A new look at international research ethics

The standard of care for subjects participating in clinical trials is not w ell defined Excessive reliance has been placed on international declarations to define what is ethical, but declarations, like constitutions, need to be interpret ed International researchers must develop a deeper understanding of the contex t within which their research is being conducted An expanded concept for standard of care is offered that takes account of t he context of the trial and is sensitive to the social, economic, and polit ical milieu National and intel national bodies concerned with research ethics need to c onfront the greatest ethical challenge-the enormous inequities in global he alth.