The Ethics Police?: The Struggle to Make Human Research Safe

Klitzman (Am I My Genes?), director of the Masters of Bioethics program at Columbia University, painstakingly leads readers through the morass of challenges faced by institutional review boards (IRBs). Stunningly, this is the first book to rigorously review these key bodies, which police U.S. clinical trials. IRBs, comprising a hodgepodge of local clinicians, researchers, and citizens, have sanctioned and shaped U.S. clinical trials since 1974. Their problems include lack of uniformity, too-long and too-secretive review processes, and a lack of oversight of%E2%80%94and appeals boards for%E2%80%94IRBs themselves. A full 36% of IRB members have industry ties "despite potential threats to integrity." Klitzman writes that "improvements are clearly possible" and presents some prospects. He also quotes IRB members who feel a decentralized IRB system is necessary to protect intensely individual local community values, but he concludes this is almost always incorrect. Still, change may not come soon. He notes that IRBs have, ironically, "seriously stymied" any attempts to police themselves. Indeed, in Klitzman's two decades of research, his own IRB was the one that was most nervous about this book. This is a detailed first look at a critical aspect of U.S. medicine that may not mesmerize causal readers, but should prove indispensable for reform. (Apr.)