AAUP Misperceives IRB Challenges
Bruce Bridgeman
To the Editor:
As chair of the Institutional Review Board (IRB) at the University of California, Santa Cruz, I am responding to Committee A’s subcommittee report on IRBs in the September–October issue of Academe. While pointing out shortcomings in accepted IRB procedures, the report relies on some misunderstandings of challenges facing IRBs and universities in managing research risks.
The report recommends that research on autonomous adults using surveys, interviews, or public observation should be exempt from IRB review of any sort. The University of California has an exemption for such research, but review by the IRB chair and a staff member is still necessary, because the principal investigator has a vested interest in minimizing a project’s apparent risk. For example, we review many proposals for surveys or interviews involving illegal activities, such as drug use, where anonymity must be protected. It is not enough simply to code results and keep a table linking names to codes in a safe place, because these records can be subpoenaed. Is it necessary to destroy such records as soon as research is completed? Many principal investigators are unaware of this problem.
In other areas, the legality of an activity is in question, such as studies of what principal investigators may call “undocumented workers” but others may identify as “illegal aliens” subject to deportation. Many such research subjects carry forged documents, so that the responsibility for their illegal activity remains unclear. IRBs must assure that strict anonymity is maintained in such cases, where principal investigators may neglect or ignore necessary safeguards.
In borderline cases, a review is necessary because of vulnerability to lawsuits, no matter how frivolous. Defending any lawsuit is expensive and traumatic for the principal investigator. Approval by a recognized university entity transfers legal responsibility to the university, which will defend principal investigators if necessary. This is a significant advantage to them.
This is not to contend that abuse has not occurred, with heavy-handed IRBs putting burdensome restrictions on unproblematic research. Our challenge is to find institutional procedures that protect both principal investigators and human subjects with appropriate and practical measures.
Bruce Bridgeman
(Psychology and Psychobiology)
University of California, Santa Cruz
The Subcommittee Responds:
We agree with Bruce Bridgeman that the “challenge is to find institutional procedures that protect both principal investigators and human subjects with appropriate and practical measures,” but we disagree that we misunderstand the “challenges facing IRBs and universities in managing research risks.”
If anything, Bridgeman’s letter illustrates the reason the AAUP asked us to prepare the report in question. Bridgeman reasons that the self-interest of principal investigators provides a per se justification for expansive and intrusive research oversight by IRBs, but he does not even consider the errors, administrative costs, delays, and other pathologies associated with IRB review. Similarly, he does not consider the costs and benefits of alternatives to IRB review in dealing with methodologies that involve minimal risk or are specifically exempt from IRB review. Instead, he flatly claims that IRBs are necessary to protect the institution, the principal investigator, and the research subjects. This failure to balance the costs and benefits of IRBs against other forms of research oversight is not unique to Bridgeman; the federal regulations focus exclusively on the protection of human subjects and give no weight whatsoever to the academic freedom of researchers or to the social costs from research that is delayed, constrained, or not performed at all.
At present, we have some empirical evidence on the cost of operating an IRB, modest empirical evidence on the cost of obtaining IRB approval, and no empirical evidence whatsoever on the benefits of IRB review. Numerous studies have documented considerable variability, inefficiency, and uneven protection of study participants in multicenter studies, where the same protocol is reviewed by multiple IRBs.
These problems with IRB review call for a balanced response. Our report did not call for the outright elimination of IRB oversight. However, in balancing the costs and benefits of research oversight, we concluded that “research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places . . . [should be] straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.” This approach will eliminate an unnecessary burden on researchers and free IRBs to focus their attention on seriously risk-imposing research projects.
Judith Jarvis Thomson
(Philosophy)
Massachusetts Institute of Technology,
chair
Catherine Elgin
(Philosophy)
Harvard Graduate School of Education
David A. Hyman
(Law and Medicine)
University of Illinois at Urbana-Champaign
Philip E. Rubin
(Surgery)
Yale University School of Medicine and Haskins Laboratories
Subcommittee Responsible for the IRB Report
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