STRATEGIC Consortium holds Consensus Workshop in Yaoundé to finalize ethics review framework for digital health technologies in subSaharan Africa

STRATEGIC Consortium holds Consensus Workshop in Yaoundé to finalize ethics review framework for digital health technologies in subSaharan Africa

We are pleased to report that on 14–15 April 2026 the STRATEGIC Consortium convened a Consensus Workshop at the University of Yaoundé 1 (Yaoundé, Cameroon) to refine and validate a sustainable ethics review framework for digital health technologies (DHTs) in clinical research across subSaharan Africa. The workshop brought together regulators, ethics committee members, researchers, digital health experts and WHO expertise to translate the STRATEGIC 5C framework into operational SOPs, tools and guidance tailored to African contexts. 

The twoday meeting aimed to operationalise the 5C framework, produce contextappropriate SOPs and tools for research ethics committees (RECs) and national regulatory authorities (NRAs), and strengthen harmonised ethical oversight across African settings. Twentytwo participants from ten countries attended (15 in person and 7 online), representing national ethics committees, regulatory authorities, academic researchers, digital health practitioners, STRATEGIC partners and a counit head from the WHO Ethics & Governance Unit. Eighteen participants had previously contributed to STRATEGIC’s cocreation activities, ensuring continuity and depth of input. 

The workshop combined plenary presentations, structured group work and consensusfocused discussions across four thematic sessions: translating the 5C framework into review practice; linebyline analysis and contextualisation of draft SOPs, checklists and riskcategorisation tools; refinement of stakeholderspecific recommendations (NECs, NRAs, academia, civil society, policymakers and funders); and codesign of a dissemination, communication and advocacy strategy to support uptake and sustainability. A WHO keynote on AI ethics and governance provided global context and highlighted critical challenges for LMICs, including benefit sharing, equitable access, power imbalances and ethics dumping. 

Key outcomes and consensus directions Workshop participants reached clear, practical agreements to guide STRATEGIC’s next steps: 

• Broad endorsement of the 5C framework as the conceptual backbone for DHT ethics review and the need to fully operationalise it through SOPs, matrices, templates and checklists. 

• Commitment to revise SOPs so they align with national and institutional procedures, clarify target audiences, harmonise terminology, and balance sufficient detail with adaptability. 

• Recognition that capacity strengthening must be continuous and institutional, including ongoing REC/NRA training, recertification and access to multidisciplinary expertise. 

• Agreement on a riskbased, lifecycle approach to ethics review supported by structured decision tools, postapproval monitoring, incident reporting and endofstudy review. 

• Integration of governance and accountability measures, fair partnerships, local participation, data ownership and authorship agreements, benefit sharing and sustainability, into the 5C/SOP architecture. 

• A targeted dissemination and advocacy plan using multiformat products (training packages, policy briefs, webinars, workshops, conference presentations and publicfacing materials), and engagement with funders to incentivise uptake. 

• Inprinciple agreement to establish an Africanled community of practice for DHT research ethics with identified champions and an online or institutional home to sustain collaboration. 

STRATEGIC will revise the 5C framework and SOPs based on workshop feedback, finalise practical tools (checklists, templates, matrices) and training materials, implement the dissemination and capacity building strategy across partner countries, and explore sustainable options for a community of practice and an online portal for STRATEGIC resources. 

On day two participants visited the University of Yaoundé 1’s Digital Development Centre and the Institute for Scientific and Medical Research (ISM), including its clinical trial unit. These visits enriched discussions and strengthened links between STRATEGIC outputs and local research infrastructure. 

This workshop marks tangible progress toward harmonised, robust ethics review for digital health research in Africa and contributes directly to strengthening regional ethics and regulatory capacity for equitable, highquality clinical research.