Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee

Abstract

A pre–post study was conducted to evaluate the utility of template documents specifically created to assist research protocol submissions to a Thai research ethics committee (REC). A total of 172 protocols during the 2014–2016 preintervention period were matched to 172 protocols during the 2017–2019 postintervention period by type of principal investigator and REC review category. The intervention was associated with a significant reduction in initial REC requirement deficiencies in the information sheet and informed consent form, resubmission turn-around time by the principal investigator, and time form protocol submission to REC approval. The most significant postintervention improvements were for information about the consent process and listed risks of study participation. In this study, utilization of a structured protocol template with guidance instructions was associated with measurable improvement in the quality of research protocol submissions and REC review process.

Keywords

template documents guidance research ethics committee quality human subjects research protocol submission

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