Research on Human Subjects: Academic Freedom and the Institutional Review Board
Thomson, Judith Jarvis, Elgin, Catherine, Hyman, David A., Rubin, Philip E., Knight, Jonathan, Academe
The report that follows, prepared by a subcommittee of the Association's Committee A on Academic Freedom and Tenure, was approved for publication by Committee A at its meeting in June 2006. The report takes issue with aspects of the federal government's regulations for research on human subjects that constitute a threat to academic freedom. The application of the federal regulations to research methodologies that present no serious risk of harm to research subjects has long been of concern to Committee A, which will continue to keep this matter and other troubling features of the regulations on its agenda. Committee A welcomes comments on the report from Association members and other interested parties and organizations. They should be addressed to Jonathan Knight at the Washington office (firstname.lastname@example.org).
Research on human subjects conducted by college and university personnel has been governed by federal regulations since the 1960s. Revisions in the regulations have been made over the years; the most recent version was published on June 23, 2001.1
What has been a constant since the outset is the requirement that-with a tew exemptions-all research on human subjects conducted at, or sponsored by, colleges, universities, hospitals, and nonprofit organizations that is to be supported by any of the federal departments and agencies that have adopted the regulations must be approved in advance by a local Institutional Review Board (IRB).2
A second requirement is currently in place, namely, that institutions at which, or under whose auspices, federally funded research on human subjects is to be conducted must provide assurance that they will protect the rights and welfare of the human subjects of all their research on human subjects, whatever its source of funding. This assurance must be approved by the federal Office of Human Research Protections. For a variety of reasons, which we will return to, most academic institutions have adopted the same protection for subjects of research that is not federally funded as for subjects of federally funded research, that is, they require advance approval of the research by an IRB.
Those requirements have generated an increasing number of complaints over the years, and there is a bynow enormous literature that points to their objectionable features.3 In section one, we draw attention to some of the complaints. In sections two and three, we make two recommendations, one to policy makers, the other to academic institutions. In section four, we make a recommendation to the AAUP.
1. Some Complaints
Under the IRB review procedure, an investigator must obtain prior IKB approval of his or her research protocol before the research can be undertaken.4 Members of a campus IRB are instructed by the regulations to decide, among other things, whether the risks the research would impose on its "subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result."5 Thus IRB members are instructed to form their own view of the risks their colleagues' research would impose on its subjects, and on the importance of the results that might be obtained from the research, and to deny permission to conduct the research if in their view the risks are not reasonable relative to the value of the likely results. There could hardly be a more obvious potentiul threat to academic freedom.
Moreover, no provision is made in the regulations for an appeal process in case a research protocol is rejected by a campus IRB. It is consistent with the regulations for an institution to provide an appeal process, but where the research is to be federally funded, or the institution has opted for a single review procedure that requires IRB approval, the appeal process would have to be to yet another IRB. We do not in fact know of any institution that makes explicit formal provision for such an appeal. …