第三方临床生物样本库运行中的挑战与发展建议  

Challenges and Development Suggestions in the Operation of Third-Party Clinical Biobank

作　　者：李海燕[1] 韩露 洪雪[1] 王雪莹 张雷 王晓民[4] 张宏家 LI Haiyan;HAN Lu;HONG Xue;WANG Xueying;ZHANG Lei;WANG Xiaomin;ZHANG Hongjia(Department of Scientific Research,Peking University Third Hospital,Beijing 100191,China;Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Beijing Life Science Park Biotechnology Research Institute Co.LTD,Beijing 102200,China;School of Basic Medicine,Capital Medical University,Beijing 100069,China)

机构地区：[1]北京大学第三医院科研处,北京100191 [2]首都医科大学附属北京朝阳医院,北京100020 [3]北京生命科学园生物科技研究院有限公司,北京102200 [4]首都医科大学基础医学院,北京100069

出　　处：《中国医学伦理学》2020年第11期1358-1362,共5页Chinese Medical Ethics

基　　金：北京市科技计划课题“基于第三方平台的重大疾病临床样本资源库建设与共享的应用研究”(Z191100008319007)。

摘　　要：目前,以建立在医院内为主的样本库面临着空间、成本和伦理审查等运行发展的压力。第三方临床生物样本库是介于生物资源提供者和使用者的一个专业化的支撑和服务平台,是一个新的建库模式,在运行中面临着伦理委员会建设和伦理审查、遗传资源安全和资质认可等方面的挑战。因此,第三方临床生物样本库应建立完善的伦理管理机制,加强自身建设,提高权威性,为样本库长期发展奠定基础;争取政府和社会资本的长期支持,保障初期阶段发展的稳定性;加强运营能力建设,获得相关利益方的认可,积极推动样本的开放和利用。At present,the biobank mainly established in the hospital is facing the pressure of space,cost and ethical review.The third-party clinical biobank is a professional support and service platform between the providers and users of biological resources.It is a new database construction model,which faces some challenges in the construction of ethics committee and ethical review,the safety of genetic resources and qualification recognition,etc.Third-party clinical biobank should establish a sound ethical management mechanism,strengthen its own construction,increase its authority and lay the foundation for the long-term development of biobank;strive for the long-term support of government and social capital,ensure the stability of the development in the initial stage;strengthen operational capacity building,obtain the recognition of relevant stakeholders and actively promote the opening and utilization of samples.

关 键 词：第三方临床生物样本库 伦理审查 人类遗传资源安全 样本库认可 

分 类 号：R197.32[医药卫生—卫生事业管理]