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Keywords

COVID-19, COVID-19 related research, Ethical review, Research ethics committee, Thailand

Abstract

Objective: To explore the challenges encountered in the ethical review process and timeline of COVID-19 related research at the Human Research Ethics Committee of Thammasat University (Medicine) (HREC-TUMED), Thailand, focusing on submission characteristics, review outcomes, and committee adaptations. Materials and Methods: This retrospective descriptive study analyzed COVID-19 research protocols submitted to HREC-TUMED between June 2020 and July 2022. Protocols were evaluated for research types, investigator affiliations, funding sources, review types, and timeline metrics, using descriptive statistics. Results: A total of 89 COVID-19 related research protocols were submitted to HREC-TUMED, with the majority originating from faculty investigators (64%). Most protocols underwent expedited review (83.1%), reflecting the predominance of minimal-risk observational and secondary data studies. At initial review, the majority of protocols required revision for approval, defined as minor revisions not requiring further committee review, while only one protocol required revision and resubmission, necessitating additional ethical review, and none were rejected. Review timelines remained stable throughout the study period. The median time from initial submission to issuance of initial review results ranged from 10 to 14 days, and the median total time from submission to final approval ranged from 33 to 52 days (range, 2–179 days). Key challenges included increased protocol volume, variability in protocol quality, and the need for timely communication with investigators. Conclusion: HREC-TUMED successfully managed the increased workload by adapting procedures, including implementing an online submission system and expanding extra meeting schedules. Continued focus on improving review efficiency and protocol quality will support ethical oversight during ongoing pandemic research and future public health emergencies.

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