title: Federal human research oversight of clinical trials in the United States.
authors.affiliation: National Library of Medicine, National Institutes of Health, Bethesda, Maryland.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Zarin
authors.affiliation: National Library of Medicine, National Institutes of Health, Bethesda, Maryland.
authors.forename: Tony
authors.initials: T
authors.lastname: Tse
authors.affiliation: Office for Human Research Protections, Department of Health and Human Services, Rockville, Maryland.
authors.forename: Jerry
authors.initials: J
authors.lastname: Menikoff
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards* / Q000706:statistics & numerical data; D016208:Databases, Factual; D028744:Ethics Committees, Research; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D035842:Research Subjects; D014481:United States; D014486:United States Food and Drug Administration