Research is not an emergency. This must be clearly understood. While infectious disease epidemics require emergency response, research conducted during emergencies may need to be fast-tracked.
However, all due diligence for proper review of the protocol needs to be maintained. This is important as the study participants and the communities are important and all efforts need to be instituted to protect them.
The protection of study participants’ welfare during research is a priority obligation of institutional review boards, and they need to ensure this. This also requires that they monitor the research they approve knowing they are equally liable for possible research misconduct.
This was a consensus reached by the 24 participants who attended the 3-day training on the review of research protocols during infectious disease epidemics organized by the West African Task Force for the Control of Emerging and Re-emerging Infectious diseases (WATER).
The training was funded by OSIWA and IRESSEF with technical support provided by the New HIV Vaccine and Microbicide Advocacy Society. Participants included researchers, social scientists, bioethicists, lay persons and institutional review board members from seven countries in West Africa.
There was extensive dialogue about the Ebola epidemic in West Africa with recognition of some unethical practices. The group recognized the gap in competency to handle research protocols. During the epidemic, research protocols required for revisions increased 4-5 folds in many countries with implications for straining the manpower required for such expert reviews.
While participants recognized that the need to provide care for those infected and affected by diseases during such emergency epidemics like that witnessed with Ebola, research cannot be excluded as it can and will contribute to the public health response.
However, there is no justification to undermine the thorough review of any research protocol during this period as research is designed to answer questions for which there are no answers yet. Research itself is not an answer to solve any of the immediate issues arising from the epidemic.
Thorough review of research protocols are therefore required especially at this time, though the research process can be fast-tracked.
Fast-tracking review of research protocols implies that institutional review boards may hold emergency or unscheduled meetings to provide feedback on protocols, and or protocol reviewers may be asked to review protocols in a shorter time.
Fast-tracking does not imply that any of the statutory processes for research protocol should be breached neither should there be undue internal or external influence for protocol reviews.
Members of institutional boards in the region still need a lot of investment on how to handle protocols during emergency with focus on how to make the needed judgment to ensure ethical integrity of research protocols.
More home grown capacity-building efforts are required as these capacity-building programmes are more attuned to the socio-cultural, economic and political realities of the countries they serve.