Ethics and Regulation of Clinical Research

Second Edition

Robert J. Levine

View Inside Price: $45.00


July 27, 1988
480 pages, 6 1/8 x 9 1/4
ISBN: 9780300042887
Paper

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

"[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 Frost, 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

"This book is a superb achievement. . . . Levine endorses the most promising theoretical approach of seeking a sensitive balance among the various moral considerations implicated in the conduct of clinical research."—Terrence F. Ackerman, Hastings Center Report

"Like the first edition, this volume is the best resource book for the ethics and regulation of clinical research. Levine's thorough scholarship and his well-reasoned positions make it required reading for anyone with an interest in medical research. The discussions are well balanced among the perspectives of medicine, regulation, and ethics and thus will be of interest and accessible to researchers physicians, lawyers, ethicists, policymakers, and members of institutional review boards."—Bruce Miller, PhD, Journal of the American Medical Association

"This book is written in a field in which few others compete; after reading it, it is difficult to imagine any other book that could. We are fortunate that such a constricted field of choice has produced a book outstanding in all respects."—Alfred O. Berg, MD, MPH, The Journal of Family Practice

"[An] impressive and excellent book. . . . [It] is a major contribution to the understanding of Taiwan's experience and of the development process generally."—Warren S. Hunsberger, Professor Emeritus of The American University

"It will be of wide interest to those keen to see advances in medical research applied to general medical practice."—Medical Book News