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

制订药物临床试验中知情同意书的设计及签署要素标准,调查首都医科大学附属北京佑安医院63项药物临床试验知情同意书的设计及2265份知情同意书的签署情况,分析各要素的出现率,该院知情同意书的设计及签署基本符合《药物临床试验质量管理规范》的要求,但仍存在要素的缺失和签署不规范的现象,针对发现的问题进行分析后提出改进对策:制定相关标准操作流程,加强知情同意书的管理,加强制度建设和教育培训,促进医院伦理建设,切实保护受试者的权益。

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 .