A new look at international research ethics

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