Scott Burris J.D.

Director of the Center for Health Law, Policy and Practice
Beasley School of Law, School of Public Health
Temple University
Email: Discipline: Law Expertise: Civil Rights, Human Subjects Research

Investigator Award
Human Subjects Protection as Regulation: A Comparative, Empirical View
Award Year: 2001 Since 1991, most of the studies conducted on human subjects in U.S. research institutions have been regulated by the Department of Health and Human Services under Title 45, Part 46 of the Code of Federal Regulations, known as The Common Rule. Although the goal of protecting human research subjects is unquestionably valid, it is not clear that the regulatory approach codified in The Common Rule is the most sensible or effective option. This project will redefine the issues and propose effective and efficient regulation. Using implementation and socio-legal research methods, the investigators will consider how successfully the Rule works and how alternative approaches would provide improvement. They will examine the current system: the problem of harm and abuse in research, the costs and benefits of institutional review boards, and tools such as informed consent. In exploring alternatives, the investigators will consider other models of risk assessment and regulation as well as human subject protection systems in other countries.


Scott Burris is a professor in both the Beasley School of Law and the School of Public Health and the director of the Center for Health Law, Policy and Practice at Temple University. He began his career in public health law during the early days of the HIV/AIDS epidemic. He was the editor of the first systematic legal analysis of HIV in the United States, AIDS and the Law: A Guide for the Public (Yale University Press, 1987; New Guide for the Public published 1993), and spent several years lobbying and litigating on behalf of people with HIV as an attorney at the American Civil Liberties Union. Since joining the Temple faculty in 1991, his research has focused on how law influences public health [current research/interests] and health behavior. He is the author of over 100 books, book chapters, articles and reports on issues including discrimination against people with HIV and other disabilities; HIV policy; research ethics; and the health effects of criminal law and drug policy. His current research topics include health governance, the regulation of sexual behavior, harm reduction and human research subject protection. He has been particularly interested in developing theory and methods aimed at promoting effective local health governance. His work has been supported by organizations including the Robert Wood Johnson Foundation, the Open Society Institute, the National Institutes of Health and the Centers for Disease Control and Prevention. He has served as a consultant on public health law with organizations ranging from the United Nations Development Programme and the American Psychological Association to the Institute of Medicine and the producers of the Oscar-winning film Philadelphia. He is a member of the Law, Policy and Ethics Core of the Center for Interdiscplinary Research on AIDS at Yale, and serves as an advisor to the Tsinghua University AIDS Institute, the Shanghai Academy of Social Sciences Research Center for HIV/AIDS Public Policy and the Program in Bioethics at Monash University. Burris is a graduate of Washington University in St. Louis and the Yale Law School.