The Oxford Textbook of Clinical Research Ethics [Hardcover]

Ezekiel J. Emanuel (Editor), Christine Grady (Editor), Robert A. Crouch (Editor), Reidar Lie (Editor), Franklin Miller (Editor), David Wendler (Editor)

Book Description

Publication Date: April 18, 2008 | ISBN-10: 0195168658 | ISBN-13: 978-0195168655 | Edition: 1

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.

Editorial Reviews

Review

Its excellent articles cover almost all historical, conceptual, and empirical topics of clinical research ethics in a comprehensive and systematic synthesis...not only an excellent resource for training researchers and members of research review committees. Beyond that, it is an essential reading and a very valuable source for anybody working on and interested in research ethics. Medical Health Care and Philosophy ...provides scholarly, well-referenced analyses of different points of view on many of the challenging issues confronting clinical trial ethics. The Lancet This is an excellent and comprehensive compedium of scholarship, novel research, practical advice, and dependable reference. The chapters dedicated to international research ethics and disparities in research are prescient of the foci that the field will have to embrace in the near future. The book's inclusive and broad focus makes it a worthwhile investment as it will remain useful for some time to come. Doody's Notes

About the Author

Ezekiel J. Emanuel is Chair of the Department of Bioethics at the National Institutes of Health.

Christine Grady is Head of the Section on Human Subjects Research at the Department of Bioethics at the National Institutes of Health.

Robert A. Crouch is at The Poynter Center for the Study of Ethics and American Institutions at Indiana University.

Reidar K. Lie is Head of International Programs in the Department of Bioethics at the National Institutes of Health.

Franklin G. Miller is on the faculty of the Department of Bioethics at the National Institutes of Health.

David Wendler is Head of the Unit on Vulnerable Populations in the Department of Bioethics at the National Institutes of Health.

Product Details

• Hardcover: 848 pages
• Publisher: Oxford University Press, USA; 1 edition (April 18, 2008)
• Language: English
• ISBN-10: 0195168658
• ISBN-13: 978-0195168655
• Product Dimensions: 11.1 x 8.7 x 1.9 inches
• Shipping Weight: 4.6 pounds (View shipping rates and policies)
• Average Customer Review: 3.7 out of 5 stars  See all reviews (3 customer reviews)
• Amazon Best Sellers Rank: #436,769 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

0 of 1 people found the following review helpful:

5.0 out of 5 stars Emanuel, September 16, 2010

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D. Thompson - See all my reviews
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This review is from: The Oxford Textbook of Clinical Research Ethics (Hardcover)

Excellent book covering the ethics that are part of the clinical research process. Similar to the previous book by the authors, but much better organized and better written.

1 of 3 people found the following review helpful:

1.0 out of 5 stars Good for federally funded research, not for pharma or device, February 14, 2010

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GeoBadge "GeoBadge" (PA, USA) - See all my reviews

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This review is from: The Oxford Textbook of Clinical Research Ethics (Hardcover)

This book is okay for a class for NIH / federally funded research, but it is certainly not a comprehensive guide to the research.

Pharmaceutical or device research are almost entirely neglected. The book works pretty much exclusively in 45 CFR 46 and rarely touches anything in 21 CFR or FDA-regulated research (except for one short chapter). Additionally, the authors critique the regulations, but never give the reader an opportunity to read them for themselves. In my opinion, no amount of education or critiques could ever substitute actually reading the regulations themselves and this book neglected even including a passage or appendix with the federal regulations. I also feel the book showed clear bias on the side for federally funded research and painted for-profit (pharma/device) research in a negative fashion and, on occasion, included misleading and incorrect information. The book is approachable on a college or graduate level and covers a wide range of topics, if you are only considering NIH-style research and you are willing to put its biased view of for-profit industry aside.

The book arrived quickly and in perfect condition. The book quality is rather low. It does not use any color and the few images included are of a low quality. The paper is thin and transparent which makes highlighting and underlining unadvisable.

0 of 2 people found the following review helpful:

5.0 out of 5 stars Professional Review Outstanding, June 21, 2010

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Bruce A. Agnew "i" (Bethesda, Maryland United States) - See all my reviews
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This review is from: The Oxford Textbook of Clinical Research Ethics (Hardcover)

A book review in the New England Journal of Medicine for Aug. 28, 2008, called this textbook "a gem"...."an accessible synthesis and discussion of the many facets of research ethics"...."a resource suitable for a course in research ethics [that] would also be helpful for those starting a career in clinical research." The review -- by Gary L. Chadwick, Pharm.D., M.P.H., of the University of Rochester (NY) -- also said, "This book supports physicians who seek to perform real-world research in the most ethical way," and that "readers will gain a better understanding of complex issues, which will hold them in good stread in discussions with peers, with research subjects, and with people thinking of becoming participants in clinical research." In addition to which, said the New England Journal review, "The writing is consistently top-drawer." This reader concurs.