Takeaways from the STRATEGIC Project 3rd Webinar: Challenges and Opportunities for Strengthening Ethics and Regulatory Capacity for Digital Health Technologies

The STRATEGIC (Sustainable eThics Reviews of digital heAlth Technology dEsiGn In Sub-Saharan Africa) project recently hosted the 3rd Webinar on October 7th, 2026. For background, the webinar builds on the understanding that digital health technologies (DHT) are reshaping clinical research through artificial intelligence, wearable devices, electronic consent, remote monitoring, and data-driven decentralised trials. Yet ethics and regulatory systems often lack the expertise, infrastructure and processes needed to assess these technologies throughout their lifecycle. 

The 3rd webinar brought together researchers, regulators, ethics experts and technology developers from six Global Health EDCTP3-funded projects to explore how these gaps can be addressed and minimised.   

The webinar discussion identified several persistent challenges and gaps across the African continent: 

• Limited specialist expertise: Ethics committees and regulators may lack the technical knowledge needed to assess complex digital health systems. This can result in excessive scrutiny and delays, or insufficient scrutiny that overlooks important risks. 

• Ethics treated as compliance: Researchers sometimes approach ethics review as a requirement to complete rather than an opportunity to examine the wider effects of their research. 

• Limited continuing oversight: Ethical review is often concentrated at the start of a project, even though technologies, data uses and associated risks can change during implementation. 

• Fragmented governance: Ethics committees and regulatory authorities may have unclear or overlapping responsibilities and operate through disconnected systems. 

• Data governance concerns: Questions remain about data ownership, privacy, cross-border sharing, storage and national capacity to manage sensitive health data. 

• Digital exclusion: Language, connectivity, accessibility and digital literacy can determine who benefits from digital health innovation and who is left behind.  

Participants agreed that training is essential, but training alone will not be enough. Stronger policies, clearer institutional responsibilities, appropriate infrastructure and sustained collaboration are also required 

A shared framework for responsible innovation and policies for DTH:   

The webinar was also intended as a continental opportunity to exchange experiences and explore how lessons from research ethics review reforms and ethics and regulatory capacity-building initiatives in sub-Saharan Africa can strengthen the responsible governance of digital health technologies across the Global Majority. At the centre of the discussion was the STRATEGIC Inclusive 5C Framework for Responsible Innovation, co-created with contributions from more than 250 stakeholders across Africa and Europe. Rather than importing a one-size-fits-all model, the framework places African realities, local ownership and equitable relationships at the heart of responsible digital health innovation for clinical research and trials. 

The 5C framework's interconnected dimensions centre: 

• Context: Designing technologies around local languages, cultures, infrastructure, connectivity, accessibility and community needs. 

• Care and Compassion: Protecting safety, autonomy and dignity through meaningful and culturally appropriate consent. 

• Collaboration: Promoting co-design, equitable partnerships, local capacity and fair sharing of benefits. 

• Compliance: Meeting ethical, legal, regulatory and technical requirements while moving beyond a tick-box approach. 

• Continuity: Providing ongoing oversight, sustainability, resilience and responsible management across the technology lifecycle. 

Building sustainable ethics and capacity infrastructure that moves from principles to practices:   

The first session, chaired by Dr Damian Eke, focuses on the ethical and legal issues of DHT in clinical trials and research and brings together insights from three projects, whereas the second session, chaired by Prof Bernd Stahl, focuses on approaches for addressing regulatory issues of DHT use for clinical trials and research. The projects represented at the webinar showed the diversity of the work carried out within the Global Health EDCTP3 funding landscape, particularly on strengthening the ethical and regulatory capacities for the global majority in Africa.  

• RERCTO and EthiMed are building the capacity of ethics committees and regulators. Their work demonstrates the importance of context-sensitive training that reaches both senior and junior personnel and remains useful as technologies evolve. 

• CHANGER is developing consultative and iterative ethics review methods. Its ethics-by-design approach supports collaboration between researchers and ethics experts, while continuous review reflects the 5C principle of continuity. 

• CECABI 2 has introduced a digital platform that connects ethics and regulatory workflows in Côte d’Ivoire. The 5Cs could provide shared criteria for reviewing participant welfare, local relevance, compliance, and sustainability. 

• CT-LUSO is strengthening and harmonising ethical and legal arrangements across Portuguese-speaking African countries. The framework could support common standards while allowing adaptation to different national and linguistic contexts. 

• SERCEA and AccessAfrica 2 support integrated safety monitoring, pharmacovigilance and guidance for decentralised clinical trials. The 5Cs can help ensure that ethical and safety responsibilities continue beyond initial approval. 

• Work associated with SINCEP-Africa demonstrates how principles can be embedded in digital infrastructure. Dynamic consent systems using accessible formats and multiple languages can make consent understandable, traceable and continuous. This brings together Context, Care and Compassion, Compliance and Continuity, turning consent from a one-time signature into an ongoing relationship. 

From separate projects to a connected ecosystem in Africa:  

The webinar demonstrated a strong consensus that future governance of digital health technologies in Africa should be context-sensitive, participatory, lifecycle-oriented, and grounded in equitable partnerships. The webinar also highlighted a clear opportunity to extend EDCTP-funded projects working on capacity building, regulatory harmonisation, community safety monitoring and digital infrastructure. Specifically, we identify that:  

1. There is significant potential for collaboration among EDCTP-funded projects working on ethics, regulation, clinical trials, and digital health governance across Africa. 

2. Digital health technologies are transforming research faster than current ethics and regulatory systems can adapt.  

3.  Ethics review should move beyond compliance and become a continuous, collaborative process embedded throughout the technology lifecycle. 

4. Data sovereignty, equitable partnerships, and local ownership are essential for responsible innovation in African healthcare 

5. The STRATEGIC 5C Framework provides an African-centred yet globally relevant model for responsible design and governance of digital health technologies. It is evident that digital health technologies should fit their context, care for people, be developed collaboratively, meet relevant requirements and remain responsible throughout their lifecycle. Applying these principles can help build a more coordinated, locally grounded and sustainable ecosystem for digital health innovation in Africa, with lessons that are relevant globally. 

We look forward to welcoming you to the next STRATEGIC Project webinar schedule for January 2027.