Ethics and Regulation of Clinical ResearchThe 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 |
Ethical Norms and Procedures | 19 |
Balance of Harms and Benefits | 37 |
Selection of Subjects 5595 | 67 |
Informed Consent | 102 |
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 | 335 |
Department of Health and Human Services Rules and Regulations | 393 |
Food and Drug Administration Rules and Regulations | 413 |
World Medical Association Declaration of Helsinki | 427 |
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Common terms and phrases
appropriate approved authority Behavioral Research Belmont Report benefits Biomedical and Behavioral Chapter Clin Res clinical research Clinical Trials Commission's committee conducted confidentiality consent form consider deception decision Declaration of Helsinki determine DHEW DHEW Publication DHHS discussion disease effects elements of informed embryos evaluate example experimental federal fetal research fetus harm Hastings Center Rept Health Human Subjects Res identified individual informed consent injury Institutional Review Board institutionalized as mentally investigator involving human subjects IRB members IRB review jects judgment justified Levine Medicine mentally infirm minimal risk negotiations nonvalidated Nuremberg Code participation in research patients persons physician placebo practice presented President's Commission problems procedures proposed prospective subjects Protection of Human protocol purpose reasons recommendations Report research involving human research subjects responsibility Rev Human Subjects role scientific social specific standard Subjects of Biomedical Subpart therapeutic therapy treatment Vitro Fertilization vulnerable