Clinical Research and the Law

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 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.

Author Biography

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.