首页 | 官方网站   微博 | 高级检索  
     

某医院近3年206项伦理审查分析
引用本文:齐松仁,姚丽波,孙瑞华.某医院近3年206项伦理审查分析[J].中华医学科研管理杂志,2011,24(2):80-83.
作者姓名:齐松仁  姚丽波  孙瑞华
作者单位:中日友好医院科研处,北京,100029
摘    要:目的通过对某医院伦理委员会近3年206项临床研究伦理审查情况分析,了解医院伦理审查的一般通过率和常见问题。方法查阅伦理会纪录,归类整理并使用ridit的CMH方法和Bootstrap方法统计分析。结果药物试验通过率为36.09%,器械为18.42%,课题为14.29%。在伦理审查发现的问题方面,知情同意占63.59%,方案占14.56%,CRF占7.77%,其他占22.82%;国内申办者的问题明显多于国外申办者。药物伦理审查通过率逐年降低,分别是2006年45.83%、2007年38.78%、2008年19.440A,2008年与2006年相比有统计学上的差异,P=0.029。在药物临床试验中修订项目审查国外明显高于国内,P=0.028。结论医院伦理会对临床研究伦理审查十分必要,审查中尤其要关注知情同意书和研究方案等。

关 键 词:医学伦理  药物试验  临床研究  医院伦理委

Analysis of 206 ethic reviews in a hospital within 3 years
QI Song-ren,YAO Li-bo,SUN Run-hua.Analysis of 206 ethic reviews in a hospital within 3 years[J].Chinese Journal of Medical Science Research Management,2011,24(2):80-83.
Authors:QI Song-ren  YAO Li-bo  SUN Run-hua
Affiliation:QI Song-ten, YAO Li-bo, SUN Run-hua. Scientific Research Department, China-Japan friendship hospital, Beijing 10029, P. R. China
Abstract:Objective To reveal the average pass rate of a general hospital's ethic review and common problems.Methods The records generated by the ethics committee of a hospital in 3 consecutive years were reviewed and analysed with ridit of CMH and Bootstrap statistical methods.Results The pass rate for drug clinical trial is 36.09%,medical instruments 18.42%,and subject evaluation 14.29%.Among the problems,those concerning informed consent take up 63.59%,of protocol 14.56%,of CRF 7.77% and of the others 22.820%.The domestic applicants had more problems than those abroad.Besides,the pass rate of drug trials decreased with year from 45.83% in 2006 to 19.44% in 2008,which was statistically significant (P=0.029).In terms of drug clinical trial,the pass rate of revised projects in foreign countries was significantly higher than the domestic ones (P=0.028).Conclusion Ethics Committee in a hospital plays a very important role in clinical researches.And informed consent and research protocol are very important in the ethic review.
Keywords:Medical Ethics  Drug trial  Clinical trials  Ethics Committees in hospital
本文献已被 维普 万方数据 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司    京ICP备09084417号-23

京公网安备 11010802026262号