U. S. Health Researchers Review their Ethics Review Boards: A Qualitative Study

Abstract

VIRTUALLY ALL RESEARCH INVOLVING HUMAN subjects in the United States must be reviewed by an institutional review board, a form of research ethics review board. This article reports the results of qualitative research on how investigators regard this regulatory regime. Interviews were conducted with forty investigators conducting health-related research. Most respondents shared the regulations' goals, but doubted that the regulations, as implemented, promoted these goals efficiently, effectively and fairly. The interviews suggest that efforts to raise researchers' ethical consciousness have been, over time, quite successful, but that implementation of the regulations remains problematic. Research aimed at better defining the problem to be solved b y the r egulatory sy stem, and at a ssessing the effectiveness of the regulatory tools for solving properly defined problems, could guide a more productive debate about human subject protection.