The IRB as deputy sheriff: proposed FDA regulation of the institutional review board.
D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D011367:Professional Staff Committees / Q000331:legislation & jurisprudence*; D012106:Research / Q000592:standards*; D012449:Safety; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration