基于循证医学方法对国内外临床研究伦理培训的分析与总结  

Clinical research ethics training:A worldwide evidence-based analysis and summary

作　　者：陈正举 王睿智 杨宗泽[3] 倪靖尧 何林[5] 陈蕾[6] Chen Zhengju;Wang Ruizhi;Yang Zongze;Ni Jingyao;He Lin;Chen Lei(Ministry of Science and Technology,West China Hospital of Sichuan University,Chengdu 610041,Sichuan Province,China;Department of Integrated Care Management Center,West China Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;West China Biobank,West China Hospital of Sichuan University,Chengdu 610041,Sichuan Province,China;Department of Clinical Research Management,West China Hospital of Sichuan University,Chengdu 610041,Sichuan Province,China;Library Intelligence Center,West China Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Department of Neurology,West China Hospital of Sichuan University,Chengdu 610041,Sichuan Province,China)

机构地区：[1]四川大学华西医院科技部,成都610041 [2]四川大学华西医院门诊部全程管理中心,成都610041 [3]四川大学华西医院生物样本库,成都610041 [4]四川大学华西医院临床研究管理部,成都610041 [5]四川大学华西医院图书信息中心,成都610041 [6]四川大学华西医院神经内科,成都610041

出　　处：《中华医学科研管理杂志》2024年第2期108-116,共9页Chinese Journal of Medical Science Research Management

基　　金：科技创新2030重大项目(2020AAA0105005);国家老年疾病临床研究中心(四川大学华西医院)立项资助课题(Z2018C02)。

摘　　要：目的总结国内外临床研究伦理培训的方法与经验,分析目前伦理培训面临的机遇和问题,探索适合我国从事临床研究相关人员的伦理培训方法。方法采用循证医学的研究方法,以医学伦理、培训、方法、教学、临床和教育为关键词在PubMed、EMbase、CNKI和WanFang Data数据库检索从2015年1月至2023年7月的文献,由2名研究者独立筛选文献和提取资料,通过对国内外培训对象、内容、方法、周期、阶段、考核、宣传和结果方面进行分析、归纳和总结。结果经过筛选,共纳入59篇文献,包括英文29篇和中文30篇,涉及55家机构。国内外培训在培训对象、内容、方法、周期、阶段、考核及结果方面都有所差异;国内外机构人员经过培训后,在伦理审查、伦理意识、伦理认知和技术操作等方面均有所提升。结论国内各单位需要改进伦理培训方法,更加系统、科学地提高参与各阶段临床研究的试验人员的意识与认知,并加强伦理审查,保障受试者的权益。Objective To summarize the methods and experience about clinical research ethics training system world widely,analyze the opportunities and problems,and explore the suitable ethics training methods of human study in China.Methods The literature between January 2015 and July 2023 was retrieved in PubMed,EMbase,CNKI and WanFang Data databases using keywords such as″clinical ethics″,″training,methods″,″teaching″,″clinical″,and″education″.Two researchers independently screened the literature,extracted the data,and carried out the analysis,induction,and summary of both domestic and foreign training objects,contents,methods,periods,stages,assessments,publicity,and results.Results After the screening,a total of 59 studies,including 29 English and 30 Chinese papers,involving 55 institutions,were selected.There were many differences of training system between China and foreign country in terms of regulations and training objects,contents,methods,periods,stages,assessments,and results.Domestic and foreign institutional personnel have been improved in ehical review,ethical awareness,ethical cognition,and technical operation after the training Conclusions It is suggested that the personnel of the Clinical Research Management Institutions in China should improve the training methods,enhance the awareness and cognition of people involved in human study more systematically and scientifically,and strengthen the ethical review,protect the rights and interests of the subjects.

关 键 词：临床研究 伦理培训 培训方法 

分 类 号：R19[医药卫生—卫生事业管理]