On June 4, 2025, a national consultative workshop was organized at Getfam Hotel, Addis Ababa, bringing together key stakeholders in Ethiopia’s clinical trial landscape. The meeting was organized by the Advisory Committee on Clinical Trials (ACT), housed at CDT-Africa, College of Health Sciences, Addis Ababa University, in collaboration with the National Research Ethics Review Board (NRERB), Ministry of Education, and the Ethiopian Food and Drug Authority (EFDA). In addition to the core organizers, other key stakeholders participating in this high-level forum included the Armauer Hansen Research Institute (AHRI) and Institutional Research Ethics Review Committees (IRERCs) chairs and research directors from Addis Ababa University College of Health Sciences, Jimma University, Mekelle University, Arba Minch University, Hawassa University and Addis Continental Institute of Public Health. The goal of the one-day consultative meeting was to draw actionable recommendations to improve the quality and efficiency of protocol review and recommending harmonized solutions.

The workshop featured presentations by representatives of selected Level-A IRERCs, NRERB and EFDA, who spoke about the efficiency, quality, and structural differences in their current review systems. Two PIs with experience in leading clinical trials, Dr. Mezgebu Silamsew, University of Gondar and Dr. Tamiru Shibru, Arba Minch University also shared their practical challenges related to protocol review and implementation issues. In a moderated discussion, participants explored key areas including the standardization of review procedures (such as joint reviews), review fee structures, harmonization of oversight activities, turnaround times for protocol review, emerging regulatory issues, systems for mutual recognition and reliance between IRERCs, capacity building for ethics reviewers and investigators, and the decentralization of review responsibilities. Actionable recommendations were made by the participants including: establishing mutual recognition between accredited IRERCs to avoid duplicative reviews; developing a uniform review fee framework, adaptable to the nature of the study; implementing maximum response timeframes and shifting toward electronic review platforms; coordinating capacity-building efforts, gradual decentralization of clinical trial reviews, following capacity strengthening and IRERC accreditation. The workshop confirmed the importance of harmonization in ensuring ethical, timely, and high-quality clinical trials in Ethiopia. NRERB committed to integrating the recommendations into upcoming guideline revisions, and all stakeholders agreed to take institutional ownership of follow-up actions. The workshop concluded with closing remarks by Professor Abebaw Fekadu, Head of CDT-Africa, and a keynote speech by Ms. Heran Gerba, Director General of EFDA, who both emphasized the urgent need and relevance of a harmonized and efficient ethics and regulatory system.