Background Performance evaluation is vital for IRB operations. As the number of IRBs and their responsibilities in reviewing and supervising clinical research grow in China, there is a significant need to evaluate their performances. To date, little research has examined IRB performance within China. The aim of this study was to ascertain the perspectives and experiences of IRB employees and researchers to understand the current status of IRBs; compare collected results with those of other countries; and identify shortcomings to improve (...) IRB performance. Methods This study was conducted in China from October 2020 to September 2021, using an online survey with the IRB-researcher assessment tool-Chinese version. Results 757 respondents were included in the analysis and classified into IRB employees, researchers, or those who are both IRB employees and researchers. Overall, the score for an ideal IRB was significantly higher than that of an actual IRB. Compared to the US National Validation study, Chinese participants and American participants both agree and differ in their perspectives on the most and least important ideal items. Conclusion This investigation provides a benchmark of the perceived performance of actual IRBs in China. IRBs in China can be precisely adjusted by targeting identified areas of weakness to improve their performances. (shrink)

BackgroundUsing 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.MethodsIn 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.ResultsParticipants’ 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.ConclusionThe IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China. (shrink)