首页 | 官方网站   微博 | 高级检索  
     

临床试验的伦理审查:招募受试者
引用本文:汪秀琴,熊宁宁,刘沈林,李七一,蒋萌,刘芳,邹建东,薛钧,卜擎燕,高维敏.临床试验的伦理审查:招募受试者[J].中国临床药理学与治疗学,2004,9(11):1313-1316.
作者姓名:汪秀琴  熊宁宁  刘沈林  李七一  蒋萌  刘芳  邹建东  薛钧  卜擎燕  高维敏
作者单位:南京中医药大学附属医院临床药理科,南京,210029,江苏
基金项目:国家科学技术部"临床试验关键技术及平台研究"课题资助(№2004AA2Z3766)
摘    要:招募合格的受试者在临床试验过程中是至关重要的,而且可能是最困难、最富有挑战性的工作。受试者招募的伦理审查主要包括招募的方式,受试人群的选择与激励补偿措施。招募方式必须考虑尊重隐私与自愿参加的原则,避免强迫和不正当影响。受试人群的选择必须考虑受益和负担公平分担和试验人群的代表性问题。对受试者参加试验的激励补偿必须考虑合理补偿与避免过度劝诱的问题。

关 键 词:临床试验  伦理委员会  伦理审查  招募受试者
文章编号:1009-2501(2004)11-1313-04
修稿时间:2004年11月17

Ethic Review in Clinical Research:Subjects Recruitment
WANG Xiu-Qin,XIONG Ning-Ning,LIU Shen-Lin,LI Qi-Yi,JIANG Meng,LIU Fang,ZOU Jian-Dong,XUE Jun,BO Qing-Yan,GAO Wei-Min.Ethic Review in Clinical Research:Subjects Recruitment[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2004,9(11):1313-1316.
Authors:WANG Xiu-Qin  XIONG Ning-Ning  LIU Shen-Lin  LI Qi-Yi  JIANG Meng  LIU Fang  ZOU Jian-Dong  XUE Jun  BO Qing-Yan  GAO Wei-Min
Affiliation:WANG Xiu-Qin,XIONG Ning-Ning,LIU Shen-Lin,LI Qi-Yi,JIANG Meng,LIU Fang,ZOU Jian-Dong,XUE Jun,BO Qing-Yan,GAO Wei-MinDepartment of Clinical Pharmacology,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing,210029,Jiangsu,China
Abstract:Recruitment of eligible subjects is of paramount importance and probably the most difficult and changeling aspect of a clinical trial. Ethic review of subjects' recruitment mainly includes the mode of recruitment , the selection of subject population, recompense and incentives to subjects. For reviewing of mode of recruitment , respect for privacy and voluntary participation, avoiding any possibility of coercion or undue influence must be taken into account; while for reviewing of selec-tion of subject population, apportion of research burdens and benefits must be equally considered among population and the representative of study cohort. The reasonable recompense and free from undue inducement must be considered when reviewing recompense and incentives to subjects .
Keywords:clinical trial  institutional review board  ethic review  subjects recruitment
本文献已被 CNKI 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