title: Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
abstract: Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important 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 considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. 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 guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process.
authors.affiliation: Department of Family Medicine, McMaster University, Hamilton, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Guenter
authors.forename: J
authors.initials: J
authors.lastname: Esparza
authors.forename: R
authors.initials: R
authors.lastname: Macklin
mesh_terms: D016915:AIDS Vaccines; D001294:Attitude to Health; D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D035061:Control Groups; D018864:Cultural Diversity; D019049:Developed Countries; D003906:Developing Countries; D026724:Ethical Review; D004989:Ethics; D004992:Ethics, Medical; D032984:Ethics, Research; D014943:Global Health; D006292:Health Priorities; D006801:Humans; D007391:International Cooperation; D038622:Internationality; D028681:Moral Obligations; D020380:Needs Assessment; D033281:Nontherapeutic Human Experimentation; D010344:Patient Advocacy; D017410:Practice Guidelines as Topic; D012107:Research Design / Q000592:standards; D035842:Research Subjects; D012935:Social Justice; D012945:Social Values; D012959:Socioeconomic Factors; D036302:Therapeutic Human Experimentation; D014480:United Nations
chemical_list: D016915:AIDS Vaccines