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conduct_of_clinical_research.pdf

conduct_of_clinical_research_final_exam.pdf

the_oxford_textbook_of_clinical_research_ethics_by_ezekiel_j._emanuel__christine_grady__robert_a._crouch__reidar_lie__franklin_miller__david_wendler__z_lib.org_.pdf

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The Oxford Textbook of
Clinical Research Ethics
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The Oxford Textbook of
Clinical Research Ethics
EDITED BY
Ezekiel J. Emanuel
Chair, Department of Bioethics, National Institutes of Health, Bethesda, Maryland
Christine Grady
Head, Section on Human Subjects Research, Department of Bioethics, National
Institutes of Health, Bethesda, Maryland
Robert A. Crouch
The Poynter Center for the Study of Ethics and American Institutions,
Indiana University, Bloomington, Indiana
Reidar K. Lie
Professor of Philosophy, University of Bergen; Head, Unit on Multinational Research,
Department of Bioethics, National Institutes of Health, Bethesda, Maryland
Franklin G. Miller
Bioethicist, National Institute of Mental Health Intramural Research Program, Department
of Bioethics, National Institutes of Health, Bethesda, Maryland
David Wendler
Head, Unit on Vulnerable Populations, Department of Bioethics, National Institutes
of Health, Bethesda, Maryland
1
2008
1
Oxford University Press, Inc., publishes works that further
Oxford University’s objective of excellence
in research, scholarship, and education.
Oxford New York
Auckland Cape Town Dar es Salaam Hong Kong Karachi
Kuala Lumpur Madrid Melbourne Mexico City Nairobi
New Delhi Shanghai Taipei Toronto
With offices in
Argentina Austria Brazil Chile Czech Republic France Greece
Guatemala Hungary Italy Japan Poland Portugal Singapore
South Korea Switzerland Thailand Turkey Ukraine Vietnam
Copyright ª 2008 by Oxford University Press, Inc.
Chapters by the following authors are in the public domain:
Agrawal, Bonham, Denny, Emanuel, Goldkind, Grady, Killen, Miller, Resnik, Rosenstein,
Schron, Temple, Varma, Weed, Wendler
Published by Oxford University Press, Inc.
198 Madison Avenue, New York, New York 10016
www.oup.com
Oxford is a registered trademark of Oxford University Press
All rights reserved. No part of this publication may be reproduced,
stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise,
without the prior permission of Oxford University Press.
Library of Congress Cataloging-in-Publication Data
The Oxford textbook of clinical research ethics = edited by Ezekiel J. Emanuel . . . [et al.].
p.; cm.
Includes bibliographical references and index.
ISBN 978-0-19-516865-5
1. Human experimentation in medicine—Moral and ethical aspects. 2. Clinical trials—Moral and ethical aspects.
3. Medical ethics. I. Emanuel, Ezekiel J., 1957– II. Title: Textbook of clinical research ethics.
[DNLM: 1. Human Experimentation—ethics. 2. Ethics Committees, Research. 3. Ethics, Research.
4. Research Subjects—legislation & jurisprudence. W 20.55.H9 O98 2008]
R853.H8O96 2008
174.2—dc22
2007016230
9 8 7 6 5 4 3 2 1
Printed in the United States of America
on acid-free paper
Dedicated to
John I. Gallin, M.D.
Whose vision and continuing support made
the Department of Bioethics at the NIH—
and, as a consequence, this texbook—
possible.
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Acknowledgments
A book such as this is a truly collaborative effort, and we have
incurred many debts along the way for which we owe thanks. We
must first thank those who contributed chapters to our volume.
Without their time and effort, this volume would not exist. The
contribution of a chapter to an edited volume is often a thankless
task, and it is one that does not receive the recognition we believe it
deserves. So we here signal our indebtedness to our contributors
and give our heartfelt thanks. We hope that the volume is sufficiently well received and widely read such that our contributing authors receive the recognition for their hard work that they deserve.
At the National Institutes of Health, we have many to thank.
We are delighted to thank our behind the scenes editor, Bruce
Agnew. Bruce read every chapter with his very keen editorial eyes,
and offered editorial and substantive suggestions on each chapter.
This was an enormous undertaking, and Bruce did it with his
characteristic good humor and aplomb. The volume is much
better because of his input. Near the end of the process, Rose
Murray and Becky Chen stepped in and helped us track down art
work and permissions. This, too, was a large undertaking, and
Rose and Becky were instrumental in helping us wrap things up.
Justine Seidenfeld helped us put together material for one chapter,
and we thank her for that. Finally, we gratefully acknowledge the
financial assistance provided by the Department of Bioethics, The
Clinical Center, National Institutes of Health.
We received a great deal of help from archivists, librarians,
and staff at a number of institutions who found material for us and
provided us with high-resolution images to include in this volume. To those who helped us at the following institutions, we
give our thanks: Bentley Historical Library, University of Michigan, Ann Arbor, Mich.; Chemical Engineering, New York, N.Y.;
March of Dimes, White Plains, N.Y.; American Philosophical Society Library, Philadelphia, Penn.; Medical Arts and Photography
Branch, National Institutes of Health, Bethesda, Md.; Rutgers
University Libraries, Special Collections and University Archives,
New Brunswick, N.J.; Indiana University Libraries, Bloomington,
Ind.; Frederick L. Ehrman Medical Library Archives, New York
University School of Medicine, New York, N.Y.; Royal College of
Physicians, Heritage Collections, London, England; United States
Holocaust Memorial Museum, Washington, D.C.; and the University of Virginia Library, Special Collections, and Historical
Collections, Charlottesville, Va.
Last but not least, we thank our editor at Oxford University
Press, Peter Ohlin, for very helpful advice and guidance from
day one, as well as tremendous patience.
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Contents
Contributors
xv
Introduction
3
I
A Selected History of Research With Humans
1
Walter Reed and the Yellow Fever Experiments
9
Susan E. Lederer
2
The Nazi Medical Experiments
18
Paul J. Weindling
3
The Imperial Japanese Experiments in China
31
Takashi Tsuchiya
4
The Randomized Controlled Trial of Streptomycin
46
Alan Yoshioka
5
The Salk Polio Vaccine Field Trial of 1954
61
Marcia L. Meldrum
6
The Jewish Chronic Disease Hospital Case
73
John D. Arras
7
The Hepatitis Experiments at the Willowbrook State School
Walter M. Robinson and Brandon T. Unruh
8
The Tuskegee Syphilis Experiment
James H. Jones
86
80
x
Contents
9
HIV Research 97
John Y. Killen Jr.
10
The Gelsinger Case
110
Robert Steinbrook
II
11
Codes, Declarations, and Other Ethical Guidance
for Research With Humans
An Ethical Framework for Biomedical Research 123
Ezekiel J. Emanuel, David Wendler, and Christine Grady
12
The Nuremberg Code
136
George J. Annas and Michael A. Grodin
13
The Declaration of Helsinki
141
Richard E. Ashcroft
14
The Belmont Report
149
Tom L. Beauchamp
15
Regulations for the Protection of Humans in Research in the United States:
The Common Rule 156
Joan P. Porter and Greg Koski
16
International Ethical Guidance From the Council for International Organizations
of Medical Sciences 168
Juhana E. Idänpään-Heikkilä and Sev S. Fluss
17
The Council of Europe
174
Pēteris Zilgalvis
18
The European Community Directives on Data Protection and Clinical Trials
Deryck Beyleveld and Sebastian Sethe
19
National Bioethics Commissions and Research Ethics
187
Eric M. Meslin and Summer Johnson
III
Context, Purpose, and Value of Clinical Research
20
Exploitation in Clinical Research
201
Alan Wertheimer
21
The Nature, Scope, and Justification of Clinical Research: What Is Research?
Who Is a Subject? 211
Robert J. Levine
22
Four Paradigms of Clinical Research and Research Oversight
222
Ezekiel J. Emanuel and Christine Grady
23
The Role of Patient Advocates and Public Representatives in Research
Rebecca Dresser
IV
Scientific Design
24
Equipoise and Randomization
245
Steven Joffe and Robert D. Truog
25
The Ethics of Placebo-Controlled Trials 261
Franklin G. Miller
231
180
Contents
26
Challenge Experiments
273
Franklin G. Miller and Donald L. Rosenstein
27
Emergency Research
280
Jason H. T. Karlawish
28
Research With Biological Samples 290
David Wendler
29
Genetic Diagnostic, Pedigree, and Screening Research 298
Eric T. Juengst and Aaron Goldenberg
30
Deception in Clinical Research 315
David Wendler and Franklin G. Miller
31
Epidemiology: Observational Studies on Human Populations
325
Douglas L. Weed and Robert E. McKeown
32
Behavioral and Social Science Research
336
Felice J. Levine and Paula R. Skedsvold
33
Phase I Oncology Research 356
Manish Agrawal and Ezekiel J. Emanuel
34
Surgical Innovation and Research 367
Grant R. Gillett
V
Participant Selection
Section A. Fair Participant Selection
35
What Is Fair Participant Selection?
377
Leslie A. Meltzer and James F. Childress
36
Incentives for Research Participants
386
Neal Dickert and Christine Grady
37
Recruiting Research Participants
397
Franklin G. Miller
Section B. Special Populations
38
Research Involving Women
407
Christine Grady and Colleen Denny
39
Research With Ethnic and Minority Populations
423
Bernard Lo and Nesrin Garan
40
Research Involving Economically Disadvantaged Participants
431
Carol Levine
41
Research Involving Those at Risk for Impaired Decision-Making Capacity
437
Donald L. Rosenstein and Franklin G. Miller
42
Research With Children
446
Alan R. Fleischman and Lauren K. Collogan
43
Research With Captive Populations: Prisoners, Students, and Soldiers
Valerie H. Bonham and Jonathan D. Moreno
44
Research With Identifiable and Targeted Communities
Morris W. Foster and Richard R. Sharp
475
461
xi
xii
Contents
45
Research With Healthy Volunteers
481
Albert R. Jonsen and Franklin G. Miller
46
Research With Fetuses, Embryos, and Stem Cells
488
Ronald M. Green
VI
Risk-Benefit Assessments
47
Risk-Benefit Analysis and the Net Risks Test 503
David Wendler and Franklin G. Miller
48
Assessing and Comparing Potential Benefits and Risks of Harm 514
Nancy M. P. King and Larry R. Churchill
49
Risk-Benefit Assessment in Pediatric Research
527
Sumeeta Varma and David Wendler
VII
Independent Review and Oversight
50
The Origins and Policies That Govern Institutional Review Boards
541
Charles R. McCarthy
51
Models of Institutional Review Board Function
552
Angela J. Bowen
52
Evaluating the Effectiveness of Institutional Review Boards
560
Marjorie A. Speers
53
Data and Safety Monitoring Boards
569
rence M. Friedman and Eleanor B. Schron
54
The Food and Drug Administration and Drug Development: Historic,
Scientific, and Ethical Considerations 577
Robert Temple and Sara F. Goldkind
VIII
55
Informed Consent
A History of Informed Consent in Clinical Research 591
Erika Blacksher and Jonathan D. Moreno
56
Philosophical Justifications of Informed Consent in Research 606
Dan W. Brock
57
Legal and Regulatory Standards of Informed Consent in Research
Alexander M. Capron
58
The Therapeutic Misconception
633
Paul S. Appelbaum and Charles W. Lidz
59
Empirical Issues in Informed Consent for Research
James H. Flory, David Wendler, and Ezekiel J. Emanuel
60
The Assent Requirement in Pediatric Research 661
David Wendler
IX
Respect for Human Research Participants
61
Confidentiality
673
James G. Hodge Jr. and rence O. Gostin
645
613
Contents
62
Liability and Compensation for Injury of Research Subjects
682
Wendy K. Mariner
63
The Obligation to Ensure Access to Beneficial Treatments for Research Participants
at the Conclusion of Clinical Trials 697
James V. Lavery
X
64
Multinational Research
Appropriate Ethical Standards
711
Ruth Macklin
65
Benefits to Host Countries
719
Ezekiel J. Emanuel
66
The Standard of Care in Multinational Research
729
Søren Holm and John Harris
67
Responsiveness to Host Community Health Needs
737
Alex John London
XI
Clinical Investigator Behavior
68
Conflict of Interest in Medical Research: Historical Developments
747
Trudo Lemmens
69
The Concept of Conflicts of Interest 758
Ezekiel J. Emanuel and Dennis F. Thompson
70
Empirical Data on Conflicts of Interest
767
Lindsay A. Hampson, Justin E. Bekelman, and Cary P. Gross
71
Industrialization of Academic Science and Threats to Scientific Integrity
Eric G. Campbell and David Blumenthal
72
Fraud, Fabrication, and Falsification
787
David B. Resnik
73
The Obligation to Publish and Disseminate Results
Drummond Rennie
Credits and Permissions
Index 809
805
795
780
xiii
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Contributors
Manish Agrawal, M.D., M.A.
Paul S. Appelbaum, M.D.
Tom L. Beauchamp, Ph.D.
Staff Oncologist, National Cancer
Institute
National Institutes of Health
Bethesda, Maryland
[email protected]
Elizabeth K. Dollard Professor of
Psychiatry, Medicine, and
College of Physicians and Surgeons
Columbia University;
Director, Division of Psychiatry,
and Ethics
New York State Psychiatric Institute
New York, New York
[email protected]
Professor, Department of Philosophy;
Senior Research Scholar
Kennedy Institute of Ethics
Georgetown University
Washington, D.C.
[email protected]
George J. Annas, J.D., M.P.H.
Edward R. Utley Professor and Chair
Department of Health , Bioethics
and Human Rights
Boston University School of Public
Health;
Professor, Boston University School of
Medicine, and School of
Boston, Massachusetts
[email protected]
John D. Arras, Ph.D.
Porterfield Professor of Biomedical
Ethics and Professor
Corcoran Department of Philosophy
University of Virginia
Charlottesville, Virginia
[email protected]
Richard E. Ashcroft, Ph.D.
Professor of Bioethics
Queen Mary University of London
School of
London, England
[email protected]
xv
Justin E. Bekelman, M.D.
Resident, Department of Radiation
Oncology
Memorial Sloan-Kettering Cancer
Center
New York, New York
[email protected]
Deryck Beyleveld, Ph.D.
Professor of and Bioethics
Department of ;
Member, Human Rights Centre
Durham University
Durham, England
[email protected]
xvi
Contributors
Erika Blacksher, Ph.D.
Alexander M. Capron, LL.B.
Rebecca Dresser, J.D.
Robert Wood Johnson Health and
Society Scholar
Columbia University
New York, New York
[email protected]
University Professor and
Scott H. Bice Chair in Healthcare ,
Policy and Ethics;
Professor of and Medicine;
Co-Director, Pacific Center for Health
Policy and Ethics
University of Southern California
Los Angeles, California
[email protected]
Daniel Noyes Kirby Professor of
Professor of Ethics in Medicine, School
of
Washington University, St. Louis
St. Louis, Missouri
[email protected]
David Blumenthal, M.D., M.P.P.
Director, Institute for Health Policy;
Physician, Massachusetts General
Hospital;
Samuel O. Thier Professor of Medicine,
Professor of Health Care Policy
Harvard Medical School
Boston, Massachusetts
[email protected]
Valerie H. Bonham, J.D.
Office of the General Counsel
Department of Health and Human
Services
Bethesda, Maryland
[email protected]
Angela J. Bowen, M.D.
President, Western Institutional Review
Board
Olympia, Washington
[email protected]
James F. Childress, Ph.D.
John Allen Hollingsworth Professor
of Ethics
Professor of Medical Education
Department of Religious Studies;
Director, Institute of Practical Ethics
and Public Life
University of Virginia
Charlottesville, Virginia
[email protected]
Eric G. Campbell, Ph.D.
Assistant Professor
Institute for Health Policy
Department of Medicine
Massachusetts General Hospital,
Harvard Medical School
Boston, Massachusetts
[email protected]
Senior Vice President and
Medical Director
March of Dimes Foundation
White Plains, New York
afl[email protected]
James H. Flory, B.A.
Medical student (Class of 2008)
University of Pennsylvania School of
Medicine
Philadelphia, Pennsylvania
jfl[email protected]
Larry R. Churchill, Ph.D.
Sev S. Fluss, M.S.
Ann Geddes Stahlman Professor of
Medical Ethics;
Co-Director, Center for Biomedical
Ethics and Society
Vanderbilt University Medical Center
Nashville, Tennessee
[email protected]
Senior Advisor
Council for International Organizations
of Medical Sciences (CIOMS)
World Health Organization
Geneva, Switzerland
fl[email protected]
Dan W. Brock, Ph.D.
Frances Glessner Lee Professor of
Medical Ethics
Department of Social Medicine;
Director, Division of Medical Ethics;
Director, Program in Ethics and Health
Harvard School of Public Health
Harvard Medical School
Boston, Massachusetts
[email protected]
Alan R. Fleischman, M.D.
Morris W. Foster, Ph.D.
Lauren K. Collogan, J.D.
student (Class of 2007)
Columbia School
New York, New York
[email protected]
Colleen Denny, B.S.
Pre-Doctoral Fellow
Department of Bioethics
National Institutes of Health
Bethesda, Maryland
[email protected]
Neal Dickert, M.D., Ph.D.
Resident, Department of Medicine,
The Johns Hopkins School of Medicine
Baltimore, Maryland
[email protected]
Professor and Acting Chair
Department of Anthropology;
Associate Director, Center for Applied
Social Research;
Assistant Associate Director, General
Clinical Research Center
University of Oklahoma
Norman, Oklahoma
[email protected]
rence M. Friedman, M.D.
Independent Consultant
Rockville, Maryland
[email protected]
Nesrin Garan, M.Sc.
student (Class of 2008)
Vanderbilt University School
Nashville, Tennessee
[email protected]
Contributors
Grant R. Gillett, M.B., Ch.B., D.Phil.,
FRACS
Professor, Bioethics Centre;
Consultant Neurosurgeon, Dunedin
Hospital;
Clinical Professor, Neurosurgery,
Dunedin School of Medicine
University of Otago
Dunedin, New Zealand
[email protected]
Michael A. Grodin, M.D.
Søren Holm, M.D., Ph.D., Dr.Med.Sci.
Professor, Department of Health ,
Bioethics and Human Rights
Boston University School of Public
Health;
Professor, Boston University School of
Medicine
Boston, Massachusetts
[email protected]
Section for Medical Ethics, University
of Oslo
Oslo, Norway;
Professor, School;
Professorial Fellow in Bioethics
Cardiff Institute of Society, Health and
Ethics;
Director, Cardiff Centre for Ethics
and Society
Cardiff University
Cardiff, Wales
[email protected]
Cary P. Gross, M.D.
Aaron Goldenberg, M.A., M.P.H.
Doctoral student, Department of
Bioethics;
Research Associate, Center for Genetic
Research Ethics and
Case Western Reserve University School
of Medicine
Cleveland, Ohio
[email protected]
Sara F. Goldkind, M.D., M.A.
Senior Bioethicist, Office of Critical Path
Program
Office of the Commissioner
Food and Drug Administration
Rockville, Maryland
[email protected]
rence O. Gostin, J.D., LL.D. (Hon).
Professor and Associate Dean (Research
and Academic Programs)
Georgetown University Center
Washington, D.C.;
Professor, Bloomberg School of Public
Health;
Director, Center for and the
Public’s Health,
The Johns Hopkins University
Baltimore, Maryland
[email protected]
Ronald M. Green, Ph.D.
Eunice & Julian Cohen Professor for the
Study of Ethics and Human Values
Department of Religion;
Director, Institute for the Study of
Applied and Professional Ethics
Dartmouth University
Hanover, New Hampshire
[email protected]
xvii
Associate Professor
Section of General Internal Medicine
Department of Internal Medicine
Yale University School of Medicine
New Haven, Connecticut
[email protected]
Steven Joffe, M.D., M.P.H.
Medical student (Class of 2009)
University of Michigan Medical School
Ann Arbor, Michigan
[email protected]
Assistant Professor of Pediatrics
Department of Pediatric Oncology
Dana-Farber Cancer Institute;
Department of Medicine, Children’s
Hospital;
Harvar …

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