Prisoners' access to HIV experimental trials: legal, ethical, and practical considerations.
Much confusion exists about federal regulations governing the enrollment of prisoners in experimental clinical trials. Given the high prevalence of HIV infection in certain incarcerated populations, the issues surrounding clinical trials need clarification. A review of the history of prisoners as human subjects and current federal regulations regarding research on prisoners is provided. Experience at two New York State Designated AIDS Centers with inmates and experimental drug trials is described. Guidelines for enrollment of inmates in clinical trials are presented.
Potler
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New York City Board of Correction, New York 10007.
Sharp
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VL
Remick
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S
D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D015507:Drugs, Investigational; D035082:Federal Government; D033161:Government Regulation; D015658:HIV Infections / Q000628:therapy*; D006297:Health Services Accessibility; D006805:Human Experimentation; D006806:Human Rights; D006801:Humans; D009518:New York; D011329:Prisoners; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence
D015507:Drugs, Investigational