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 will interview 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. Protocol has been reviewed by the NIAID IRB. Survey instruments are being developed and pretested. 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. In conjunction with African clinical researchers we are examining the question of what constitutes benefits of clinical research and what level of benefits are necessary for ethical multi-national research. Similarly we are trying to define a full set of principles and benchmarks to provide a general framework for determining when clinical research in developing countries is ethical. The empirical research is focusing on whether subjects in African countries are coerced into participating in research, whether they understand the details, including the risks and enefits, of the research and how participants in clinical research perceive the benefits of the research
