title: Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low- and middle-income countries.
abstract: OBJECTIVE
  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.
authors.affiliation: University of Maryland School of Medicine, Baltimore, Maryland, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Silverman
authors.affiliation: National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
authors.forename: Hany
authors.initials: H
authors.lastname: Sleem
authors.affiliation: University of Stellenbosch, Matieland, South Africa.
authors.forename: Keymanthri
authors.initials: K
authors.lastname: Moodley
authors.affiliation: Indian Council of Medical Research, Chennai, India.
authors.forename: Nandini
authors.initials: N
authors.lastname: Kumar
authors.affiliation: University of the Western Cape, Matieland, South Africa.
authors.forename: Sudeshni
authors.initials: S
authors.lastname: Naidoo
authors.affiliation: Indian Council of Medical Research, Chennai, India.
authors.forename: Thilakavathi
authors.initials: T
authors.lastname: Subramanian
authors.affiliation: Ain Wazein Hospital, Beirut, Lebanon.
authors.forename: Rola
authors.initials: R
authors.lastname: Jaafar
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
authors.forename: Malini
authors.initials: M
authors.lastname: Moni
mesh_terms: D002017:Budgets; D003906:Developing Countries; D004534:Egypt; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000592:standards / Q000706:statistics & numerical data; D032984:Ethics, Research; D006801:Humans; D007182:Income; D007194:India; D007258:Informed Consent; D011203:Poverty; D013019:South Africa
keywords: Developing Countries; Ethical Review; Informed Consent; Research Ethics Committees