Human Subjects Protection as Regulation: A Comparative, Empirical View

Award Year:
Scott Burris, Zita Lazzarini
Human Subjects Research
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.