Community-Based AIDS Research

Abstract

Institutional review boards (IRBs) that review community-based AIDS research, like their counterparts in hospital-based or academic settings, are charged with protecting the rights and welfare of subjects. Fulfilling this charge presents all the challenges that face other IRBs, but with the added urgency of issues particular to the disease and the community setting. Investigators in community-based AIDS research are often primary care providers who have close relationships with their patients; they are not, by and large, trained as clinical investigators. A patient-centered medical ethic may differ in significant ways from knowledge-oriented research ethics. Furthermore, patients with AIDS, living with a disease with no cure or effective long-term treatment, urgently need access to promising drugs and therapies. Community research IRBs thus must grapple with generic research design and ethical issues that assume special salience under these conditions. One can characterize these issues as questions of scientific validity, not ethics, but they are both. The challenge to the IRB is to balance the values of scientific credibility with the moral principles of respect for persons, including autonomy, beneficence, and justice. The experience of the IRB of New York City's Community Research Initiative (CRI) in dealing with this tension may be instructive for others examining the community-based research model. In the process of reviewing protocols, the IRB has developed policies that address issues of research design, subject selection, and confounding variables.