Tuesday, December 26, 2006

Carpenter and Hyman

The Northwestern Law Review is preparing a symposium issue about IRBs. At least two papers from the symposium have appeared on SSRN.

Dale Carpenter, in "Institutional Review Boards, Regulatory Incentives, and Some Modest Proposals for Reform," writes that "IRBs understand well the physical risks to subjects that come from biomedical research. They are much less adept at identifying substantial nonphysical risks or the research methods in social science that can create them. Thus, in an abundance of caution, they 'make decisions on the basis of worst-case scenarios.' Fear of these worst-case scenarios leads them to over-regulate."

David Hyman, one of the authors of the recent AAUP report on IRBs, is more aggressive in his piece, "Institutional Review Boards: Is This the Least Worst We Can Do?" He notes that even in biomedical research, "there is no empirical evidence that IRBs have any benefit whatsoever," and that "it is hard to make the case that IRBs, with their obsession with paperwork and the tweaking of consent forms, actually promote the protection of human subjects." Both agree that the current system punishes IRB members for approving dangerous research but not for blocking legitimate research, thus encouraging boards to be over-cautious and censorious.

Both Carpenter and Hyman offer what they term "modest reforms." But many of their suggestions are anything but modest. In particular, excluding from review all interview-based research with legally competent adults (as advocated by the AAUP) seems to require either a rewriting of federal regulations (and corresponding state laws) or a willingness of institutions to risk the suspension of all research by the federal Office of Human Research Protections. I hope that legal scholars will do more to determine exactly how to change the current regulations or establish a saner and more consistent interpretation of them than the arbitrary pronouncements of the past few years.

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