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

Overview

Journal BMC Med Ethics

Publisher Biomed Central

Specialty Medical Ethics

Date 2021 Sep 29

PMID 34583718

Citations 2

Authors

Xing Liu

Ying Wu

Min Yang

Yang Li

Jessica Hahne

Kaveh Khoshnood

Linda Coleman

Xiaomin Wang

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Analysis of factors influencing the organizational capacity of Institutional Review Boards In China: a crisp-set Qualitative Comparative Analysis based on 107 cases.

Lu L, Shi S, Liu B, Liu C BMC Med Ethics. 2023; 24(1):74.

PMID: 37749525 PMC: 10521463. DOI: 10.1186/s12910-023-00956-3.

Performance of IRBs in China: a survey on IRB employees and researchers' experiences and perceptions.

Liu X, Wu Y, Yang M, Li Y, Khoshnood K, Luo E BMC Med Ethics. 2022; 23(1):89.

PMID: 36038889 PMC: 9426015. DOI: 10.1186/s12910-022-00826-4.

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