What makes research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, this presentation proposes seven requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted.