Report: Researchers need more approval discretion

January 12th, 2015

It’s starting to get a little ugly out there: The American Association of University Professors (AAUP) has just released a report taking institutional review boards (IRBs) to task over what they call “inappropriate, indeed absurd, alterations in research protocols” and overly-stringent guidelines for study submission and approval.

The AAUP calls for more researcher autonomy for deciding whether a federally-funded study needs IRB review, rather than relying on IRB members who “have no special competence in assessing research projects in the wide range of disciplines they are called on to assess, whose approval is required for an only minimally restricted range of research projects … who are only minimally restricted in the demands they may make on the researchers, and whose judgments about whether to permit the research to be carried out at all are, in most institutions, final. When one steps back from it, one can find oneself amazed that such an institution has developed on university campuses across the country.”

Ouch. However, the report makes clear that the AAUP does not care to abolish the IRB system entirely, particularly as it relates to medical research. Rather, it calls on the U.S. Department of Health and Human Services (HHS) to give researchers the authority to determine whether behavioral and social science studies are exempt from review if the methodology: “(a) imposes no more than minimal risk of harm on its subjects, or (b) consists entirely in speech or writing, freely engaged in, between subject and researcher.” A 1995 HHS report recommended that "investigators should not have the authority to make an independent determination that research involving human subjects is exempt."

It’s also a matter of academic freedom – a subject that does not come up much in human subjects research, says study co-author and George Mason University history professor Zachary Schrag.

Whether IRB members will agree with his assertions remains to be seen. Tune in to the April issue of IRB Advisor for more coverage of the report, statements from report author Zachary Schrag, and industry reactions.