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Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version

BACKGROUND: Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB’s effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published...

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Autores principales: Liu, Xing, Wu, Ying, Yang, Min, Li, Yang, Hahne, Jessica, Khoshnood, Kaveh, Coleman, Linda, Wang, Xiaomin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479956/
https://www.ncbi.nlm.nih.gov/pubmed/34583718
http://dx.doi.org/10.1186/s12910-021-00699-z
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author Liu, Xing
Wu, Ying
Yang, Min
Li, Yang
Hahne, Jessica
Khoshnood, Kaveh
Coleman, Linda
Wang, Xiaomin
author_facet Liu, Xing
Wu, Ying
Yang, Min
Li, Yang
Hahne, Jessica
Khoshnood, Kaveh
Coleman, Linda
Wang, Xiaomin
author_sort Liu, Xing
collection PubMed
description BACKGROUND: Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB’s effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published in China evaluating IRB performance measures by the use of a standardized tool. This study was therefore conducted to develop a Chinese version of the IRB Researcher Assessment Tool (IRB-RAT), assess the psychometric properties of the Chinese version (IRB-RAT-CV), and validate the tool for use in China. METHODS: In this cultural adaptation, cross-sectional validation study, the IRB-RAT-CV was developed through a back-translation process and then distributed to 587 IRB staff members and researchers in medical institutions and schools in Hunan Province that review biomedical and social-behavioral research. Data from the 470 valid questionnaires collected from participants was used to evaluate the reliability, content validity, and construct validity of the IRB-RAT-CV. RESULTS: Participants’ ratings of their ideal and actual IRB as measured by the IRB-RAT-CV achieved Cronbach's alpha 0.989 and 0.992, Spearman-Brown coefficient 0.964 and 0.968, and item-total correlation values ranging from 0.631 to 0.886 and 0.743 to 0.910, respectively. CONCLUSION: The IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China.
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spelling pubmed-84799562021-09-29 Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version Liu, Xing Wu, Ying Yang, Min Li, Yang Hahne, Jessica Khoshnood, Kaveh Coleman, Linda Wang, Xiaomin BMC Med Ethics Research BACKGROUND: Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB’s effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published in China evaluating IRB performance measures by the use of a standardized tool. This study was therefore conducted to develop a Chinese version of the IRB Researcher Assessment Tool (IRB-RAT), assess the psychometric properties of the Chinese version (IRB-RAT-CV), and validate the tool for use in China. METHODS: In this cultural adaptation, cross-sectional validation study, the IRB-RAT-CV was developed through a back-translation process and then distributed to 587 IRB staff members and researchers in medical institutions and schools in Hunan Province that review biomedical and social-behavioral research. Data from the 470 valid questionnaires collected from participants was used to evaluate the reliability, content validity, and construct validity of the IRB-RAT-CV. RESULTS: Participants’ ratings of their ideal and actual IRB as measured by the IRB-RAT-CV achieved Cronbach's alpha 0.989 and 0.992, Spearman-Brown coefficient 0.964 and 0.968, and item-total correlation values ranging from 0.631 to 0.886 and 0.743 to 0.910, respectively. CONCLUSION: The IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China. BioMed Central 2021-09-28 /pmc/articles/PMC8479956/ /pubmed/34583718 http://dx.doi.org/10.1186/s12910-021-00699-z Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Liu, Xing
Wu, Ying
Yang, Min
Li, Yang
Hahne, Jessica
Khoshnood, Kaveh
Coleman, Linda
Wang, Xiaomin
Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title_full Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title_fullStr Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title_full_unstemmed Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title_short Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version
title_sort cross-cultural validation of the irb researcher assessment tool: chinese version
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479956/
https://www.ncbi.nlm.nih.gov/pubmed/34583718
http://dx.doi.org/10.1186/s12910-021-00699-z
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