中外药物临床试验知情同意书中妊娠告知差异的研究  

Study on the Differences of Pregnancy Informs between Chinese and Foreign Informed Consent Form in Drug Clinical Trial

作　　者：徐娜娜[1] 陆瑶[1] 陈瑞芳[1] 温改艳 阳国平[1] 黄志军[1] 项玉霞[1] 李莹[1] 袁洪[1] 彭艳[1] 

机构地区：[1]中南大学湘雅三医院临床药理中心,湖南长沙410013

出　　处：《中国医学伦理学》2016年第2期293-297,共5页Chinese Medical Ethics

基　　金：国家"重大新药创制科技"重大专项:重大疾病新药临床评价研究综合技术平台建设(2012ZX09303014001);国家自然科学基金:肾功能损害合并高血压患者优化降压方案的研究(81273594);十二五国家科技支撑计划课题:老年人群治疗风险及策略的临床转化医学技术研究(2012BAI37B05)

摘　　要：目的探讨中外药物临床试验知情同意书中妊娠告知内容和告知形式的差异。方法收集中南大学湘雅三医院伦理委员会近5年审批的中外药物临床试验知情同意书,参考国内外相关法则,归纳知情同意书中妊娠告知的要素标准和告知形式,通过分析要素完整性、各要素告知率及告知形式采用率,比较中外知情同意书中妊娠的告知内容和告知形式的差异。结果本次研究共抽取知情同意书177份,其中中国107份,国外70份。中国知情同意书妊娠告知完整的比例低于国外(19%vs.56%,P=0.000)。与国外相比,中国告知率较低的要素有:妊娠风险研究(32%vs.73%,P=0.000)、随访期妊娠检查(33%vs.56%,P=0.002)和避孕措施(22%vs.53%,P=0.000)。结论中国药物临床试验知情同意书妊娠告知完整性低于国外,其中妊娠风险研究、随访期妊娠检查和避孕措施具有明显的告知缺陷;中国知情同意书妊娠告知形式相比较差。Objective： To explore and discuss the differences of pregnancy contents and inform formats in informed 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 standards 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 inform formats between Chinese ICFs and foreign ICFs. Results： The total number of ICFs was 177 in this study,including 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 elements 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 measurements for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferior to abroad.

关 键 词：药物临床试验 知情同意书 妊娠告知 

分 类 号：R-052[医药卫生]