The Censor's Hand: The Misregulation of Human-Subject Research

The Censor's Hand: The Misregulation of Human-Subject Research

by Carl E. Schneider

Hardcover(New Edition)

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Overview

An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good.

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.

Product Details

ISBN-13: 9780262028912
Publisher: MIT Press
Publication date: 04/10/2015
Series: Basic Bioethics
Edition description: New Edition
Pages: 296
Sales rank: 944,589
Product dimensions: 5.90(w) x 9.10(h) x 1.10(d)
Age Range: 18 Years

About the Author

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 Disclosur e, The Practice of Autonomy: Patients, Doctors, and Medical Decisions , and numerous other books and articles.

Table of Contents

Series Foreword ix

Preface xi

Acknowledgments xv

Introduction xix

Part I More Good than Harm

1 Research Risk and Regulationst Stereotypes 3

2 Cost Is No Object 33

Part II The Quality of IRB Decisions

3 Arbitrary and Capricious Decisions 71

4 The Misshapen Ideology of the IRB System 107

5 The Rule of Law: The Lessons of Due Process 141

6 Censorship in a System of Free Expression 163

Conclusion: The Imperial IRB 185

Notes 203

Index 255

What People are Saying About This

Malcolm M. Feeley

Schneider reveals IRB regulations for what they are, a form of censorship and prior restraint that impedes social research and undermines American universities. Let's hope that someone takes his ideas and runs with them—to a federal court, to challenge IRBs as unconstitutional denials of free expression.

Philip Hamburger

This is a profoundly important book. In his inimitable prose, Schneider reveals the oppression, danger, and sheer inanity of IRB censorship.

From the Publisher

This is a profoundly important book. In his inimitable prose, Schneider reveals the oppression, danger, and sheer inanity of IRB censorship.

Philip Hamburger , Maurice and Hilda Friedman Professor of Law, Columbia Law School

Schneider reveals IRB regulations for what they are, a form of censorship and prior restraint that impedes social research and undermines American universities. Let's hope that someone takes his ideas and runs with them—to a federal court, to challenge IRBs as unconstitutional denials of free expression.

Malcolm M. Feeley , Claire Sanders Clements Professor, Jurisprudence and Social Policy Program, Boalt Hall School of Law; President of the Law & Society Association, 2007-09

IRBs are the crabgrass of academia—destructive, unwanted, unnecessary, relentlessly expanding. In The Censor's Hand , Carl Schneider expertly exposes their incompetence, ignorance, lawlessness, and record of killing more people than they save. He makes me glad I no longer work in a university, subject to IRB oversight.

Howard S. Becker , author of What About Mozart? What About Murder? Reasoning from Cases

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.

Jon Tyson , MD, MPH, Vice Dean for Clinical Research and Healthcare Quality, University of Texas-Houston Medical School

Endorsement

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.

Jon Tyson, MD, MPH, Vice Dean for Clinical Research and Healthcare Quality, University of Texas-Houston Medical School

Howard S. Becker

IRBs are the crabgrass of academia—destructive, unwanted, unnecessary, relentlessly expanding. In The Censor's Hand, Carl Schneider expertly exposes their incompetence, ignorance, lawlessness, and record of killing more people than they save. He makes me glad I no longer work in a university, subject to IRB oversight.

Jon Tyson

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.

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