NAIROBI – JULY 10-12, 2025

EXPANDING TRACE INTO KENYA

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 Board (PPB), where TRACE representatives engaged with senior officials from Kenya’s regulatory and ethics bodies to discuss goals, collaborative strategies, and future actions. Key Kenyan institutions set to be engaged include the National Ethics Committee, PPB, National Commission for Science, Technology and Innovation (NACOSTI), 2 IRBs and county-level authorities. As Kenya is being considered for formal inclusion in the project, to ensure clarity and coordination, a virtual stakeholders’ meeting was planned to introduce the project and outline project roles.

STRENGTHENING OVERSIGHT AND FUTURE COLLABORATION

The meeting underscored Kenya’s commitment to reviewing legal and regulatory frameworks to reduce duplication and align with global best practices, building digital platforms to manage ethics and regulatory submissions, and enhancing capacity development through partnerships with MRCT and AVAREF. Stakeholders agreed that community engagement and benefit sharing must remain central to research implementation. Kenya will begin with a national needs assessment to map current ethics systems and identify priorities, followed by WHO Ethics Committee Benchmarking exercises to guide future collaboration. With Kenya’s inclusion, TRACE will extend its reach across East Africa further advancing efforts toward a harmonized, efficient, and digitalized clinical trial ethics ecosystem.

The outcomes of the meeting were to develop detailed work packages and a costed concept note with key institutions as stated above for alignment with the overall TRACE project.