AAUP Committee A recommends IRB reforms

Two years ago, the U.S. Department of Health and Human Services announced a proposed rulemaking procedure in which it suggested that changes might be on the way to promote reform of the role of Institutional Review Boards (IRBs) in examining research involving human subjects.  While no new proposed regulations have emerged from DHHS in the interim, the American Association of University Professors' Committee A on academic freedom released a report this week recommending substantial change to the existing procedures, both as they are outlined in federal regulations and as they are practiced at universities and colleges across the United States.

Alas the report itself lacks a clearly defined section focusing on its recommendations (which may limit its impact on policymakers); an article covering the release of the AAUP report at Inside Higher Ed by Carl Straumsheim, however, suggests that the regulations themselves are less of an issue than the need for IRBs to be involved in determining whether or not they apply in the first place:

The AAUP traces most of the criticism aggregated in its report to a 1995 decision by the Department of Health and Human Services that recommended "investigators should not have the authority to make an independent determination that research involving human subjects is exempt" from IRB reviews. Prior to that decision, the AAUP writes “the IRB system provoked relatively few complaints of infringement of academic freedom.”

“The rules had fundamentally changed: the mistrust of researchers that is expressed in the 1995 recommendation, and enforced since then, is quite remarkable,” the report states. “We can think of no one single emendation in the current regulations that would contribute more to the improvement of the IRB system than a rescinding of that recommendation.”

Another key recommendation, according to Strausheim, would “carve out an exemption for all research conducted solely by interviewing or surveying, as well as for research that imposes only a ‘minimal risk of harm on its subjects.’ ”  Certainly these exemptions would cover the vast majority of social and behavioral science research, even if limited (as they probably should be) to physically and mentally competent, non-institutionalized adults.

Hopefully DHHS will seriously consider these recommendations, when and if they see fit to publish new guidelines for research on human subjects.

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