Final Report (all chapters)

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."
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