Clinical Research and the Law PDF

Rating: Author: Patricia M. Tereskerz ISBN : 9781405195676 New from $61.02 Format: PDF

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This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.

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• Product Details
• Table of Contents
• Reviews

• Paperback: 280 pages
• Publisher: Wiley-Blackwell; 1 edition (May 7, 2012)
• Language: English
• ISBN-10: 1405195673
• ISBN-13: 978-1405195676
• Product Dimensions: 0.6 x 5.5 x 8.5 inches
• Shipping Weight: 11.4 ounces (View shipping rates and policies)

Clinical Research and the Law PDF

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
• informed consent
• conflicts of interest
• research contracts
• establishing clinical trials
• the disclosure and withholding of clinical trial results

Clinical Research and the Law comprehensively discusses these topics and provides the 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 counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.