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
Four TRACE countries are currently implementing digital system optimization Rwanda, Zimbabwe, Nigeria and Tanzania.
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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
MEETING AND TRAINING WORKSHOP TO ADVANCE DISCUSSIONS ON STRENGTHENING RESEARCH ETHICS GOVERNANCE IN NIGERIA
Abuja (19–21 January 2026)
A productive meeting was held at Transcorp Hilton Hotel in Abuja -Nigeria during the National Health Research Ethics Committee (NHREC) Meeting and Training Workshop to advance discussions on strengthening research ethics governance in Nigeria and the role of the TRACE Project in supporting national priorities.
TRACE PROJECT EXPLORES EXPANSION INTO KENYA
NAIROBI – JULY 10-12, 2025
The TRACE Project is set to expand into Kenya, following initial consultations with national stakeholders on integrating the country into the initiative to strengthen clinical trial oversight and ethics systems. In July 2025, a meeting was convened in Nairobi at the Pharmacy and Poisons
TRACE DIGITAL BENCHMARKING EFFORTS
KAMPALA - JULY 24-26, 2025
TRACE concluded a three-day benchmarking visit to the Uganda National Council for Science and Technology (UNCST), aimed at learning from their pioneering experience in digital ethics and clinical trial oversight. Held from 24th –26th July 2025, the mission was led by Mr. Collins Mwesigwa
MODERNISING MEDICAL RESEARCH FRAMEWORK AMID DIGITAL TRANSFORMATION
HARARE – JUNE 19, 2025
Zimbabwe is modernizing its medical research governance and accelerating digital ethics review systems after decades under outdated regulations. The MRCZ, established in 1974 under the Rhodesian Government Notice 225, has operated under a legal framework that has remained unchanged for over 50 years. In
STRENGTHENING CLINICAL RESEARCH GOVERNANCE – INSIGHTS FROM THE TRACE SCOPING MISSION
DAR ES SALAAM - JANUARY 28, 2025.
A scoping mission in Tanzania has provided critical insights into the country’s national ethics systems, paving the way for stronger regulatory oversight and collaboration in clinical trials. Held from the 21st to 24th January 2025, the mission engaged key institutions including the
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