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Institutional review boards

Minnesota lawprof and Volokh conspirator Dale Carpenter has an SSRN paper on a problem I've been following for a long time, namely the federal regs that require universities to empower Institutional Review Boards (IRBs) to prescreen and approve research on human subjects, to avoid unethical exploitation and the like. One can see the rationale as regards invasive experimentation such as is found in trials of new drugs and medical procedures, but IRBs also review (and often impede/discourage) social science research involving the administration of relatively innocuous surveys and questionnaires, observation of people in social settings, the taking of oral histories, etc. An excerpt:

While most law professors conduct their research in an almost unregulated environment - [poring] through cases, statutes, and each other's articles, all without the kind of human interaction subject to IRB regulation - their colleagues elsewhere in the university have been coping for decades with an increasingly intrusive bureaucracy that sometimes undermines basic academic values. ...

The reforms I propose broadly fall into three categories: IRB membership and structure, substantive IRB jurisdiction, and institutional liability. In the first category, IRB membership and structure, I propose that we should require basic First Amendment training for IRB members and include a First Amendment expert as a member of the IRB; that we should require that more than one, perhaps even a majority, of the members of the IRB have the expertise and competence to evaluate the risks and benefits of the particular research being reviewed; and that every research institution using IRBs should establish separate boards for biomedical and social science research. In the second category, substantive IRB jurisdiction, I propose that oral history and other interview-based research should be exempt from IRB approval; that IRBs should be permitted to prohibit or alter research in the social sciences only where the risks of the research substantially outweigh the anticipated benefits; that rather than have IRBs screen social science research before it is performed, they should review it (and enforce internal discipline on researchers, if necessary) only after ethical [breaches] cause some harm; and that social science researchers themselves, rather than IRBs, should determine at the threshold whether their research is exempt from prior IRB approval. In the third category, institutional liability, I propose that evidentiary rules in civil trials should exclude evidence of a university's failure to adopt the Common Rule for non-federally-funded research.

More: OL, Sept. 16, 2004 (Mark Kleiman criticizes regs).



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.