Clinical Research and the Law

Informationen zum Autor Patricia M. Tereskerz Associate Professor and Director, Program in Ethics and Policy in Healthcare, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, VA, USA Klappentext 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 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. Zusammenfassung This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. Inhaltsverzeichnis Preface, ix Chapter 1: Research malpractice and negligence, 1 1.1 Background, 1 1.2 Drugs: brief description of definitions, 4 1.3 Brief overview: conduct of clinical trials, 5 1.4 Medical devices, 6 1.5 Research malpractice: the basics, 7 1.6 Negligence actions and research: interesting aspects of medical research negligence cases, 8 Chapter 2: Duty of care: understanding the legal differences between medical treatment and medical research, 23 2.1 Establishing duty of care, 23 2.2 Do sponsors have a legal duty?, 27 Chapter 3: Establishing standard of care and violation of standard of care, 33 3.1 Research malpractice and using expert testimony to establish the standard of care, 34 3.2 Lessons learned from surgical innovation cases, 35 3.3 Standard of care and informed consent cases, 36 Chapter 4: Informed consent in clinical research, 37 4.1 Basics on informed consent in the clinical treatment setting: background, 37 4.2 Informed consent as applied to the research setting, 40 4.3 Informed consent and federal regulations, 42 4.4 Case law and federal regulations, 43 4.5 Clinical trials and pediatric patients, 46 Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs), 55 5.1 Liability for negligence, 56 5.2 Standard of care, 57 5.3 Proximate cause and damages, 59 5.4 Defense, 60 5.5 Practical considerations: the need for indemnification, 62 5.6 Special considerations for DSMBs, 62 Chapter 6: Legal aspects of financial conflicts of interest in clinical trials, 65 6.1 Overview, 66 6.2 Legislative background: road to creating financial conflicts of interest, 68 6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic, 69 6.4 Regulations/legislation, 70 6.5 Litigation involving financial conflicts of interest in clinical trials, 74 6.6 Applying novel legal theories to financial conflicts of interest cases, 79 6.7 Other clinical trial cases involving fina...

List of contents

Preface
 
Chapter One: Research Malpractice & Negligence
 
Chapter Two: Duty of Care: Understanding the Legal
 
Differences Between Medical Treatment and Medical Research
 
Chapter Three: Establishing Standard of Care & Violation of Standard of Care
 
Chapter Four: Informed Consent in Clinical Research
 
Chapter Five: Liability Issues for Institutional Review
 
Boards (IRB's) and Data Safety Monitoring Boards (DSMB's)
 
Chapter Six: Legal Aspects of Financial Conflicts of Interest in Clinical Trials
 
Chapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study Results
 
Chapter Eight: Clinical Trials & Insider Trading
 
Chapter Nine: Clinical Trials and Criminal Law
 
Chapter Ten: Clinical Trial Contracts
 
Appendix A Glossary
 
Appendix B NIH Policy on Inclusion of Children as Participants in Research Involving Human Subjects
 
Appendix C Best Pharmaceuticals for Children Act p>Appendix D Pediatric Research Equity Act 2003
 
Appendix E Code of Federal Regulations Title 21
 
Appendix F NCI model contract
 
Appendix G Conflicts of Interest
 
Index

Report

"Clinical Research and the Law" provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation." ( Journal of Clinical Research Best Practices , 1 October 2012)

Product details

• Authors: Patricia M Tereskerz, Patricia M. Tereskerz, Patricia M. (Associate Professor Tereskerz, Patricia. M Tereskerz, Pm Tereskerz
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Paperback / Softback
• Released: 19.04.2012
• EAN: 9781405195676
• ISBN: 978-1-4051-9567-6
• No. of pages: 280
• Subjects: Natural sciences, medicine, IT, technology > Medicine > General; Social sciences, law, business > Law > Labour law, social law; Medizin, Medizin /Recht, Medical Science, Medizinrecht u. Ethik, Medical Law & Ethics