《人类遗传资源管理条例实施细则》政策解读与新时期的管理策略分析  

Policy interpretation of the implementation Rules of the Regulations on the Management of Human Genetic Resources and analysis of the management strategies in the new era

作　　者：魏锣沛 宋润泽 程周楠 孔双蕾 浦佳丽[1] 旷苗 张召才[1] Wei Luopei;Song Runze;Cheng Zhounan;Kong Shuanglei;Pu Jiali;Kuang Miao;Zhang Zhaocai(The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310009,Zhejiang Province,China;China National Center for Biotechnology Development,Beijing 100039,China;Peking University Cancer Hospital&Institute,Beijing 100142,China)

机构地区：[1]浙江大学医学院附属第二医院,杭州310009 [2]中国生物技术发展中心,北京100039 [3]北京大学肿瘤医院,北京100142

出　　处：《中华医学科研管理杂志》2024年第2期98-102,共5页Chinese Journal of Medical Science Research Management

摘　　要：目的通过解读《人类遗传资源管理条例实施细则》(以下简称为"《细则》"),为各机构在新时期开展人类遗传资源的规范化管理提供建议。方法梳理《细则》实施对人类遗传资源管理带来的挑战,结合实际工作经验讨论新时期人类遗传资源的管理策略。结果人类遗传资源管理在生物样本安全、数据管理、知识产权保护和项目过程管理等方面仍面临重大挑战。结论新时期各机构应加速生物样本平台和科研数据平台的建设,加强知识产权管理,优化项目过程管理,做好人类遗传资源管理和服务工作。Objective To interpret the Implementation Rules of the Regulations on the Management of Human Genetic Resources(hereinafter referred to as the″Rules″),and to provide suggestions for further standardized management of human genetic resources in the new era.Methods The challenges brought by the implementation of the Rules were summarized,and management strategies for human genetic resources were provided.Results Human genetic resource management still faced significant challenges,including sample security,data management,intellectual property protection,and project process management.Conclusions In the new era,research institutions should accelerate the construction of biobanks and research data platforms,strengthen intellectual property management,and optimize project process management.

关 键 词：人类遗传资源管理条例实施细则 生物样本平台 人类遗传资源数据 知识产权 过程管理 

分 类 号：R197.32[医药卫生—卫生事业管理]