摘要
儿童药物临床试验为儿童安全用药与药物研发提供了重要的支持。知情同意为儿童受试者的安全与权益提供了重要保障,在药物临床试验开展前必须对受试者或其监护人/代理人进行知情同意。然而目前儿童药物临床试验前的知情同意存在忽视儿童受试者的主体性、知情同意书设计不完整、信息告知不全及知情同意过程不规范等诸多问题,威胁到受试儿童的个人权益。在总结、分析儿童药物临床试验知情同意中的问题的基础上提出优化知情同意的相关举措,以期为完善儿童药物临床试验的规范性,推进儿童药物研发提供建议。
Drug clinical trials of children provide an important support for safety medications and drug development in children. Informed consent provides an important guarantee for the safety and rights of children subjects. Informed consent must be given to the subjects or their guardians/agents before the drug clinical trials are carried out. However, there are many problems in the informed consent before the drug clinical trials of children, such as neglecting the subjectivity of children subjects, incomplete design of informed consent, incomplete information informing and irregular process of informed consent, which have threatened the individual rights and interests of children. Based on the summary and analysis of the problems in the informed consent for the drug clinical trials of children, this study puts forward relevant measures to optimize informed consent, in order to improve the standardization of drug clinical trials of children and promote the research and development of drug for children.
作者
赵琼姝
梁頔
赵博
刘锦钰
袁静
郑博
李志刚
邰隽
ZHAO Qiongshu;LIANG Di;ZHAO Bo;LIU Jinyu;YUAN Jing;ZHENG Bo;LI Zhigang;TAI Jun(Department of Scientific Research,National Center for Children’s Health/ Beijing Children’s HospitalAffiliated to Capital Medical University, Beijing 100045, China)
出处
《中国医学伦理学》
2019年第10期1247-1252,共6页
Chinese Medical Ethics
基金
北京市卫生健康委北京市医学伦理管理和审查质量提高项目“基于儿科人群特点的临床研究伦理审查要点”(京伦2019-3)
2017年重大新药创制科技重大专项“儿童示范性新药临床评价技术平台建设”(2017ZX09304029),子课题一“儿童示范性新药临床评价支撑体系”(2017ZX09304029001)
北京市医院管理中心儿科学科协同发展中心专项经费资助(XTXK201901)
2018年度首都医科大学附属北京儿童医院管理课题项“建立多中心儿童临床研究伦理协作审查体系”(YGLQ201802)
关键词
知情同意
药物临床试验
儿童药物
科研伦理
医患关系
Informed Consent
Drug Clinical Trial
Children Drug
Research Ethic
Doctor-patient Relationship
