PURPOSE: To examine Department of Corrections (DOC) policies prohibiting prisoner participation in research studies and to assess the variables associated with state policies and practices relating to access by inmates in U.S. prisons to HIV-related clinical studies and experimental therapies. METHODS: A telephone survey conducted in 1994-95 of DOC medical directors from 32 states throughout the United States to obtain information about state DOC policies and practices relating to HIV clinical studies. RESULTS: State policies governing prisoner participation in clinical trials and access to new therapies vary widely. States with high AIDS incidence rates, a large number of AIDS-related deaths in prison, and high concentrations of minorities in the correctional system were more likely to allow prisoners to enroll in clinical studies and to receive experimental medications. Overall, a relatively small number of prisoners in state prisons have enrolled in clinical studies. Participation of a prison representative on the board reviewing a clinical study was identified as an important factor in allowing prisoner participation in studies. CONCLUSIONS: Barriers to prisoner participation in clinical studies are numerous but not insurmountable. Results from this study have led to efforts in Minnesota to revise current policy in order to permit prisoner participation in studies if appropriate guidelines are followed.
PURPOSE: To examine Department of Corrections (DOC) policies prohibiting prisoner participation in research studies and to assess the variables associated with state policies and practices relating to access by inmates in U.S. prisons to HIV-related clinical studies and experimental therapies. METHODS: A telephone survey conducted in 1994-95 of DOC medical directors from 32 states throughout the United States to obtain information about state DOC policies and practices relating to HIV clinical studies. RESULTS: State policies governing prisoner participation in clinical trials and access to new therapies vary widely. States with high AIDS incidence rates, a large number of AIDS-related deaths in prison, and high concentrations of minorities in the correctional system were more likely to allow prisoners to enroll in clinical studies and to receive experimental medications. Overall, a relatively small number of prisoners in state prisons have enrolled in clinical studies. Participation of a prison representative on the board reviewing a clinical study was identified as an important factor in allowing prisoner participation in studies. CONCLUSIONS: Barriers to prisoner participation in clinical studies are numerous but not insurmountable. Results from this study have led to efforts in Minnesota to revise current policy in order to permit prisoner participation in studies if appropriate guidelines are followed.
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Keywords:
Biomedical and Behavioral Research; DHHS Guidelines; Empirical Approach; Health Care and Public Health