Kenya has officially joined the TRACE Project, a regional initiative, aimed at strengthening ethics and regulatory systems governing clinical trials across Africa through digital integration and harmonized review processes.
The Trial Regulation and Clinical Ethics Optimization (TRACE) Project announced Kenya’s inclusion on May 14, 2026, expanding the initiative’s footprint beyond Tanzania, Rwanda, Nigeria and Zimbabwe.
The Kenyan rollout will be implemented jointly by the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), the Kenya Medical Research Institute (KEMRI), and the Moi Teaching and Referral Hospital/Moi University College of Health Sciences Institutional Scientific and Ethical Review Committee (MTRH/MU-ISERC).
The consortium said the initiative seeks to improve efficiency, transparency and coordination in clinical trial review systems while maintaining participant safety and ethical compliance.
Among the key reforms planned under the Kenyan programme is the adoption of parallel review mechanisms between ethics review boards and the PPB to reduce duplication and shorten approval timelines for research protocols.
The project will also support modernization and integration of digital platforms to enable seamless end-to-end submission, review and management of clinical trial applications.
According to the consortium, the reforms are expected to improve workflow coordination, data management and interoperability among research oversight institutions.
The TRACE Project further aims to strengthen institutional capacity through training programmes, standardized review tools and continuous professional development for ethics and regulatory reviewers.
Another priority area will be enhancement of Institutional Review Board accreditation and oversight systems in collaboration with NACOSTI to promote consistency and accountability in clinical research governance.
The consortium said the project targets reducing protocol review timelines to below 60 days through improved coordination and streamlined operational procedures.
“The TRACE Project is dedicated to improving the transparency, predictability and efficiency of clinical trial ethics and regulatory reviews,” the consortium said in a statement.
The initiative leverages digital tools and collaborative frameworks to accelerate delivery of medical innovations and life-saving interventions across participating countries.
The consortium also highlighted milestones already achieved in partner states since the project’s implementation.
One of the notable achievements is the launch of the TRACE Bioethics Forum, a quarterly engagement platform bringing together National Research Ethics Committees and Institutional Review Boards to deliberate on emerging ethical challenges in health research.
The inaugural session, co-led by Rwanda, focused on ethical considerations during the 2024 Marburg outbreak response.
Zimbabwe has also made progress in developing an integrated Clinical Trials and Protocol Processing System designed to support electronic submission, screening and review of research protocols.
The system has already been presented to the Medicines Control Authority of Zimbabwe and the Medical Research Council of Zimbabwe, while user training materials have been prepared ahead of implementation.
In Rwanda, technical specifications for a National Digital Ethics Review System have been finalized to facilitate parallel submissions with the Rwanda Food and Drugs Authority.
The TRACE Project additionally supported revision of Standard Operating Procedures for Rwanda’s National Ethics Committee to align them with international ethical and regulatory standards.
Meanwhile, Nigeria is nearing completion of a review of its National Code of Health Research Ethics aimed at strengthening clinical trial review mechanisms and reliance frameworks.
Plans are also underway to enhance Nigeria’s National Health Research Ethics Committee digital platform to improve research submission and review workflows.
In Tanzania, the National Institute for Medical Research has intensified training and mentorship programmes for regulators, ethics committee members and researchers to strengthen understanding of clinical trial review procedures and good regulatory practices.
Tanzania has also commenced development of National Traditional Medicine Research Guidelines intended to bridge existing regulatory gaps and align local research practices with international ethical standards.
The TRACE consortium is expected to convene in Harare in early June for its second physical regional meeting to assess progress and coordinate the next phase of implementation across participating countries.
By Anita Kariuki
