STRATEGIC

The challenge

Digital tools are becoming increasingly central to both research and clinical practice. They have a wide range of applications, spanning diagnosis, support for clinical decision-making, storage of health data in electronic patient records, through to data collection, storage and analysis in research. A growing number of these tools now have integrated artificial intelligence (AI) functionalities.

These tools have great potential to enhance the quality and efficiency of care delivery, as well as facilitate the use of clinical data for research purposes. However, they also create or exacerbate existing ethical and regulatory issues. Key issues include privacy and data security, informed consent, safety, equity and accessibility, algorithmic bias and discrimination, accountability and liability, and ethical use of big data.

It is therefore essential that further development and deployment of such tools take place within a robust governance environment tailored to local contextual realities in sub-Saharan Africa.

The project

The STRATEGIC project is bringing together a wide range of stakeholders from across sub-Saharan Africa to support the collaborative development of a robust, evidence-based and contextually appropriate approach to the oversight of research and innovation involving digital health tools. 

It will systematically map the existing ethical and legal infrastructure covering digital tools in sub-Saharan Africa, highlighting gaps and needs. It will also identify emerging applications and study five digital technology use cases to explore key issues. 

The project team will then collaborate with a broad range of stakeholders from different sectors to co-develop a comprehensive new oversight framework for digital technologies in healthcare. The project will develop training materials, which will be disseminated through existing training infrastructure and networks. It will also develop and pilot culturally sensitive, flexible and adaptive review processes.

Key outputs will include a handbook on stakeholder inclusion and responsible design of digital health technologies. The project’s activities will create a sustainable e-community, supporting longer-term sharing of knowledge and best practices.

The STRATEGIC consortium includes the hosting body of a national ethics committee, as well as a European umbrella association (EUREC) that links multiple national research ethics committees, and four universities. The African partners represent English-, French- and Portuguese-speaking countries in sub-Saharan Africa, ensuring that its outputs will have wide applicability. 

Impact

The STRATEGIC project will strengthen the capacity of countries in sub-Saharan Africa to oversee the use of digital health technologies in research and clinical practice. It will: 

• Strengthen established ethics review processes that do not yet consider the ethical issues raised by digital health technologies.
• Facilitate greater use of digital health technologies in clinical trials in Africa.

The development of a rigorously developed, consistent, and culturally sensitive framework will help ensure that the great potential of digital health technologies can be realised while maintaining respect for key individual rights and garnering public support.