Ethics and Regulation of Clinical Research

Front Cover
Yale University Press, 1988 - Language Arts & Disciplines - 452 pages
The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved.
"[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine
"Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine
"You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal
"Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology
 

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Contents

Basic Concepts and Definitions 1
1
Ethical Norms and Procedures
19
Balance of Harms and Benefits
37
Selection of Subjects
67
Informed Consent
95
Compensation for ResearchInduced Injury
155
Privacy and Confidentiality
163
Randomized Clinical Trials
185
Those Institutionalized as Mentally Infirm
257
Prisoners
277
The Fetus and the Embryo
297
The Institutional Review Board
321
References
365
Appendix
366
Department of Health and Human Services Rules and Regulations
393
Food and Drug Administration Rules and Regulations
413

Deception
213
Children
235
World Medical Association Declaration of Helsinki
427
Copyright

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