Factors Affecting Protocol Review Process in Standard
Operating Procedures of The Human Ethics Committee of
Thammasat University No. 1 (Faculty of Medicine)
Kondo S, PhD1, Khawcharoenporn T, MD1, Tharavanij T, MD1, Sritipsukho P, MD1, Chanvimalueng W, MD1
Affiliation :
1 Human Ethics Committee of Thammasat University No. 1 (Faculty of Medicine), Thammasat University, Pathumthani, Thailand
In 2002, the Faculty of Medicine’s Human Ethics Committee of Thammasat University No. 1 (TU-EC1) was established,
creating standard operating procedures (SOP). Our previous study revealed there was a notable delay in the protocol review process.
The authors identified factors that would improve the process for principal investigators (PIs); this would help advance research
commencement. A survey was performed using questionnaires. Descriptive data were analyzed by STATA version 9.0. Time used
from protocol submission to returning the initial review results to PIs in 2015 to 2018 were collected from protocol review
records and analyzed by mean and interquartile range (IQR), 25% and 75%. Problems with literature review, research methodology
i.e. limited details, and research design, were the most prevalent delay factors noted by reviewers. Other issues were inadequately
written information sheets/informed consent: unnecessary information, inappropriate language choices, and overly complex
design. These findings provide important clues to improve the TU-EC1 review process. PIs would likely benefit from more protocol
training. In addition, identifying pitfalls, learning the ethics for human studies, and coaching/mentorship programs for new
researchers and reviewers would help support the quality and efficiency of the process.
Keywords : Human ethics committee of Thammasat University No. 1 (Faculty of Medicine), Efficiency, Protocol review process,
Ethical approval
All Articles
Download