The Oxford Textbook of Clinical Research Ethics

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Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David D. Wendler
Oxford University Press, Apr 18, 2008 - Medical - 848 pages
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The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
 

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Contents

Introduction
3
A Selected History of Research With Humans
7
Codes Declarations and Other Ethical Guidance for Research With Humans
121
Context Purpose and Value of Clinical Research
199
Scientic Design
243
Participant Selection
375
RiskBenet Assessments
501
Independent Review and Oversight
539
Informed Consent
589
Respect for Human Research Participants
671
Multinational Research
709
Clinical Investigator Behavior
745
Credits and Permissions
805
Index
809
Copyright

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About the author (2008)

Emanuel: Chair, Department of Bioethics, NIH. Grady: Department of Bioethics, NIH. Crouch: Poynter Center for the Study of Ethics, Indiana University. Lie: Department of Bioethics, NIH. Miller: Department of Bioethics, NIH. Wendler: Department of Bioethics, NIH

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