Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study

Abstract

Abstract Background: Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance. Materials and Methods Study Design: This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee. Results: Accredited EC’s (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC’s after accreditation. Only a few EC ‘s fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC’s like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc. Conclusion: Accreditation results in improving of EC functioning in terms of quality and governance.