title: Self-evaluation of ethical review committees functioning at Foundation University Medical College (FUMC) through structured constitution-practice-outcome (CPO) assessment model.
abstract: OBJECTIVE
  To assess the operational efficiency of the ethical review committee of a medical college.
  
  
  METHODS
  This study was conducted at the Foundation University Medical College, Islamabad, Pakistan, from 2012 to 2014. On the basis of literature review, methods for assessment of various features of ethical review committee were studied. A constitution-practice-outcome measurement model for evaluation of ethical review committee assessment process was developed. Data submitted to ethical review committee since its constitution was extracted and quantitatively analysed.
  
  
  RESULTS
  The ethical review committee comprised 14 members, including 4(28.6%) permanent and 10(71.4%) rotating clinical, basic sciences and non-medical members. As many as 45 research protocols were submitted, with submission frequency of 8(17.8%), 12(26.7%) and 25(55.5%) per year respectively, and issued ethical approval certificates within a mean duration of 7.2±3.2 days from the time of first submission to final notification. Issues looked into were according to World Health Organisation guidelines. Standard review was done on 29(64.4%) studies and expedited on 16(35.5%). In addition, 24(53.3%) protocols needed resubmission. Only 2(4.4%) protocols were not approved. The number of issues raised for resubmission was 71. Main reasons for resubmission were found to be incomplete documents 26(36.6%), invalid informed consent forms 12(16.9%) and negligence in maintaining confidentiality of study participants 9(12.7%).
  
  
  CONCLUSIONS
  Ethical review committee with its limited resources was fulfilling its founding objectives as depicted by constitution-practice-outcome model.
authors.affiliation: Physiology, Foundation University Medical College, Islamabad, Pakistan.
authors.forename: Sadia
authors.initials: S
authors.lastname: Ahsin
authors.affiliation: Physiology, Foundation University Medical College, Islamabad, Pakistan.
authors.forename: Gul E
authors.initials: GE
authors.lastname: Naghma Saeed
mesh_terms: D026683:Advisory Committees / Q000458:organization & administration* / Q000592:standards*; D026724:Ethical Review; D006801:Humans; D017146:Models, Organizational; D010154:Pakistan; D012577:Schools, Medical / Q000458:organization & administration*; D014495:Universities / Q000458:organization & administration*
keywords: Ethical review committee, Self-audit.