Research ethics committee member insights into the structures, processes, responsibilities and needs of health research ethics committees in Malawi: a mixed methods.

Abstract

Background: The dearth of studies on the composition and functioning of Malawi’s research ethics committees (RECs)prompted this study. The aim of the study was to describe Malawi’s two health RECs. Towards better understanding REC members’ insights into the structures, processes, responsibilities and needs of Health Research Ethics in Malawi, the following variables and components were considered: REC demographics, composition, training, guideline use, processes and procedures, financial and material resources, and affiliation. Methods: This study used a mixed method approach where quantitative descriptive cross-sectional survey and a retrospective record review/document analysis design were used. The study focused on RECs which review health research protocols only. We targeted a sample size of 30 participants. Sample selection was through a convenience sampling method. Results: The response rate for our study was 80% (24/30) of the total REC members from Malawi’s two RECs. Medical doctors dominate in membership. Most members (87%) had official training in research ethics after joining the RECs. The types of research most commonly reviewed by these RECs included: Public health research, laboratory research and health systems research. REC meetings were held either monthly or bi-monthly. On average, 33.5 protocols were reviewed per month, inclusive of all minimal risk and continuing research. REC members report the Declaration of Helsinki (83.3%), ICH GCP guidelines (75%)and the CIOMS guidelines (45.8%)as the most commonly used international guidelines, in conjunction with Malawi’s own ethical guidelines, law and policy. Application fees and research levies allow the RECs to generate their own income. This covers some of their basic expenses, the RECs lack the funding for a dedicated office space, transportation, and information and communication technologies. Eighty-three percent of members indicated the need for training in research ethics, especially in placebo-controlled clinical trials and scientific design issues in health research. Both RECs are accredited by a regulatory body in Malawi. Conclusion: REC members highlighted many strengths and some challenges and weaknesses in their RECs which require some consideration for the RECs to function more effectively. Some of the strengths include record keeping, use of international and local law, policy and research ethics guidelines, creative means of income generation and training of REC members. The RECs expressed a need for national audit and monitor ring mechanisms, and for specific research ethics training for their members.