The structure and functioning of ethical review committees.

Abstract

This overview of ethics committees for biomedical and behavioral research considers principal issues in the role and operation of these committees in various countries. It suggests general guidelines derived from a literature review and from a survey of existing committees by the Council for International Organizations of Medical Sciences. Aspects of present practice discussed are the governance and authority of ethics committees, the scope of activities subject to review, committee size and composition, and special concerns in review. These concerns include informed consent, risk/benefit assessment, qualifications of investigators, research design, selection of subjects, privacy, and compensation for injury.