Summary points:
* The standards 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, taking into account the context of the trial as well as being sensitive to the social, economic and political milieu, is offered.
* National and international bodies concerned with research ethics need to confront the greatest ethical challenge – the enormous inequities in global health.