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

In this intelligent, rigorous book, Robert Kiltzman looks at the morality of morality—at how the bodies set up to protect research subjects can end up injuring us all. This examination of our confused notions of safety, honesty, and transparency demonstrates that none of these is simple, and that in striving toward any one, we easily betray the others. It is a book about how seeking to do the right thing can lead to justice, and about how equally often it fails to do so.
- Andrew Solomon, author of Far from the Tree (National Book Critics Circle Award winner), and Noonday Demon ( National Book Award winner)

A number of scientists consider IRBs – the Institutional Review Boards that in accord with federal law oversee human-subject research in universities and hospitals – tantamount to an arbitrary ethical police, nitpicking, insular, ignorant, and inconsistent, in all an impediment to scientific progress. In this thoughtful and probing study, Robert Klitzman concludes both that the IRB system is flawed but that the boards do not by and large operate as an abusive police and are most assuredly needed. The first scholar to examine the memberships of the boards and the contents of their deliberations, Klitzman, himself a physician and scientist, finds that his colleagues might get along better with their IRBs if they appreciated the difficulties of the tasks they face. He also proposes significant reforms in the structure, approach, and procedures of the IRB system that make this book a must read for anyone concerned with balancing the protection of human subjects and safeguarding the practice and progress of science.
-Daniel J. Kevles, Stanley Woodward Professor of History, Yale University, Author of The Baltimore Case, among other works.

Few institutions in America are as powerful and yet as invisible to the public as scientific Institutional Review Boards (IRBs). In this important, pioneering book, Robert Klitzman details the challenges facing IRBs today and offers concrete proposals about how they might function better tomorrow.
-Howard Gardner, Hobbs Professor of Cognition and Education, Harvard University, author of Frames of Mind: The Theory of Multiple Intelligences and other works

Protection of participants is an important—and inescapable—part of the contemporary world of research. In this sensitive exploration of the groups charged with that task, Robert Klitzman elucidates the complexities of human subjects protection and the reasons why it so often seems less-than-optimal. If we are ever to do better, we must begin with precisely this sort of in-depth appreciation of the challenge of balancing the advance of knowledge with the protection of our fellow human beings.
-Paul S. Appelbaum, MD, Elizabeth K. Dollard Professor of Psychiatry, Medicine & Law, Columbia University