Development of an Accessible Self-Assessment Tool for Research Ethics Committees in Developing Countries

Abstract

In response to increased research being performed in developing countries, many research ethics committees (RECs) have been established, but the quality of their ethics review systems remains unknown. Evaluating the performance of an REC remains a challenging task. Absent an accreditation process, a self-assessment mechanism would provide RECs a way to review their policies and processes against recognized international standards. We describe a self-assessment tool that was developed and reviewed by REC members and researchers from the Middle East. This tool reflects pragmatic aspects of human subjects protection, is based on international standards, is straightforward in its completion, and its items are relevant to the administrative processes that exist in many RECs in the developing world.

Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low- and middle-income countries

“…We used the self-assessment tool previously developed by individuals from LMICs with expertise in the operations of RECs and research ethics 19. The items in the tool were based on international standards 19.…”

“…The items in the tool were based on international standards 19. The tool contains the following domains: indices of institutional commitment; policies and procedures of the REC; membership composition and training; submission processes and documents received; recording of minutes; policies and procedures for review; criteria for ethical review; criteria for informed consent; elements of a decision letter; and criteria for continuing review.…”

“…However, a self-assessment process might provide an intermediate step to help RECs evaluate their performance and demonstrate their legitimacy to their stakeholders. We previously developed a self-assessment tool for RECs from LMICs based on international standards for RECs 19. The aim of this study was to have RECs from different LMICs complete this self-assessment tool so that we can determine its feasibility and collect benchmarking data against which other RECs can make comparisons.…”

Review of the Medical Research Ethics Committee (MREC), National Research Center of Egypt, 2003–2011

“…The tool was developed and reviewed by REC members and researchers from the Middle East. This tool reflects pragmatic aspects of human subjects protection, is based on international standards, is straightforward in its completion, and its items are relevant to the administrative processes that exist in many RECs in the developing world 25 .…”

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity

“…A recent study involving Egyptian RECs showed that institutional commitment is lacking, as measured by the extent to which institutions have developed policies for conflicts of interests, support investigator training in research ethics, and provides resources to support their RECs 23 .…”