中国伦理委员会的表现：一项对伦理委员会员工和研究人员的经验和看法的调查。
Performance of IRBs in China: a survey on IRB employees and researchers' experiences and perceptions.
机构信息
Medical Ethics Committee, Xiangya Hospital of Central South University, 87 Xiangya Road, Changsha, 410008, Hunan, People's Republic of China.
School of Literature and Journalism, Central South University, Changsha, 410012, Hunan, People's Republic of China.
出版信息
BMC Med Ethics. 2022 Aug 29;23(1):89. doi: 10.1186/s12910-022-00826-4.
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 (1) understand the current status of IRBs; (2) compare collected results with those of other countries; and (3) 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.
背景
绩效评估对于 IRB 运作至关重要。随着中国 IRB 的数量及其在审查和监督临床研究方面的职责的增加，对其绩效进行评估的需求非常大。迄今为止，针对中国的 IRB 绩效评估的研究很少。本研究的目的是了解 IRB 员工和研究人员的观点和经验，以（1）了解 IRB 的现状；（2）将收集到的结果与其他国家进行比较；（3）确定不足之处，以提高 IRB 的绩效。
方法
本研究于 2020 年 10 月至 2021 年 9 月在中国进行，采用在线调查和中国版的 IRB-研究人员评估工具。
结果
共有 757 名受访者参与了分析，分为 IRB 员工、研究人员，或同时担任 IRB 员工和研究人员的人员。总体而言，理想 IRB 的得分明显高于实际 IRB。与美国国家验证研究相比，中国参与者和美国参与者在对最理想和最不重要的理想项目的看法上既存在共识，也存在分歧。
结论
本研究为中国实际 IRB 的绩效提供了基准。可以通过针对确定的薄弱环节进行调整，来精确地调整中国的 IRB，以提高其绩效。
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