Ethical Analysis on Design and Signature of 2265 Clinical Trial Informed Consent Forms
- VernacularTitle: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
- Author:
Shuqin DING
;
Min JIA
;
Meixia WANG
;
Liqing WANG
;
Fengmin ZHENG
;
Aijuan SHENG
- Publication Type:Journal Article
- Keywords:
Clinical Trial for Drugs;
Informed Consent Form;
Medical Ethics;
Subjects′s Interests
- From:
Chinese Medical Ethics
2015;(5):762-764
- CountryChina
- Language:Chinese
-
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 .
