A delphi study to establish important aspects of ethics review.

Little research has been done to examine the cost-effectiveness of REC review, or the components of review that make the greatest contributions to the protection of human subjects. We describe a process used to obtain consensus on the important categories and outcomes of REC review using the Delphi method and an array of stakeholders in a limited domain of research (biomedical). Study participants recruited from the University of Michigan Medical School's RECs, REC council, and principal investigators identified the following six categories as being the most important aspects of REC review: (1) A favorable risk/benefit ratio; (2) minimization of risk to subjects; (3) clarity of consent; (4) protection of vulnerable populations; (5) protection of privacy and confidentiality; and (6) review time. We believe that this kind of information can be used to assist in the development of a metric to assess the effectiveness and efficiency of REC review in the various research domains.