Medical researchers' ancillary clinical care responsibilities

Abstract
Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? This question arises regularly, especially in developing countries, yet (with rare exceptions1) existing literature and guidelines on research ethics do not consider ancillary clinical care. We propose an ethical framework that will help delineate researchers' responsibilities.