StATS: Academic freedom and the Institutional Review Board (created 2006-10-17)

The American Association of University Professors (AAUP) recently published a report, Research on Human Subjects: Academic freedom and the Institutional Review Board, that is available on the web at

• www.aaup.org/AAUP/pubsres/academe/2006/SO/Rep/ResearchonHumanSubjects

This report is sharply critical of Institutional Review Boards (IRBs) and cites several anecdotes of abuse and misuse of the review process by IRBs. It points out that any system that can effectively prevent researchers from adopting a particular research approach is

obvious potential threat to academic freedom.

The report notes that there is no formal appeal process for an unfavorable IRB finding, except possibly to another IRB. This represents

unchecked power granted to IRBs.

The AAUP report considered and rejected a recommendation that all research in the social sciences and hmanities be exempted from research, but did still make a rather strong recommendation. The report called for

research whose methodology consists entirely of collecting data by surveys, conducting interviews, or observing behavior in public places be exempt from the requirement of IRB review.

The AAUP report noted that much survey work was already exempt, but noted the privacy issues that many IRBs have raised concerns about.

Confidentiality in respect to research data is certainly of great importance. But we think that this concern is entirely met by long-standing departmental and disciplinary practices for collecting and storing data. We see no reason for believing that IRB members are better equipped to assess practices for handling data in a discipline than members of the discipline are, and we therefore see no reason for believing that additional oversight by an IRB is necessary.

The problem, according to the report, is that IRBs overreact out of concern for potential lawsuits.

Indeed, IRBs have objected to research protocols on the ground that the subjects might find it distressing even to be asked the questions the researcher wishes to ask them. We regard that as an unpardonable piece of paternalism where the subjects are adults who are free to end their participation at any time, or to refuse to participate at all.

If research involving human subjects is so tightly regulated, how does the AAUP report suggest that the process be changed without requiring an act of Congress? Most institutions have adopted a Federalwide Assurance (FWA), an assurance that all research, and not just federally funded research, will be reviewed by the IRB and will comply with all the appropriate federal regulations.

The AAUP report argues that colleges and universities should adopt a separate set of procedures for reviewing research that is not federally funded. What sort of procedures? The report is deliberately vague on this point, but does mention some possibilities.

Schools might consider an alternative under which the approval required is limited to approval by the researcher’s department or other appropriate academic unit; this is arguably suitable at least for student research—students do a considerable amount of the social science research conducted by academic personnel. Or they might consider a revised version of the IRB system mandated for federally funded research.

This is a rather provocative report and there are many issues to be argued on both sides. Some researchers have long argued that IRBs are too powerful and they are overly intrusive and meddlesome. Others have argued that the existing regulations on research are already too weak and fail to prevent many existing research abuses. I, myself, have conflicting feelings about this report and would have difficulty fully endorsing or totally rejecting their recommendations.

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Ethics in research.