Clinical Research and the Law

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.

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