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.