Human Experimentation and Research

653 Pages·2001·41.197 MB·English

by  George F. Tomossy, David N Weisstub

Human Experimentation and Research
The International Library of Medicine, Ethics and Law
Series Editor: Michael D. Freeman
Titles in the Series
Death, Dying and the Ending of Life Rights and Resources
Margaret P. Battin, Leslie Francis and Frances H. Miller
Bruce Landesman
AIDS: Society, Ethics and Law
Abortion Udo Schüklenk
Belinda Bennett
Women, Medicine, Ethics and the Law
Ethics and Medical Decision-Making Susan Sherwin and Barbara Parish
Michael D. Freeman
Legal and Ethical Issues in Human
Children, Medicine and the Law Reproduction
Michael D. Freeman Bonnie Steinbock
Mental Illness, Medicine and Law Medical Practice and Malpractice
Martin Lyon Levine Harvey Teff
The Elderly Human Experimentation and Research
Martin Lyon Levine George F. Tomossy and David N. Weisstub
The Genome Project and Gene Therapy Medicine and Industry
Sheila A.M. McLean George F. Tomossy
Human Experimentation
and Research
Edited by
George F.Tomossy and David N. Weisstub
University of Sydney, Australia and Université de Montréal, Canada
Firstpublished2001 byAshgatePublishing
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Contents
Acknowledgements ix
Series Preface xiii
Introduction: Human Research Ethics XV
PART I THE HISTORICAL AND PHILOSOPHICAL FOUNDATIONS
1 Hans Jonas (1969), ‘Philosophical Reflections on Experimenting with Human
Subjects’, Dœdalus, 98, pp. 219-47. 3
2 Ruth Macklin and Susan Sherwin (1975), ‘Experimenting on Human Subjects:
Philosophical Perspectives’, Case Western Reserve Law Review, 25, pp. 434-71. 33
3 Eric M. Meslin, Heather J. Sutherland, James V. Lavery and James E. Till (1995),.
‘Principlism and the Ethical Appraisal of Clinical Trials’, Bioethics, 9,
pp. 399^18. 71
4 David J. Rothman (1998), ‘The Nuremberg Code in Light of Previous Principles
and Practices in Human Experimentation’, in Ulrich Tröhler and Stella Reiter-
Theil in cooperation with Eckhard Herych (eds), Ethics Codes in Medicine:
Foundations and Achievements of Codification Since 1947, Ashgate: Aldershot,
pp. 50-59. 91
5 James F. Childress (2000), ‘Nuremberg’s Legacy: Some Ethical Reflections’,
Perspectives in Biology and Medicine, 43, pp. 347-61. 101
6 Allen Buchanan (1996), ‘The Controversy over Retrospective Moral Judgment’,
Kennedy Institute of Ethics Journal, 6, pp. 245-50. 117
7 Tom L. Beauchamp (1996), ‘Looking Back and Judging Our Predecessors’,
Kennedy Institute of Ethics Journal, 6, pp. 251-70. 123
8 Arthur L. Caplan (1992), ‘When Evil Intrudes’, Hastings Center Report, 22,
pp. 29-32. 143
9 Sissela Bok (1995), ‘Shading the Truth in Seeking Informed Consent for Research
Purposes’, Kennedy Institute of Ethics Journal, 5, pp. 1-17. 147
10 Nancy E. Kass, Jeremy Sugarman, Ruth Faden and Monica Schoch-Spana (1996),
‘Trust: The Fragile Foundation of Contemporary Biomedical Research’, Hastings
Center Report, 26, pp. 25-29. 165
11 George J. Annas (1996), ‘Questing for Grails: Duplicity, Betrayal and Self-
Deception in Postmodern Medical Research’, Journal of Contemporary Health
Law and Policy, 12, pp. 297-324. 171
12 David N. Weisstub (1996), ‘Roles and Fictions in Clinical and Research Ethics’,
Health Law Journal, 4, pp. 259-82. 199
vi Human Experimentation and Research
PART II PROTECTING HUMAN SUBJECTS
13 Jay Katz (1993), ‘Human Experimentation and Human Rights’, Saint Louis
University Law Journal, 38, pp. 7-54. 225
14 Paul R. Benson (1989), ‘The Social Control of Human Biomedical Research: An
Overview and Review of the Literature’, Social Science and Medicine, 29,
pp. 1-12. 273
15 Jonathan D. Moreno (2001), ‘Goodbye to All That: The End of Moderate
Protectionism in Human Subjects Research’, Hastings Center Report, 31, pp. 9-17. 285
16 Alexander Morgan Capron (1999), ‘Is National, Independent Oversight Needed
for the Protection of Human Subjects?’, Accountability in Research, 7, pp. 283-92. 295
17 Anna C. Mastroianni (1999), ‘National, Independent Oversight: Reinforcing the
Safety Net for Human Subjects Research’, Accountability in Research, 7,
pp. 303-309. 305
18 Marshall B. Kapp (2002), ‘Regulating Research for the Decisionally Impaired:
Implications for Mental Health Professionals’, Journal of Clinical Geropsychology,
8, pp. 35-51. 313
19 Robert Michels (1999), ‘Are Research Ethics Bad for Our Mental Health?’, New
England Journal of Medicine, 340, pp. 1427-30. 331
20 George F. Tomossy and David N. Weisstub (1997), ‘The Reform of Adult
Guardianship Laws: The Case of Non-Therapeutic Experimentation’, International
Journal of Law and Psychiatry, 20, pp. 113-39. 335
PART III RISK AND RESPONSIBILITY
21 Charles Weijer (2000), ‘The Ethical Analysis of Risk’, Journal of Law, Medicine
and Ethics, 28, pp. 344-61. 365
22 Nancy M.P. King (2000), ‘Defining and Describing Benefit Appropriately in
Clinical Trials’, Journal of Law, Medicine and Ethics, 28, pp. 332-43. 383
23 David Wendler (2002), ‘What Research with Stored Samples Teaches us about
Research with Human Subjects’, Bioethics, 16, pp. 33-54. 395
24 Robert J. Levine (1988), ‘Uncertainty in Clinical Research’, Law, Medicine and
Health Care, 16, pp. 174-82. 417
25 Benjamin Freedman (1987), ‘Equipoise and the Ethics of Clinical Research’, New
England Journal of Medicine, 317, pp. 141-45. 427
26 Richard Ashcroft (1999), ‘Equipoise, Knowledge and Ethics in Clinical Research
and Practice’, Bioethics, 13, pp. 314-26. 433
27 S. Senn (2002), ‘Ethical Considerations Concerning Treatment Allocation in Drug
Development Trials’, Statistical Methods in Medical Research, 11, pp. 403-11. 447
28 Baruch A. Brody (1997), ‘When are Placebo-Controlled Trials No Longer
Appropriate?’, Control Clinical Trials, 18, pp. 602-12. 457
Human Experimentation and Research vii
PART IV GLOBALIZATION AND CORPORATION - TRUST AND
PARTICIPATION
29 Ruth Macklin (1999), ‘International Research: Ethical Imperialism or Ethical
Pluralism?’, Accountability in Research, 7, pp. 59-83. 471
30 Marcia Angell (2000), ‘Is Academic Medicine for Sale?’, New England Journal
of Medicine, 342, pp. 1516-18. 497
31 James T. Rule and Adil E. Shamoo (1997), ‘Ethical Issues in Research
Relationships between Universities and Industry’, Accountability in Research, 5,
pp. 239-49. 501
32 Thomas Bodenheimer (2000), ‘Uneasy Alliance: Clinical Investigators and the
Pharmaceutical Industry’, New England Journal of Medicine, 342, pp. 1539-44. 513
33 Trudo Lemmens and Benjamin Freedman (2000), ‘Ethics Review for Sale?
Conflict of Interest and Commercial Research Review Boards’, Milbank Quarterly
Review, 78, pp. 547-84. 519
34 Jesse A. Goldner (2000), ‘Dealing with Conflicts of Interest in Biomedical
Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach’,
Journal of Law, Medicine and Ethics, 28, pp. 379-404. 557
35 Mark Yarborough and Richard R. Sharp (2002), ‘Restoring and Preserving Trust
in Biomedical Research’, Academic Medicine, 77, pp. 8-14. 583
36 David B. Resnik (1999), ‘Privatized Biomedical Research, Public Fears, and the
Hazards of Government Regulation: Lessons from Stem Cell Research’, Health
Care Analysis, 7, pp. 273-87. 591
Name Index 607

Acknowledgements
The editors and publishers wish to thank the following for permission to use copyright material.
George J. Annas (1996), ‘Questing for Grails: Duplicity, Betrayal and Self-Deception in
Postmodern Medical Research’, Journal of Contemporary Health Law and Policy, 12, pp. 297-
324. Copyright © George J. Annas.
Ashgate Publishing Limited for the essay: David J. Rothman (1998), ‘The Nuremberg Code in
Light of Previous Principles and Practices in Human Experimentation’, in Ulrich Tröhler and
Stella Reiter-Theil in cooperation with Eckhard Herych (eds), Ethics Codes in Medicine:
Foundations and Achievements of Codification Since 1947, Ashgate: Aldershot, pp. 50-59.
Association of American Medical Colleges for the essay: Mark Yarborough and Richard R.
Sharp (2002), ‘Restoring and Preserving Trust in Biomedical Research’, Academic Medicine,
77, pp. 8-14. Copyright © 2002 Association of American Medical Colleges.
American Society of Law, Medicine and Ethics for the essays: Jesse A. Goldner (2000), ‘Dealing
with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to
the Abolitionist Approach’, Journal of Law, Medicine and Ethics, 28, pp. 379-404. Copyright
© 2000 American Society of Law, Medicine and Ethics; Charles Weijer (2000), ‘The Ethical
Analysis of Risk’, Journal of Law, Medicine and Ethics, 28, pp. 344-61. Copyright © 2000
Charles Weijer; Nancy M.P. King (2000), ‘Defining and Describing Benefit Appropriately in
Clinical Trials’, Journal of Law, Medicine and Ethics, 28, pp. 332-43. Copyright © 2000
American Society of Law, Medicine and Ethics; Robert J. Levine (1988), ‘Uncertainty in Clinical
Research’, Law, Medicine and Health Care, 16, pp. 174-82. Copyright © 1998 American Society
of Law, Medicine and Ethics. Reprinted with the permission of the American Society of Law,
Medicine and Ethics. All rights reserved.
Arnold Journals & Reference for the essay: S. Senn (2002), ‘Ethical Considerations Concerning
Treatment Allocation in Drug Development Trials’, Statistical Methods in Medical Research,
11, pp. 403-11. Copyright © 2002 Arnold.
Blackwell Publishing Ltd for the essays: Eric M. Meslin, Heather J. Sutherland, James V. Lavery
and James E. Till (1995), ‘Principlism and the Ethical Appraisal of Clinical Trials’, Bioethics,
9, pp. 399-418. Copyright © 1995 Blackwell Publishers Ltd; Richard Ashcroft (1999),
‘Equipoise, Knowledge and Ethics in Clinical Research and Practice’, Bioethics, 13, pp. 314-
26.Copyright © 1999 Blackwell Publishers Ltd; David Wendler (2002), ‘What Research with
Stored Samples Teaches us about Research with Human Subjects’, Bioethics, 16, pp. 33-54.
Copyright © 2002 Blackwell Publishers Ltd; Trudo Lemmens and Benjamin Freedman (2000),
‘Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards’, Milbank
Quarterly Review, 78, pp. 547-84.