Ethical and Regulatory Aspects of Clinical Research
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Ethical and Regulatory Aspects of Clinical Research by Ezekiel J. Emanuel
Book DescriptionAll 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 process: 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.
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Book DetailsISBN: 9780801878138
(280mm x 216mm x 31mm)
Imprint: Johns Hopkins University Press
Publisher: Johns Hopkins University Press
Publish Date: 1-Jan-2004
Country of Publication: United States
Books By Author Ezekiel J. Emanuel
Oxford Textbook of Clinical Research Ethics, Paperback (February 2011)
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics.
Exploitation and Developing Countries, Paperback (August 2008)» View all books by Ezekiel J. Emanuel
Exploitation is a concept in ordinary moral thought that has not often been analyzed outside the Marxist tradition. This work reflects on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation.
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Author Biography - Ezekiel J. Emanuel
Ezekiel J. Emanuel, M.D., Ph.D., is Chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center at the National Institutes of Health. Robert A. Crouch, M.A., is an Assistant Professor in the Biomedical Ethics Unit and the Department of Social Studies of Medicine at McGill University. John D. Arras, Ph.D., is Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia. Jonathan D. Moreno, Ph.D., is Director of the Center for Biomedical Ethics at the University of Virginia. Christine Grady, R.N., Ph.D., is Head, Section on Human Subjects Research in the Department of Clinical Bioethics at the National Institutes of Health.
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