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作 者:魏锣沛 孔双蕾[2] 胡新华 张召才[1] 胡新央[1] 陈海乐[1] Wei Luopei;Kong Shuanglei;Hu Xinhua;Zhang Zhaocai;Hu Xinyang;Chen Haile(Department of science and development,Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310009,China;Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Research department,Peking University Cancer Hospital&Institute,Beijing 100142,China;Center of Clinical Pharmacology,Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310009,China)
机构地区:[1]浙江大学医学院附属第二医院科研部,杭州310009 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所科研处,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [3]浙江大学医学院附属第二医院临床药理中心,杭州310009
出 处:《中华医学科研管理杂志》2022年第2期97-101,共5页Chinese Journal of Medical Science Research Management
摘 要:目的通过对医院人类遗传资源管理模式及现状进行梳理, 探索人类遗传资源管理的范式, 为其他医疗机构开展相关工作提供参考。方法基于麦肯锡7S模型理论构建人类遗传资源管理体系, 针对人类遗传资源审批/备案的项目, 就其类型分布、涉及人类遗传资源情况和主要研究者特征等角度进行分析。结果《人类遗传资源管理条例》实施以来, 人类遗传资源审批/备案项目共计82项, 以注册上市为目的的研究占多数;审批/备案项目涉及人类遗传资源材料主要为血液、尿液、血清和血浆等, 涉及人类遗传资源数据主要为临床数据、影像数据;主要研究者多为正高级职称, 且集中分布在重点学科。结论麦肯锡7S理论为医疗机构开展人类遗传资源管理工作提供了新的参考路径。Objective This paper aims to explore the management of human genetic resources in medical institutions,according to reflections of the management mode of a particular hospital,providing possible reference for other medical institutions.Methods The management system of human genetic resources was constructed refer to the McKinsey 7S model.Approved projects information includes the types of projects,characteristics of human genetic resources involved and the characteristics of principal investigator are analyzed.Results A total number of 82 projects were approved Since the implementation of newly updated Regulation of the People′s Republic of China on the Administration of Human Genetic Resources(hereinafter referred to as the regulations),and majority of which are drug clinical trials.The human genetic resources materials and data involved are mainly blood,urine,serum,plasma,clinical data,imaging data,etc.Most of the principal investigators with senior professional title are from key disciplines.Conclusions McKinsey 7S model provides a new reference path for medical institutions to carry out human genetic resources management.
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