Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership (...) composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)

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. (shrink)