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Clinical and Epidemiologic Research on HIV Infection and AIDS Among Correctional Inmates

Regulations, Ethics, and Procedures

Abt Associates Inc.

Nancy Neveloff Dubler

Montefiore Medical Center/The Albert Einstein College of Medicine

A long history of abuse led the U.S. government, in 1983, to promulgate extremely stringent regulations regarding use of prisoners in biomedical and behavioral research. These regulations have virtually eliminated such research among prisoners. The HIV epidemic has brought these issues alive again in a new light. Over 5,000 cases of AIDS have been reported among U.S. correctional inmates. Yet prisoners have been virtually excluded from clinical trials of experimental HIV therapces. This article reviews two major types of HIV-related research among prisoners: (a) blinded epidemiologic studies of HIV seroprevalence and transmission based on antibody tests, and (b) participation of prisoners in clinical trials of HIV therapies. The authors argue that epidemiologic studies produce sufficiently useful information to be permitted subject to Institutional Review Board approval and with careful attention to confidentiality protections. With regard to clinical trials, the article contends that prisoners should have access to Phase II and III (efficacy) trials without placebo arms, but should not be permitted to participate in Phase I (safety) trials. The argument is that, although there are serious concerns regarding confiden tiality and potential discrimination, prisoners should have the right to make their own decisions about participation in trials. It is indefensible to deny them opportunities to receive potentially efficacious medications.

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