September 29, 2008
By Robert B. Townsend
In a letter sent today to the federal Office of Human Research Protections (OHRP), the American Historical Association asks for care in the implementation of new and more rigorous training and education programs for Institutional Review Boards (IRBs). Drawing on the experiences of members of our discipline, the letter expresses concern that “the proposed training program will reinforce the tendency to treat all research as if it was conducted in the experimental sciences,” and fail to “include room for discerning among different types of research methods.”
OHRP first requested comments on the issue back in July. The request was a bit vague, talking in notional terms about whether more rigorous training might be needed. But the general tenor of the request indicated that there was a significant problem with the way IRBs are exercising their authority—which is hardly news to members of our profession—and implying that the next step would be articulating new training policies. Given that, the Association felt it was necessary to weigh in at this stage.
If OHRP does proceed with new training policies, the AHA asks that it “include training that distinguishes between the experimental sciences and the humanities.” As the letter observes, one of the fundamental problems in the way the regulations have been implemented is that IRBs rarely seem to “meet the requirement in 45 CFR 46.107 that the IRB will ‘include persons knowledgeable’ in the areas under review. OHRP should make clear than an IRB whose members are unwilling to learn the methods and ethics of each discipline it reviews is not compliant with the Common Rule.”
The letter concludes by reiterating the Association’s standing policy that oral history should be excluded from IRB oversight, and asks OHRP to “reissue its 2003 statement on oral history in clearer form, providing unambiguous exclusion of oral history from IRB jurisdiction on the grounds that it is does not meet the federal definition of generalizable research under the Common Rule.”