results directly relevant to the
donor’s health. Finally, preventing abuses in the area of somatic cell nuclear transplantation
would require keeping track of the number of donated eggs and their uses.
13.1.3 Sperm
Practices surrounding the trade, storage, and use of human sperm raise only modest ethical
concerns. Unlike embryo and oocyte donation, sperm donation has a long history in the United
States. The first recorded U.S. case dates back to nineteenth century. A full-blown market for
sperm emerged only in the early 1960s. Nowadays, sperm banks have become a common and
profitable industry across the country. The industry is represented by the American Association
of Tissue Banks, which includes among its members many other types of tissue banks.
As for embryos and oocytes, the new FDA rules governing the production, trade, and use of
cellular tissues (HCT/P rules) protect against the spread of communicable diseases. In this area,
no additional action is necessary. 7 The FDA rules, however, do not address several important
questions not directly related to preventing the spread of communicable diseases. For example,
few sperm banks have policies to avoid the marriage between half-siblings, a substantial risk
considering that sperm banks impose very few limitations on the maximum number of donations
by an individual. Should Congress determine that this area is ripe for regulations, additional
record-keeping requirements may be necessary.
Also in need of scrutiny is the long-standing industry practice to jealously protect donors’
anonymity. This measure makes eminently good business sense, but it is far from clear that it is
also in the best interest of children born through anonymous sperm donation. Requiring that
sperm banks be able to identify sperm donors is likely to greatly reduce the pool of potential
donors and to negatively impact this business sector. We are not arguing that Congress should
eliminate donor anonymity, but it is worth pondering whether this practice can be justified.
Finally, the HCT/P rules are not designed to resolve whether eugenic practices should be
tolerated. Sperm banks compete in part by encouraging prospective parents to select a sperm
donor on the basis of physical, aesthetic, and academic stereotypes. Selecting a sperm donor in
many cases is reduced to a shopping act: It is simply a matter of consulting a catalogue. That
6
7
David Cyranoski and Erika Check, "Clone Star Admits Lies over Eggs," Nature 438, no. 7068 (2005); David
Cyranoski and Erika Check, "Korean Stem-Cell Crisis Deepens," Nature 438, no. 7067 (2005); Constance
Holden, Gretchen Vogel, and Dennis Normile, "Korean Cloner Admits Lying About Oocyte Donations," Science
310, no. 5753 (2005).
Despite its importance to the ART industry, no reliable information was available until recently about the
number of existing sperm banks and their mode of operation. The HCT/P registration requirements will close
this gap; as of February 28, 2005, 1,579 establishments had registered with the FDA. The actual number of
sperm banks is significantly smaller, however, because this figure also includes IVF programs, embryo
laboratories, and other kinds of human tissue establishments. See
http://www.fda.gov/cber/tissue/hctregestabl.htm.
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many prospective parents are attracted by physical appearance and academic performance is
understandable, but the question remains as to whether Congress should unintentionally
contribute to reinforcing all manner of stereotypes or whether it should limit the type of
information prospective parents are entitled to request.
13.2 Standard Reproductive Procedures
To the extent that the enabling legislation emphasizes protection of the health and wellbeing
of ART children, the tracking system would require regulators systematically to gather
data and information about a wide range of ART-related defects and malformations. The British
HFEA has been collecting ART-related health data since 1994. The kind of information the
HFEA gathers on a regular basis is illustrated Table 11, gleaned from the 1999-2000 HFEA
annual report. 8 This data has been collected every year since 1994, allowing the HFEA to
identify both absolute and relative risks of various ART treatments and to detect possible longterm
public health concerns.
Congenital abnormalities Total Fresh
IVF
Frozen
IVF
Donor
Insemination
Micromanipulation
Cleft lip with cleft palate 5 2 3
Anomalies of the alimentary system 5 1 1 3
Cardiac murmurs 6 3 3
Ventricular septal defect 5 2 1 2
Other congenital cardiac anomalies 12 4 2 3 3
Other anomalies of the cardiac septa 1 1
Patent ductus 3 1 2
Anomalies of the cardiovascular 4 1 3
system
Hypospadias, epispadias 2 1 1
Renal anomalies 13 3 3 1 6
Reduction deformities of the limbs 1 1
Talipes 9 2 2 5
Congenital dislocation of the hip 2 1 1
Other anomalies of the limbs
2 1 1
or limb girdles
Anomalies of the nose, face,
2 1 1
neck, and skull
Ear anomalies 7 1 6
Exomphalos 5 1 4
Total number of children born 120 41 9 16 54
Table 11: Congenital abnormalities in ART children in 1999 (extract).
In an effort to improve its ability to detect new health risks, the HFEA has begun testing a
new alert system designed to anonymously gather detailed information about new incidents. This
8
Human Fertilisation and Embryology Authority (HFEA), "Ninth Annual Report and Accounts 2000," (London:
2000).
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information is stored in a database and made available to all licensed facilities, thus contributing
to improving the safety and efficacy of ART treatments. According to the HFEA, clinics have
responded very positively to this initiative.
It should be mentioned that the British tracking system falls far short of a full-fledged
longitudinal system of monitoring. While conducting a long-term longitudinal study of ART
children in the United States as proposed by the President’s Council on Bioethics would certainly
be very useful, systematically monitoring the health of ART children up to one year of age
would be considerably less costly and would provide a wealth of information currently not
available. Putting the threshold at one year is not an arbitrary choice. ART specialists point out
that some chromosomal and congenital abnormalities do not become immediately apparent, but
that most of them have surfaced by one year of age.
It appears that as part of its collaboration with the Society for Assisted Reproductive
Technology, the CDC has begun gathering data and information beyond success rates.
Unfortunately, no details are available about these practices. Implementing a system of
monitoring as outlined in this section would certainly be more costly than what is considered
standard practice today, but far less costly than feared by the ART industry. Tracking the health
of ART children up to one year of age does not pose insurmountable technical or legal problems.
Technically, the system could be based on chip cards technology. This technology has been
adopted by many transit systems around the country and by the credit card industry; it is
considered mature and it is inexpensive. Chip card technology would allow select individuals,
such as ART practitioners, pediatricians, parents, and regulators to verify, store, and retrieve
personal health data while preventing unauthorized parties from accessing sensitive information.
By affording adequate protection against the misuse of personal health data, this technology
should be received favorably by prospective parents. Trust in this technical solution should also
ensure high levels of participation and make a mandatory adoption superfluous.
13.3 Innovative Reproductive Treatments
The notion of innovative reproductive treatments was discussed in some detail in chapter 4.
In a nutshell, innovative reproductive procedures, unlike standard reproductive treatments, may
not only expose the future child to heightened health and safety risks, but may also be
unacceptable from an ethical standpoint. Regulators have no systematic way to monitor these
kinds of reproductive treatments. What so far has come to regulators’ attention is sufficiently
problematic as to justify adopting a robust system of monitoring and evaluation, including the
possibility that regulators may impose a moratorium or ban on certain types of treatments.
Any suggestion that the practice of medicine should be regulated is bound to be
controversial. Critics are likely to offer a broad range of arguments against direct regulatory
interventions at the federal level, of a legal nature and of other varieties as well. While legal
arguments against direct regulatory interventions are weak, some of the arguments offered by the
profession to protect their autonomy are important and deserve to be taken seriously.
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Traditionally, the practice of medicine has been regulated at the state level, and Congress
has been very careful to avoid any suggestion that it intends to directly regulate the practice of
medicine. 9 Perhaps for this reason, it is generally assumed that Congress does not have the
authority to regulate this profession. We believe that this assumption is unfounded. Medical
autonomy is certainly a jealously protected professional prerogative, but it is neither absolute nor
uncontested. Congress indirectly regulates the practice of medicine in numerous ways. The FDA
regulates drugs, biologics, and medical devices. The Medicare and Medicaid programs directly
affect the selection of prescription drugs. The Department of Health and Human Services
regulates clinical trials through informed consent regulations. Many of the measures aimed at
containing the explosion of health care costs are predicated on limiting the discretion of the
medical profession in choosing medical technologies and treatments. 10
Some may argue that a direct regulatory intervention may run afoul of constitutional
guarantees. A detailed examination of this question is well beyond the scope of the present
discussion, but this argument seems implausible. If medical doctors had a constitutionally
protected right to exercise their profession, then it is difficult to see why other professions
shouldn’t enjoy the same kind of constitutional protection. Shouldn’t accountants, then, also be
shielded from oversight by the Securities and Exchange Commission? Perhaps the medical
profession does enjoy a modicum of constitutional protection. Washington v. Glucksberg, a case
involving medically assisted suicide, does not lend much credibility to this hypothesis. A full
discussion of this issue is beyond the scope of this chapter, but it is reasonable to assume that the
Supreme Court is very unlikely to discover a broad new class of fundamental rights.
A more important argument against direct regulatory intervention is what may be described
as asymmetrical information. Medicine remains both a science and an art. Dramatic advances in
medical science and technology have not undermined the need for good professional judgment.
Expert medical opinion remains indispensable to selecting the most appropriate therapy. Only
the physician is in a position to select an appropriate treatment based on a set of unique clinical
circumstances. 11 In its essence, this is an argument about the importance of decentralized, tacit
knowledge. It is precisely because this kind of knowledge is both decentralized and tacit (i.e.,
not codified) that a regulatory authority should refrain from intervening in medical practice.
9
10
11
For example, the 1997 FDA Modernization Act (FDAMA) restates a doctor’s right to prescribe drugs for offlabel
uses, an issue that was highly contentious at the time FDAMA was passed. Steven R. Salbu, "Off-Label
Use, Prescription, and Marketing of FDA-Approved Drugs: An Assessment of Legislative and Regulatory
Policy," Florida Law Review 51 (1999).
Barry R. Furrow, "Regulating the Managed Care Revolution: Private Accreditation and a New System Ethos,"
Villanova Law Review 43 (1998); Alycia C. Regan, "Regulating the Business of Medicine: Models for
Integrating Ethics and Managed Care," Columbia Journal of Law and Social Problems 30 (1997).
Not coincidentally, this is the same argument offered by advocates of the free market against excessive
regulatory interventions.
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Failure to acknowledge this fact, so the argument goes, often produces ineffective, wasteful, and
quite possibly counterproductive rules and regulations. 12
Generally speaking this argument has lost nothing of its relevance. In the case of the medical
profession, however, it must be qualified in two important respects. Asymmetrical information
should urge regulators to be cautious when considering intervening in medical decisions, but this
argument is entirely irrelevant in examining the ethical aspects of these choices. As repeatedly
argued in this report, bioethical dilemmas should not be decided by the medical profession and
patients alone. Just as important is the observation that the health care sector has a very poor
health and safety record. Consider the following bit of information: In 2000, the National
Academy of Medicine estimated that every year in the United States, between 50,000 and
100,000 persons die from preventable medical errors. 13 No other sector in the United States has
such a poor safety record. If the chemical or the airline industry caused 50,000 deaths per year,
the federal government would immediately shut them down. Against this background, the
argument that the federal government would do more harm than good in considering regulatory
interventions in this sector loses much if not all plausibility.
It is instructive to explore some of the reasons for this situation. To date, the health care
industry’s main response to medical errors is the morbidity and mortality (M&M) conference.
M&M conferences are convened on a regular basis at university hospitals around the country.
Their primary purpose is to offer to doctors in residence an opportunity to discuss their mistakes
with their colleagues without fear of incurring in legal liabilities. 14 M&M conferences have
proven remarkably ineffective in reducing medical errors. Information about incidents and
accidents is not gathered in a systematic way or widely shared. More importantly, perhaps,
M&M conferences are informed by a very narrow view of safety, one that is focused exclusively
on the actions taken by a medical practitioner. Broader organizational considerations that may
negatively affect the performance of medical personnel are generally absent. Every incident is
examined in isolation, and no effort is made to identify possible connections among similar
incidents. Nor would it be possible to conduct a similar analysis, because, as mentioned earlier,
no standardized system of data gathering exists in the health care sector. To make things worse,
informal sanctions against poorly performing doctors, according to some insider reports, are
largely ineffective. 15
The situation in private medical practices is qualitatively different, but not much more
encouraging. For example, it has been shown that randomized clinical trials often contradict
12
13
14
15
Perhaps the most forceful advocate of this perspective is Friedrich Hayek. Friedrich A. Hayek, Individualism and
Economic Order. (London: Routledge & Kegan Paul, 1976); Friedrich A. Hayek, The Fatal Conceit: The Errors
of Socialism, The Collected Works of F.A. Hayek. Vol. 1 (London: Routledge & Kegan Paul, 1988).
Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy
Press, 2000).
Edgar Pierluissi et al., "Discussion of Medical Error in Morbidity and Mortality Conferences," Journal of the
American Medical Association 290, no. 21 (2003).
Gawande, Complications: Decisions and Dilemmas of a Surgeon's Life.
337

eliefs firmly held by medical practitioners about the efficacy of a given medical treatment. In
some cases, these treatments do not even have a discernible therapeutic effect; in others, they are
actually counterproductive. 16 Yet it appears that many physicians remain distinctively reluctant
to accept recommendations based on randomized clinical trials. Conversely, physicians are more
inclined to accept as validated knowledge recommendations from colleagues, even if these are
based on a sample size of one. In sum, compared to other business sectors, the health care
industry’s approach to safety and quality assurance is wholly inadequate.
In the case of the ART industry in general, and of innovative reproductive treatments in
particular, the situation is both better and worse. It is better because these treatments (and
reproductive medicine more generally) clearly are not as dangerous for the patients as other
medical fields. It is worse because in its 30-year history, reproductive medicine has never
attempted to closely monitor the health and safety of the children born through ART. 17 Yet our
discussion of innovative reproductive treatments in chapter 4 has shown that there have been
several instances of ART practitioners performing potentially unsafe and quite possibly unethical
procedures. The available evidence seems to indicate that ART physicians indeed are inclined to
try wholly untested procedures on their patients but, absent a robust system of monitoring, it is
impossible to determine whether these stories are isolated incidents or should be regarded merely
as the tip of the proverbial iceberg. To use a now (in)famous formulation: In the area of
reproductive medicine, regulators simply don’t know what they don’t know. What we do know is
that we should learn a lot more about the nature and scope of innovative reproductive
procedures.
In proposing a system of monitoring for innovative ART treatments, an important design
consideration is minimizing intrusiveness. Practitioners should remain free to choose what they
regard as the most promising course of action, even if this course of action may be regarded by
some as an innovative but untested ART treatment. In this sense, our approach to monitoring
preserves professional autonomy. However, the ART community and regulators should be able
to examine the rationale for these procedures, analyze possible risks for the mother and the child,
and evaluate the relevance of various ethical concerns. The concept of “information regulation”
meets these requirements. This regulatory approach should not be confused with the wellestablished
notion of informed consent, although the two concepts are related. By information
regulation, we mean a system of mandatory information disclosure that would require ART
practitioners to report to regulators every instance of an innovative ART treatment. Reporting
requirements would include a statement explaining the reasons for the course of action taken, an
16
17
John F. Burnum, "Medical Practice a La Mode. How Medical Fashions Determine Medical Care," New England
Journal of Medicine 317 (1987); David A. Grimes, "Technology Follies: The Uncritical Acceptance of Medical
Innovation," Journal of the American Medical Association 269 (1993).
This can be attributed in part to the fact that in this field of medicine, it is considerably more costly to conduct
clinical trials and to follow the patients than in other fields of medicine, and in part to the fact that one party to
the doctor-patient relationship, the child-to-be, cannot give his or her consent to performing an experimental
reproductive procedure.
338

assessment of possible health and safety risks to the prospective mother and her child, and a
discussion of possible ethical concerns. Regulators would use this information to build a record
for various innovative ART procedures. The report would also form the basis for determining if
the procedure poses unacceptable risks or serious ethical concerns. To this end, the regulators
would solicit comments from the ART practitioners and from professional bioethicists. Note that
this process would not have a suspensive effect on the proposed ART treatment unless the
agency determines that it poses an obvious and immediate threat to the health and well-being of
the child and/or the mother.
The rationale for mandating information disclosure is straightforward: Requiring that both
the rationale for performing an innovative procedure be made available to the regulators and
their peers will encourage ART physicians to more carefully examine the pros and cons of
performing the procedure in the first place. It is not unreasonable to assume that mandatory
disclosure requirements will discourage some ART practitioners from performing questionable
procedures. They are also likely to induce the ART profession to evaluate much more carefully
possible dangers associated with these procedures. Furthermore, mandatory disclosure
requirements will set off a debate among ART professionals about the wisdom of the course of
action taken, its benefits, and possible harms. An unintended but welcome consequence of these
internal debates is the identification of alternative, less problematic, or less risky procedures. In
sum, information regulation not only encourages accountability among ART practitioners; it is
also an institutionalized mechanism of monitoring and learning.
Information regulation as proposed in this section has several precedents. It is at the core of
many financial disclosure requirements mandated by the Securities and Exchange Commission;
it has successfully been used to improve the safety of U.S. nuclear power plants, 18 and has found
numerous applications in environmental policy. 19 Perhaps the single most successful example of
information regulation is the Toxic Release Inventory (TRI) program established as part of the
Emergency Planning and Community Right-to-Know Act of 1986 by the EPA. The TRI program
requires industrial facilities to report to the EPA on a yearly basis the production of
approximately 650 hazardous chemicals (as of 1999). It should be emphasized that the EPA does
not directly regulate the production and disposal of the chemicals listed in the TRI; it only
requires that chemical plants report hazardous waste production on an annual basis. According to
18
19
Rees, Hostages of Each Other: The Transformation of Nuclear Safety since Three Mile Island.
Paul R. Kleindorfer and Eric W. Orts, "Information Regulation of Environmental Risks," Risk Analysis 18, no. 2
(1998). An illustration is provided by the Global Reporting Initiative, a program launched by the United Nations
Environment Programme designed to improve environmental disclosure by large international corporations. See
http://www.globalreporting.org/index.asp for more information. See also Thomas C. Beierle, "Environmental
Information Disclosure: Three Cases of Policy and Politics," (Washington, D.C.: Resources for the Future,
2003). In developing countries, information disclosure has gained some popularity as a low-cost, effective
regulatory tool. See for example Shakeb Afsah and Jeffrey R. Vincent, "Putting Pressure on Polluters:
Indonesia's Proper Program " (Harvard Institute for International Development, 1997); Tom Tietenberg and
David Wheeler, "Empowering the Community: Information Strategies for Pollution Control" (paper presented at
the Frontiers of Environmental Economics Conference, Airlie House, VA, October 23-25, 1998).
339

some studies, the TRI program has been spectacularly successful in reducing the volume of
hazardous wastes. 20
There have been some instances of information regulation in medicine as well. The state of
New York, for example, makes available to the public risk-adjusted mortality rates for cardiac
artery bypass surgery on hospital-by-hospital basis and for individual physicians. 21 Whether this
particular form of information regulation is an effective way to reduce medical errors is doubtful.
Underlying this kind of mandatory system of disclosure is the assumption that patients will select
a surgeon based on his or her safety record. This assumption may be seriously flawed. Every
surgeon, even the best one, in his or her career will make at least one tragic error. 22 Prospective
patients may be able to make an “informed decision,” but one may wonder just how informed
this decision really is.
Implementing a system of monitoring and information disclosure as envisaged in this
section requires solving several problems. Among them is defining what constitutes an
innovative treatment. Distinguishing between innovative and standard treatments is not as
problematic as one might assume, however. The ART industry has settled on fairly
straightforward definitions of standard treatments. Their number is small. A list of these
procedures, complete with a brief description, fits comfortably on one page. 23 Reproductive
endocrinologists routinely tweak and adapt these procedures to meet specific clinical
requirements, but these modifications do not warrant introducing new categories. For example,
some reproductive practitioners allow the embryo to develop in vitro for five instead of the more
common three days. Tweaking the time of in vitro embryo development is just that, a marginal
change that should not be construed as an innovative treatment.
Innovative procedures by definition have never been tested in animal models and depart
significantly from standard ART treatments. Accurately defining “significant departure” may
require some trial-and-error. Initial definitions are bound to be controversial, and in some
instances, the courts may be called upon to resolve these controversies. It is quite possible that
initially, regulators will cast the net too broadly. As a result, they may consider as innovative
20
21
22
23
Bradley C. Karkkainen, "Information as Environmental Regulation: TRI and Performance Benchmarking,
Precursor to a New Paradigm?," Georgetown Law Journal 89 (2001); King and Lenox, "Industry Self-
Regulation without Sanctions: The Chemical Industry's Responsible Care Program."
See http://www.health.state.ny.us/press/releases/2004/cardiac_release_05-06-2004.htm. For a general discussion,
see William M. Sage, "Regulating through Information: Disclosure Laws and American Healthcare," Columbia
Law Review 99 (1999). It appears that information disclosure has little impact on actual consumer choices, but it
does have a measure of impact on the quality of service. See Mark R. Chassin, E. L. Hannan, and B. A.
DeBuono, "Benefits and Hazards of Reporting Medical Outcomes Publicly," New England Journal of Medicine
334 (1996); Edward L. Hannan et al., "Improving the Outcomes of Coronary Artery Bypass Surgery in New
York State," Journal of the American Medical Association 271, no. 10 (1994); Eric C. Schneider and Arnold M.
Epstein, "Influence of Cardiac-Surgery Performance Reports on Referral Practices and Access to Care," New
England Journal of Medicine 335 (1996).
Gawande, Complications: Decisions and Dilemmas of a Surgeon's Life.
Centers for Disease Control and Prevention, "Survey of Assisted Reproductive Technology: Embryo Laboratory
Procedures and Practices," (Chamblee, GA: Public Health Practice Program Office, Division of Laboratory
Systems, Laboratory Practice Assessment Branch, 1999), Appendix G, p.2.
340

many procedures the industry regards merely as a form of tweaking. In time, however, a
consensus between the regulators and the industry on what constitutes a “significant departure”
is likely to emerge.
As a general principle, reporting requirements should ensure that other ART physicians
could reproduce the procedure. The rationale provided by the performing practitioner should be
specific enough as to allow other reproductive endocrinologists to debate the pros and cons of his
or her decision. Finally, the performing ART practitioner should conduct a risk-benefit analysis
that includes not only the prospective parents but the future child as well. We realize that riskbenefit
analysis is an exercise fraught with unknowns and questionable assumptions.
Implementing this requirement may represent a considerable hurdle for many ART practitioners.
To overcome these difficulties, the regulators could provide extensive scientific and medical
assistance, as well as detailed guidelines. More or less sophisticated approaches can be
envisaged, but the principle that performing an innovative reproductive treatment requires
assessing possible health and safety risks should be retained.
Performing innovative procedures will also trigger stricter standards of informed consent. A
key aspect of these standards is informing the prospective parents that the reproductive
procedure envisaged is indeed experimental. Whether stricter standards of informed consent will
prompt prospective parents to reconsider questionable reproductive procedures is doubtful. As
we have shown in chapter 4, the dividing line between parental desperation and reckless
behavior is a thin one. Many parents are likely to expose future children to excessive risks even
if they have received extensive and in-depth information about these risks. Nevertheless, we
believe that the experimental nature of innovative reproductive procedures warrants a more
rigorous approach to informed consent.
Having examined an innovative reproductive protocol, its rationale, its risks, and its
benefits, and having heard the ART practitioners’ views on the merits or demerits of the
procedure in question, regulators can make one of several possible determinations. They may
decide that the procedure in question does not raise significant concerns. Alternatively, given the
uncertain nature of the risks involved, they may call for a moratorium while more research is
conducted. They may also come to the conclusion that the risks outweigh the benefits and justify
a ban. Finally, based on the feedback submitted by the ART industry, they may recommend
taking a number of precautions and suggest tweaks that would mitigate the most important risks.
Reproductive specialists are likely to find these requirements problematic. There is no doubt
that implementing a system of monitoring as discussed in this section would increase the cost of
ART treatments and may prevent some prospective parents from realizing their dream. But the
system of monitoring proposed here also has several important benefits. It provides a measure of
legitimacy and legal protection to reproductive endocrinologists performing innovative
reproductive procedures deemed acceptable by regulators; it protects the interests of ART
children in a much more effective way; it improves the quality and safety of reproductive
procedures; and it expands the number of reproductive treatments available to the ART industry.
These benefits are well worth their costs.
341

13.4 Technologies of Reproductive Customization
Technologies of reproductive customization set themselves apart from standard reproductive
techniques and innovative treatments for their purpose. These technologies are not used simply
to increase the prospective parents’ chances to have a family, but to meet specific parental
requirements. A classic example is the use of pre-implantation genetic diagnosis for elective sex
selection.
With regard to monitoring the use of technologies of customization or reproductive control,
no additional action is needed. As for innovative reproductive treatments, ART practitioners
would have to provide an assessment of possible health and safety risks and a discussion of
possible ethical concerns, if the contemplated procedure is not already regulated. The notion of
risk in this case should be construed broadly to include harm to the well-being of the child, and
not simply health threats in the narrow sense of this term. Consistent with the view that
technologies of reproductive customization should be more closely scrutinized, the review
process would have a suspensive effect. The proposed procedure may not be performed until the
agency has evaluated the documentation and has received feedback from the ART industry and
the bioethics community.
Depending on the type of procedure and the concerns expressed, the agency could proceed
as in the case of innovative reproductive treatments – i.e., offer a specific opinion on the pros and
cons of the proposed treatment, or determine that the procedure at issue deserves broader public
scrutiny. In the latter case, it would propose a new rule and initiate a process of public
consultation.
Initially, the legal definition of a technology of reproductive customization could create
some difficulties. It may not always be clear whether a certain treatment should be regarded as
an instance of a traditional ART treatment, as an innovative technique, or rather as a technology
of reproductive customization. Nor is determining what harm the child may experience a trivial
matter. The debate over reproductive cloning has shown that it may be surprisingly difficult (but
certainly not impossible) to demonstrate harm for the children involved. This is also the reason
why we have suggested establishing an independent agency with quasi-judicial powers.
13.5 Biomedical Research
Of the four policy domains identified in this report, biomedical research poses perhaps the
greatest challenge. Science and scientific institutions enjoy a special position in modern
America. The public continues to regard science and technology as crucial to the future of our
country. The libertarian ethos that is one of the constitutive elements of American
exceptionalism is particularly strong among scientists. 24 Representatives of this profession often
consider scientific freedom sacrosanct. Attempts by Congress to restrict freedom of research are
24
See, for example, Lipset, American Exceptionalism: A Double-Edged Sword.
342

likely to meet with fierce resistance, more so perhaps than the suggestion that the practice of
reproductive medicine should be regulated.
In select areas, the scientific community has recognized the importance of conducting
research in a manner that is regarded by the public as ethical. The “Guidelines for Human
Embryonic Stem Cells,” a report published by the National Academy of Sciences (NAS) in early
2005, provides an illustration. Unlike most legislative proposals introduced in Congress over the
last few years, the NAS report, in addition to recommending the usual procedural safeguards,
proposes the creation of an infrastructure of evaluation and monitoring. The proposal is by far
the most sophisticated and serious effort to establish a regulatory framework for a field of
biomedical research. For this reason, we examine its main elements in some detail.
The NAS report establishes the principle that research proposals should be evaluated not
merely on procedural but also on substantive grounds. Crucially, the report distinguishes
between research that is “permissible” (i.e., that does not require additional review), research that
is permissible only after additional review, and research that “should not be permitted at this
time.”
The derivation of new stem cell lines, either from donated embryos or created through
somatic cell nuclear transfer, would trigger additional review. Additional scrutiny would also be
necessary for introducing human embryonic stem cells into non-human animals at any stage of
embryonic, fetal, or postnatal development. 25 Among the activities that should not be permitted
are (a) the in vitro culture of human embryos for longer than 14 days or until the formation of the
primitive streak, whichever occurs first; (b) research in which human embryonic stem cells are
introduced into non-human primate blastocysts, or in which any embryonic stem cells are
introduced into human blastocysts; and (c) the breeding of animals in which human embryonic
stem cells have been introduced at any stage of development. 26
Taken together, these provisions suggest that the scientific community is beginning to
recognize the need to distinguish between research that is largely unproblematic, research that
warrants additional scrutiny, and research that should not be conducted. In our view, this
recognition is more important than where exactly the specific ethical lines should be drawn. The
NAS recommendations are noteworthy for another reason as well: They implicitly acknowledge
the need to create a regulatory institution that can operate in a contingent, quasi-adjudicative way
rather than suggesting the creation of a system based on the seriously misleading assumption that
ethical controversies can be resolved in an abstract, a priori fashion.
Chiefly responsible for the evaluation of research proposals would be an Embryonic Stem
Cell Research Oversight (ESCRO) committee. ESCROs would be established at each research
institution at which human embryonic stem cell research is being conducted, but they would not
duplicate the functions of institutional review boards. The report recommends that
25
26
Committee on Guidelines for Human Embryonic Stem Cell Research, Guidelines for Human Embryonic Stem
Cell Research, p.87.
Ibid., p.87-88.
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epresentatives of the general public as well as professional bioethicists and legal scholars be
represented on each ESCRO. 27
It also recognizes the crucial importance of compliance
assurance, and proposes what at first seems a practicable approach to compliance assurance –
identifying in private institutions such as funding agencies, professional societies, publishers, and
institutional review panels entities that can provide “valuable community pressure” and “impose
appropriate sanctions to ensure compliance.” 28 More specifically, the report recommends that
compliance be ensured through three private institutions – review committees such as ESCROs
and IRBs, funding agencies, and journals. 29
Having emphasized several commendable aspects of the NAS report, three major
shortcomings should mentioned. First, the role of the general public remains unspecified.
Presumably, this requirement is inspired by the now fairly common practice to include a
“community representative” on IRBs and ethics committees. This approach may be reasonable in
the case of medical ethics committees, but it is hard to see how a few representatives of a local
community may contribute to defuse anxieties, concerns, and opposition to controversial
research proposals. Should a research protocol be prevented from moving forward if the local
community is opposed to it? In which way are the community representatives accountable to the
community? Should they be elected or simply selected by the research institution to participate?
The credibility of ESCRO committees as moral authorities and independent bodies of evaluation
and oversight depends crucially on how these issues are resolved.
One may also wonder why the report suggests implementing a decentralized system of
oversight. Quite possibly, the preference for a decentralized over a federal system of oversight
resides in a deep-seated distrust of the G.W. Bush administration, often regarded by the scientific
community as being captured by religious interests inimical to medical science and to the
scientific enterprise more generally. This argument ignores the simple fact that a decentralized
system of oversight is not better protected against skeptical views than a federal system of
oversight would be, and has some shortcomings of its own. As shown in chapter 10, citizen
advisory boards can quickly become a platform for skeptical groups to voice their opposition.
ESCRO committees, too, could become the focus of heated, protracted, and ultimately sterile
political controversies between a research institution and the local community. A federal system
27
28
29
Ibid., p.44-46.
Ibid., p.12. There is ample empirical evidence that private systems of reciprocal monitoring can produce
surprisingly high levels of compliance with privately enacted rules and norms. See, for example, Lisa Bernstein,
"Opting out of the Legal System: Extralegal Contractual Relations in the Diamond Industry," Journal of Legal
Studies 21, no. 1 (1992); Lisa Bernstein, "Private Commercial Law in the Cotton Industry: Creating Cooperation
through Rules, Norms and Institutions," Michigan Law Review 99 (2001); Robert D. Cooter, "Decentralized Law
for a Complex Economy: The Structural Approach to Adjudicating the New Law Merchant," University of
Pennsylvania Law Review 144, no. 5 (1996); Avery Katz, "Taking Private Ordering Seriously," University of
Pennsylvania Law Review 144, no. 5 (1996); Mark D. West, "Private Ordering at the World’s First Futures
Exchange," Michigan Law Review 98 (2000).
Committee on Guidelines for Human Embryonic Stem Cell Research, Guidelines for Human Embryonic Stem
Cell Research, p.12.
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of oversight as laid out in this report would provide both legal protection and legitimacy to the
research community independently of idiosyncratic political landscapes at the local level.
The system of compliance assurance proposed by the NAS report has the merit of focusing
on private organizations such as funding agencies and publishers that by virtue of their position
could ensure high levels of compliance. These organizations could require sufficient and credible
evidence of compliance with the NAS guidelines as a condition for funding or publication. In
select areas, mainly with regard to compliance with procedures of informed consent, this
approach could prove workable. In this case, the task of reviewing compliance records may be
manageable, and the reviewing institutions could be expected to have the necessary
administrative expertise to perform this task. Certainly, the leading funding institutions and
highly reputable journals could perform this task. Smaller organizations, such as foundations and
second-tier journals, may not have the necessary expertise and may be far less inclined to assume
these responsibilities. Importantly, the system of compliance assurance proposed by the NAS
guidelines does not explicitly contemplate a system of inspection, nor does it include any kind of
sanctions for non-compliance. Finally, the report does not elaborate on how the integrity of a
private system of compliance assurance could be protected.
Finally, as laid out in this report, the responsibility for determining the acceptability of new
research protocols resides with the scientific community and with it alone. Local communities
have an opportunity to be heard, but they certainly do not have the authority to prevent new
research from moving forward. This is precisely the opposite of what we have proposed in this
report: Scientists and the general public must be given ample opportunities to be heard, but the
authority to decide what may or may not move forward must reside with an administrative entity
created by Congress. It should be the responsibility of the regulatory advisory board (see chapter
11) to examine new research protocols and to make recommendations for the regulatory
commission. For these reasons, we believe that the guidelines proposed by the National
Academy of Sciences do not form the basis for a robust and trustworthy regulatory
infrastructure.
13.6 Designing a System of Compliance Assurance
Implementing an efficient and effective system of compliance assurance is no easy task. In
this regard, the British experience is only of limited help. As of August 31, 2004, the HFEA had
exercised its oversight over 108 ART programs and ART laboratories. 30
Inspecting these
facilities on a regular basis is a manageable task, considering the modest number of facilities and
the limited travel distances involved. A U.S. regulatory agency would face a much more
complex organizational landscape that includes more than 400 ART clinics, countless embryo
labs, more than 900 biotech companies, several large pharmaceutical companies, and a
potentially significant number of university laboratories. Furthermore, this very diverse
30
Human Fertilisation and Embryology Authority (HFEA), "HFEA Annual Report 2003/04," p.8.
345

population of firms, clinics, laboratories, and universities is scattered over a very large territory,
making it difficult for any administrative agency to implement a credible and effective system of
compliance assurance.
Regulatory agencies facing a challenge of this magnitude routinely delegate some
monitoring and enforcement authority to third parties, such as trade and professional
organizations. Obvious candidates for surveying ART programs are the American Society for
Reproductive Medicine and the Society for Assisted Reproductive Technologies. The
Biotechnology Industry Organization could monitor the biotech sector, and leading scientific
societies such as the American Association for the Advancement of Science and the Federation
of American Societies for Experimental Biology could audit academic laboratories.
Delegating monitoring and enforcement authority to third parties – referred to as
intermediary organizations in the remainder of this section – has a crucial limitation: Trade and
professional associations would have a very limited authority to ensure compliance; members
could easily avoid compliance by simply leaving the association, while non-members would be
exempt from oversight in the first place. This is not, however, an insurmountable problem. While
limited, an intermediary organization’s authority is not negligible; it varies depending on the
nature of the benefits it provides to its members. 31
Intermediary organizations providing
valuable, exclusive benefits to their members make it more difficult for a member to leave. The
more valuable the exclusive benefits, the more difficult it is for a member to leave, and the more
powerful an intermediary organization becomes. 32
Regulators could bolster these embryonic systems of private governance either by making
membership in intermediary organizations more attractive or by increasing the cost of leaving an
intermediary group. For example, regulators could decide that the members of an intermediary
organization would be inspected less frequently, and that the inspection process should be
collaborative and should emphasize the correction of violations and the adoption of best
practices over punishment, fines, and prosecution. The agency could also determine that serious
violations by a member of an intermediary organization should be treated more leniently. By
contrast, non-members would be inspected more frequently, their inspection process would be
antagonistic, and violations would trigger severe penalties. Importantly, members of an
intermediary organization would be inspected by their peers or by representatives of their
intermediary organization, while non-members would be inspected by the regulators.
In this architecture of compliance, the regulator’s main role shifts from compliance
assurance to ensuring the integrity of a decentralized system of monitoring and inspection, i.e., to
monitoring the monitors. Assuring the credibility and integrity of this system entails addressing
several concerns. Chief among them are ensuring consistency of inspection and preventing
31
32
Typically, national trade associations advocate vigorously for their members, to avoid or mitigate regulations or
to obtain specific benefits. They also offer a wide range of training and educational opportunities.
Mancur Olson, The Logic of Collective Action: Public Goods and the Theory of Groups (Cambridge, MA:
Harvard University Press, 1965); Posner, "The Regulation of Groups: The Influence of Legal and Nonlegal
Sanctions on Collective Action."
346

collusion between inspectors and inspected parties. To achieve these goals, regulators would
adopt a certification scheme. Only certified intermediary organizations would be delegated the
authority to conduct inspections. Maintaining the certification would require intermediary
organizations to periodically undergo extensive audits, for example, every three to five years.
Serious irregularities could trigger monetary and other penalties for both the auditing and the
audited organization. For the most egregious violations, the regulators could revoke the
certification. The consequences of this measure would be severe, because in this case, both the
intermediary organization and its members would be punished. 33
Revoking certification is perhaps the most extreme illustration of a collective sanction. The
threat of collective sanctions, if properly designed, could have several unintended but welcome
consequences. It could trigger collaborative efforts to identify best practices and promote their
adoption throughout the group. It could also encourage the members of an intermediary group to
exercise pressure on violators to comply with all applicable laws and regulations. Failure to
demonstrate improvement on the part of violators could prompt some members to file a report
with the intermediary group. Finally, individual members would have an incentive to report
cases of collusion between an audited organization and the auditor to the regulators. 34
Collective sanctions are neither new nor unusual. In the early 1970s, the scientific
community effectively faced a collective threat when its leaders at the Asilomar Conference
proposed to establish a system of self-regulation. In this case, the threat originated not with
regulators but with the general public. Scientific leaders recognized that even a single accident
associated with recombinant DNA technology would have damaged the reputation of this
nascent field of research beyond repair. This is by no means an exceptional pattern. Over the last
20 years, many industries that experienced a highly visible, catastrophic incident reacted by
establishing elaborate systems of self-governance. 35
This somewhat simplistic analysis of the impact of collective sanctions on intermediary
organizations and their members masks a subtle but very important phenomenon: the gradual
emergence among these organizations of civic norms and attitudes, i.e., the recognition of the
crucial importance of obtaining a “public license” for conducting ethically controversial medical
research. Key to initiating this learning process is a new professional role: a person charged by
33
34
35
The threat of revoking certification is credible only if the intermediary organization being audited is not too large
compared to other intermediary organizations. Should a large intermediary organization loose its certification, it
may be difficult for regulators to find a replacement. In turn, this would make the threat of decertification less
credible.
Note that whistle-blowing as outlined in this passage provides an additional incentive to intermediary
organizations to properly audit their members.
The classic example is the Responsible Care Program established by the American Chemistry Council (formerly
the Chemical Manufacturers Association) in the aftermath of the Bhopal accident. Cf. Howard, Nash, and
Ehrenfeld, "Standard or Smokescreen? Implementation of a Voluntary Environmental Code."; King and Lenox,
"Industry Self-Regulation without Sanctions: The Chemical Industry's Responsible Care Program." Other
chemical sub-sectors have followed suit, adopting their own programs of safety and environmental management.
A similar approach has been taken by the nuclear power industry in the wake of Three Mile Island. Rees,
Hostages of Each Other: The Transformation of Nuclear Safety since Three Mile Island.
347

an ART program, a biotech company, or a university to ensure compliance with applicable laws
and regulations – a compliance assurance officer, so to speak. This person’s job would be not
only to make sure that researchers and ART practitioners follow procedures and maintain proper
documentation, but also to determine whether a certain ART treatments should be considered
traditional, innovative, or technologies of customization, and what ethical concerns they may
raise. In the case of biomedical research, this person would help determine whether a given
research proposal might raise special ethical concerns. Crucially, the compliance officer would
cooperate with compliance officers at other ART programs or research institutions to resolve
complex ethical problems created by new research protocols, and to identify possible harms
involved in novel reproductive treatments. These patterns of collaboration eventually will morph
into a horizontal network of personal and professional relations, and lead to the emergence of a
professional culture that will find itself at the intersection of public virtues and private interests.
From a regulatory standpoint, the emergence of this network would have several important
benefits: It would reduce the risks of collusion between member organizations and auditors. It
would spur the ethical analysis of novel ART treatments and biomedical research protocols. It
would contribute to developing new techniques of risk assessment. Importantly, it would also
become an effective promoter of civic values among biomedical researchers and medical
professionals. 36
Admittedly, creating the position of compliance assurance officer, by itself, is unlikely to
produce the kind of cultural change envisaged here. No one should be under the illusion that
civic norms would quickly emerge. That compliance assurance could initiate a process of
societal change is, however, both surprising and encouraging. This alone would justify its
implementation costs, as discussed in the next section.
13.7 Operating Costs
In this section, we provide a rough estimate of the costs of operating a new regulatory entity
as outlined in this report. This discussion is not meant to provide precise cost estimates. It is
simply a back-of-the-envelope calculation that should demonstrate how modest the overall costs
of operating a new regulatory agency would be. Our calculations are based on data derived from
the British regulatory system, one of the most intrusive systems of ART regulation worldwide.
The data is derived from the 2001, 2002, and 2003 annual HFEA reports, available on the HFEA
Web site. 37 Each of them includes a financial statement and other operational data. They also
describe in some detail the scope of the HFEA’s regulatory activities.
36
37
An important precedent to this professional role is the environmental and safety (ES) manager common at large
industrial firms. Several trade groups in the chemical sectors that in recent times have adopted extensive systems
of self-regulation have learned that ES managers play a crucial role in resolving complex questions of
implementation and in promoting high levels of compliance.
See http://www.hfea.gov.uk.
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Consider first the scope of the HFEA’s regulatory activities. In 2003, the agency was
responsible for overseeing 110 facilities. Most of them (80) offer both treatment and storage
services; 15 had received all three kinds of license (treatment, storage, and research); the
remaining ones are specialized in just one type of licensed activity. (See Table 12.)
Type of HFEA-licensed center Number of centers
Treatment only 2
Storage only 8
Treatment and storage 80
Treatment with storage and research 15
Research only 5
Total 110
Table 12: The ART industry in Britain, 2002-2003, p.8.
Another measure of the size of the British ART industry is the number of licensed
treatments granted by the HFEA on a clinic-by-clinic basis. As Table 13 shows, not every clinic
is licensed to perform all ART treatments, but most perform donor insemination, in vitro
fertilization, and intracytoplasmic sperm injection. They also offer the storage of embryos and
sperm.
HFEA-licensed treatments
Number of centers
Storage of eggs (including ovarian tissue) 20
Storage of sperm (including testicular tissue) 103
Storage of embryos 76
Donor insemination 96
In vitro fertilization 75
Intracytoplasmic sperm injection 74
Pre-implantation genetic diagnosis 8
Pre-implantation genetic screening for aneuploidy 5
Table 13: Licensed treatments in Britain, 2002-2003, p.8.
Clinics are generally inspected on a yearly basis, although facilities in good standing are
fully inspected only once every three years. Table 14 provides another indication of the tight
control exercised by the HFEA over the ART industry, in the form of the total number of
inspections conducted in 1999, 2000, 2002, and 2003.
Inspection 1998-1999 1999-2000 2001-2002 2002-2003
Number of inspection visits 106 109 115 121
Number of audits 28 25 106 93
Number of ICSI practitioners inspected 35 22 18
30
Number of PGD practitioners inspected 0 1
n/a
Table 14: Inspection visits and audits, 1999-2003.
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By all accounts, the British regulatory system can only be described as comprehensive and
fairly intrusive. And while the British ART industry is considerably smaller than its U.S.
counterpart, it is large and complex enough to serve as a basis for assessing the operational costs
of a domestic regulatory program.
Just how expensive is it to operate the HFEA licensing and inspecting scheme? Actual
financial information about these two operational aspects is not available, but total operating
expenses are a good substitute. Information about total expenditures is readily available and is
reported in Table 15.
Year 1998 1999 2000 2001 2002 2003 2004
Total expenditures 1,552,909 1,706,657 1,772,910 2,743,558 1,716,845 5,629,560 7,444,580
Staff costs 848,288 932,093 969,503 1,363,038 1,263,038 2,523,912 3,665,204
Table 15: HFEA operating costs, 1998-2004 (in pounds).
Until 2000, total expenditures remained largely unchanged. In response to the rapid growth
of the ART industry in 2001, the HFEA budget and its staff expanded considerably. Section 16
of the Human Fertilisation and Embryology Act requires the HFEA to recover 70 percent of its
expenditures. The HFEA recoups its operating expenses through licensing fees (for first-time and
for renewal applications) and through an annual fee based on the number of ART cycles
performed. In 2000, the fee for performing an IVF cycle was reduced from £40 to £36, whereas
fees for donor insemination were raised from £10 to £18. The HFEA has been quite good at
achieving a 70 percent level of self-funding. In the fiscal year 2000-2001, its self-funding level
was 67 percent. In 1999-2000, it reached 101 percent of its cash limit.
The U.S. ART industry is approximately four times larger than its British counterpart, not
counting the sperm and embryo banks already regulated by the new FDA human cellular and
tissue-based products rules. 38
The 2002 CDC report on ART success rates lists 391 ART
programs, up from 384 a year before. 39 These programs generally do not conduct basic research
on human embryos. On the other hand, according to news media reports, restrictions on federal
funding for embryonic stem cell research have prompted private foundations to fill this gap, so it
is quite possible that a fair number of universities are now receiving human embryos, though
how many is anyone’s guess. 40
38
39
40
See chapter 5 for a discussion of these rules.
These are the reporting programs. Appendix C of the report lists 37 non-reporting programs. Cf. Centers for
Disease Control and Prevention, "2002 Assisted Reproductive Technology Success Rates: National Summary
and Fertility Clinic Reports."
Anne Harding, Harvard Has Human Cloning Plans. Institute Seeks Nod to Create Embryos Using Genes from
Patients with Diabetes, Parkinson's (The Scientist, October 15, 2004 [cited September 20, 2005]); available from
http://www.biomedcentral.com/news/20041015/03; Nancy Touchette, New Stem Cells Created for Research:
Harvard Scientist Will Make 17 New Lines Available (Genome News Network, March 3, 2004 [cited September
20, 2005]); available from http://www.genomenewsnetwork.org/articles/2004/03/03/stem_cells.php.
350

There is some evidence that the biotech industry does conduct research in this area, but just
how much research is unknown. A fairly recent survey conducted by the Department of
Commerce in cooperation with BIO, the leading biotech industry trade association, shows that of
776 surveyed firms, 41 percent did perform “culturing/manipulation of cells, tissues,,
embryos.” 41 However, the survey does not provide any information on the relative importance of
embryo research proper, or the significance of this research area in the industry research
portfolio.
For the purpose of this discussion, we assume that the newly created regulatory agency
would have to fund itself through user fees. (This is a worst-case scenario, as Congress is likely
to fund this agency at least in part.) The regulators, then, would have to adopt a fee system
similar to the one operated by the British HFEA. A simple way to assess the burden imposed on
the ART industry and patients by this fee system is to compare fee levels to the cost of ART
services to patients. Assessing the cost of ART services in the United Sates is no easy task.
Prices vary considerably depending on the type of service rendered and the clinic’s reputation
and location. ASRM does not provide reliable cost information, nor does the CDC gather this
kind of data. A rough estimate of the cost of various ART services can be gleaned from Web
resources offering information to prospective parents and from fertility clinics’ own published
information. For example, www.babycenter.com provides the following price estimates per
cycle:
• Artificial insemination: $300 to $700
• In vitro fertilization: $8,000 to $15,000
• Gamete intrafallopian transfer: $8,000 to $15,000
• Zygote intrafallopian transfer: $8,000 to $15,000
• Intracytoplasmic sperm injection: $10,000 to $17,000 42
Note that these categories are not mutually exclusive. An individual cycle may require
performing ICSI followed by traditional IVF. Other cycle-related services such as testing of
reproductive tissues are charged separately. In the United States, by far the most common
procedure remains IVF. According to the CDC, in 2001, 107,587 ART cycles were performed. 43
Assuming that the U.S. regulatory counterpart would charge the same fee as the British HFEA
(i.e. £36, or $64), 44 and given the average price of $12,000 per cycle, a U.S. regulatory system
41
42
43
44
U.S. Department of Commerce, "A Survey of the Use of Biotechnology in the U.S. Industry," (Washington,
D.C.: Technology Administration, Bureau of Industry and Security, 2003).
See http://www.babycenter.com/refcap/preconception/fertilityproblems/1228997.html, page visited on July 20,
2005.
Centers for Disease Control and Prevention, "2001 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," (Atlanta, GA: National Center for Chronic Disease Prevention and
Health Promotion, Division of Reproductive Health, 2003), p.6.
Exchange rate as of April 26, 2006.
351

would add roughly 0.56 percent to the cost of this ART service. This figure must be regarded as
a rough estimate; it does not include the one-time costs to ART programs to implement the new
record-keeping and reporting requirements, and it does not include the additional operating
expenses ART programs would incur in complying with reporting and other regulatory
requirements. On the other end, it is quite possible that a U.S. regulatory agency would be less
costly to operate and could charge lower user fees.
The new record-keeping requirements are likely to increase the operational costs of ART
programs, though it is unclear by just how much. If we assume that ART programs depend on
effective systems of record-keeping for their daily operations, and that in cooperation with SART
and the CDC they have already adopted an IT-based reporting system, compliance with new
reporting requirements is likely to cause only modest additional costs.
352

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