This study seeks to inform deliberation and resolution of ethical issues related to multinational clinical research through interviewing various participants of the ESPRIT study. ESPRIT is a multinational collaborative clinical trial of Interleukin-2 in HIV disease. Our study is interviewing four groups participating in ESPRIT: (1) chairs of the Institute Review Board (IRB) or REC which reviewed ESPRIT; (2) principal investigators implementing ESPRIT; (3) persons who negotiated the Cooperative Project Assurances with the U.S. government; and (4) selected subjects participating in ESPRIT. The purpose is to compare their attitudes and experiences regarding important ethical issues associated with ESPRIT. There has been substantial controversy about the ethics of human subjects research in developing countries. This study is designed to provide an ethical framework for clinical research in developing countries and investigate empirically some of the more controversial issues in this research. Still conducting interviews with IRB chairs, PIs, and research participants in several countries.
