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美国重组DNA咨询委员会的演变史
引用本文:吴焱斌,王岳.美国重组DNA咨询委员会的演变史[J].科技导报(北京),2022,40(15):113-122.
作者姓名:吴焱斌  王岳
作者单位:北京大学医学人文学院, 北京 100191
基金项目:国家卫生健康委员会法制司项目(FZS2018-05)
摘    要: 重组DNA技术于1972年诞生于美国高校实验室。重组DNA咨询委员会(简称RAC)问世于1974年,并于2019年退出历史舞台,为美国基因操作技术的风险规制立下了汗马功劳。RAC在美国基因操作技术风险规制中跌宕起伏的演变史,是美国基因操作技术的风险规制由稚嫩逐步走向成熟的印证。通过探究RAC及其监管权是在哪些力量的作用下问世,还原RAC在基因操作技术风险阴霾笼罩下被政府当局质疑能力的历史图景,呈现美国基因治疗的基本规制路径,描述RAC审批首次基因治疗的经过以及RAC在首次基因治疗致死事件中的应对表现,阐述RAC退出历史舞台的过程和缘由,从而描摹一幅美国重组DNA咨询委员会演变历程的脉络图。

关 键 词:基因编辑  重组DNA咨询委员会  基因治疗  风险规制  
收稿时间:2021-07-06

The evolution of the recombinant DNA advisory committee of the United States
WU Yanbin,WANG Yue.The evolution of the recombinant DNA advisory committee of the United States[J].Science & Technology Review,2022,40(15):113-122.
Authors:WU Yanbin  WANG Yue
Institution:School of Health Humanities, Peking University, Beijing 100191, China
Abstract:The recombinant DNA technology was developed by a university laboratory in the U.S in 1972.The Recombinant DNA Advisory Committee (RAC) was established by the government of U.S in 1974 and played a significant role in regulating the risks of gene manipulation technology until 2019.With the ups and downs of RAC in the course of risk regulation of gene manipulation technology in the U.S,the technical risk regulation of gene manipulation technology in the U.S has gradually developed from infant to mature.This article depicts the roadmap for the RAC and its regulatory power to come into being,retrieves the contributions that RAC made to regulating the technical risks under the haze of gene manipulation technology risks with plenty doubts from government authorities,and presents the basic regulation of gene therapy in the United States.The article also narrates the critical event of the gene therapy,including the process of the first case with RAC's approval and the performance of RAC facing the first fatal case.
Keywords:gene editing  Recombinant DNA Advisory Committee  gene therapy  risk regulation  
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