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    Trial Regulation And Clinical
    Ethics Optimization

    Mission

    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.

    Vision

    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, and Zimbabwe (expanding to 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.

    WHERE
    WE WORK

    Why TRACE

    2%

    Africa conducts only 1–2% of global clinical trials.

    25%

    Africa bears ~25% of the global disease burden but receives <2% of global health research funding.

    1

    Ten African countries have achieved WHO Maturity Level 3 (ML3) for medicines regulation.

    < 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.

    Latest News / Milestones

    Be the first one to know about our publications, events and careers.

    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

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    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

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    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

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    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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    ADVANCING DIGITAL ETHICS AND RESEARCH GOVERNANCE

    ABUJA – MAY 5, 2025

    Nigeria has reaffirmed its commitment to ethical and transparent clinical research through the TRACE mission held in Abuja. The mission brought together the TRACE team and the NHREC as well as Institutional and local committees to strengthen clinical trial oversight. Stakeholders explored the potential

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    ADVANCING COORDINATION AND NEXT STEPS

    KIGALI – JULY 5, 2025

    The TRACE Core Team meet in Kigali. The three-day in-person meeting delivered a unified roadmap for strengthening clinical trial oversight through harmonized ethics and regulatory systems, enhanced digital transformation, and sustainable financing models.

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    Our
    PARTNERS
    • Harmonize clinical trials ethics review processes in Africa
    • Build capacity for NECs, IRBs, and NRAs.
    • Advocate for digital tools to streamline approvals.
    • Engage stakeholders policymakers, researchers, and communities.