Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS)

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively? high social and economic development, and condu cted in countries that are relatively less developed, gives rise to many im portant ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are c onsidered "developing" countries. Safeguarding the rights and welfare of in dividuals participating as research subjects in developing countries is a p riority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidanc e that might facilitate the ethical design and conduct of HIV vaccine trial s in international contexts. This paper summarises the major outcomes of th e UNAIDS consultative process.