Research Ethics Committee Systems Optimization

Research Ethics Committee Systems Optimization

TRACE (Trial Regulatory and Clinical Ethics Optimization) is a dynamic initiative to strengthen and streamline clinical trial regulatory and ethics systems across Africa. Its mission is to remove barriers to clinical research by streamlining review processes, reducing duplication, and establishing clear, efficient timelines.

Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.

The MRCT Center, as a member of TRACE’s Core Project Team and lead of the Capacity Building & Accreditation and Funding Models sub-teams, is working alongside the African Vaccine Regulatory Forum (AVAREF) and Garnet Partners, with funding support from the Gates Foundation, to design and implement sustainable regulatory and ethics solutions.

In close collaboration with local stakeholders, TRACE co-develops tools, templates, and resources tailored to the needs of African ethics committees. It promotes inter-institutional coordination and cooperation.

By bringing together national ethics committees (NECs), institutional review boards (IRBs), regulatory agencies, and sponsors, TRACE fosters a transparent, efficient, and sustainable environment for clinical research oversight. The initiative’s goal is to position Africa as a leading hub for clinical research, with pilot efforts currently underway in Rwanda, Tanzania, Zimbabwe, and Nigeria.

As part of its role, the MRCT Center leads national system assessments using the WHO Global Benchmarking Tool for Ethics Committees, provides targeted training and capacity-building programs for NECs, and supports the implementation of IRB reliance strategies. It is also collaborating with stakeholders to design a model fee structure and contributing to long-term financial sustainability and regulatory alignment.

To further support training, the MRCT Center offers an online, on-demand training course on Ethics and Review of Interventional Clinical Research available free on the WHO Academy platform. A follow-up course, Ethics and Review of Interventional Clinical Research II, is currently in development and expected in fall 2025.

Ultimately, TRACE is committed to establishing a sustainable, efficient, and globally dependable landscape for clinical research across Africa by tackling persistent challenges such as manual workflows, redundant reviews, and inconsistent timelines.

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