Revision of a self-assessment tool for research ethics committees in low- and middle-income countries: Incorporation of elements that safeguard participants' rights and welfare.

Abstract

Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self-Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare. To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences. We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.