Ethics of Research Involving Human Subjects:
Facing the 21st Century
Edited by Harold Y. Vanderpool
We stand at a pivotal moment in the history of human
experimentation. This admirable collection of essays, skillfully assembled
and annotated . . . demonstrates how high the stakes are in the ethics of
human experimentation.
—The
New England Journal of Medicine, David J. Rothman, PhD
I was stunned by the depth, thoughtfulness, and sensitivity with which the
complex issues of human research were discussed, and
particularly, by the diversity of viewpoints expressed in this volume, which can only
enrich the scholarship and protect more adequately the interests of subjects of
research, on the one hand, and the claims of scientific progress, on the other.
—Jay
Katz, JD, Yale University
Vanderpool’s book is to be read now by anyone interested in medical research, and kept on the shelf for future reference.
—The
Times Literary Supplement, Baroness Mary Warnock
Outstanding Academic Book of 1996.
—Choice,
The American Library Association
The Ethics of Research Involving Human Subjects: Facing the 21st Century
is one of the most interesting, illuminating, and important
books I have recently read in bioethics. It both accurately reflects the current state
of controversy and helpfully points the direction for creative change. . . . Most
importantly, it provides valuable perspectives for continued reflection on the conceptual and
normative frameworks for human subjects research.
—Medical Humanities Review, James F. Childress, PhD
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Ethics of Research Involving Human Subjects
Table of Contents
Preface
Acknowledgments
Contributors
1. Introduction and Overview: Ethics, Historical Case Studies and the Research
Enterprise, Harold Y. Vanderpool
Part I
Introduction to Part I: Current Debate Over
Research Ethics and Regulations, Harold Y. Vanderpool
2. From Nuremberg Through the 1990s: The Priority of Autonomy
Robert M.
Veatch
3. The Weight and Weighing of Ethical Principles
Albert R. Jonsen
4. Choosing Between Nuremberg and the National Commission: The Balancing of
Moral Principles in Clinical Research
Terrence F. Ackerman
5. Changing Views of Justice after Belmont: AIDS and the Inclusion of
“Vulnerable” Subjects
Carol Levine
6. Challenges to IRBs in the Coming Decades
Charles R. McCarthy
Part II
Introduction to Part II: Conflicts of Interest,
Harold Y. Vanderpool
7. The Promise and Perils of Public Bioethics
John C. Fletcher and Franklin
G. Miller
8. Financial Issues and Incentives Related to Clinical Research and Innovative
Therapies
Stuart E. Lind
9. Physicians’ Conflicts of Interest in Post-Marketing Research: What the Public
Should Know, and Why Industry Should Tell Them
John La Puma
Part III
Introduction to Part III: Controversy Over
Cross-Cultural Research, Harold Y. Vanderpool
10. International Codes and Guidelines for Research Ethics: A Critical Appraisal
Robert J. Levine
11. The Distinction Between Ethical Pluralism and Ethical Relativism:
Implications for the Conduct of Transcultural Clinical Research
Nicholas A. Christakis
12. Medical Research and the Principle of Respect for Persons in Non-Western
Cultures
Carel B. IJsselmuiden and Ruth R. Faden
Part IV
Introduction to Part IV: Critical Issues in
Specialized Areas, Harold Y. Vanderpool
13. The Ethical Analysis of Clinical Trials: New Lessons for and from Cancer
Research
Benjamin Freedman
14. Ethical Issues in Pediatric Research
William G. Bartholome
15. Fetal and Embryo Research: A Changing Scientific, Political, and Ethical
Landscape
Constance M. Pechura
16. Respecting Human Subjects in Genome Research: A Preliminary Policy Agenda
Eric T. Juengst
Appendices
A. Nuremberg Code, 1946
B. Declaration of Helsinki 1964, revised 1975, 1983, 1989
C. The Belmont Report, April 1979
D. Code of Federal Regulations, Title 45, U.S. Code of Federal Regulations, Part
46 (revised 18 June 1991)
E. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in
Clinical Research, March 1995
F. CIOMS/WHO, International Ethical Guidelines for Biomedical Research Involving
Human Subjects, 1993
Index