Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary [Paperback]

Ezekiel J. Emanuel (Editor), Robert A. Crouch (Editor), John D. Arras (Editor), Jonathan D. Moreno (Editor), Christine Grady (Editor)

Book Description

ISBN-10: 0801878136 | ISBN-13: 978-0801878138 | Publication Date: September 30, 2003 | Edition: 1

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 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.

Editorial Reviews

Review

Provides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of literature included. A lot of information is made available at a very affordable price.

(Quality Assurance Journal 2005)

Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics.

(Leonardo D. de Castro Bulletin of the World Health Organization 2004)

One word will suffice to describe the book—outstanding.

(Sanjay A. Pai Current Science 2004)

About the Author

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.

Product Details

• Paperback: 528 pages
• Publisher: The Johns Hopkins University Press; 1 edition (September 30, 2003)
• Language: English
• ISBN-10: 0801878136
• ISBN-13: 978-0801878138
• Product Dimensions: 10.9 x 8.5 x 1.2 inches
• Shipping Weight: 3.2 pounds (View shipping rates and policies)
• Average Customer Review: 5.0 out of 5 stars  See all reviews (3 customer reviews)
• Amazon Best Sellers Rank: #176,440 in Books (See Top 100 in Books)

More About the Author

See Jonathan's website at wwwjonathandmoreno.com.

Jonathan D. Moreno is one of thirteen Penn Integrates Knowledge university professors at the University of Pennsylvania, holding the David and Lyn Silfen chair. He is also Professor of Medical Ethics and Health Policy, of History and Sociology of Science, and of Philosophy. In 2008-09 he served as a member of President Barack Obama's transition team.

Moreno is an elected member of the Institute of Medicine of the National Academy of Sciences and is a National Associate of the National Research Council. He has served as a senior staff member for three presidential advisory commissions, including the current bioethics commission under President Obama, and has given invited testimony for both houses of congress. He was an Andrew W. Mellon post doctoral fellow, holds an honorary doctorate from Hofstra University, and is a recipient of the Benjamin Rush Medal from the College of William and Mary Law School.

Moreno is a Senior Fellow at the Center for American Progress in Washington, DC, where he edits the magazine Science Progress (www.scienceprogress.org). Moreno has served as adviser to many non-governmental organizations, including the Howard Hughes Medical Institute and the Bill and Melinda Gates Foundation. He is a member of the Governing Board of the International Neuroethics Society, a Faculty Affiliate of the Kennedy Institute of Ethics at Georgetown University, a Fellow of the Hastings Center and the New York Academy of Medicine, and a past president of the American Society for Bioethics and Humanities. He advises various science, health, and national security agencies and serves as a member of the Defense Intelligence Agency's TIGER committee on potentially disruptive novel technologies.

Kirkus Reviews said that Moreno's new book, The Body Politic: "illuminates intricate threads of history and complex philosophical arguments. Patient general readers, as well as scholars and students of bioethics, will benefit from Moreno's erudition and fairness...." Publisher's Weekly called it "[a]n important analysis of the societal currents swirling around volatile scientific issues . . . Moreno delivers a powerful defense of science [and] respects his readers' intelligence in this nuanced and thoughtful book." JAMA described Progress in Bioethics (2010) as "provocative and stimulating." Publisher's Weekly said that his book Science Next (2009) "brings hope into focus with reports of innovation that will enhance lives." The journal Nature called Mind Wars: Brain Research and National Defense (2006), "fascinating and sometimes unsettling." The New York Times said that Undue Risk: Secret State Experiments on Humans (1999) was "an earnest and chilling account." His other books include Ethical Guidelines for Innovative Surgery (2006); Is There an Ethicist in the House? (2005); In the Wake of Terror: Medicine and Morality in a Time of Crisis (2003); Ethical and Regulatory Aspects of Clinical Research (2003); Deciding Together: Bioethics and Moral Consensus (1995); Ethics in Clinical Practice (2000); and Arguing Euthanasia (1995). Moreno has published about 300 papers, reviews and book chapters, and is a member of several editorial boards.

Customer Reviews

Most Helpful Customer Reviews

5.0 out of 5 stars Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, August 30, 2011

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American Express "Matts" (Canada) - See all my reviews
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This review is from: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Paperback)

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, is a brilliantly written book. It is so, even for people new to clinical trials like me. As a masters student, I love the many scenarios it presents. It captures the many biomedical ethical situations in a succinct and comprehensive way.

Bioethics is a very dynamic/ever changing field. This book stimulates you to think about that which you might not have thought of and enables you to acquire transferable knowledge to address many other scenarios in an equally brilliant way.

Thanks Ezikiel et al :)

Mugala
MSc in Clinical Research Programme

1 of 2 people found the following review helpful:

5.0 out of 5 stars Very informative, January 10, 2007

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Byung Mook LIM - See all my reviews
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This review is from: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Paperback)

This book is an excellent textbook for bioethics with wonderful framework, comprehensive approach, and many relevant articles.
You can get overall outline and detailed information & discussion on bioethics by this book, therefore this book is good for beginner as well as for expert on this field.

1 of 3 people found the following review helpful:

5.0 out of 5 stars Excellent Reference, February 13, 2008

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Danethic (Lakeland, FL) - See all my reviews

This review is from: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Paperback)

This book is a great resource and reference. It's a great collection of short articles useful for those interested in the ethical issues surrounding research. It has full copies of the Nuremberg and other ethical codes.