Standards of care in research

The interpretation of “standard of care” in research has generated a lot of controversy among researchers. It has underpinned much of the debate on the use of placebos in randomised controlled trials such as the one around the zidovudine trials, which were proposed to prevent mother to child transmission of HIV infection in Africa. These trials entailed an evaluation of a short course treatment regimen in comparison with a control population receiving nothing.1^–3 A high profile debate ensued that led to a reconsideration of guidelines on international research as well and spurred initiatives to make low cost antiretroviral treatment available in developing countries.4 5

In October 2000, the World Medical Association modified the Helsinki declaration to state that “the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.”6 The Council for …