Preimplantation Genetic Diagnosis - Genetics & Public Policy Center

have authority to sanction members for noncompliance.
Unless the organization is specifically authorized by the federal
government to act on the government’s behalf in
administering and enforcing government standards, actions of
the professional organization do not have the force of law.
For PGD, a few different professional organizations have
relevant expertise and either currently possess or could in the
future develop PGD-specific guidelines or standards. For
example, the American Society for Reproductive Medicine
(ASRM) is a professional organization whose members are
health professionals engaged in reproductive medicine. ASRM
issues policy statements, guidelines and opinions regarding a
variety of medical and ethical issues that reflect the thinking of
the organization’s various practice committees. These
documents, while not binding on members, may be viewed as
evidence of standards of practice in legal settings.
In 2001 ASRM issued a practice committee opinion
addressing PGD stating that PGD “appears to be a viable
alternative to post-conception diagnosis and pregnancy
termination.” It further states that while it is important for
patients be aware of “potential diagnostic errors and the
possibility of currently unknown long-term consequences on
the fetus” from the biopsy procedure, “PGD should be
regarded as an established technique with specific and
expanding applications for standard clinical practice.” ASRM
has also issued an ethics committee opinion cautioning against
the use of PGD for sex selection in the absence of a serious
sex-linked disease.
to organize meetings and workshops on PGD research.
PGDIS may take on additional functions in the future.
An international organization, the European Society for
Human Reproduction and Embryology (ESHRE), tracks
PGD outcomes on a voluntary basis, but captures primarily
European data. ESHRE is an organization comprising
individuals active in the field of reproductive medicine and
science and is dedicated to facilitating the study and analysis of
all aspects of human reproduction and embryology. ESHRE
has over 4000 members, including some U.S. physicians and
scientists engaged in PGD efforts.
A few professional organizations oversee the conduct of
clinical laboratories and potentially could extend their
oversight to the laboratory component of PGD. For example,
the College of American Pathologists (CAP) has been
empowered by the federal government to inspect laboratories
seeking certification under the Clinical Laboratory
Improvement Amendments. CAP also has developed a
voluntary certification program for reproductive laboratories
that perform embryology testing. However, this latter program
does not currently include standards for PGD.
Similarly, the American College of Medical Genetics (ACMG)
develops laboratory standards and clinical practice guidelines
for genetic tests. However, these guidelines and standards do
not currently address PGD.
Another example of professional oversight is the Society for
Assisted Reproductive Technologies (SART). SART, an
affiliate of the ASRM, is a professional society whose
members comprise clinics engaged in reproductive medicine.
As discussed above, SART, together with CDC, administers
the legislatively mandated reporting requirements for fertility
clinics. SART is responsible for collecting the data that is then
analyzed and reported by CDC.
Compliance with the reporting and data validation
requirements of the statute is a requirement of SART
membership. SART provides voluntary consultation and
guidelines to members in order to improve the quality of
clinical practice. Its committees also develop practice,
laboratory, advertising and other guidelines to which SART
members must agree to adhere. The organization does not
have any guidelines specifically addressing PGD. Overall, it
views its role as a private “watchdog” whose activities will
instill consumer confidence and preclude the need for
governmental intervention. According to SART, its members
represent 95 percent of all IVF establishments in the U.S.
One organization has recently formed to focus specifically on
PGD. The PGD International Society (PGDIS), founded in
2003 in the United States, was created to promote PGD and
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