Ethics of Research Involving Human Subjects

Facing the 21st Century

Edited by Harold Y. Vanderpool

1996. 544 pages. Index

Hardcover: ISBN 1-55572-036-6.

$59.00 plus $4.75 S&H.

Please ask about instructors' discounts.

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 viewpointsexpressed 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

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