Beyond Regulations: Ethics in Human Subjects Research
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.
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Beyond Regulations: Ethics in Human Subjects Research
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.
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Beyond Regulations: Ethics in Human Subjects Research

Beyond Regulations: Ethics in Human Subjects Research

Beyond Regulations: Ethics in Human Subjects Research

Beyond Regulations: Ethics in Human Subjects Research

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Overview

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.

Product Details

ISBN-13: 9780807876060
Publisher: The University of North Carolina Press
Publication date: 10/12/2005
Series: Studies in Social Medicine
Sold by: Barnes & Noble
Format: eBook
Pages: 296
File size: 3 MB

About 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.

Table of Contents

Contents

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

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

Case 1. Contracts and Covenants
Introduction
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
Introduction
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
Introduction
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
Introduction
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
Introduction
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?
Introduction
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
References
Contributors
Index

What People are Saying About This

From the Publisher

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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