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13th International AIDS ConferenceDurban, South Africa - July 9-July 14, 2000 |
Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrA601)
Lazzarini Z, Altice FL
Z. Lazzarini, University of Connecticut Health Center, Department of Community Medicine, 263 Farmington Ave. MC-6325, Farmington, CT 06030-6325, United States, Tel.: +860-679-5494, Fax: +860-679-5463, E-mail: lazzarini@nso.uchc.edu
ISSUES: Historically, human experimentation often led to exploitation of prisoners. Modern human subjects regulations in the United States (U.S.) sharply restrict medical research involving prisoners. Banning prisoners from all clinical trials, however, represents a denial of possible benefits for some prisoners, especially in rapidly advancing areas such as HIV care.
DESCRIPTION: The project considered the legal and ethical issues raised by permitting prisoners to participate in HIV clinical trials and made preliminary recommendations for changes in the regulatory system to promote ethical research.
CONCLUSIONS: In the U.S., laws and regulations completely ban research involving prisoners in federal prisons and some states. In other jurisdictions serious concerns include how poor prison conditions and the inherently coercive nature of prison life conflict with basic tenets of human subjects research, particularly that human subjects' participation must be wholly voluntary and free from conditions of undue influence or coercion. Preliminary recommendations include, legal and regulatory changes to permit prisoner participation under specific conditions: 1) improved oversight of research including site-specific evaluation of prison conditions both before and during research; 2) provision of HIV therapy and management for all HIV-infected prisoners that conforms to current national guidelines; 3) elimination of financial incentives that unduly influence prison authorities or investigators to encourage prisoner participation; and 4) clarification by federal regulatory authorities of regulations governing prisoner research.
Copyright © 2000 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.
