Ethical considerations in international biomedical research

The proliferation of international biomedical research has stimulated growing concern regarding the potential for exploitation of vulnerable populations in low-income countries by research sponsors in high-income countries. Three sets of international guidelines on ethical biomedical research — the WMA Declaration of Helsinki, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the UNESCO Universal Declaration on Bioethics and Human Rights — have been generated and yet none are legally binding. The UNESCO Declaration is unique among the three because it was written as an intergovernmental instrument on bioethics, intended to guide the development of novel national ethical policies worldwide, and particularly in developing nations. Policies that emphasize prescribed negotiations between the sponsoring and host countries, the mandatory inclusion of benefi t sharing for the host population after completion of the study, and the formation of local Research Ethics Committees to oversee the research from planning through completion are some examples of important steps to be taken. Creation and enforcement of policies such as these will empower developing nations to infl uence the way in which biomedical research is conducted within their borders and on their citizens.