中国临床药理学杂志2017，Vol.33Issue(3)：267-270,4.DOI:10.13699/j.cnki.1001-6821.2017.03.022
儿科临床研究知情同意书完整性调查分析
Investigation and analysis of the integrity of informed consent form for minors in the clinical trial
摘要
Abstract
Objective To study the integrity of informed consent form (ICF) for the minors.Methods The ICFs of 43 clinical trials conducted in our hospital during 2012 to 2015 were collected to study the missing rate of elements according to the elements list of ICF arranged by our hospital medical ethics committee.Initial review notification letters were consulted to analyze the concerns of ethical review.Results The ratios of ICF integrity (＞ 60％) were 54.54％,87.50％ and 100.00％respectively in 2012-2013,2014 and 2015.Compared with the integrity in 2012-2013,there were significandy different (P ＜ 0.05).There was no statistically significant difference between the integrity in 2014 and 2015 (P ＞0.05).In ICFs of legal guardian,there was statistically significant difference among drug,medical instrument and in vitro diagnostic regen clinical trial (P ＜0.01).The ratio of ICF integrity (＞80％) was 57.69％ in drug clinical trial,and there were none in medical instrument and in vitro diagnostic regen clinical trial.The integrity of all the ICFs of the minors,which were all from drug clinical trial,were over 60％,and the ratio of the integrity (＞ 80％) was 45.45％.The excellent and good rate of foreign sponsors' ICFs integrity was 100％,and that of the domestic sponsors' was only 33.33％.There was statistically significant difference between them (P ＜ 0.01).The major missing elements were consistent with the concerns of ethical review:the lack of special ICFs for the minors to read and the age group to obtain informed consent.Conclusion To improve the quality of ICFs and design the suitable ones for the minors will be good for protecting the rights and interests of subjects and promoting the development of clinical trial of minors.关键词
儿科临床研究/未成年人/知情同意书/要素/完整性Key words
clinical trial/minors/informed consent form/element/integrity分类
医药卫生引用本文复制引用
漆林艳,潘薇薇,李春梅,倪韶青..儿科临床研究知情同意书完整性调查分析[J].中国临床药理学杂志,2017,33(3):267-270,4.基金项目
国家“重大新药创制”科技重大专项基金资助项目(2013ZX09303003) （2013ZX09303003）
国家自然科学基金资助项目(81573516) （81573516）
