某医院近3年206项伦理审查分析  

Analysis of 206 ethic reviews in a hospital within 3 years

作　　者：齐松仁[1] 姚丽波[1] 孙瑞华[1] 

机构地区：[1]中日友好医院科研处,北京100029

出　　处：《中华医学科研管理杂志》2011年第2期80-83,共4页Chinese Journal of Medical Science Research Management

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。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 consec utive 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. 770% and of the others 22.82%. 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.

关 键 词：医学伦理 药物试验 临床研究 医院伦理委 

分 类 号：R-052[医药卫生]