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About the Book

Beyond the Book

<span style="" >Beyond Regulations</span>

296 pp., 6.125 x 9.25, 1 table, 1 fig., appends., notes, bibl., index

Studies in Social Medicine

ISBN  978-0-8078-4770-1
Published: April 1999

Beyond Regulations

Ethics in Human Subjects Research

Edited By Nancy M. P. King, Gail E. Henderson and Jane Stein

Across a broad range of disciplines--in medicine, social science, and the humanities--researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm.

This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful.

Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak.

Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them.

This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.

About the Author

Nancy M. P. King, Gail E. Henderson, and Jane Stein are all affiliated with the University of North Carolina at Chapel Hill. Nancy King is associate professor of social medicine. Gail Henderson is associate professor of social medicine and adjunct professor of sociology. Jane Stein teaches research and evaluation methods in maternal and child health and international health.


"Clearly illustrates the importance of a relationship-based perspective to research ethics as a necessary complement to the principalist paradigm. . . . I would recommend this book to social science and biomedical science researchers and general readers with an interest in research ethics."
--Journal of Medical Ethics

"It is high time to rethink the ethical premises and procedures for research with human subjects, a task to which Beyond Regulations makes an indispensable contribution. This superb collection of essays, carefully structured around six cases, analyzes the attendant policy issues with great insight, while also giving substance to the 'relationship paradigm' as an alternative to the principlist approach that has dominated bioethics for a generation. Besides a rich theoretical discussion that will intrigue and stimulate bioethics scholars and students, this volume provides invaluable practical guidance for IRBs, researchers, and public officials alike."
--Alexander M. Capron, School of Law, University of Southern California

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