• IRB: ETHICS & HUMAN RESEARCH

The Guinea Phase III Ebola Vaccine Trial: Lessons for Research Ethics Review in Public Health Emergencies

This paper discusses the ethics review by one of the three research ethics committees that approved the Ebola vaccine trial carried out in the Republic of Guinea in 2015. It describes several deficiencies in the process and, on that basis, makes recommendations for how to best review clinical trials conducted during public health emergencies. We suggest that review by multiple committees is inefficient and may well undermine the quality of the review. We therefore suggest that a single committee should be responsible for the ethics review of clinical trials conducted in public health emergencies. To ensure appropriate review, the committee needs to have in place a clear plan to conduct a more rapid review than is typical in clinical research without sacrificing the protection of subjects. This proposal is contrasted with some previous suggestions for review of research during public health emergencies.

Keywords: Ebola vaccine trial, clinical trials, public health emergencies, research ethics committees, research ethics