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 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.

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

Patricia M. Tereskerz, JD, Ph.D. Associate Professor, Research Director, Program in Ethics & Policy
Patti Tereskerz joined the University of Virginia Center for Biomedical Ethics in the fall of 2001. She is Director of the Program in Ethics and Policy at the Center and chairs the Conflicts of Interest Committee for the University. Previously she served as Assistant Professor of Internal Medicine and Director of Health Law and Policy at the University′s International Healthcare Worker Safety Center, where she was a recipient of the AORN Journal′s Excellence in Research Award. Prior to joining the faculty of the Medical School, Tereskerz practiced law with Buck, Hogshire & Tereskerz, Ltd., in Charlottesville, and remains of counsel with the firm, now Buck, Toscano &Tereskerz, Ltd. Tereskerz has many publications in areas of both law and medical research, some of which have appeared in the New England Journal of Medicine, the Journal of the American Medical Association (JAMA), and the Milbank Quarterly (See attached CV). She and a colleague have recently published several articles on patent law and proposed patent reform, including two which appeared in Nature Biotechnology and another article is forthcoming in Nature Biotechnology in September. She is also author of a published handbook on needlestick injuries and the law, and is co–author of a book on the prevention and management of occupational exposure to HIV. She has served on various editorial boards.

  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)