Menikoff began his speech with a word for IRB critics: "Yes, we hear you." He then spent most of his hour summarizing some of the more prominent critiques of the U.S. IRB system. Among them:
- Carl Schneider, Personal Statement, in President's Council on Bioethics, The Changing Moral Focus of Newborn Screening: An Ethical Analysis by the President's Council on Bioethics, 2008.
- Department of Health and Human Services. Office of Inspector General, Institutional Review Boards: A Time for Reform (1998)
- Philip Hamburger, "The New Censorship: Institutional Review Boards" (2005).
- University of Illinois, The Illinois White Paper. Improving the System for Protecting Human Subjects:. Counteracting IRB “Mission Creep” (2005).
- Northwestern University Law Review, Symposium on Censorship and Institutional Review Boards (2006)
- American Association of University Professors, Research on Human Subjects: Academic Freedom and the Institutional Review Board (2006)
An institution can choose to impose rules that are more restrictive than [federal] regulations. But complaints about censorship resulting from such a circumstance would seem more appropriately directed at the specific institutions that are choosing to do this, rather than the IRB system itself, as created by the federal regulations. (792, n. 6)Such analysis ignored the role of OPRR/OHRP in encouraging institutions to impose requirements beyond those in the regulations. In particular, in 1995, OPRR advised institutions "that investigators should not have the authority to make an independent determination that research involving human subjects is exempt." More recently, OHRP contributed to a 2008 report that recommended expedited review for several hypothetical projects that would seem to merit exemption. In his Michigan speech, Menikoff did better. He conceded that OHRP continues to recommend that researchers should not make exemption determinations. But he also noted, "it's just a recommendation. You don't have to follow it." He pledged that OHRP would clarify this. While this concession is welcome, it is pretty small stuff. Even on the narrow issue of the Common Rule exemptions, it ignores the question of why OHRP continues to promulgate guidance that contradicts the intent of the authors of the exemptions and that originally emerged from the panic of the mid-1990s that almost everyone agrees led to the overregulation of human subjects research. Nor can I put much faith in a promise that new guidance from OHRP is just around the corner. More importantly, it's frustrating that Menikoff missed the opportunity to address the central problem posed by the critics he cited: there is no evidence that the IRB system does more good than harm. The question of self-exemption is important, but in the context of the overall critique of the system outlined in the speech, Menikoff's emphasis on this one point becomes a bit of a red herring. Finally, I must object to Menikoff's patronizing remarks about the emotional state of IRB critics:
It's not as if everything or even the bulk of what these people are claiming is necessarily true or valid, but nonetheless we again have to be aware of the strength of their feelings and the source of it. There is this heartfelt feeling about at least parts of the human protection system that they are wrong.
Yes, critics are angry, but it is insulting to portray us as so overcome with emotion that we cannot form "true or valid" complaints. It is not the strength of our feelings that should concern Menikoff, but the accuracy of our facts and the logic of our arguments.