J Med Assoc Thai 2020; 103 (3):109

Views: 878 | Downloads: 27 | Responses: 0

PDF XML Respond to this article Print Alert & updates Request permissions Email to a friend


Factors Affecting Protocol Review Process in Standard Operating Procedures of The Human Ethics Committee of Thammasat University No. 1 (Faculty of Medicine)
Kondo S Mail, Khawcharoenporn T , Tharavanij T , Sritipsukho P , Chanvimalueng W

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


Download: PDF