中国医学伦理学Issue(5)：762-764,3.
2265份药物临床试验知情同意书设计及签署情况的伦理分析
Ethical Analysis on Design and Signature of 2265 Clinical Trial Informed Consent Forms
丁淑芹 1贾敏 1王美霞 1王立清 1郑凤敏 1盛艾娟1
作者信息
- 1. 首都医科大学附属北京佑安医院国家药物临床试验机构，北京 100069
- 折叠
摘要
Abstract
Items of design and signature from clinical trial drugs were made , the occurrence ratio of every item in 2265 informed consent form ( ICF) from 63 clinical trial drugs in Beijing Youan Hospital affiliated to Capital U-niversity of Medical Sciences were analyzed , and items with lower occurrence ratio were explored .Generally , the design and signature of ICF met the requirement of GCP .However , there were some defects of ICF and antonym of signature .Based on the analysis on the problems , some measures were put forward:formulate relevant standard op-erating procedures , strengthening the management of informed consent , and strengthen the system construction and education training , promote the hospital ethics construction , to protect the rights and interests of the subjects .关键词
药物临床试验/知情同意书/医学伦理/受试者利益Key words
Clinical Trial for Drugs/Informed Consent Form/Medical Ethics/Subjects′s Interests分类
医药卫生引用本文复制引用
丁淑芹,贾敏,王美霞,王立清,郑凤敏,盛艾娟..2265份药物临床试验知情同意书设计及签署情况的伦理分析[J].中国医学伦理学,2015,(5):762-764,3.
