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Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low- and middle-income countries
  1. Henry Silverman1,
  2. Hany Sleem2,
  3. Keymanthri Moodley3,
  4. Nandini Kumar4,
  5. Sudeshni Naidoo5,
  6. Thilakavathi Subramanian4,
  7. Rola Jaafar6,
  8. Malini Moni7
  1. 1University of Maryland School of Medicine, Baltimore, Maryland, USA
  2. 2National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt
  3. 3University of Stellenbosch, Matieland, South Africa
  4. 4Indian Council of Medical Research, Chennai, India
  5. 5University of the Western Cape, Matieland, South Africa
  6. 6Ain Wazein Hospital, Beirut, Lebanon
  7. 7Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Dr Henry Silverman, University of Maryland School of Medicine, 110 South Paca Street/2nd Floor, Baltimore, MD 21201, USA; hsilverm{at}medicine.umaryland.edu

Abstract

Purpose Many research ethics committees (RECs) have been established in low- and middle-income countries (LMICs) in response to increased research in these countries. How well these RECs are functioning remains largely unknown. Our objective was to assess the usefulness of a self-assessment tool in obtaining benchmarking data on the extent to which RECs are in compliance with recognised international standards.

Methods REC chairs from several LMICs (Egypt, South Africa and India) were asked to complete an online self-assessment tool for RECs with a maximum score of 200. Individual responses were collected anonymously.

Results The aggregate mean score was 137.4±35.8 (∼70% of maximum score); mean scores were significantly associated with the presence of a budget (p<0.001), but not with duration of existence, frequency of meetings, or the presence of national guidelines. As a group, RECs achieved more than 80% of the maximum score for the following domains: submission processes and documents received, recording of meeting minutes, criteria for ethical review and criteria for informed consent. RECs achieved less than 80% of the maximum score for the following domains: institutional commitment, policies and procedures of the REC, membership composition and training, policies and procedures for protocol review, elements of a decision letter and criteria for continuing review.

Conclusions This study highlights areas where RECs from LMICs can improve to be in compliance with recommended international standards for RECs. The self-assessment tool provides valuable benchmarking data for RECs and can serve as a quality improvement method to help RECs enhance their operations.

  • Research Ethics Committees
  • Developing Countries
  • Informed Consent
  • Ethical Review

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