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IRBs and Academic Freedom

Dear Colleague:

Out this week from the AAUP is a new report, Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board. (http://www.aaup.org/AAUP/comm/rep/A/irb.htm)

This is the third report the AAUP has issued on the tensions between preservation of academic freedom and the protection of human participants in research through the establishment of institutional review boards (IRBs). In 1981, a subcommittee reported on new federal regulations and warned that “the IRB mechanism can be a serious threat to academic freedom.” In 2006, a second report noted researchers’ complaints about the IRB system and recommended, among other things, a change in federal regulations to eliminate IRB oversight of “research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places.”

In July 2011, the federal government took what may be the first step in the most substantial change in the regulations since 1981, issuing an advance notice of proposed rulemaking, or ANPRM. More than 1,100 individuals and associations submitted formal comments, and the new report, drafted by a subcommittee of the Association’s Committee A on Academic Freedom and Tenure, is the our response to both the ANPRM and the comments.

The current report notes the subcommittee’s continued frustration with the structure of the current regulations, which require IRB review of any research with humans unless it fits one or more listed exceptions. “Out of respect for liberty,” the report notes, “it is normally expected that government regulation of behavior will consist in listing what is forbidden, all else being permitted.” The report goes on to suggest ways in which the regulations could be rewritten along these lines.

The report also questions the current reliance on local committees whose members 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 and who are invited to bring to bear in assessing them an only minimally restricted body of what they take to be information, 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.

It notes that university departments, faculty committees, and trustworthy researchers themselves might be better suited for some of the tasks now assigned to IRBs and their staffs. And it calls for the federal government to develop more evidence on which to base its policies.

The subcommittee was chaired by Judith Jarvis Thomson (Philosophy, MIT), who also chaired the 1981 and 2006 subcommittees.

Committee A welcomes comments on the report from Association members and other interested parties. They should be addressed to B. Robert Kreiser (bkreiser@aaup.org) at the AAUP’s Washington office by September 28, 2012.