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.
- HIV vaccine
- clinical trials
- research ethics
- international research
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Dale Guenter, MD, is Assistant Professor in the Department of Family Medicine, McMaster University, Hamilton, Canada. Jose Esparza, MD, is Leader, Vaccine Team, the Joint United Nations Programme on HIV/AIDS (UNAIDS), Geneva, Switzerland and Ruth Macklin, PhD, is Professor of Bioethics in the Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, New York, USA and Chair, UNAIDS Ethical Review Committee, Geneva, Switzerland.
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