title: Revolution or reform in human subjects research oversight.
abstract: The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
authors.affiliation: Harvard Medical School, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D003362:Cost-Benefit Analysis; D017598:Efficiency, Organizational; D028744:Ethics Committees, Research / Q000191:economics / Q000458:organization & administration*; D019983:Guideline Adherence / Q000191:economics / Q000458:organization & administration; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D017146:Models, Organizational; D014481:United States