Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research.

The procedural requirements of the U.S. federal regulations designed to protect human subjects are now well institutionalized.' These requirements include the mandate that an Institutional Review Board (IRB) review and approve research studies before investigators recruit individuals for, and enroll them in, their studies. Over the last decade, lapses in compliance with various regulatory provisions and the highly publicized deaths of a few research subjects resulted in federal regulators temporarily suspending human subjects research at major academic medical centers. In addition to the regulatory action, investigations by several national advisory bodies raised questions about whether IRBs can adequately protect individuals who participate in research. Several reports concluded that the IRB system is in need of reform and made numerous recommendations-from global restructuring of the entire IRB system to tinkering with components of the administrative review process.2 Yet there is no empirical evidence that the enhancement of regulatory compliance will improve the ethical quality of the IRB oversight system. Indeed, procedural compliance may inadvertently divert an IRB's attention from its assessment of the ethics of the human subjects research under review. Although attention to regulatory compliance is necessary, a robust measure does not yet exist for determining whether IRB review of proposed research achieves the ethical goals of research review derived from the Belmont Report3-protecting the welfare of subjects, promoting respect, and attending to justice in human research. An effort to develop such a measure should be initiated. A measure of ethical quality would be valuable to human subjects protection programs, social scientists, and public agencies interested in enhancing the IRB review process. Finally-and perhaps most importantly in terms of the impact of this proposal on public policy-the swing toward regulatory compliance among IRB