Beyond Regulations: Ethics in Human Subjects ResearchNancy M. P. King, Gail E. Henderson, 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. |
Contents
1 | |
19 | |
CASE 1 CONTRACTS AND COVENANTS | 45 |
CASE 2 COMMUNITYBASED HIV RESEARCH | 81 |
CASE 3 CORPORATE SPONSORSHIP OF RESEARCH | 109 |
CASE 4 RISK AND TRUST IN ABORTION RESEARCH | 135 |
CASE 5 STUDYING MALTREATMENT IN FAMILIES | 159 |
CASE 6 WHOSE CONSENT? | 187 |
APPENDIX B Federal Common Rule | 227 |
APPENDIX C CIOMS Epidemiological Research Guidelines | 239 |
APPENDIX D CIOMS Biomedical Research Guidelines | 247 |
APPENDIX E Contract between Alan Benjamin and Congregation Mikve IsraelEmanuel | 252 |
APPENDIX F Letter from Alan Benjamin to the Congregation | 255 |
References | 258 |
Contributors | 272 |
Index | 275 |
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abortion Abuse and Neglect academic African American Alan Benjamin Anthropology approval asked authority autonomy Balán and Ramos behavior Belmont Report biomedical research CAB members child abuse clinical concerns conduct confidentiality consent forms context contract countries cultural Curaçao Curaçaoan developing disclosure discussion emergency research ethical issues ethical principles example experience Faden federal funding guidelines harm HIV vaccine HIV/AIDS hospital human subjects research Ijsselmuiden individual industry infant informed consent institution institutional review board intervention interview investigators LONGSCAN maltreatment Medicine ment Mikvé Israel-Emanuel moral munity Nestlé North Carolina Nuremberg Code participation patients Popkin potential principlist paradigm problem procedures questions regulations relationships paradigm research ethics research involving research subjects respect for persons review committee role scientists Sephardi Jews social science research sponsoring tion treatment Tuskegee Tuskegee syphilis study vaccine trials waiver women