Our goal is to develop recommendations for integrating Responsible Innovation approaches into the ethics review processes for digital technology applications in clinical research within sub-Saharan Africa (SSA). Previous work packages have identified gaps in the ethics review processes of National Ethics Committees (NECs) and National Research Authorities (NRAs). We aim to enhance and prioritise the infrastructure for good governance of digital health technologies (DHTs) in our current activities.
These prioritisation activities include conducting virtual and in-person focus groups, consultations, a policy roundtable, and a consensus workshop with research ethics experts, representatives of regulatory bodies, technology developers, and investigators in Africa and the EU.
So far, we have developed and consolidated a methodology during the STRATEGIC General Assembly (GA) held in Cameroon, 8-10 April 2025. This includes two online stakeholder consultation meetings scheduled for 30 July and 4 September 2025; three virtual focus group discussions (FGDs) on 22 October, 3 December 2025, and 26 February 2026; a policy roundtable to be held in Mozambique on 10 September 2025; and a consensus workshop in Cameroon on 14-15 April 2026.
The discussions and consultations will cover a range of topics, including the ethical implications of using DHTs in clinical research and trials in SSA, the preparedness of ethics committees to review research protocols involving DHTs, prioritising training needs for Research Ethics Committees (RECs), NRAs, and investigators, stakeholder engagement, and regulatory capacities in the region. Additionally, we will discuss the knowledge, attitudes, and practices related to ethical legal issues in digital health technology, as well as community awareness and perceptions.
All these activities will contribute to the development of actionable policy recommendations for integrating Responsible Innovation approaches into the ethics review processes for digital technology applications in clinical research in sub-Saharan Africa.