FDA seeks tighter controls over research with human subjects.
The Food and Drug Administration and other federal agencies have proposed or adopted regulations for institutions involved in research with human subjects. As a consequence, institutional review boards (IRBs) are becoming a necessity in many hospitals that did not previously need them. Unfortunately, the various requirements, especially those proposed by the FDA, imposed upon IRBs often make compliance for hospitals a complex undertaking.
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D028741:Ethics Committees, Clinical; D028744:Ethics Committees, Research; D005161:Facility Regulation and Control; D035082:Federal Government; D033161:Government Regulation; D006739:Hospital Administration / Q000331:legislation & jurisprudence*; D006805:Human Experimentation; D006801:Humans; D008499:Medical Records; D008505:Medical Staff, Hospital / Q000331:legislation & jurisprudence; D011367:Professional Staff Committees; D012106:Research; D014481:United States; D014486:United States Food and Drug Administration