he TRACE (Trial Regulation and Clinical Ethics Optimization) Project is a multi-country African initiative launched in 2025 to strengthen and harmonize clinical trial ethics and regulatory oversight. The below Q&A with Elly Kourany-Lefoll and Collins Mitambo of the TRACE Project team details its work with national ethics committees, regulators, and research institutions to make review systems more transparent, predictable, and efficient through capacity building, policy and standard operating procedures (SOP) harmonization, digitalization, sustainable financing models, and stronger coordination with regional and continental frameworks. TRACE has been active in Nigeria, Rwanda, Tanzania, and Zimbabwe, and has recently expanded into Kenya.

Framework and Structure

Where and how does/will the TRACE project align with the African Medicines Agency framework?

The Trial Regulation and Clinical Ethics Optimization (TRACE) Project in Africa strengthens national clinical trial ethics and regulatory systems in ways that directly support the objectives of the African Medicines Agency (AMA). While AMA operates at the continental level to promote regulatory harmonization and reliance, TRACE focuses on building the local national foundations for clinical trials in terms of governance, transparency, predictability, digital infrastructure, and reviewer capacity, to enable effective participation in regional convergence frameworks.

TRACE operations include five technical subteams. Would you briefly explain the short- and long-term goals for each team?

The five TRACE technical subteams, and their short- and long-term goals, are:

• Harmonization
  Short-term: Align SOPs, clarify roles, and streamline review pathways within countries for clinical trials.
  Long-term: Position national systems to engage confidently in regional reliance and AMA-aligned processes.
• Clinical Trial Capacity Building
  Short-term: Deliver structured training, strengthen reviewer competence, and support formal registration and accreditation processes for Institutional Review Boards (IRBs).
  Long-term: Institutionalize continuous professional development for ethics committee members and advance IRB accreditation, reinforcing quality standards and institutional credibility for IRBs and National Ethics Committees (NECs).
• Digitalization
  Short-term: Upgrade ethics and regulatory platforms to improve traceability and end-to-end oversight of a clinical trial, from initial submission through review and approval, implementation, amendments, safety reporting, inspections, and trial closure/reporting.
  Long-term: Develop interoperable systems that support transparency and future cross-border collaboration.
• Financing Models
  Short-term: Address critical funding gaps and stabilize the core operational capacity of ethics committees, including staffing, review processes, and administrative functions.
  Long-term: Establish financially sustainable oversight institutions supported by predictable and diversified funding mechanisms that ensure continuity of operations and reduce reliance on external funding.
• Communication
  Short-term: Improve transparency and visibility of TRACE activities and outputs through clearer public communication, including newsletters, website content, and stakeholder engagement.
  Long-term: Build institutional credibility and trust with both local investigators and global sponsors through consistent, transparent, accessible communication. The communication workstream focuses on transparency and visibility of TRACE activities as a whole including system reforms, tools, and country progress, not only on clinical trials. Clinical trial oversight is central, but the objective is to strengthen communication and engagement across the wider clinical research ecosystem.

TRACE’s monitoring and evaluation framework tracks measurable outputs, such as adoption of harmonized SOPs, digital system functionality, training completion, and reduced variability in regulator and ethics committee clinical trial application review timelines, to progressively align national reforms with AMA principles of regulatory convergence, transparency, and predictability.

In essence, TRACE strengthens the national pillars of clinical trials oversight and, more broadly, clinical research governance, upon which effective continental harmonization depends.

System Reform and Harmonization

TRACE is working across countries with very different legal, regulatory, and ethics review traditions. What has been the hardest element to harmonize so far: processes, timelines, standards, or institutional incentives? And why?

The most difficult element to harmonize has been institutional mandates embedded in different legal and regulatory traditions.

Across TRACE countries, workflows can be mapped and timelines optimized. However, authority is distributed differently between national regulatory authorities and ethics committees, often in ways defined explicitly by law. Where mandates overlap or are ambiguously defined, reform requires more than procedural alignment; it requires governance clarification and, in some cases, legislative reform.

For example, in Zimbabwe, modernization efforts intersected directly with drafting a new Medical Research Bill to replace a legal framework dating back to the 1970s. The bill governs all operational and clinical research involving human participants in Zimbabwe. Without an updated legislative foundation, digital reforms and streamlined review pathways could not be sustainably anchored.

In Nigeria, the ongoing revision of the National Code of Health Research Ethics is addressing the role of the National Health Research Ethics Committee (NHREC) in relation to institutional ethics committees, with the aim of strengthening national coherence and clarifying oversight responsibilities. This process illustrates how harmonization often depends on parallel legal and policy reform.

At the continental level, TRACE has worked with the WHO-African Vaccine Regulatory Forum (AVAREF), which plays a critical role in promoting joint reviews, regulatory collaboration, and alignment of clinical trial standards across countries. However, through the harmonization workstream, AVAREF also faces challenges such as varying levels of institutional capacity, differences in national legal mandates that limit reliance models, and uneven digital maturity across authorities. These experiences demonstrate that harmonization is less about synchronizing timelines and more about aligning governance structures within diverse legal frameworks. Without clarity of institutional authority, even well-designed operational reforms struggle to scale nationally.

Much of the reform narrative focuses on reducing delays and duplication in clinical trial application review processes. How do you ensure that gains in efficiency do not come at the expense of ethical rigor or contextual sensitivity?

Much of the reform narrative focuses on reducing delays and duplication of clinical trial application (CTA) review and approval processes, but TRACE is explicit that efficiency must not come at the expense of ethical rigor or contextual sensitivity.

Process optimization targets redundancy, not scientific scrutiny. In Rwanda, for example, SOP reviews streamlined workflow steps while preserving ethics committee quorum requirements (i.e., maintaining the minimum number and composition of members required for valid decision-making), independent scientific assessment, and documentation standards. The objective was clarity and predictability, not dilution, of clinical trial protocol review.

Similarly, in Kenya and Rwanda, parallel submission pathways are being developed to allow ethics and regulatory review to proceed concurrently rather than sequentially. This removes unnecessary waiting periods but maintains independent decision-making and full technical assessment by each authority.

Capacity building further safeguards rigor. Training on complex trials, safety oversight, and emerging issues such as AI ensures that faster workflows are supported by stronger expertise. Digital platforms enhance traceability and accountability through audit trails and structured templates.

Several countries are piloting joint or better-aligned ethics and regulatory workflows. From your perspective, what signals indicate that harmonization is improving review quality rather than just speed?

While several countries are piloting more aligned or parallel ethics and regulatory workflows (such as Tanzania and Kenya, for example), formal cross-country joint protocol review is not within the core scope of TRACE. That mandate sits more directly with initiatives such as AVAREF. TRACE focuses instead on strengthening national systems including governance, process alignment within countries, digitalization, and capacity building.

Harmonization improves quality, not just speed, when it results in clearer, risk-proportionate standards, stronger and more consistent scientific queries, better-documented decisions, and enhanced reviewer capacity.

However, TRACE integrates capacity building of EC members (both NECs and IRBs) as a core pillar of harmonization. Through targeted technical assistance and training on regulatory science and research ethics, TRACE strengthens the competence and confidence of reviewers; Tanzania and Zimbabwe, for example, have recently completed member training for several IRBs. Through the Capacity Building workstream, TRACE will ensure that harmonization does not dilute standards but instead strengthens their consistent and rigorous application, aligned with international best practices.

Digital Transformation

Digital ethics platforms are a major pillar of TRACE’s approach (e.g., Nigeria’s NHREC e-Portal, Zimbabwe’s ethics committee new portal). What design or governance choices have proven most critical to adoption by ethics committees and regulators?

Digital platforms are a major pillar of TRACE, but adoption has depended far more on governance and collaboration than on the technology itself.

In Nigeria, for example, rollout of the NHREC e-Portal, which supports the submission, review, and tracking of research protocols, was accompanied by structured training for ethics committees and secretariats. Hands-on training sessions, user guidance, and phased onboarding helped demystify the system and build confidence. Adoption improved because committees were not simply given a platform; they were supported through the transition.

In Zimbabwe, the development of the new Medical Research Council of Zimbabwe (MRCZ) ethics portal was characterized by very strong collaboration between MRCZ and the Medicines Control Authority of Zimbabwe (MCAZ). Early alignment between the ethics and regulatory authorities ensured that key workflows (including protocol submission, document management, completeness screening, reviewer evaluation, and overall application processing) were coherent and that institutional roles were respected. This collaboration increased trust in the system and reduced resistance to change.

Across countries, several governance choices have proven critical to strengthening clinical research oversight systems, including clinical trials:

• Early and continuous stakeholder engagement
• Clear institutional ownership
• Alignment of digital workflows with national SOPs and legal mandates
• Investment in training and change management
• Cross-institutional collaboration where mandates intersect.

Across countries, what recurring digital challenges (connectivity, payments, interoperability, user training) could become bottlenecks, and how is TRACE addressing them early?

Recurring digital challenges across countries include interoperability between institutions, system optimization to accommodate new functionalities (such as adverse event monitoring), and sustained user capacity. While clinical trials are a primary focus, these challenges apply more broadly to clinical research oversight systems, which must also support other types of research—including behavioral and social research—reviewed by ethics committees and which must also be captured, managed, and routed within digital systems. Therefore, interoperability, system functionality, and user capacity must be designed to support the full research ecosystem, not just clinical trials.

As platforms mature, many authorities are expanding their purpose beyond protocol submission to support end-to-end lifecycle oversight of clinical research, including review, amendments, safety reporting, and study closure. This requires upgrading existing systems that were not originally designed for modular expansion. Without early technical and governance alignment, such upgrades can strain legacy architecture and institutional workflows.

Tanzania provides a useful example. Under TRACE, upgrades to the National Health Research Management Information System’s (NIMR) Research Ethics Information Management System (REIMS) include interoperability with the Tanzanian Medicines & Medical Devices Agency’s (TMDA) Regulatory Information Management System (RIMS) for real-time clinical trial status access, automated turnaround-time calculations, red-flag alert systems, and integration with national institutions such as the Tanzania Commission for Science and Technology (COSTECH). These enhancements illustrate the shift from static submission portals to active oversight tools.

TRACE addresses these bottlenecks early through co-design, joint technical planning across institutions, phased implementation, and broad, structured user training on digital systems across clinical research workflows (not just one protocol or trial). Digital reform is therefore approached not as a one-time build, but as an iterative governance and capacity-strengthening process.

Scoping to Implementation to Scale

As TRACE moves from scoping to implementation, what early indicators are you watching most closely to decide whether a country is ready to scale clinical trial reforms nationally?

As TRACE moves from scoping to implementation, we focus less on activity completion and more on institutional readiness signals. Key early indicators include:

• National regulatory authority ownership of (and leadership commitment to) reforms; revision of the National Code of Health Research Ethics in Nigeria, for example, signals institutional willingness to anchor reforms in updated governance frameworks.
• Legal and regulatory alignment, such as in Zimbabwe, where legislative updates are underway to strengthen oversight of research involving human participants, including clinical trials. Scaling is unlikely without this foundation.
• Operational use of new systems, not just developing digital platforms but generating pilot evidence of their successful use in CTA reviews and decision-making.
• Cross-institutional coordination, particularly between ethics committees and regulatory authorities to reduce duplication and fragmented oversight in clinical trial review.
• Sustainability planning including budget allocation, IT support structures, and training plans that pick up where TRACE funding ends.

Scale becomes realistic when reforms are embedded into routine practice, supported by governance structures, and internally owned. This also includes ensuring that sustainable financing mechanisms are in place to support clinical trial oversight beyond TRACE funding. Without these signals, national expansion risks replicating tools rather than strengthening systems.

Additional TRACE examples illustrate these readiness signals in practice. In Tanzania, interoperability between NIMR’s research ethics system and TMDA’s regulatory platform is being developed to support real-time tracking of clinical trial status and improved coordination across institutions. In Nigeria, TRACE is supporting the strengthening and optimization of the NHREC e-portal, including user training and system enhancements to improve functionality and adoption in clinical trial review processes.

With Kenya now included in TRACE, what lessons from the first four countries are shaping how TRACE approaches expansion?

As TRACE has expanded to include Kenyan institutions, several lessons from the first four countries (Rwanda, Tanzania, Nigeria, and Zimbabwe) are shaping our approach.

First, clearly defined objectives supported by a robust monitoring and evaluation framework are important. Early experience demonstrated that broad reform ambitions must be translated into concrete outputs, measurable outcomes, defined timelines, and accountable functional leads; for example, designated focal points within national regulatory authorities, ethics committees, and implementing partners responsible for delivering specific activities. Expansion is therefore anchored in structured workplans and KPI frameworks from the outset.

Second, early and deliberate cross-institutional collaboration is essential. In Kenya, four institutions are engaged in CTA review from the very beginning: the Pharmacy and Poisons Board (PPB), the National Commission for Science, Technology and Innovation (NACOSTI), the Kenya Medical Research Institute (KEMRI) Ethics Committee, and the Moi Teaching & Referral Hospital/Moi University – Institutional Scientific & Ethical Review Committee (MTRH/MU-ISERC). A central priority is enabling parallel review of clinical trial applications between ethics committees and PPB, alongside strengthening digital systems to improve workflows within each institution. Another key objective is to ensure appropriate alignment of information flows between IRBs and NACOSTI, without requiring full system integration. Experience from other countries has shown that digital implementation and parallel review mechanisms can become fragmented if governance arrangements, data flows, and institutional roles are not explicitly aligned early.

Third, digital reform is approached as a joint governance exercise, not merely a technical deployment. Interoperability, coordinated SOP development, and harmonized parallel review pathways are prioritized to prevent duplication and siloed oversight structures.

In short, expansion is no longer about replicating tools. It is about embedding structured objectives, measurable outcomes, and institutional coordination mechanisms from the outset to ensure that reforms are coherent, scalable, and nationally owned.

Your March 2026 newsletter provides updates on several national initiatives; would you please recap a few highlights from these or other national initiatives?

The March 2026 TRACE Newsletter reflects a clear shift from scoping to implementation across participating countries.

The TRACE project in Rwanda moved beyond system assessment to concrete system design. This includes the validation of revised SOPs for administrative screening, initial review, and monitoring, which are set to be featured on the recently revamped Rwanda National Ethics Committee (RNEC) website. The team has finalized a technical roadmap to integrate a new locally owned digital ethics review system with the Rwanda Food and Drugs Authority’s Integrated Regulatory Information Management System (IRIMS) platform, which is expected to directly address critical vulnerabilities identified during a digital needs assessment of the previous third-party system solution.

In Nigeria, nationwide rollout of the NHREC e-Portal, accompanied by user training of more than 60 ethics committee members, demonstrates that digital reform is not merely conceptual but is operational. Importantly, discussions on sustainable fee models and the ongoing review of the National Code of Health Research Ethics indicate that governance and quality improvement are advancing alongside digitalization.

In Tanzania, strengthened coordination between the National Health Research Management Information System (NIMR) and the Tanzanian Medicines & Medical Devices Agency (TMDA), and plans to enhance its National Research Ethics Information Management System (NREIMS) to manage amendments and serious adverse events, illustrate a move toward lifecycle oversight and regulatory-ethics synergy. Tanzania also achieved a landmark milestone with the development of the National Traditional Medicine Research Guidelines, a move that diversifies the clinical trial ecosystem by bridging regulatory gaps for traditional medicine research.

In Zimbabwe, modernization efforts combine legislative reform, through drafting a new Medical Research Bill, with the launch of a revamped website for the Medical Research Council of Zimbabwe (MRCZ) and development of an integrated digital review system linking the MRCZ and the Medicines Control Authority of Zimbabwe (MCAZ). This dual approach addresses both structural and operational bottlenecks.

Kenya has transitioned into the project following a successful prioritization meeting in Nairobi, focusing on a costed concept note to enable parallel review pathways and sustainable financing.

Additionally, TRACE’s benchmarking visit to the Uganda National Council for Science and Technology (UNCST) highlights a forward-looking commitment to learning from established digital platforms, particularly regarding interoperability and joint review models. Finally, the project reached a collaborative milestone with the successful kick-off of the TRACE Bioethics Forum webinar series, led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. The inaugural session, hosted by Rwanda, focused on the complex ethical considerations of the Marburg Virus Outbreak clinical trials. By sharing lessons learned from the outbreak, the forum has established a vital platform for institutional growth and ethical preparedness across the continent.

Long-Term Vision and Impact

Looking ahead five to 10 years, what would success look like for TRACE engagement in Africa: stronger institutions, a larger pipeline of locally led trials, or a different relationship between African regulators and global sponsors?

Success for TRACE would be evidence of system-level transformation anchored in transparency, efficiency, and predictability related to clinical research.

First, success would mean stronger, self-sustaining institutions responsible for clinical research oversight; i.e., ethics committees and regulatory authorities operating under stable funding/financial models, clear mandates, updated/current legal frameworks, and interoperable digital systems. Transparent processes, publicly available guidelines, and traceable digital workflows would make decision-making by ethics committees and regulatory authorities clearer and more accountable. Predictable timelines and standardized procedures would reduce uncertainty for investigators and sponsors alike.

Second, we would expect to see a larger and more diverse pipeline of locally led clinical trials. When review systems are transparent and predictable, local investigators are better positioned to initiate research aligned with national health priorities because they can be confident that oversight processes are rigorous but navigable.

Third, success would reshape the relationship between African regulators and global sponsors. Transparent standards and predictable processes foster trust. Instead of being perceived as opaque or slow, regulatory and ethics authorities would be recognized as reliable, technically competent partners who are fully integrated into the global research ecosystem and yet retain contextual authority.

Ultimately, TRACE’s long-term impact would be measured not only in shorter regulatory timelines but in institutional credibility, research sovereignty, and a culture of accountable, high-quality oversight grounded in transparency and predictability.

How can regulatory and ethics professionals interested in your work learn more about or perhaps even support/contribute to your work?

Regulatory and ethics professionals interested in TRACE can engage with the project in several ways.

First, we encourage colleagues to visit the TRACE website to access newsletters, country updates, and technical insights. Professionals can also connect directly via connect@traceclinicalethics.com or follow TRACE on LinkedIn and X (@traceinafrica on both platforms) for ongoing updates.

Second, TRACE welcomes technical collaboration and peer learning. Regulatory authorities, ethics committees, academic institutions, and digital health experts may contribute through benchmarking exchanges, harmonization dialogues, capacity-building initiatives, and knowledge sharing on topics such as digital oversight systems, IRB accreditation, reliance models, and sustainable financing frameworks.

Third, institutions interested in strengthening their own ethics and regulatory systems may explore partnership discussions, particularly in areas aligned with TRACE’s five technical workstreams.

TRACE is fundamentally collaborative. Strengthening clinical trial oversight across Africa requires a growing network of professionals committed to transparency, predictability, and high-quality review. We welcome engagement from those who share this vision.

On Sustainability and Financing

How is TRACE addressing financial sustainability of clinical trial oversight systems?

Financial sustainability is a core component of TRACE, as effective clinical trial oversight depends on reliable and predictable resources. Across countries, key challenges include limited and fragmented funding, reliance on donor support, and constrained financial autonomy of ethics committees and regulatory authorities. TRACE supports countries in addressing these gaps by developing practical financing approaches, including structured review fee models for clinical trial applications, financial planning tools, and revenue projections aligned with national systems. The objective is to enable oversight institutions to operate sustainably, support essential functions such as review and monitoring, and progressively strengthen their independence and readiness for higher levels of regulatory maturity.