Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

by Robert A. Crouch (Editor), Ezekiel J. Emanuel (Editor), John D. Arras (Editor)

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.

528 pages, Paperback

First published September 30, 2003

Reviews

[loafingcactus]

The book consists entirely of primary sources from the history of medical research ethics. I can't imagine why anyone would use a different book for training in research ethics.