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Clinical Research and the Law

Book Hero Magic crafted this summary to help describe this book. While it's new and still learning, it may not be perfect - your feedback is welcome! Summary
Clinical Research and the Law guides readers through the increasingly complex legal landscape surrounding clinical research and trials. It addresses essential topics such as standards of care, conflicts of interest, informed consent, research contracts, and the disclosure of trial results. This practical guide helps clinical investigators, institutional risk managers, research administrators, and healthcare professionals navigate legal compliance to avoid pitfalls in medical research.
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Format: Paperback / softback
$14099
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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 is ideal for clinical investigators, institutional administrators, healthcare and risk managers, members of institutional review boards, medical students, postgraduate research scholars, and legal professionals involved in hospital or clinical research settings.

Book Hero thinking about your next read

This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research.

Book Hero Magic formatted this description to make it easier to read. While it's new and still learning, it may not be perfect - your feedback is welcome! Description

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.

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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

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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