title: FDA seeks tighter controls over research with human subjects.
abstract: 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.
authors.forename: N
authors.initials: N
authors.lastname: Hershey
authors.forename: R D
authors.initials: RD
authors.lastname: Miller
mesh_terms: 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