Clinical Research and the Law

Clinical Research and the Law By Patricia M. Tereskerz(auth.)
2012 | 269 Pages | ISBN: 1405195673 | PDF | 2 MB
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 careinformed consentconflicts of interestresearch contractsestablishing clinical trialsthe disclosure and withholding of clinical trial resultsClinical 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.Content: Chapter 1 Research Malpractice and Negligence (pages 1-22): Chapter 2 Duty of Care: Understanding the Legal Differences Between Medical Treatment and Medical Research (pages 23-31): Chapter 3 Establishing Standard of Care and Violation of Standard of Care (pages 33-36): Chapter 4 Informed Consent in Clinical Research (pages 37-53): Chapter 5 Liability Issues for Institutional Review Boards (IRBS) and Data Safety Monitoring Boards (DSMBS) (pages 55-63): Chapter 6 Legal Aspects of Financial Conflicts of Interest in Clinical Trials (pages 65-86): Chapter 7 Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study Results (pages 87-103): Chapter 8 Clinical Trials and Insider Trading (pages 105-115): Chapter 9 Clinical Trials and Criminal Law (pages 117-144): Chapter 10 Clinical Trial Contracts (pages 145-149):

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