Clinical Research and the Law
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Clinical Research and the Law
Book Hero Magic created this recommendation. While it's new and still learning, it may not be perfect - your feedback is welcome! IS THIS YOUR NEXT READ?
This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research.
Clinical Research and the Law
The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent, and researchers need to ensure current compliance on a wide range of issues, including:
- standards and duty of care
- conflicts of interest
- establishing clinical trials
- informed consent
- research contracts
- the disclosure and withholding of clinical trial results
Clinical Research and the Law comprehensively discusses these topics and provides answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards.
This book is also a key resource for medical students, postgraduate research students, practicing attorneys, and counsellors for teaching hospitals and institutions undertaking clinical research and contract research organisations.
Book Hero Magic summarised reviews for this book. While it's new and still learning, it may not be perfect - your feedback is welcome! HOW HAS THIS BEEN REVIEWED?
The Journal of Clinical Research Best Practices praises the book for delivering thoughtful and practical information on a broad range of legal issues related to clinical research, particularly focusing on subject injury liability. It is noted as especially useful for those without expert legal backgrounds, offering numerous citations for deeper investigation.
Book Details
INFORMATION
ISBN: 9781405195676
Publisher: John Wiley and Sons Ltd
Format: Paperback / softback
Date Published: 19 April 2012
Country: United Kingdom
Imprint: Wiley-Blackwell
Audience: Professional and scholarly
DIMENSIONS
Spine width: 14.0mm
Width: 140.0mm
Height: 216.0mm
Weight: 304g
Pages: 288
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About the Author
Patricia M. Tereskerz, JD, Ph.D. Associate Professor,Research Director, Program in Ethics & Policy Patti Tereskerz joined the University of Virginia Center forBiomedical Ethics in the fall of 2001. She is Director of theProgram in Ethics and Policy at the Center and chairs the Conflictsof Interest Committee for the University. Previously she served asAssistant Professor of Internal Medicine and Director of Health Lawand Policy at the University's International Healthcare WorkerSafety Center, where she was a recipient of the AORNJournal's Excellence in Research Award. Prior to joining thefaculty of the Medical School, Tereskerz practiced law with Buck,Hogshire & Tereskerz, Ltd., in Charlottesville, and remains ofcounsel with the firm, now Buck, Toscano &Tereskerz, Ltd.Tereskerz has many publications in areas of both law and medicalresearch, some of which have appeared in the New England Journalof Medicine, the Journal of the American Medical Association(JAMA), and the Milbank Quarterly (See attached CV). Sheand a colleague have recently published several articles on patentlaw and proposed patent reform, including two which appeared inNature Biotechnology and another article is forthcoming in NatureBiotechnology in September. She is also author of a publishedhandbook on needlestick injuries and the law, and is co-author of abook on the prevention and management of occupational exposure toHIV. She has served on various editorial boards.
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