What is Human Subject

This chapter elaborates on some of the existing concerns and ethical issues that may arise when biomedical research protocols are proposed or funded by research institutes (private or public) in developed countries but human subjects are recruited from resource-poor countries. Over the last two decades, clinical research conducted by sponsors and researchers from developed countries to be carried out in developing countries has increased dramatically. The article examines the situations in which vulnerable populations in developing countries are likely to be exploited and/or there is no guarantee of any benefit from the research product, if proven successful, to the local community. By examining the structure and functions of ethics committees in developing countries, the article focuses on the issues which a local ethics committee should take into account when reviewing externally-sponsored research. In conclusion, by emphasizing capacity building for local research ethics committees, the article suggests that assigning the national ethics committee (if one exists) or an ethics committee specifically charged with the task of reviewing externally-sponsored proposals would bring better results in protecting human subjects as well as ensuring benefit-sharing with the local community.