title: Protecting research subjects--what must be done.
authors.affiliation: Department of Health and Human Services, Washington, DC 20201, USA.
authors.forename: D
authors.initials: D
authors.lastname: Shalala
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D015316:Genetic Therapy / Q000331:legislation & jurisprudence / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D009316:National Institutes of Health (U.S.); D018579:Patient Selection; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration