{"title":"使用模板文件与指导提高人类受试者研究方案提交给泰国研究伦理委员会的质量。","authors":"Thana Khawcharoenporn, Wilaiwan Chimkhong, Varanya Roestpricha","doi":"10.1177/15562646211025470","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"16 5","pages":"501-513"},"PeriodicalIF":1.7000,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/15562646211025470","citationCount":"0","resultStr":"{\"title\":\"Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee.\",\"authors\":\"Thana Khawcharoenporn, Wilaiwan Chimkhong, Varanya Roestpricha\",\"doi\":\"10.1177/15562646211025470\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":50211,\"journal\":{\"name\":\"Journal of Empirical Research on Human Research Ethics\",\"volume\":\"16 5\",\"pages\":\"501-513\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2021-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1177/15562646211025470\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Empirical Research on Human Research Ethics\",\"FirstCategoryId\":\"98\",\"ListUrlMain\":\"https://doi.org/10.1177/15562646211025470\",\"RegionNum\":4,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/6/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Empirical Research on Human Research Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1177/15562646211025470","RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/6/14 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee.
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.
期刊介绍：
The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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