Balanced Ethics Review: A Guide for Institutional Review Board Members by Simon N. Whitney (review)

For more than half a century, the US government has insisted that researchers who work with human subjects get approval from institutional review boards (IRBs) before interacting with the people they wish to study. Originally limited to projects directly funded by the Public Health Service (which included some social science), IRB review has spread to include all manner of research conducted at US universities, whether or not it is directly supported by a government grant. Similar systems govern research in other countries, especially Anglophone nations.

Because IRBs can delay, restrict, or outright prohibit research, they wield immense power, enough to derail grants, projects, graduate degrees, and whole careers. In Balanced Ethics Review, Simon Whitney, who is trained in both medicine and law, begs IRB members to use that power responsibly. That such a plea is necessary tells us much about the current state of ethics review.

Balanced Ethics Review is best understood as a challenge to other manuals for IRB members, including Adil E. Shamoo and Felix A. Khin-Maung-Gyi, Ethics of the Use of Human Subjects in Research: Practical Guide (London: Garland Science, 2002), Dennis J. Mazur, Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members (Baltimore, MD: Johns Hopkins University Press, 2007), and Robert Amdur and Elizabeth A. Bankert, Institutional Review Board: Member Handbook, 3rd ed. (Sudbury, MA: Jones and Bartlett, 2011). As Whitney notes, it is hard to find in any of these previous manuals a warning that IRBs sometimes restrict research in a way that imposes social costs disproportionate to any reduction of risk to the research participants. Instead, those books suggest that IRBs restrict research on the barest suspicion and impose burdensome practices on researchers and on themselves. Mazur, for example, recommends that IRBs conduct their own scientific literature review for every proposal that comes before them. Whitney points out that "no IRB could routinely meet this standard," and he challenges Mazur to show that any do (36).

Throughout Balanced Ethics Review, Whitney questions the assumptions, both factual and ethical, underlying the dominant advice. While the standard literature lists horror stories of research gone bad (the Nazi experiments, the Tuskegee Syphilis Study), Whitney also reminds readers of research that saved lives or exposed evil, noting that "it is…highly ethical to conduct research that reduces the burden of cancer, lessens the disparities in health between rich and poor, or exposes racial discrimination" (14). To hamper such research by, for instance, demanding an unnecessarily frightening consent form "is not a conservative safeguard, it is an error" (49).

Whitney recommends, instead, a light touch. "If you find a glaring ethical problem you should respond appropriately," he writes. "But please resist the temptation to tweak the consent form" (48). And if IRBs do demand changes to a research protocol, Whitney advises, they should be prepared to provide evidence that those changes will be helpful. If they act based on speculation, they risk hindering valuable research and doing more harm than good.

Whitney's approach is basically utilitarian, arguing that the good research creates outweighs its harms. In this vein, he values social science research as the equivalent of medical research. "Research in the social sciences matters because society benefits when scholars expose plagues like racial discrimination," he explains (16). That is true enough, but what of research that, like much humanities research and a fair amount of social science, aims only to increase human knowledge? Since such research might not fare well under Whitney's scheme, it is a relief to read that "this manual's advice on how to review the humanities consists of a single word: don't" (57).

At 110 pages plus notes and references, Whitney's book is short enough to reach IRB members who must squeeze their IRB preparation into schedules full of their own research, teaching, and other administrative duties. But that same brevity makes it impossible for...