IRB: Ethics & Human Research

What Makes IRBs Tick? An Empirical Analysis of IRBs and Their Relationship with Researchers

Robert Klitzman’s provocatively titled book, The Ethics Police? The Struggle to Make Human Research Safe, explores the often contentious relationship between the scientists who conduct human subjects research and the institutional review boards (IRBs) that oversee them. On the one hand, he acknowledges that IRBs provide important protections for vulnerable human subjects. On the other hand, he points out that “many well-respected, seemingly rational scientists . . . vehemently dislike IRBs.” Criticisms of IRBs are particularly pronounced in the social sciences, where researchers argue that IRBs stifle valuable inquiry despite an extremely low risk of harm to the participants in their studies. Partly in response to these critiques, federal agencies are now considering significant changes to the regulations governing human subjects research, with a key goal of focusing IRBs’ energies on high-risk studies involving significant ethical dilemmas. For Klitzman, however, what the regulations actually require tells only part of the story. To understand how IRBs exercise their discretion, Klitzman conducted a series of focus groups with IRB members and researchers, followed by in-depth individual interviews with IRB members, chairs, and staff members. In this book, he emphasizes the wide range of discretion that any system of ethical review necessarily involves and offers several useful suggestions for improving the IRB system, none of which would require any regulatory changes.


Key words: The Ethics Police? The Struggle to Make Human Research Safe, Robert Klitzman, institutional review boards, regulation of human subjects research