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Ethical and policy issues in international research: clinical trials in developing countries

This report, published by the US National Bioethics Advisory Commission (NBAC) — which has now been replaced the President's Council on Bioethics — is a very useful resource, despite being restricted in scope to clinical research sponsored by or conducted in collaboration with the United States.

The report has two volumes. Volume I contains the report and recommendations of NBAC and covers ethical issues in international research, ethical considerations in the design and conduct of clinical trials, voluntary and informed consent to research, access to the benefits of research, and means of protecting research participants. While the discussion about means of protecting research participants is primarily of relevance to the United States, elsewhere in the report the recommendations are of more general applicability. Discussions about standards of care focus on the need to provide members of the control group in research with an ‘established effective’ treatment, whether or not such treatment is available in the country where the research is bring conducted.

Volume II contains research commissioned for the report and staff analysis. It includes a number of interesting findings on matters such as experiences with US human subjects regulation, international perspectives on protecting research subjects and the relevance of culture to consent processes.

The executive summary is also available in French and Spanish.

 

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