Evaluation of functioning of ethics committee of a tertiary care teaching institute during covid 19 pandemic

Author: 
Ganesh Dakhle., Mrunalini Kalikar and Akhil Giradkar

Introduction: Since December 2019, the world is facing a new humanitarian emergency due to a novel corona virus. Lack of effective treatment or prevention of COVID-19 demands research on a priority basis. Despite the urgent situation, safety and quality of research must be guaranteed. Absence of any SOP to deal with emergency situations and lockdowns hampered the functioning of the ECs. The present study was planned to evaluate the functioning of ethics committee of a tertiary care teaching institute during COVID 19 pandemic. Material and method: A retrospective observational study was initiated after obtaining approval from Institutional Ethics Committee (IEC). Evaluation of the activities of the IEC was done in respect to the protocols of regulatory clinical trials and academic research submitted to IEC between March 2020 to October 2020. Results: The number of meetings conducted by IEC for review of regulatory trials was 11. Four were conducted virtually and the rest were face to face. The protocol synopsis was circulated 2-8 days prior to the meeting to the EC members for review for protocols of COVID regulatory trials. Monitoring by EC was done for 8 out of 14 clinical trials. Conclusion: IEC was able to carry out its duties even in emergency situation despite number of challenges mainly because of amendment of SOP for emergency research review for conducting virtual meeting, accelerating the review and approval process by shortening timelines whenever required.

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DOI: 
http://dx.doi.org/10.24327/ijcar.2021.24294.4816
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