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从临床研究人员对伦理认知及满意度现状展望伦理工作

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目的 了解浙江大学医学院附属邵逸夫医院研究人员伦理审查主观清楚、客观了解及伦理工作满意度的情况,以及三者之间的关系,为医院伦理审查工作提供改进意见。方法 通过问卷调查,对浙江大学医学院附属邵逸夫医院共578名相关人员于2023年10月进行临床研究伦理认知及满意度的调查。比较不同岗位、职称分布对伦理审查工作的认知与满意度,对伦理审查主观清楚、客观了解情况与总体满意度进行相关性分析,采用二元logistic回归分析临床研究人员伦理审查满意度的影响因素。结果 各类临床研究人员对伦理审查的主观清楚程度均偏低,总人群的了解率为20。59%,低于客观了解程度的78。03%,总体满意度为45。67%。主客观了解程度得分与满意度得分之间呈正相关性(P<0。001)。二元logistic回归分析显示,主观清楚是研究人员伦理审查满意的重要影响因素(P<0。001)。结论 为提高临床研究人员的伦理知识水平,应面向全院人员定期开展相关医学伦理和生命伦理的培训,普及相关政策法规和知识。同时,伦理办公室应立足于服务好临床研究者及临床研究质量,改进工作方式方法,为临床研究人员提供咨询服务和技术支持。
Prospect of Ethical Work From the Current Situation of Clinical Researchers'Ethical Cognition and Satisfaction
Objective To understand the subjective clarity,objective understanding and satisfaction with ethical work of researchers in Sir Run Run Shaw Hospital,Zhejiang University School of Medicine,and the relationship between the three,so as to provide suggestions for improving the ethical review of the hospital.Methods Through questionnaire survey,a total of 578 relevant personnel of Sir Run Run Shaw Hospital,Zhejiang University School of Medicine were investigated on the cognition and satisfaction of clinical research ethics work in October 2023.The cognition and satisfaction of ethical review work in different positions and titles were compared.The correlation between subjective clear,objective knowledge of ethical review and overall satisfaction was analyzed.Binary logistic regression was used to analyze the influencing factors of clinical researchers'satisfaction with ethical review.Results All kinds of clinical researchers have low subjective awareness of ethical review.The understanding rate of the total population was 20.59%,which is lower than the objective understanding of 78.03%.The overall satisfaction rate was 45.67%.There was a positive correlation between subjective and objective understanding scores and satisfaction scores(P<0.001).Binary logistic regression analysis showed that subjective clarity was an important influence on researchers'satisfaction with ethical review(P<0.001).Conclusion In order to improve the ethical knowledge level of clinical researchers,training on medical ethics and bioethics should be carried out regularly for all staffs in the hospital,and relevant policies,regulations and knowledge should be popularized.At the same time,the ethics office should focus on serving clinical researchers and the quality of clinical research,improving working methods,and providing consulting services and technical support for clinical researchers.

clinical researchethical cognitionethics reviewsatisfactioncorrelationprospect

许鸣、杨漾池、金烨成、方滢芝

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浙江大学医学院附属邵逸夫医院科研办公室,浙江杭州 310000

临床研究 伦理认知 伦理审查 满意度 相关性 展望

2024

中国卫生标准管理
《中国卫生标准管理》杂志社

中国卫生标准管理

影响因子:1.374
ISSN:1674-9316
年,卷(期):2024.15(18)