Study on the Differences of Pregnancy Informs between Chinese and Foreign Informed Consent Form in Drug Clinical Trial
- VernacularTitle:中外药物临床试验知情同意书中妊娠告知差异的研究?
- Author:
Nana XU
;
Yao LU
;
Ruifang CHEN
;
Gaiyan WEN
;
Guoping YANG
;
Zhijun HUANG
;
Yuxia XIANG
;
Ying LI
;
Hong YUAN
;
Yan PENG
- Publication Type:Journal Article
- Keywords:
Drug Clinical Trial;
Informed Consent Form;
Pregnancy Inform
- From:
Chinese Medical Ethics
2016;29(2):293-297
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore and discuss the differences of pregnancy contents and inform formats in in-formed consent form ( ICF) for the drug clinical trial between China and foreign countries. Methods:We collected Chinese and foreign ICFs for drug clinical trial that had been audited by the Ethics Committee of the third Xiangya Hospital for the past five years. Based on the relevant domestic and foreign law, we concluded the element stand-ards and inform formats about pregnancy inform. By analyzing the integrity of the whole elements, the inform rate of every element and the using rate of every inform format, we compared the differences of pregnancy contents and in-form formats between Chinese ICFs and foreign ICFs. Results:The total number of ICFs was 177 in this study, in-cluding 107 Chinese ICFs and 70 foreign ICFs. The integrity rate of pregnancy in Chinese ICFs was statistically lower than them in foreign ICFs (19% vs. 56%, P=0. 000). Compared with foreign ICFs, the low informed ele-ments were the study of the pregnancy risk (32% vs. 73%, P=0. 000), the pregnancy test during the following-up period (33% vs. 56%, P=0. 002) and the measurements for contraception (22% vs. 53%, P=0. 000). Conclusion:The integrity level of pregnancy content in Chinese ICFs was lower than that of the foreign ICFs. And the three elements including pregnancy risk study, pregnancy test during the following-up period and measure-ments for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferi-or to abroad.
