Revista de SIDA e investigación clínica

Enhancing the Efficiency and Quality of African Research Ethics Review Processes - Through an Automated Review Platform

Abstract

Boitumelo Mokgatla, Prince Bahati and Carel I Jsselmuiden

Background: The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies have resulted in unprecedented ethics review timelines. Method: The Research for Health Innovation Organiser (RHInnO Ethics), an automated review platform, facilitates and manages the entire ethics review process. In 2015, RHInnO Ethics was used by 25 RECs in 8 African countries. We evaluated its impact on efficiency, data security and cost using an online questionnaire administered to REC administrators in user countries. Results: The RECs interviewed were diverse with membership of 9-46 members; reviewing between 50–2000 protocols annually including observational, investigational new drugs and diagnostics. Reported areas of high impact (81%-100% of respondents) included improved: protocol submission and distribution process, quality of communication between RECs and researchers, standardized review process and data security. Reported areas of medium impact (60%-80% of respondents) included reduced; REC administrator’s workload and RECs’ administrative costs. Improved reviews of multicenter trials were reported by <60% of respondents. 20% of respondents who used RHInnO Ethics for >2 years reported 57% reduction in review time while those who used RHInnO Ethics for ± 1 year, (80%) reported it is too early to tell. Conclusion: RHInnO Ethics has achieved high-impact on data security, submission process, communication, standardization and cost reduction. However, a long-term evaluation approach is needed to determine impact on review timelines. Integration of new M&E indicators on efficiency into the platform would improve RECs capacity to conduct long-term impact.