人类遗传资源管理在儿童临床研究伦理审查中的协同效用探讨  

Discussion on the Synergistic Effect of Human Genetic Resource Management in the Ethics Review of Children Clinical Research

作　　者：梁頔 赵琼姝[1] 李志刚[1] 刘锦钰 赵博[1] 袁静 聂菁 郑博 邰隽[1] LIANG Di;ZHAO Qiongshu;LI Zhigang;LIU Jinyu;ZHAO BO;YUAN Jing;NIE Jing;ZHENG Bo;TAI Jun(Department of Scientific Research,National Center for Children’s Health Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]国家儿童医学中心/首都医科大学附属北京儿童医院科研处

出　　处：《中国医学伦理学》2020年第2期169-174,共6页Chinese Medical Ethics

基　　金：2018年重大新药创制科技重大专项“儿童用药品种及关键技术研发”(2018ZX09721003);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);北京市医院管理中心儿科学科协同发展中心学科提升项目(XTXK201901);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)

摘　　要：对儿童人类遗传资源的有效管理和深入研究是实现儿童临床研究进步的有效途径。通过对涉及人类遗传资源管理的儿童临床研究审查现状、临床研究特点、所面临的伦理问题进行分析,在结合实践综合评估方案可行性、多重保障研究团队能力及研究经费、开展长期或跟踪随访研究、儿童成人后提出退出研究的规范程序等方面提出了相应的伦理审查要点。进一步建议通过健全优化儿童伦理审查机构人员配置及审查程序、注重多中心儿童临床试验的受试人群选择与伦理时效以及保障遗传信息数据的匿名性与安全性等手段实现儿童临床研究中人类遗传资源管理与伦理审核的协同优化,维护和发挥我国人类遗传资源优势,共同促进儿童临床研究的科学性以及伦理合理性。The effective management and in-depth study of children s human genetic resources are the effective way to realize the progress of children clinical research.By analyzing the review status,characteristics and ethical problems of children clinical research involved in human genetic resource management,this study put forward the corresponding ethical review points in terms of evaluating the feasibility of the plan comprehensively in combination with practice,multiply guaranteeing for research team capabilities and research funding,conducting the long-term or follow-up study,proposing standardized procedures for children to withdraw from the study after they become adults.It is further suggested that the collaborative optimization of human genetic resource management and ethical review in children clinical research should be realized by some methods,including:to improve and optimize the staffing and review procedures of children s ethical review institutions,to focus on the selection of subjects in multi-center children s clinical trials and the ethical timeliness,to ensure the anonymity and safety of genetic information data,so as to maintain and give full play to the advantages of human genetic resources in China,and jointly promote the scientific and ethical rationality of children clinical research.

关 键 词：人类遗传资源 儿童临床研究 伦理审查 协同效用 儿童权益 

分 类 号：R-052[医药卫生]