A review of the legal and ethical issues for the conduct of HIV-related research in prisons.

This article sets the stage for future discussions of expanding prisoners' access to clinical trials in an effort to move from commentary and recommendations to changes in practice. It describes barriers to access to clinical trials, the demographics of HIV/AIDS in prisons, the unique situation posed by the potential for HIV-related research in prisons, and examines briefly the history of prisoner research in the U.S. The article considers both ethical and legal responses to clinical trials in prisons, noting the potential for and limitations of legal actions. Finally, it makes recommendations for conditions necessary to conduct ethical research in prisons and calls for more cooperation between prison systems and HIV/AIDS clinical trials researchers to make expanded access to clinical trials a reality.