The Censor's Hand: The Misregulation Of Human-subject Research

Hardcover | April 10, 2015

byCarl E. Schneider

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Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called "institutional review boards" (IRBs). Do -- can -- these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question.

Schneider answers the question by consulting a critical but ignored experience -- the law's learning about regulation -- and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging -- universities.

In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.

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From the Publisher

Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called "institutional review boards" (IRBs). Do -- can -- these IRBs do more harm than good? In The Censor's Hand, Sch...

Carl E. Schneider is Chauncey Stillman Professor of Law and Professor of Internal Medicine at the University of Michigan. He has written More Than You Wanted to Know: The Failure of Mandated Disclosure, The Practice of Autonomy: Patients, Doctors, and Medical Decisions, and numerous other books and articles.

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Format:HardcoverDimensions:296 pages, 9 × 6 × 0.5 inPublished:April 10, 2015Publisher:The MIT PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0262028913

ISBN - 13:9780262028912

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This is by far the most carefully researched, lucid, incisive, and cogent critique yet of the regulation of human-subject research. It should be read by anyone committed to promoting quality improvement efforts and clinical research of the highest ethical and scientific quality or a learning healthcare system that accelerates advances in healthcare, clinical outcomes, and population health.