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

Performance of IRBs in China: a survey on IRB employees and researchers' experiences and perceptions.
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DOI:
10.1186/s12910-022-00826-4
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发表时间:
2022-08-29
期刊:
影响因子:
2.7
通讯作者:
Wang, Xiaomin
Wang, Xiaomin
中科院分区:
人文科学2区
文献类型:
--
作者:
Liu, Xing;Wu, Ying;Yang, Min;Li, Yang;Khoshnood, Kaveh;Luo, Esther;Li, Lun;Wang, Xiaomin

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绩效评估对于 IRB 运营至关重要。随着中国 IRB 的数量及其审查和监督临床研究职责的增加,非常有必要对其绩效进行评估。迄今为止,很少有研究考察中国境内IRB的表现。本研究的目的是确定IRB员工和研究人员的观点和经验,以(1)了解IRB的现状; (2)将收集的结果与其他国家的结果进行比较; (3) 找出不足之处以改进 IRB 绩效。本研究于2020年10月至2021年9月在中国进行,采用IRB-研究员评估工具中文版在线调查。 757 名受访者被纳入分析,并分为 IRB 雇员、研究人员或既是 IRB 雇员又是研究人员的人员。总体而言,理想 IRB 的得分明显高于实际 IRB 的得分。与美国国家验证研究相比,中国参与者和美国参与者对最重要和最不重要的理想项目的看法既有相同点,也有不同点。这项调查为中国实际IRB 的感知绩效提供了基准。中国的IRB可以通过针对已确定的薄弱环节进行精确调整,以改善其绩效。
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 (1) understand the current status of IRBs; (2) compare collected results with those of other countries; and (3) identify shortcomings to improve IRB performance. This study was conducted in China from October 2020 to September 2021, using an online survey with the IRB-researcher assessment tool-Chinese version. 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. 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.
机构审查委员会社区成员:他们是谁,他们做什么,他们代表谁?
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