Unmet Research Ethics Committee Requirement Components and Review Outcomes of Medical Trainees’ Research Protocols in a Thai Medical School
Khawcharoenporn T, MD, MSc1,3, Kondo S, PhD2,3, Tharavanij T, MD1,3
Affiliation : 1 Department of Internal Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand 2 Department of Pre-clinical Science, Faculty of Medicine, Thammasat University, Pathumthani, Thailand 3 Human Ethics Committee of Thammasat University No. 1, Faculty of Medicine, Thammasat University, Pathumthani, Thailand
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
