The KEMRI’s Scientific and Ethics Review Unit (SERU) has prioritized the following key outcomes to be achieved through the TRACE project initiative:

• 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.

MTRH/MU – ISERC has prioritized the following key outcomes to be achieved through the TRACE Project initiative:

• 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.

NACOSTI has proposed the following priority outcomes to strengthen clinical trials ethical review and oversight in Kenya:

• 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.