Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?

Abstract

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project.

Contribution of Biomedical Research Ethics in Public Health Advances

“…In contrast, the number of approvals of medical devices by the Food and Drug Administration (FDA) has increased steadily each year [23]. Driven by demand, total medical spending on devices has increased at a rate that is several times that for health services and twice that for drugs [5,30].…”

“…Whatever the circumstances, however, society has a dual responsibility to ensure that [30] i. all drugs, devices and vaccines under investigation in human subjects meet adequate standards of safety; and…”

“…This requires a reevaluation of funding priorities, open interactions among researchers, and creating a more effective relations among stakeholders, government, foundations and institutions of higher learning. There is also the need for a shift in paradigm in biomedical research towards poverty related diseases and emerging diseases to reduce the 90/10 gap [6,30].…”

Genomic Research Data Generation, Analysis and Sharing – Challenges in the African Setting

“…Although most African countries have some form of research review process, some still do not have national RECs (Nyika et al 2009;Kirigia et al 2005). Furthermore, IRB/RECs requirements and guidelines vary across African borders with local challenges (McWilliams et al 2003).…”

“…General research ethics challenges in Africa include concerns about independence of RECs, inadequate funding and inadequate qualified staff in a background of weak health system infrastructures (Kass et al 2007a;Nyika et al 2009;Coleman and Bouësseau 2008). There is widespread poor capacity to handle ethical issues with serious implications for efficient functioning of RECs (Marzouk et al 2014;Shabrawy et al 2014).…”