Evaluating Research Ethics Committees Using a Newly Developed Assessment Tool: Experience from Sri Lanka

Abstract Introduction Effective research ethics committees (RECs) are essential for safeguarding research participants and maintaining public trust in health research. The economic crisis in Sri Lanka made external accreditation financially difficult, and a locally led, affordable approach was required to strengthen ethics oversight and quality assurance. Methods The Forum for Research Ethics Committees in Sri Lanka developed a locally led framework and digital assessment tool to evaluate REC practices. Indicators were selected through a modified Delphi process, based on World Health Organization’s “Guidance for Evaluating Ethical Review Practices” and the “Benchmarking Tool for Ethics Oversight of Health-related Research”. Indicators assessed REC structure, resources, procedures, transparency, performance monitoring, and completeness of the ethics review process. A secure digital tool was developed and piloted through on-site surveys of two RECs representing different institutional maturity levels and medical systems and was refined for local applicability. Discussion/ Findings The framework enabled systematic assessment of both institutional readiness and actual ethics review practices. Incorporating document review and direct observation allowed identification of strengths and gaps not captured by benchmarking indicators alone. The process was feasible, resource-appropriate, and supported national capacity building through training of surveyors. The paperless digital approach improved standardisation, traceability and feasibility at low cost. Conclusion The FRECSL mechanism provides a transparent, low-cost approach to quality assurance of RECs in resource-limited settings. By combining readiness assessment with evaluation of review practice, it offers a balanced model aligned with international standards and may be adapted by other countries seeking to strengthen ethical oversight of health-related research.