title: Some reflections on evaluating institutional review board effectiveness.
abstract: Most commentators agree that it is important to conduct empirical research on the effectiveness of institutional review board (IRB) review and oversight but the studies that have been published so far do not directly address this question because they do not attempt to measure the impact of the IRB on the welfare or rights of human subjects. Additional studies on IRB composition, staffing, review times, consistency, and so forth will not yield that evidence that is needed to measure IRB effectiveness if they do not also collect data on the welfare and rights of human research subjects. Researchers should consider developing studies, such as randomized, controlled trials, or prospective, cohort designs, which directly measure IRB effectiveness. Such studies could yield information that will be invaluable in improving IRB review and oversight and protecting human research subjects.
authors.affiliation: National Institute of Environmental Health Sciences, National Institutes of Health, 111 Alexander Drive, Research Triangle Park, Box 12233, NC, 27709, United States. Electronic address: resnikd@niehs.nih.gov.
authors.forename: David B
authors.initials: DB
authors.lastname: Resnik
mesh_terms: D028744:Ethics Committees, Research / Q000458:organization & administration* / Q000592:standards; D006805:Human Experimentation / Q000941:ethics*; D006806:Human Rights; D006801:Humans; D064887:Observational Studies as Topic / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics
keywords: Effectiveness; Empirical research; Ethics; Institutional review boards; Oversight; Prospective cohort studies; Randomized controlled trials