Beyond Regulations: Ethics in Human Subjects Research / Edition 1

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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 Balán, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renée 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.

The book contains black-and-white illustrations.

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Editorial Reviews

From the Publisher
Clearly illustrates the importance of a relationship-based perspective to research ethics as a necessary complement to the principalist paradigm.

Journal of Medical Ethics

This superb collection of essays, carefully structured around six cases, analyzes the attendant policy issues with great insight.

Alexander M. Capron, School of Law, University of Southern California

Begins a series exploring how medicine shapes and is shaped by social forces, using broader strokes than the well-established specialties of social sciences that address medicine. The six case studies do more than apply accepted theory to specific situations, but contribute to ethical theory in general. The material was prepared for the November 1995 conference From Reg's to Relationships: Reexamining Research Ethics held in Chapel Hill where the editors and many of the authors are affiliated with the University of North Carolina. Annotation c. Book News, Inc., Portland, OR (
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Product Details

  • ISBN-13: 9780807847701
  • Publisher: The University of North Carolina Press
  • Publication date: 4/26/1999
  • Series: Studies in Social Medicine Series
  • Edition description: 1
  • Edition number: 1
  • Pages: 296
  • Product dimensions: 6.08 (w) x 9.20 (h) x 0.74 (d)

Meet the Author

Nancy King is associate professor of social medicine t the University of North Carolina at Chapel Hill.

Gail Henderson is associate professor of social medicine and adjunct professor of sociology at the University of North Carolina at Chapel Hill.

Jane Stein teaches research and evaluation methods in maternal and child health and international health at the University of North Carolina at Chapel Hill.

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Table of Contents


Foreword by Allan M. Brandt and Larry R. Churchill
Introduction. Relationships in Research: A New Paradigm
Nancy M. P. King, Gail E. Henderson, and Jane Stein

Keynote Essay
Is Ethics Universal?: Gender, Science, and Culture in Reproductive Health Research
Ruth Macklin

Case 1. Contracts and Covenants
Contract and Covenant in Cura ao: Reciprocal Relationships in Scholarly Research
Alan F. Benjamin
Commentary 1. Contract and Covenant in Ethnographic Research
Renée C. Fox
Commentary 2. The Gaze of Scholars and Subjects: Roles, Relationships, and Obligations in Ethnographic Research
Sue E. Estroff

Case 2. Community-based HIV Research
Community Assessment and Perceptions: Preparation for HIV Vaccine Efficacy Trials
Lynn Blanchard
Commentary 1. Community Advisory Board-Investigator Relationships in Community-Based HIV/AIDS Research
Ronald P. Strauss
Commentary 2. Research Partnerships and People "at Risk": HIV Vaccine Efficacy Trials and African American Communities
Keith A. Wailoo

Case 3. Corporate Sponsorship of Research
Truth-in-funding: Studying the Infant-feeding Controversy with Industry Support
Barry M. Popkin
Commentary 1. Bias and Conflicts of Interest in Science: Controversial Industry Funding of Infant-feeding Studies
Loretta M. Kopelman
Commentary 2. Context and Community: Assessing the Ethics of Industry-funded Research
Allan M. Brandt and Lara Freidenfelds

Case 4. Risk and Trust in Abortion Research
Research on Induced Abortion in Argentina: Avoiding Self-Incrimination
Jorge Balán and Silvina Ramos
Commentary 1. Research on Induced Abortion in Argentina: Avoiding Self-Incrimination
Cynthia Waszak
Commentary 2. The Contexts of Social Research
Barbara Entwisle

Case 5. Studying Maltreatment in Families
Maltreatment in Families: A Research Dilemma
Desmond K. Runyan
Commentary 1. Child Abuse Research: Can Ethical Standards Be the Same in Developed and Developing Countries?
Marcela Aracena Alvarez
Commentary 2. Research in Distressed Families: How Should Societies Make Judgments about Parents and Children?
Nancy M. P. King

Case 6. Whose Consent?
Can Community Consultation Substitute for Informed Consent in Emergency Medicine Research?
Ernest N. Kraybill and B. Susan Bauer
Commentary 1. Can Community Consultation Substitute for Informed Consent in Emergency Medicine Research?: A Response
J. Pat Browder
Commentary 2. Medical Research: Using a New Paradigm Where the Old Might Do
Nancy M. P. King

Conclusion. Regulations and Relationships: Toward a New Synthesis
Nancy M. P. King, Gail E. Henderson, and Jane Stein

Appendix A. Nuremberg Code
Appendix B. Federal Common Rule
Appendix C. CIOMS Epidemiological Research Guidelines
Appendix D. CIOMS Biomedical Research Guidelines
Appendix E. Contract between Alan Benjamin and Congregation Mikvé Israel-Emanuel
Appendix F. Letter from Alan Benjamin to the Congregation

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