This comprehensive report was produced by an international working party which met over two years. The first half of the report outlines the contexts within which externally-sponsored research is conducted in developing countries, with chapters devoted to considering current healthcare needs, social and cultural issues, and the current regulatory framework. An ethical framework is then proposed for externally-sponsored research and the second half of the report considers how this framework should be applied in four areas: consent to research, standards of care, ethical review of research and what happens once research is over.

Perhaps the most controversial recommendation in the report concerns appropriate standards of care during research. In contrast to the provisions in the Declaration of Helsinki, the working party concludes that the appropriate standard of care to be provided in a research project can only be defined in consultation with those who work within the country in which the research is to be conducted. It considers that participants in the control group should be offered a 'universal' standard of care for the disease being studied where appropriate. However, where this is inappropriate, the minimum that should be offered is the best intervention currently available as part of the national public health system.

The executive summary is also available in French and Spanish (pdf files).