Final Report (all chapters)

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).
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