Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”
Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.
Robert Klitzman. The Ethics Police?: The Struggle to Make Human Research Safe. New York: Oxford University Press, 2015.
In theory, institutional review boards, or IRBs, constitute a thin red line between the rights and welfare of participants in research studies and their exploitation by researchers who, intoxicated by scientific curiosity and their own ambition, can easily forget that their actions can harm the people they study. Since the 1960s, federal rules have required an increasing number of scholarly studies to be reviewed by IRBs, which operate independently in universities and research hospitals across the United States. The hope is that they will dispassionately referee between the scientist and the subject.
In practice, IRBs have gained a reputation for impeding science without protecting anyone. “Almost every researcher I know,” reports psychiatrist, bioethicist, and scholar Robert Klitzman, “has complained at some point, often vociferously, about an IRB having unnecessarily blocked or delayed his or her research.” (6) Klitzman himself has been kicked around by IRBs; early in his career, he lost eight months of a twelve-month fellowship trying to get approval from an IRB that, in the end, found nothing of concern in his protocol.