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 | 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 |
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Common terms and phrases
accepted according action activities addition adequate Administration applicable appropriate approved authority behavior benefits Biomedical Board called Center Chapter clinical Commission committee competent concerned conducted confidentiality consent form consequences consider consideration course deception decision Department designed determine DHHS direct discussion disease drug effects ethical example expected experience federal fetus further harm Health Human Subjects Res identified important individual informed consent injury institution interests investigator issue judgment knowledge means meet necessary negotiations parents participation particular patients performed persons physician possible practice presented principles prisoners problems procedures proposed prospective subjects Protection protocol published reasons receive recommendations records regulations relationship Report research involving research subjects respect responsibility Rev Human Subjects risk role scientific social standard statement therapeutic therapy treatment trial types various
Bibliographic information
| Title | Ethics and Regulation of Clinical Research |
| Author | Robert J. Levine |
| Edition | illustrated, reprint |
| Publisher | Yale University Press, 1988 |
| ISBN | 0300042884, 9780300042887 |
| Length | 452 pages |
| Subjects | › Language Arts & Disciplines / Rhetoric |
| Export Citation | BiBTeX EndNote RefMan |