Trial Regulation And Clinical
Ethics Optimization
To harmonize, strengthen, and digitalize the clinical trial ethics oversight ecosystem in participating African countries, while supporting improved coordination with regulatory authorities. TRACE project aims to enhance transparency, predictability, and efficiency in review processes and to enable safe, ethical, high-quality research.
An Africa-led clinical research ethics oversight environment that is transparent, efficient, predictable and trusted; one that protects research participants, supports innovation, and is better prepared to respond to public health priorities and emergencies.
KEY OBJECTIVES
- To streamline and harmonize clinical trial ethics review processes in participating countries.
- Build capacity for National Ethics Committees (NECs) and Institutional Review Boards (IRBs), in collaboration with National Regulatory Authorities (NRAs).
- Strengthen and optimize digital systems for ethics and clinical trial oversight to improve efficiency, transparency and coordination within each TRACE country.
- Engage policymakers, regulators and institutional stakeholders to strengthen ethics governance and coordination.
- Ensure all NECs implement a financial sustainability plan to support long- term operational effectiveness.
Expected Outcomes
- Efficiency & Quality of Clinical Trial Application (CTA) review processes: Countries deliver CTA decisions in line with AVAREF recommended timelines.
- Quality assurance & Peer review: Countries introduce quality-assurance mechanisms, including peer-learning approaches and agreed-upon quality benchmarks for ethics review.
- Digital CTA review systems: Countries strengthen or adopt an efficient digital CTA platform for ethics oversight to improve transparency and reduce delays.
- Accreditation: Countries advance NEC and IRB systems and work toward implementing context-appropriate accreditation and certification models.
- Regulatory reliance: Countries implement Institution Review Board (IRB) reliance models for multi-site clinical trials.
- Financial sustainability: Countries develop sustainability plans for NEC operations, including analysis of fee structures, cost elements, and long- term financing options with the aim to achieve 100% self-funding within five years.
WHAT IS TRACE PROJECT?
TRACE is a multi-country initiative working with ethics committees and regulators in Rwanda, Tanzania, Nigeria, Zimbabwe and Kenya to strengthen and harmonize clinical trial oversight. By improving capacity, governance, and digital systems, TRACE makes ethics and regulatory processes more transparent, predictable, and efficient while ensuring strong participant protection.
2%
Africa conducts only 1–2% of global clinical trials.
<
0
%
Less than 10% of African countries use fully digital ethics or regulatory review systems.
1
Five TRACE countries are currently implementing digital system optimization Rwanda, Zimbabwe, Nigeria, Tanzania and Kenya.
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Strengthening Research Ethics in Rwanda: Highlights from the IRB Capacity Building Workshop
KIGALI – JULY, 2026
The TRACE Project successfully hosted a two-day Capacity Building Workshop for Institutional Review Boards (IRBs) across Rwanda. Achieving a 100% attendance rate from invited IRBs, the event underscored a strong national commitment to harmonizing research ethics, optimizing oversight, and advancing good clinical practice (GCP).
Accelerating Clinical Trial Excellence: Key Highlights from the Harare Face-to-Face Core Group Meeting
HARARE – JUNE, 2026
Moving closely towards the last months of the second year of the TRACE Project, the initiative has entered a high-execution phase of national implementation.
NIMR And TMDA Partner to Elevate Clinical Trial Review and Traditional Medicine Research Standards
MOROGORO - JUNE, 2026.
The TRACE Project achieved major milestones in strengthening Africa's clinical research systems through two targeted capacity-building initiatives in Morogoro, Tanzania. Implemented by the National Institute for Medical Research (NIMR) in close collaboration with the Tanzania Medicines and Medical Devices Authority (TMDA), these efforts mark a
Elevating Research Transparency in Zimbabwe
ZIMBABWE - May, 2026
As a core partner of the TRACE initiative, Zimbabwe is moving beyond traditional oversight to establish a more visible and accountable research ecosystem. By modernizing its national approach to research ethics, the country is ensuring that its regulatory processes meet the highest international standards while
PRESS RELEASE: Kenya Integrates into TRACE to Streamline Clinical Trial Reviews through Parallel Submission and System Strengthening
NAIROBI - May, 2026
The TRACE Project (Trial Regulation and Clinical Ethics Optimization) is proud to announce the formal inclusion of Kenya into its multi-country initiative which is already being implement in Tanzania, Nigeria, Rwanda and Zimbabwe. This expansion aims to strengthen and align Kenya’s clinical trial oversight systems
Request for Proposals: Digital Ethics Review System Development
14 April 2026
CIIC-HIN, through the TRACE Project is seeking a qualified firm to develop Rwanda’s next-generation Digital Research Ethics Review System for Rwanda National Research Ethics Committee (RNEC) and Institutional Review Boards(IRBs). The platform will improve efficiency, transparency, compliance, and oversight of research protocol review through a shared
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