Competence and Vulnerability in Biomedical Research

244 Pages·2008·2.164 MB·English

by  Phil Bielby (auth.)

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Competence and Vulnerability
in Biomedical Research
INTERNATIONAL LIBRARY OF ETHICS, LAW,
AND THE NEW MEDICINE
Founding Editors
DAVID C. THOMASMA†
DAVID N. WEISSTUB, Université de Montréal, Canada
THOMASINE KIMBROUGH KUSHNER, University of California,
Berkeley,U.S.A.
Editor
DAVID N. WEISSTUB, Université de Montréal, Canada
Editorial Board
TERRY CARNEY, University of Sydney, Australia
MARCUS DÜWELL, Utrecht University, Utrecht, the Netherlands
SØREN HOLM, University of Cardiff, Wales, United Kingdom
GERRIT K. KIMSMA, Vrije Universiteit, Amsterdam, the Netherlands
DAVID NOVAK, University of Toronto, Canada
EDMUND D. PELLEGRINO, Georgetown University, Washington D.C., U.S.A.
DOM RENZO PEGORARO, Fondazione Lanza and University of Padua, Italy
DANIEL P. SULMASY, Saint Vincent Catholic Medical Centers, New York, U.S.A.
LAWRENCE TANCREDI, New York University, New York, U.S.A.
VOLUME 40
For other titles published in this series, go to
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Phil Bielby
Competence and Vulnerability
in Biomedical Research
Phil Bielby
Law School and Institute of Applied Ethics
The University of Hull
UK
ISBN 978-1-4020-8603-8 e-ISBN 978-1-4020-8604-5
Library of Congress Control Number: 2008931007
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Acknowledgements
This book derives from my doctoral thesis, awarded by The University of
Sheffield. I am particularly grateful to my examiners, Søren Holm and Mark
Taylor, for their perceptive comments and constructive criticism, which have
influenced the revisions I have made in converting the thesis into a book. I must
also thank Deryck Beyleveld for his insightful and patient supervision of the
original thesis, which considerably enhanced the clarity of my thinking on these
issues and the cogency of the arguments. More recently, the two anonymous
reviewers for Springer provided useful feedback on the manuscript and sugges-
tions for improvement. I have been fortunate to be a part of the Sheffield Institute
of Biotechnological Law and Ethics and, latterly, the Institute of Applied Ethics
at Hull, which have both offered vibrant inter-disciplinary research cultures in
which to explore ideas. A number of colleagues and friends have provided helpful
advice, comments and information at various times, especially Don Carrick, Bev
Clucas, Fiona Cownie, Sam Hardy, John McMillan, Shaun Pattinson and Tony
Ward. Apologies to anyone I have overlooked. Of course, none of them are
responsible for any shortcomings in the text.
The University of Sheffield School of Law supported the first three years of my
doctoral studies through a generous scholarship, which allowed me to commence
research on this topic earlier than I otherwise might. A period of research leave
from The University of Hull Law School in the first semester of the academic year
2006–07 facilitated work on the manuscript, and I am grateful to colleagues who
covered my teaching and administrative responsibilities during this time. In addi-
tion, I would like to express considerable thanks to my publishing editor at Springer,
Fritz Schmuhl, and to Marion Wagenaar for their efficiency and patience in waiting
for the final version of the manuscript.
Chapters One and Seven include and develop material originally presented in
my article ‘The Conflation of Competence and Capacity in English Medical Law:
a philosophical critique’ (Bielby 2005b), which appeared in Medicine, Health Care
and Philosophy, published by Springer. Chapter Two contains previously published
work drawn from my article ‘Equality and Vulnerability in Biomedical Research on
Human Subjects’ (Bielby, 2005a), and I am grateful to Steve Smith, editor of
Imprints: egalitarian theory and practice, for permission to use this material.
v
vi Acknowledgements
Excerpts from my forthcoming book chapter, ‘Towards supported decision-making
in biomedical research with cognitively vulnerable adults’ (Bielby, 2008), which
will be published as part of The Limits of Consent: A socio-ethical approach to
human subject research in medicine (Corrigan et al eds.), appear in Chapters Three,
Six and Seven. I wish to thank the publishers, Oxford University Press, for granting
permission for their use here.
On a personal note, my parents and sister have shown bounteous moral support and
hospitality, particularly in the period when I was commuting between Sheffield and
Hull. At home, Mappin and Flapjack have offered much feline friendship, especially
during late nights working in the study. My deepest gratitude, however, is to Hannah,
my wife. Throughout, her encouragement, optimism, empathy and wry humour have
sustained me enormously. In the final stages, her help proved especially invaluable.
The many personal sacrifices she has willingly made to allow me to finish my doctoral
thesis – and then to indulge my keenness to turn it into a book – are a measure of how
extraordinarily caring (and tolerant) she is. I dedicate this book to her.
28 March 2008 Phil Bielby
Contents
Main Abbreviations ....................................................................................... xi
Note on the Text .............................................................................................. xiii
Introduction .................................................................................................... 1
1 Five Concepts of Competence ................................................................. 9
Agency Competence .................................................................................. 10
Task Competence ....................................................................................... 12
Decisional Competence ............................................................................. 16
Risk-Relative (Asymmetrical) Competence ......................................... 18
Decision-Relative Competence ............................................................ 24
Societal Competence ................................................................................. 28
Legal Competence ..................................................................................... 31
First Sense of Legal Competence ......................................................... 32
Second Sense of Legal Competence .................................................... 35
Third Sense of Legal Competence ....................................................... 35
2 Consent, Vulnerability and Research ..................................................... 39
Competence to Give Informed Consent .................................................... 39
Individual Autonomy ................................................................................. 43
Why Biomedical ‘Research’? .................................................................... 47
The Evolution of the Rights of Research Participants ............................... 50
The Meaning of Vulnerability ................................................................... 52
Cognitive Vulnerability and Consent to Biomedical Research ................. 56
Why Conduct Biomedical Research with Cognitively
Vulnerable Groups? ................................................................................... 62
3 Gewirth’s Theory of Agency Rights ....................................................... 67
The Argument to the PGC ......................................................................... 68
The Methodology of the PGC ................................................................... 72
vii
viii Contents
Defi ning the Content of Agency Rights .................................................... 75
Resolving Confl icts of Rights Under the PGC .......................................... 77
Direct and Indirect Applications of the PGC ............................................ 79
Consent and the PGC ................................................................................. 82
An Evaluation of the PGC Against Two Alternative
Rationalist Ethical Theories ...................................................................... 84
John Rawls ........................................................................................... 84
David Gauthier ..................................................................................... 87
Summary .................................................................................................... 90
4 Proportionality, Precaution and Judgments
of Competence .......................................................................................... 93
The Principle of Proportionality ................................................................ 94
Precautionary Reasoning ........................................................................... 97
Ostensible Agents ................................................................................. 98
Apparent Partial Agents ....................................................................... 99
Ostensible Intermittent Agents ............................................................. 100
Evidence of Agency and Duties of Protection ........................................... 101
The Criterion of Avoidance of More Probable Harm ................................ 103
Degrees of Displaying GCAb and Its Relationship
with Task and Decisional Competences .................................................... 105
Ostensible Agents ................................................................................. 105
Ostensible Intermittent Agents ............................................................. 106
Ostensible Intermittent Agents Who are Close to Having
the Capacities Needed to Be an Agent
in a Standing Fashion ........................................................................... 107
Ostensible Intermittent Agents Who are Less Close
to Having the Capacities Needed to Be an Agent
in a Standing Fashion ........................................................................... 108
Apparent Partial Agents ....................................................................... 109
Summary .................................................................................................... 109
5 The Competences of Cognitively Vulnerable Groups ........................... 111
Older Children and Adolescents ................................................................ 112
Adults with Intellectual Disabilities .......................................................... 115
Adults with Depression ............................................................................. 120
Adults with Schizophrenia ........................................................................ 124
Adults with Alzheimer’s Disease and Other Dementias ........................... 129
Summary .................................................................................................... 135
6 Cognitive Vulnerability and Consent
to Biomedical Research ........................................................................... 139
Decisional Competence and Supported Decision-Making ........................ 140
Contents ix
Older Children and Adolescents ................................................................ 143
Adults with Intellectual Disabilities .......................................................... 147
Adults with Depression ............................................................................. 149
Adults with Schizophrenia ........................................................................ 153
Adults with Alzheimer’s Disease and Other Dementias ........................... 158
Summary .................................................................................................... 163
7 Cognitive Vulnerability and Consent
to Biomedical Research in England and Wales ..................................... 167
Three Approaches to Determining FPCLC ............................................... 168
The Meaning of FPCLC Consent in England and Wales .......................... 169
Adults ........................................................................................................ 170
Children ..................................................................................................... 175
Problems Surrounding the Use of Capacity .............................................. 178
Towards Supported Decision-Making? ..................................................... 180
The Signifi cance of European Regulation of Capacity ............................. 181
Ethical Guidance on Decisional Competence
in Biomedical Research in the UK ............................................................ 184
Summary .................................................................................................... 188
8 Cognitive Vulnerability and Consent to Biomedical
Research in the United States ................................................................. 189
The Meaning of Competence and Capacity
in the United States .................................................................................... 189
Federal Law ............................................................................................... 190
State Law ................................................................................................... 194
Policy Documents on Decisional Competence .......................................... 201
President’s Commission: Making Health Care
Decisions (1982)................................................................................... 201
Expert Panel Report to the National Institutes of Health:
Research Involving Individuals with Questionable
Capacity to Consent (1997) .................................................................. 203
National Bioethics Advisory Commission: Research Involving
Persons with Mental Disorders That May Affect Decisionmaking
Capacity (1998) .................................................................................... 205
NIHPolicy and Guidelines on the Inclusion
of Children as Participants in Research Involving
Human Subjects (1998) ........................................................................ 206
Summary .................................................................................................... 207
Conclusion ...................................................................................................... 209
References ....................................................................................................... 213