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. The book is organized around the federal regulations; their application frequently requires interpretation and judgment. Levine explains the regulations and provides accounts of their history, their foundation in ethics and public policy, and their uncertainties.
New in this edition are sections on academic misconduct, research on diseases with anticipated permanent incompetence (eg, Alzheimer's), research on the fetus, and in vitro fertilization. Other chapters are updated and expanded. The first edition made extensive use of the reports of the National
Miller BL. Ethics and Regulation of Clinical Research. JAMA. 1989;261(23):3479–3480. doi:10.1001/jama.1989.03420230133044
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