Prior Agreements in International Clinical Trials: Ensuring the Benefits of Research to Developing Countries

Abstract

When biomedical research is conducted in the developing world, the disparity in power between rich and poor nations manifests itself in two ways. In most cases, the industrialized world sets the agenda and carries out the research. The involvement of developing countries is limited (a gradual change, however, is evident), and only in a few instances do they function as full and equal partners. Moreover, although it assumes very few research burdens, the industrialized world receives the great majority-and in some cases, all-of the research benefits because, unlike the developing world, it can afford to buy a proven intervention. The burdens of research, in contrast, are borne by developing countries whose poorest inhabitants serve as research subjects but rarely share in its benefits. Many interventions are well beyond the economic reach of both research subjects and their governments. Under these circumstances, for the research to be ethical, research benefits must be fairly and equitably apportioned to the host community, a term which may be difficult to define in a particular research setting. One of the greatest challenges facing international research ethics is crafting practical and economically feasible solutions to help ensure that citizens of developing countries are not exploited for the benefit of the industrialized world. Data from a survey conducted for the benefit of the United States National Bioethics Advisory Commission (NBAC) indicate that, to some extent, post-trial availability of research benefits is a consideration in research hosted by developing countries. Nevertheless, forty-eight percent of researchers in developing countries and thirty-three percent of U.S. researchers who responded believed that the interventions tested in their research were unlikely to become available to most host community residents in the foreseeable future.