我国国情对知情同意的影响  

Influence of China national conditions on informed consent

作　　者：张维[1] 彭莉[1] 王靖雯[1] 马忠英[1] 文爱东[1] 

机构地区：[1]第四军医大学西京医院药剂科,陕西西安710033

出　　处：《中国新药与临床杂志》2013年第4期277-278,共2页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家"重大新药创制"十二五科技重大专项(2012ZXJ09202-013)

摘　　要：知情同意起源于西方,自引入到中国后被中华传统文化影响而改变:受试者对临床试验的误解导致了知情同意过程的形式化,从而变成了手术前要求患者家属或临床试验前诱导患者签字的行为模式,逐渐偏离了知情同意的主旨,在一线医务人员和患者中引发了诸多困惑和不满。本文阐述了我国国情对知情同意的影响,为探讨如何更好的实施知情同意原则提供借鉴。Informed consent originated in the Western culture. Since it was introduced into China, it has been impacted and assimilated by Chinese traditional culture： the misunderstanding of subjects to clinical trials led to the formalization of informed consent process, becaming a behavioral pattern of asking for signatures from volunteers （patients） or their family before clinical trials or surgery. It was deviating from the main aim of the informed consent and caused a lot of confusion and dissatisfaction from medical staff and patients. This paper reviewed the effect of our national conditions on the informed consent, to provide reference for discussing how to better carry out the principle of informed consent.

关 键 词：知情同意 中国国情 医患关系 临床试验 临床方案 

分 类 号：R-052[医药卫生]