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

Abstract

BackgroundHealth research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world [1]. This changing cascade of biomedical research poses new challenges for research ethics committees (RECs) review efficiency and quality. The sheer amount of research now being conducted in Africa has resulted in an unprecedented increase in RECs' workload [2] and the growing trend of multi-centre trials complicate the traditional, institutionoriented oversight system. This places a severe burden on RECs, which have always operated under significant resource constraints [3]. Majority (93% of the mapped 169 RECs in 37 African countries) use complex paper based review systems [4], which have proven to be problematic in terms of providing comprehensive oversight and tracking of submitted research protocols, monitoring and evaluation, effective communication, data storage and poor continuity of work due to the high turnover of REC membership [5]. The ChallengeThe etiology of REC inefficiency is complex. REC members spend a great deal of time preparing REC applications, amendments, renewals, and reports. Poorly functioning review systems can lead to inefficiencies or long review timelines which ultimately lengthens the time to licensure for new medicines, vaccines and medical technologies [6].169 RECs are reported to be operational in 37 African countries, with great variability in skills, membership, capacity and resources [4]. Most of these RECs are facing substantial challenges, including limited financial and human resources, insufficient training and inadequate standard operational procedures (SOPs), and lack of modernised information management technologies [3]. One of the major bottlenecks for ethical clearance is the complex paper based review systems widely used by African RECs, which are unable to absorb significantly increased submission volumes [4]. To address the latter, the Council on Health Research for Development (COHRED), working with partners in Africa, designed an intervention to address the need to provide much faster ethical review of research: the RHInnO Ethics, a cloud-based management information system for RECs (http:// www.rhinno.net) [1]. Since its first rollout in 2012, no study has been conducted to evaluate the platform's impact, nor has any study been conducted to evaluate the technological needs of RECs in Africa, hence the motivation for this survey. MethodologyAn online questionnaire was used to collect both qualitative and quantitative data from the 8 African countries currently using RHInnO Ethics. Enhancing the Efficiency and Quality of African Research Ethics Review Processes -Through an Automated Review PlatformBoitumelo Mokgatla*, Prince Bahati and Carel I Jsselmuiden International AIDS Vaccine Initiative (IAVI), Botswana AbstractBackground: 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 tim...

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“…This simple online product is intended to simplify the process of ethical review by moving RECs from a paper-based to an online system, and also facilitates tracking of approved projects. RHInnO was launched in 2012, and has already been found to have had a significant impact on various metrics of REC performance, principally in improving efficiency, communication, and data security, and reducing reliance on paper [375]. Online technologies such as video conferencing should also be exploited to support rapid review meetings in fast-moving outbreak contexts (such as for outbreaks of Ebola and Zika) [376].…”

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“…If training is required, through the VC, the Chairman should request for tech-Journal of Biosciences and Medicines nical support from the COHRED. According to Mokgatla et al [40], ethics review committees that have institutionalized RHInnO Ethics have realized remarkable benefits in terms of improved data security, submission process, communication, standardization, and cost savings.…”