Final Report (all chapters)

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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 11
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. 12
Page 2: Beyond Bioethics: A Proposal for Mo
Page 5 and 6: (ARTs) as well as laboratory resear
Page 7 and 8: issues raised by new biotechnologie
Page 9 and 10: human and animals cells, tissues, a
Page 11 and 12: (CLIA) of 1988 and, more importantl
Page 13: the activities of both private and
Page 17 and 18: 5.5 Creating a New Regulatory Insti
Page 19 and 20: egarding reproductive biomedicine t
Page 21 and 22: to represent constituencies that ar
Page 23 and 24: “Deliberative panels,” the term
Page 25 and 26: participants may be able to engage
Page 27 and 28: outer limits of the right to privac
Page 30: About the Authors Francis Fukuyama
Page 33 and 34: 1.1 THE CHALLENGE OF NEW BIOTECHNOL
Page 35 and 36: 7.1 TRADITIONAL REPRODUCTIVE TECHNO
Page 37 and 38: Shortness as a Psychological and So
Page 40 and 41: 1 Introduction This report presents
Page 42 and 43: them only on the basis of safety an
Page 44 and 45: esearch, and clinical and medical p
Page 46 and 47: Congress’ powers over scientific
Page 48 and 49: of newborns; destruction of an embr
Page 50: 1.6 Bibliography Evans, John H. Pla
Page 53 and 54: endogenous growth hormone secretion
Page 55 and 56: slippery slope toward blanket uses
Page 57 and 58: proposed by Eli Lilly - a rather su
Page 59 and 60: Committee tended, predictably, to r
Page 61 and 62: coincidentally, she was also one of
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2.5 Bibliography American Academy o
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• Limits on the commercialization
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the sick and relieving the pain and
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give for opposing this practice var
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We recognize that for some people,
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3.6 Bibliography Baruch, Susannah,
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taxonomies are likely to exist. For
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that an investigator may not be abl
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ecome part of this complex transact
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These concerns are not unfounded, a
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cryopreservation a good example of
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A 2003 news story published in Popu
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episode. Reputational incentives ar
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Would you approve or disapprove if
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strong preference for a mixed famil
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controversial not because it provid
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esearch. On the other end are situa
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nucleus of a somatic cell, such as
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And we have to have some degree - a
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father. The experiment could also l
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The availability of oocytes in larg
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and the tail of serpent. In biology
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our view, that the scientific commu
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Bonnicksen, Andrea. "Innovative ART
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Kubawara, Y., T. Okai, S. Kozuma, N
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Shamblott, Michael J., Joyce Axelma
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116
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iotech companies or university clin
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As an infrastructure of quality ass
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toward implementing a comprehensive
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clinical research, 22 while the FDA
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principles of good governance as fe
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sustainable way. Examples include c
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cloning to register with the Depart
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kind of cloning or they limit the b
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The federal government has been rel
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includes ethicists, scientists, men
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Society for Assisted Reproductive T
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Reproductive Endocrinology Subspeci
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safety guidelines aimed at ranking
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elatively mundane. 67 For example,
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Fallon, Peter, and Zafiris Tzannato
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148
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6.1 Italy - from the “Wild West
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also prohibited. 13 The law activel
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selection technologies, but only fo
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eproductive technologies in section
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Neither the RIHEA nor its explanato
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inspect all licensees, or how often
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(principle (e)). 43 Canada affords
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traditional views of reproduction,
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y the Canadian authorities and the
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esearch on human embryos. It requir
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This argument is not likely to conv
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• Maintain a formal register of i
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The remaining three positions reser
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type of research. The HFEA is requi
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The relevance of the Code of Practi
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180
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182
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of saving the life of an older sibl
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procreative right, unlikely as it i
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assisted suicide, the Court has est
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or that there are an infinite numbe
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What is obvious is that the Court s
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generalizing from a strong but gene
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are not any societal traditions tha
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the First Amendment’s protection
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least preferable among all forms of
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Surrogacy 16 Donor egg 14 Donor spe
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To recap, the survey data shows a s
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Robertson, John A. Children of Choi
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media and from polling organization
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Before diving into the data, the me
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(126), and allowing parents to have
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esearch cloning. Two questions (150
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asked five times whether the public
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the creation of embryos solely for
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Our conclusions could be criticized
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about embryonic stem cells? The ans
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were essentially split (44 percent
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226
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228
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coincidence that U.S. scientists id
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assertion of jurisdiction in this c
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of the opposition to genetically mo
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More generally, it is shortsighted
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Process.” 19 According to their i
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another branch of medicine. ART pra
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242
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Navasky, Victor S., and Christopher
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to extract benefits for their membe
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entails. 3 CAMR, a very large and h
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of scientists in these debates woul
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elatively modest. Canada and Austra
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ighteous manner, justifying their c
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eaching out to the public, the agen
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ultimately benefits more the patien
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In many cases, these efforts are pe
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The rationale for including stakeho
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years away. Again, no scientific ba
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The view that deliberation can shar
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members and instructed to reach con
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Deliberation: This requirement has
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One may wonder why public hearings
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conference. Denmark is the clear le
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legislative and regulatory process.
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10.9.1 The National Environmental P
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considered in the process, identify
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vicinity of black residential areas
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it significantly constraints the ag
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286
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Dunkerley, David, and Peter Glasner
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———. "The Courts and the Ossi
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292
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agency’s ability to implement Con
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areas that were thought to require
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Small decision-making bodies such a
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accountability also comes the very
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and remains the British solution to
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equirement is very difficult to imp
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advisory board, the higher the chan
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11.2.2 The Advisory Board as a Boar
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suggesting candidates. They include
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312
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Morrison, Alan B. "How Independent
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12.1 Deliberative Panels Deliberati
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complexity would be to convene deli
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deliberative panels, however, delib
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Participation suffered from conside
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12.3 Public Consultation and Rule-M
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divide the public, it is quite unli
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328
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Among the parties subject to record
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demand in-depth health screening, a
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many prospective parents are attrac
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Traditionally, the practice of medi
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eliefs firmly held by medical pract
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some studies, the TRI program has b
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13.4 Technologies of Reproductive C
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epresentatives of the general publi
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population of firms, clinics, labor
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an ART program, a biotech company,
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By all accounts, the British regula
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would add roughly 0.56 percent to t
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[cited September 20, 2005]. Availab
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