SECRET

The challenge

Clinical trial activity in sub-Saharan Africa has increased substantially in recent years, yet the regulatory and ethical oversight infrastructure has not kept pace. The key gaps in clinical trial review and oversight in the region include:

• Limited clinical trials ethics review capacity: Few research ethics committees (RECs) have the capacity to review and provide oversight for clinical trials in the region.
• Absent accreditation systems: National accreditation frameworks that guarantee the quality of ethical review are largely absent, raising questions about the protection of research participants.
• Low trial registration: Many clinical trials, particularly single-country studies, remain unregistered, undermining transparency and accountability in research.
• Paper-based protocol submission systems: Nearly half of RECs across the region still rely on paper-based protocol submission systems, limiting efficiency and data management capacity.
• Emergency response gaps: Slow ethical review turnaround during outbreaks and epidemics constrains Africa's ability to generate timely research evidence when it is most needed.

The project

SECRET takes a systems-strengthening approach across four interlinked objectives:

1. National accreditation systems. Establishing formal accreditation frameworks for research ethics committees (RECs) in Ethiopia, ensuring that ethical review meets national and international quality standards and is recognised by funders, regulators, and the global research community.2
2. Capacity building for REC review of clinical trials. Providing targeted training and support to RECs to strengthen their ability to review complex clinical trials, including those conducted during outbreaks and epidemics
3. National clinical trial registries. Establishing a national clinical trial registry in Uganda, linked to the Pan-African Clinical Trials Registry and aligned with the WHO international registration standards, to increase transparency and accountability in research conducted in the region.
4. Digital protocol submission systems. Developing and implementing electronic protocol submission systems to modernise REC operations, reduce administrative burden, improve turnaround times, and enable better data management and reporting.

Impact

By the end of the project, SECRET will have created a stronger, more efficient, and internationally recognised research ethics environment in Uganda and Ethiopia. Specifically, the project will:

• Increase participation of Uganda and Ethiopia in high-quality clinical trials by ensuring their ethics review systems meet international standards.
• Improve the protection of research participants through rigorous, well-resourced, and independently accredited ethics review.
• Provide a replicable model for national ethics system strengthening that can be adapted and scaled across East Africa and beyond.
• Strengthen Africa's capacity to conduct timely, well-regulated research during health emergencies and outbreaks.
• Contribute to Sustainable Development Goal 3 on good health and well-being by enabling more and better clinical research on poverty-related and neglected infectious diseases in the region.