The Censor’s Hand: The Misregulation of Human-Subject Research PDF
Preview The Censor’s Hand: The Misregulation of Human-Subject Research
The Censor’s Hand Basic Bioethics Arthur Caplan, editor A complete list of the books in the Basic Bioethics series appears at the back of this book. The Censor’s Hand The Misregulation of Human-Subject Research Carl E. Schneider The MIT Press Cambridge, Massachusetts London, England © 2015 Massachusetts Institute of Technology All rights reserved. No part of this book may be reproduced in any form by any electronic or mechanical means (including photocopying, recording, or information storage and retrieval) without permission in writing from the publisher. MIT Press books may be purchased at special quantity discounts for business or sales promotional use. For information, please email [email protected]. This book was set in Sabon by the MIT Press. Printed and bound in the United States of America. Library of Congress Cataloging-in-Publication Data Schneider, Carl E., 1948– , author. The censor's hand : the misregulation of human-subject research / Carl E. Schneider. p. ; cm. — (Basic bioethics) Includes bibliographical references and index. ISBN 978-0-262-02891-2 (hardcover : alk. paper) I. Title. II. Series: Basic bioethics. [DNLM: 1. Human Experimentation—ethics. 2. Bioethical Issues. 3. Ethics, Research. 4. Research Subjects. W 20.55.H9] R853.H8 174.2'8—dc23 2014034246 10 9 8 7 6 5 4 3 2 1 TO JOAN κλαῖε δ᾽ ἔχων ἄλοχον θυμαρέα, κεδνὰ ἰδυῖαν. Contents Series Foreword ix Preface xi Acknowledgments xv Introduction xix Part I: More Good than Harm 1 Research Risk and Regulationist 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 Series Foreword Glenn McGee and I developed the Basic Bioethics series and collaborated as series coeditors from 1998 to 2008. In fall 2008 and spring 2009, the series was reconstituted, with a new editorial board, under my sole editor- ship. I am pleased to present the forty-fourth book in the series. The Basic Bioethics series makes innovative works in bioethics avail- able to a broad audience and introduces seminal scholarly manuscripts, state-of-the-art reference works, and textbooks. Topics engaged include the philosophy of medicine, advancing genetics and biotechnology, end- of-life care, health and social policy, and the empirical study of biomedi- cal life. Interdisciplinary work is encouraged. Arthur Caplan Basic Bioethics Series Editorial Board Joseph J. Fins Rosamond Rhodes Nadia N. Sawicki Jan Helge Solbakk
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