浅析临床科研中知情同意书撰写存在的问题  

A brief analysis of problems existing in the composition of informed consent form in scientific research

作　　者：吴翠云[1] 伍蓉[1] 曹国英[1] 陈小音[1] 

机构地区：[1]复旦大学附属华山医院伦理审查委员会,上海200040

出　　处：《中国医学伦理学》2009年第3期153-154,共2页Chinese Medical Ethics

基　　金：上海市科委基金项目资助;课题名称为"人体生物医学研究伦理审查规范和关键技术研究";课题编号:08411965200

摘　　要：通过对2007年度和2008年度某院伦理审查委员会受理的178份涉及人的临床科研项目知情同意书进行整理和分析,归纳和总结出主要存在问题:用语不通俗易懂,不符合普通大众的理解水平;基本要素缺项或告知不充分;言语表达存在诱导或广告性语言等。由此展开讨论并提出改进建议。Based on the collation and analysis of 178 informed consent forms of clinical research projects related to human accepted by the ethical review committee of one hospital in 2007 and 2008, major problems were summarized as follows： the expression was difficult to be understood and was unsuitable for popular apprehension; lack of basic elements or insufficiently informed ; inductive or advertising expressions existed, etc. Accordingly, the discussion was made for some recommendations of improvement.

关 键 词：临床科研 知情同意书 要素 

分 类 号：R-052[医药卫生]