Kenya

Clinical research ethics and regulatory oversight in Kenya are coordinated through nationally mandated institutions with complementary roles. The National Commission for Science, Technology and Innovation (NACOSTI) is responsible for national research authorization and the accreditation of Institutional Scientific and Ethics Review Committees (ISERCs). The Pharmacy and Poisons Board (PPB) serves as the national regulatory authority for medicines, medical devices, diagnostics, and clinical trials.

Ethical review of health research is conducted by accredited institutional committees based within universities, research institutions, and referral hospitals, including committees hosted by Kenya Medical Research Institute (KEMRI) and Moi University, in collaboration with Moi Teaching and Referral Hospital. These committees have been established to ensure that all proposals that the ISERC oversee adhere to scientific and ethical principles that are fundamental to the conduct of research involving human participants.

KEMRI| Moi University| NACOSTI | PPB

COUNTRY BACKGROUND

Kenya has a well-established clinical research oversight system supported by a strong legal and institutional framework. Ethical review is implemented through a decentralized network of NACOSTI-accredited ISERCs operating across academic, research, and clinical institutions. National coordination and accountability are maintained through NACOSTI, while regulatory oversight of clinical trials and regulation of health products is led by PPB, helping to ensure alignment between ethical review processes and product regulation.

The country has a high level of research activity, including multi-site and multi-country studies, which places increasing operational and review demands on ethics and regulatory systems. In response, Kenya continues to explore opportunities to strengthen coordination between ethics committees and regulatory authorities, streamline review pathways, and enhance transparency and efficiency, including the progressive adoption of digital systems to support ethics and regulatory oversight.

KPIs and Milestones

The following institutions have prioritized the following key outcomes to be achieved through the TRACE project initiative.

Kenya Medical Research Institute (KEMRI):

Strengthening of institutional capacity to oversee clinical trials through an optimized digital management system.
Reduction of clinical trial review timelines through establishment of benchmark of review timelines over past 2 or 3 years for interventional studies and development of process map of current and future state.
Establishment of an ethics review reliance model to reduce duplication of effort across sites.
Securing a sustainable institutional financing framework for long-term clinical trial oversight operations.

Moi Teaching and Referral Hospital/Moi University – Institutional Scientific & Ethics Review Committee (MTRH/MU – ISERC):

Optimize ISERC Review Processes:

To re-engineer protocol review workflow by transitioning to a committee-centred review model with a closed pool of expert reviewers holding formal appointment letters; develop SOPs for reliance agreements and parallel submission of clinical trial protocols; and establish a dedicated review pathway for clinical trial protocols. Target: reduce review timeline to less than 60 days.
Digital System Upgrade and Capacity Strengthening:

To drive RHInnO platform adoption through phased, hands-on training workshops for all committee members and expert reviewers; and leverage on automated protocol tagging & AI-assisted review features; to upgrade the digital system to enable full protocol review – amendments, continuing review, reporting of SAEs; and to integrate the digital system with that of NACOSTI and PPB. Target: achieve 75% digital adoption.
Enhance Reviewer Motivation and Engagement:

To formalize ISERC work value by negotiating inclusion in MTRH and Moi University promotion criteria; and establish Annual Service Excellence Awards and formal recognition program. Target: improve reviewer satisfaction by 25%.
Strengthen ISERC Member and Staff Capacity:

To implement continuous training programs covering research ethics, regulatory standards, AI in research, and post-approval monitoring. Target: 100% capacity certification.
Establish a Sustainable Financial Model:

To engage financial consultant to audit current processes, develop diversified revenue streams, and reintroduce continuing review fees. Target: achieve 50% operational budget coverage with <10% variance.

National Commission for Science Technology and Innovation (NACOSTI):

Harmonize and refine regulatory review processes through standardized ethical frameworks to ensure consistent and efficient research oversight in Kenya.
Strengthen staff and ISERC capacity in the review and oversight of clinical trials through development of training materials and tool kits.
Enhance the Research Information Management System (RIMS) to support online submission of applications, license renewals, and effective monitoring and coordination of clinical trial ethics review committees.
Facilitate reliance and mutual recognition of ethical approvals among clinical trial ethics review committees for multi-site trials to promote efficiency and reduce review duplication.
Establish sustainable financing models to support clinical trial oversight, monitoring, and evaluation activities.

Pharmacy and Poisons Board (PPB):

Harmonize and refine regulatory and ethics review processes through the implementation of the Parallel Review Framework to reduce prolonged timelines, accelerate trial approvals, and maintain high-quality oversight.
Improve the digital platform through the revision of standard operating procedures and guidelines, and the implementation of multi-site tracking systems, to enable a global safety reporting gateway and align Kenya's requirements with regional and continental frameworks.
Strengthen stakeholder capacity in electronic submissions, workflow tracking, and data integrity to improve efficiency in the review process through collaboration with MRCT and NACOSTI.

PRESS RELEASE: Kenya Integrates into TRACE to Streamline Clinical Trial Reviews through Parallel Submission and System Strengthening

The TRACE Project (Trial Regulation and Clinical Ethics Optimization) is proud to announce the formal inclusion of Kenya into its multi-country initiative which is already being implement in Tanzania, Nigeria, Rwanda and Zimbabwe. This expansion aims to strengthen and align Kenya’s clinical trial oversight systems with regional best practices.

The TRACE Project Explores Expansion 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.