Summary of Discussions of the Ethics Working Group on Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease

The first round of trials on novel therapeutics for Ebola are set to begin imminently. Members of the Ebola Response Anthropology Platform, Ann Kelly and Clare Chandler, represented the Platform by participating in the WHO Ethics Working Group meetings in September and October 2014 to discuss ethical considerations for trials of new vaccines and therapeutics for Ebola viral disease.

At a previous WHO consultation in August 2014, the Panel concluded unanimously that it would be acceptable on both ethical and evidential grounds to use as potential treatments or for prevention unregistered interventions provided that certain conditions were met. In the subsequent meetings, the details of the design and conduct of these trials was discussed.

In this latest report, released on 5th November 2014, the working group members reviewed different possible study design options and put forward recommendations for ethically appropriate designs for “monitored emergency use of unregistered and experimental interventions”. Particular concerns from an anthropological perspective include how to attend to the local clinical context of trials as well as the local social context. Each of these concerns was incorporated into the discussions and reflected in the recommendations in the report.

In addition, the report calls explicitly for anthropological involvement in these efforts, “There is an urgent need to review existing anthropological research and to conduct further anthropological studies to learn more about effective ways of engaging local communities, particularly during epidemics.”


World Health Organization / 2014 / World Health Organization


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