Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee-Reference-Cited by-同舟云学术

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

Published:2021-06-14 Issue:5 Volume:16 Page:501-513
ISSN:1556-2646
Container-title:Journal of Empirical Research on Human Research Ethics
language:en
Short-container-title:Journal of Empirical Research on Human Research Ethics

Author:

Khawcharoenporn Thana¹²^ORCID,Chimkhong Wilaiwan²,Roestpricha Varanya²

Affiliation:

1. Department of Internal Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand

2. Human Research Ethics Committee of Thammasat University (Medicine), Thammasat University, Pathumthani, Thailand

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.

Funder

Faculty of Medicine, Thammasat University

Publisher

SAGE Publications

Subject

Communication,Education,Social Psychology

Link

http://journals.sagepub.com/doi/pdf/10.1177/15562646211025470

Reference22 articles.

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