Self-evaluation of ethical review committee’s functioning at Foundation University Medical College (FUMC) through structured constitution-practice-outcome (CPO) assessment model

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%). conclusion: ethical review committee with its limited resources was fulfilling its founding objectives as depicted by constitution-practice-outcome model. � 2017,pakistan medical association. all rights reserved.