esearch involving human subjects in the United States and many other countries is subjected to rigorous ethical review. While the system of regulation and review of research is generally believed to be valuable in ensuring respectful treatment of volunteers, little research has been conducted on the process itself. Despite its significant costs (in both dollars and in faculty and staff time), it is unknown which elements of ethical review of research perform as intended and whether their benefits exceed their costs. The faculty working group on Research on Research Ethics will examine the prospects for a Harvard-based research program that would assess this process by investigating and evaluating the principal features of ethical review. The research program would be a collaboration among three categories of Harvard faculty and staff:

• Faculty conducting research in ethics and health

• Health researchers willing to permit the ethics faculty to test hypotheses about the effects and efficacy of ethical review procedures and requirements in the context of their ongoing projects.

• Staff members of Harvard human subjects committees, both to work with the investigators to ensure that their research proposals were themselves compliant with human subjects regulations and, on occasion, as co-investigators.

A program of research on research ethics and regulation, perhaps linked to colleagues elsewhere and to such agencies as the Office of Human Research Protections and the World Health Organization, would attempt to improve the empirical and conceptual basis for ethical review and regulation of health research. Its research would seek to sort those ethical review practices that are worth their cost from those that are not, and to identify ways of improving the performance of Institutional Review Boards.

Harvard faculty interested in attending meetings of this group may contact Professor Dan Wikler (wikler@hsph.harvard.edu).