摘要
目的 对某院近5年临床研究初始审查项目进行分析,旨在总结伦理审查经验和分析存在的问题,为今后医院伦理审查提供借鉴.方法 对近5年临床研究初始审查项目会议记录进行归纳分析.结果 药物临床试验、器械临床验证和科研项目在科学设计和伦理合理性方面存在不同程度问题.结论 伦理委员会要加强研究方案科学性和知情同意书方面的审查,不断完善自身体系建设,保证伦理委员会高效运行.
Objective In this paper,we analyzed the initial review projects of clinical research during past five years in a hospital,which aims to summarize the experience and analysis existent problems,in order to provide a reference for the future hospital ethics review.Methods Summarizing and analyzing the meeting records during past five years,which were also in the field of the initial review projects of clinical research.Results Clinical trials of drug and divice,and clinical research projects exist in varying degrees of problems,which express in these two aspects：research design and ethical rational.Conclusions Ethics Committee should stengthen review the following two parts,the scientific of research project and the informed consent form.Improve their own system constantly,and ensure the efficient operation of the Ethics Committee.
作者
余中光
陈燕芬
常宗平
李琳
闫旭
孙瑞华
Yu Zhongguang Chen Yanfen Chang Zongping Li Lin Yan Xu Sun Ruihua(Science Department of China Japan Friendship Hospital ,Beijing 100029, P. R. China)
出处
《中华医学科研管理杂志》
2016年第6期477-480,共4页
Chinese Journal of Medical Science Research Management
关键词
临床研究
伦理
初始审查
Clinical research
Ethics
Initial review
