title: IRB/FDA requirements relevant to HIV/AIDS clinical trials in correctional settings.
abstract: Federally funded research involving inmates in US correctional facilities requires the approval of the Office for Protection from Research Risks (now called the Office for Human Research Protections [OHRP] and located in the Office of the Secretary of the Department of Health and Human Services). Trials that are carried out by pharmaceutical companies (not federally funded) fall under the jurisdiction of the FDA. This article reviews OHRP and FDA guidelines relevant to the conduct of HIV/AIDS clinical trials in correctional settings.
authors.affiliation: Division of Human Subject Protection, Office for Human Research Protections, Department of Health and Human Services, Rockville, Md., USA.
authors.forename: J
authors.initials: J
authors.lastname: Cohen
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D015658:HIV Infections / Q000188:drug therapy*; D006805:Human Experimentation; D006801:Humans; D011329:Prisoners; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*