儿科临床研究知情同意书完整性调查分析

发布时间：2018-05-23 20:35

本文选题：儿科临床研究 + 未成年人　；参考：《中国临床药理学杂志》2017年03期

【摘要】：目的调查儿科临床研究知情同意书的完整性。方法制定知情同意审查要素表,对我院伦理委员会在2012年至2015年受理的43个临床试验项目的知情同意书进行整理分析,统计各要素的缺失情况,并调阅各项目的初始审查伦理意见书,分析伦理审查关注点。结果 2014,2015年的知情同意书完整性60%的比率分别为87.50%,100.00%,与2012-2013年的54.54%比较,差异均有统计学意义(P0.05),但2014年与2015年的知情同意书完整性比较差异无统计学意义(P0.05)。监护人版的知情同意书中,药物类的完整性在80%以上的占57.69%,器械类与体外诊断试剂均没有完整性在80%以上的项目,差异有统计学意义(P0.01);未成年人版知情同意书全部来自于药物类,完整性均在60%以上,在80%以上的占45.45%。国外申办方(主要是欧美地区的公司)的优良率在100.00%,而国内的优良率仅为33.33%,差异有统计学意义(P0.01)。知情同意书主要缺失的要素与会议审查关注点基本相符,缺少儿童适用的知情同意书及儿童应签署知情同意的年龄。结论提高知情同意书的质量,设计未成年人受试者及监护人适用的知情同意书,才能更好地保护受试者权益,从而促进儿科临床研究的发展。
[Abstract]:Objective to investigate the integrity of informed consent form in pediatric clinical study. Methods the essential factors of informed consent examination were made, and the informed consent forms of 43 clinical trial items accepted by our ethics committee from 2012 to 2015 were analyzed, and the missing conditions of each element were counted. And read the initial review of each project ethics opinion, analysis of ethical review concerns. Results in 2014 and 2015, the percentage of the integrity of informed consent was 87.50% and 100.00%, respectively, compared with 54.54% in 2012-2013, the difference was statistically significant (P 0.05), but there was no significant difference between 2014 and 2015 (P 0.05). In the informed consent form of guardian version, the integrality of drugs was more than 80% (57.69%), and that of instrument type and in vitro diagnostic reagent was not above 80%. The difference was statistically significant (P 0.01). All the informed consent forms of minors came from drugs, the integrality was more than 60%, and 45.45% of them were above 80%. The excellent and good rate of foreign bidders (mainly companies in Europe and America) is 100.000.The excellent and good rate in China is only 33.333.The difference is statistically significant. The main missing elements of informed consent are basically consistent with the focus of the meeting review, and the lack of applicable informed consent and the age at which the child should sign informed consent. Conclusion only by improving the quality of informed consent forms and designing informed consent forms for minors and guardians can the rights and interests of subjects be better protected and the development of pediatric clinical research be promoted.
【作者单位】：浙江大学医学院附属儿童医院药物临床试验机构办公室;
【基金】：国家“重大新药创制”科技重大专项基金资助项目(2013ZX09303003) 国家自然科学基金资助项目(81573516)
【分类号】：R969.4

【参考文献】