Walking the digital Divide: Research Ethics Committees capacity and needs assessment and its implication for the introduction of a digital ethics review platform in Kenya.

Background: HATUA Kenya-Enabling compliance and building capacity and community for clinical Research in Kenya is a consortium involving six multi-sectoral partners. In 2018, Hatua Kenya obtained funding from EDCTP to carry out activities aimed at build clinical research capacity in Kenya. One of the key outputs of this project was installing and training RECs members to adopt a cloud-based online protocol submission and ethics review platform, known as RHInnO Ethics. Method: All research ethics committees (RECs) that were accredited as of May 2018 (n=28) were invited to a capacity and needs assessment workshop. The RECs filled in assessment questionnaires which were analysed and used to select eight (RECs) with the highest numbers of clinical trials reviews. Each REC was required to sign a memorandum of understandings (MOU) before being installed with the RHInnO Ethics platform. Results: Of the Twenty-eight accredited RECs, 25 attended the workshop and 23 responded to the assessment questionnaire. Of the twenty-three, 52% reviewed clinical trials, 78% reviewed other biomedical research, while 22% did not review biomedical research. In the year preceding the assessment (2017), the RECs had reviewed 94 biomedical research protocols, 68 clinical trials, 191 behavioural and 743 other types of studies with an average turnaround time of 2-3 months for clinical trials. 87% of the RECs charged for reviewing protocols, 74% had offices, 96% had internet connection, and 57% had REC administrators. Most REC lacked decision-making capacity to authorise procurement of the platform, while others subsequently reported plans to develop their own platforms. Adopting new changes in the consortium agreement contributed to delays in timely implementation of the project. Four RECs have been installed with the platform. Discussion: Despite interest in adapting the digital platform, uptake was slow. Factors attributed to this include limited support by host institutions, plans by some RECs to develop their own platforms, perceived high annual recurrent fees and overall sustainability of the platform. Budget limitations by RECs resulted to prolonged consultation with host institutions, before signing MOUs. RECs' limited financial resources and budget autonomy affected timely installation of the platform. The projects highlights important dynamics in multi-sectoral consortia management.