Ethics and Regulation of Clinical Research

Description

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 Contents Preface To The First Edition Preface To The Second Edition Acknowledgments Chapter 1. Basic Concepts And Definitions Chapter 2. Ethical Norms And Procedures Chapter 3. Balance Of Harms And Benefits Chapter 4. Selection Of Subjects Chapter 5. Informed Consent Chapter 6. Compensation For Research-Induced Injury Chapter 7. Privacy And Confidentiality Chapter 8. Randomized Clinical Trials Chapter 9. Deception Chapter 10. Children Chapter 11. Those Institutionalized As Mentally Infirm Chapter 12. Prisoners Chapter 13. The Fetus And The Embryo Chapter 14. The Institutional Review Board References Appendix 1: Department Of Health And Human Services Rules And Regulations Appendix 2: Food And Drug Administration Rules And Regulations Appendix 3: The Nuremberg Code Appendix 4: World Medical Association Declaration Of Helsinki Appendix 5: Leo Szilard's Ten Commandments Index