ABSTRACT

Individual informed consent has been recognized as a principle of ethical clinical research for more than a century. The ethical conduct of clinical research does not end when informed consent is obtained. Four benchmarks ensure social value. First, it should be determined who will benefit from the research. Second, the potential value of the research for each of the prospective beneficiaries should be outlined. Third, it is important to develop mechanisms to enhance the social value of research. Fourth, the conduct of the research should not undermine the community's existing health-care services. Disagreement on the balancing of the various benchmarks does not necessarily make one assessment ethical and the other unethical. To minimize concerns regard to researchers' conflicts of interest and to ensure public accountability, independent ethical review of all clinical research protocols is necessary. An ethical framework for multinational research should minimize the possibilities of exploitation.