儿童药物临床试验知情同意书设计及签署要素分析

发布时间：2018-04-25 23:08

本文选题：儿童 + 药物临床试验　；参考：《中国临床药理学杂志》2017年15期

【摘要】：目的为制订儿童药物临床试验中知情同意书的设计及签署要素标准奠定基础。方法调查2010-2015年北京儿童医院的11项Ⅱ~Ⅲ期药物临床试验知情同意书的设计及443份知情同意书的签署情况,分析设计要素中试验背景、试验目的、试验流程、试验相关信息、签署信息及签署要素中签署早于试验(早于试验筛选期)、签署版本为伦理委员会批准的最新版本、法定监护人签名、日期、联系方式、注明法定监护人与受试者的关系、研究者签名、日期及联系方式、研究者签署日期不早于受试者、签署时间具体到分钟以及是否有针对不同人群的不同版本知情同意书、儿童版的是否便于儿童理解(有图画、彩色)等要素的出现率。结果我院知情同意书的设计及签署基本符合《药物临床试验质量管理规范》的要求,但仍存在要素缺失和签署不规范现象,且国内多中心项目较国际多中心项目要素缺失比率高。结论制订儿童药物临床试验中知情同意书的设计及签署要素标准。加强对研究者伦理审查相关培训,切实保护受试者的权益。
[Abstract]:Objective to lay a foundation for the design and signature criteria of informed consent in children's drug clinical trials. Methods the design of 11 informed consent forms and the signing of 443 informed consent forms were investigated in Beijing Children's Hospital from 2010 to 2015. The background, purpose, procedure and relevant information of the design were analyzed. Signature information and signature elements prior to the test (earlier than the test screening period, signed version is the latest version approved by the ethics committee, legal guardian signature, date, contact information, indicating the relationship between legal guardian and subject, The researcher's signature, date and contact information, the researcher's signature date was no earlier than the subject's, the signature time was specific to minutes, and whether there were different versions of the informed consent form for different groups of people, and whether the children's version was easy for children to understand (there were pictures, The rate of occurrence of elements such as color. Results the design and signing of informed consent in our hospital basically accord with the requirements of quality Management Standard of Drug Clinical trial, but there are still some factors missing and signing nonstandard phenomenon. Moreover, the missing ratio of elements in domestic multi-center project is higher than that in international multi-center project. Conclusion the design and signature criteria of informed consent in children's drug clinical trials are established. Strengthen the relevant training to the ethical review of researchers, and protect the rights and interests of the subjects.
【作者单位】：首都医科大学附属北京儿童医院药学部;
【分类号】：R95

【参考文献】