Objective: To assess unmet research ethics committee (REC) requirement components and review outcomes of the trainees’
research protocols submitted to the REC.
Materials and Methods: We conducted a retrospective study of protocols which trainees were principle investigators of and were submitted to Human Ethics Committee of Thammasat University during 2014 to 2016. Unmet REC requirement components and review outcomes of the trainees’ protocols were compared with the faculty’s protocols of which review type and review period were matched.
Results: 86 trainees’ protocols and 86 faculty’s matched protocols were included. The most common unmet REC requirement component for the trainees’ protocols were inadequate description of methodology (71%). Significantly higher proportion of the trainees’ protocols had inadequate literature review, incorrect sample size calculation, and inadequate privacy and confidential management compared to the faculty’s protocols. Protocol approval rate were not different between the trainees’ and faculty’s protocols (98% vs. 95%). However, the median time from initial protocol submission to approval was significantly longer among the trainees’ protocols (71 vs. 53 days; p = 0.005).
Conclusion: Feedbacks and focused education on these unmet REC requirement components are necessary for the trainees to
improve their knowledge on research ethics and efficiency in research protocol submission to the REC.

Keywords: Medical trainees, Research protocol, Research ethics committee, Unmet requirement, Review outcomes