Informed Consent: Patient Autonomy and Physician Beneficence within Clinical Medicine

179 Pages·1993·4.934 MB·English

by  Stephen Wear (auth.)

INFORMED CONSENT
Clinical Medical Ethics
VOLUME 4
Editors
H. Tristram Engelhardt, Jr., The Center for Ethics, Medicine and Public Issues, Baylor
College of Medicine, Houston, Texas
Stuart F. Spicker, School of Medicine, University of Connecticut Health Center,
Farmington, Connecticut
Editorial Advisory Board
George J. Agich, School of Medicine, Southern Illinois University, Springfield, Illinois
Dan W. Brock, Department of Philosophy, Brown University, Providence, Rhode
Island
Baruch A. Brody, Center for Ethics, Medicine and Public Issues, Baylor College of
Medicine, Houston, Texas
Allen E. Buchanan, Department of Philosophy and Division of Social Perspectives in
Medicine, College of Medicine, University ofA rizona, Tucson, Arizona
Antonio M. Gotto, Jr., Department of Medicine, Baylor College of Medicine, Houston,
Texas
Angela R. Holder, School of Medicine, Yale University, New Haven, Connecticut
Jay Katz, Yale Law School, Yale University, New Haven, Connecticut
Loretta M. Kopelman, Department of Medical Humanities, School of Medicine, East
Carolina University, Greenville, North Carolina
Edmund D. Pellegrino, Center for the Advanced Study of Ethics, Georgetown
University, Washington, D.C.
Kenneth J. Ryan, Department of Obstetrics and Gyneacology, Brigham and Women's
Hospital, Harvard Medical School, Boston, Massachusetts
Kevin Wm. Wildes, S.J., Center for Ethics, Medicine and Public Issues, Baylor
College of Medicine, Houston, Texas
The titles published in this series are listed at the end oft his volume.
Informed Consent
Patient Autonomy and
Physician Beneficence within
Clinical Medicine
STEPHEN WEAR
Department of Medicine,
Department ofG ynecology-Obstetrics,
School of Medicine and Health Sciences
Department of Philosophy,
School of Social Sciences
State University ofN ew York at Buffalo, U.S.A.
Head, Ombudsman Consultation Team,
Veterans Administration Medical Center - Buffalo, U.S.A.
SPRINGER-SCIENCE+BUSINESS MEDIA, B.V.
Library of Congress Cataloging-in-Publication Data
Wear. Stephan.
Inforled consent : patlent autonolY and physlclan beneflcence
wlthln cllnlcal ledlclna / by Stephen Wear.
p. CI. -- (Cllnlcal ledlcal ethlcs ; v. 4)
Includes blbllographlcal references and Index.
ISBN 978-90-481-4219-4 ISBN 978-94-015-8122-6 (eBook)
DOI 10.1007/978-94-015-8122-6
1. Inforaed consent (Medical law) 2. Medical ethlcs. 1. Tltle.
II. Ser Ies.
[ONLM: 1. Ethlcs. Medical. 2. InforlIIed Consent. 3. Patlent
Partlclpatlon. 4. Physlclan-Patlent Relatlons. W1 CL73N v. 4 / W
50 W3621]
R724.W355 1993
174' .2--dc20
ONLM/OLC
for Llbrary of Congress 92-48748
ISBN 978-90-481-4219-4
Printed on acid-free paper
AlI Rights Reserved
© 1993 Springer Science+Business Media Dordrecht
Originally published by Kluwer Academic Publishers in 1993
Softcover reprint ofthe hardcover lst edition 1993
No part of the material protected by this copyright notice may be reproduced or
utilized in any form or by any means, electronic or mechanical,
including photocopying, recording or by any information storage and
retrieval system, without written permission from the copyright owner.
To Christa and Cullen,
My wife and son,
And in memory of my grandmother,
Florence Ella Wear
Table of Contents
Acknowledgements xi
Notice xiii
Introduction
PART I: THE SOURCES OF A MODEL OF INFORMED CONSENT 5
Chapter One: The Legal Doctrine of Informed Consent 5
I. The Goals and Sources of the Legal Doctrine of Informed Consent 6
II. Elements of the Legal Doctrine 9
A. Competence to Consent 10
B. Disclosure 12
C. Evaluation and Consent 14
D. Exceptions to the Rule 15
1. The Emergency Exception
2. The Therapeutic Privilege Exception 16
3. The Waiver Exception 17
III. Summary 18
Notes 21
Chapter Two: The New Ethos of Patient Autonomy 22
I. Early Concerns about Patient Autonomy 23
A. Concerns about Research Subjects
B. The Influence of Extraordinary Cases 24
II. A Reply from the Paternalist 25
III. Patients and Physicians as Moral Strangers 28
IV. Freedom in Health Care 30
A. Freedom from Interference and Informed Consent 32
B. Restoring Freedom 33
C. Enhancing Freedom 34
D. The Heterogeneity of Clinical Needs and Tasks 36
V. This Is All Very Well And Good, But ... 37
VI. Retrospect and Prospect 38
Notes 39
viii Table of Contents
Chapter Three: The Clinical Experience of Patient Autonomy and 40
Informed Consent
I. Anecdotes about Patient Autonomy and Informed Consent 41
II. Empirical Studies of Informed Consent 42
A. Patient Understanding of Disclosed Information 43
B. Other Empirical Findings 44
C. Implications of the Preceding 45
III. Diminished Competence 46
A. Factors Ingredient in Illness 47
B. Common Psychological Responses to Illness 48
C. Long Term Psychological Characteristics 49
D. Other Diminishing Factors
IV. Barriers to Patient Autonomy and Informed Consent 50
A. Institutional Barriers
B. The Nature of Clinical Decision Making 52
V. Summary Remarks
Notes 53
Chapter Four: The Potential Benefits of Informed Consent 55
I. The Value of Patient Participation in Clinical Decision Making 56
II. Goods and Values that Informed Consent Might Capture 60
A. Substantial Goods and Values That Are Often At Stake 62
B. Less Common but Profound Goods and Values 63
III. Retrospect and Prospect 64
~w ~
PART II: A MODEL OF INFORMED CONSENT 67
Chapter Five: Toward a Model of Informed Consent -
Theoretical and Programmatic Considerations
I. Theoretical Considerations and Commitments 70
A. The Theory of Informed Consent of Faden and Beauchamp 71
B. Theoretical Commitments and Biases of this Work 73
I. Ethical Theory 74
2. Rights
3. Respect for Patient Autonomy 75
4. The Nature of the Argument of this Work 76
Table of Contents ix
II. The Basic Structure of the Model Advocated in this Work 77
A. The Need for a Standardized Basic Model
B. A Heterogeneity of Needs and Possibilities 79
C. Informed Consent-Event or Process?
D. The Primacy of an Informed Consent Event in this Account 81
Notes 83
Chapter Six: The Informed Consent Event 84
I. Stage I: The Comprehensive Disclosure 85
A. The Broader Context of the Decision at Hand 86
B. Diagnosis 88
C. Prognosis without Treatment
D. The Recommended Treatment with Attendant Risks and 89
Benefits
1. Identifying the Potential Benefits of a Given Intervention 90
2. Identifying Risks and Potential Complications 91
E. Specification of Alternative Treatments 95
1. Clear Treatment of Choice with No Alternatives 96
2. Clear Treatment of Choice with Alternatives Only from a
Technical or Professional Point of View
3. Alternative Modalities Exist, but the Physician Could Not
Conscientiously Offer Them
4. Alternative Therapies Exist, Have Some Merit, but the 97
Physician Feels the Recommended Treatment has
Substantial Advantages
5. Alternative Modalities Exist and One of Them May
Well be Preferred By the Patient, but the Physician
Still has a Marked Preference
6. No Recommendation Can be Legitimately Given, as the
Alternatives are Equally Appropriate and Reasonable
II. Stage II: The Core Disclosure 99
A. The Transparency Model of Howard Brody
B. Considerations in Offering the Core Disclosure 102
III. Stage III: Assessment, Clarification and Patient Choice 104
IV. Retrospect and Prospect 106
Notes
x Table of Contents
Chapter Seven: The Issue of Competence 108
I. The Standard of Practice Regarding Competence: An 110
Emerging Consensus
II. Competence as Both Status and Capacity 114
III. Triggering the Competency Assessment 117
A. The "Favorability" Trigger Revisited 119
B. Clinical Considerations in Responding to Such Triggers 121
IV. Performing the Competency Assessment 122
A. The Generic Assessment of Competency 123
B. "To the Task" Assessments of Competency 125
I. The Order of Investigation in "To The Task" Testing
2. Negative Findings in "To The Task" Assessments of 128
Competency
a. Patient Performance within a "To The Task" 129
Assessment
V. Summary Remarks 131
Notes 132
Chapter Eight: Exceptions to Informed Consent 134
I. The Emergency Exception
A. The Competing Value of Informed Consent 135
B. The Time Factor and Treatment Refusals in an Emergency 136
C. The Abbreviated Consent Option 137
D. Emergency Response in the Context of Terminal or Severe 138
Chronic Illness
II. The Waiver Exception 139
III. The Therapeutic Privilege Exception 143
IV. Summary Remarks 146
Chapter Nine: The Enterprise of Informed Consent 147
Bibliography 151
Index 163
Acknowledgements
I would like to express my deep gratitude to the following colleagues who
provided me with detailed critical reactions to this manuscript: H. Tristram
Engelhardt, Jr., Ph.D., M.D., George Khushf, M.A., Susan LaGaipa, M.S.,
R.N., Laurence McCullough, Ph.D., Jonathan Moreno, Ph.D., E. Haavi
Morreim, Ph.D., Benjamin Phillips, M.S., R.N. and Stuart Spicker, Ph.D.
A parallel debt should also be acknowledged to my clinical colleagues in
the Buffalo medical community who helped me gain insight into the realities
of clinical medicine. John Banas, M.D., William Coles, M.D., Jack Freer,
M.D. and Paul Katz, M.D. merit special thanks in this regard. Norman
Chassin, M.D., also deserves singling out, especially for his extended and
patient attempt to help me see that the tradition of physician beneficence was
truly worthy of the name, however much we may continue to quarrel about
its specific pronouncements. Special thanks are also due to Paul Davis, M.D.
and Gerald Logue, M.D., who encouraged and supported me in my work in
clinical medicine as an ethics consultant, and provided me with access to their
patients and staff.
Finally, a special note of appreciation is due to H. Tristram Engelhardt,
Jr., Ph.D., M.D., and Laurence McCullough, Ph.D., not only for their
assistance with this book, but especially for their sustained support,
encouragement, understanding and friendship over the years.
xi