科技人文

美国重组DNA咨询委员会的演变史

  • 吴焱斌 ,
  • 王岳
展开
  • 北京大学医学人文学院, 北京 100191
吴焱斌,博士研究生,研究方向为医药政策史、卫生法,电子信箱:wuyanbin@pku.edu.cn

收稿日期: 2021-07-06

  修回日期: 2021-12-07

  网络出版日期: 2022-09-13

基金资助

国家卫生健康委员会法制司项目(FZS2018-05)

The evolution of the recombinant DNA advisory committee of the United States

  • WU Yanbin ,
  • WANG Yue
Expand
  • School of Health Humanities, Peking University, Beijing 100191, China

Received date: 2021-07-06

  Revised date: 2021-12-07

  Online published: 2022-09-13

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。

本文引用格式

吴焱斌 , 王岳 . 美国重组DNA咨询委员会的演变史[J]. 科技导报, 2022 , 40(15) : 113 -122 . DOI: 10.3981/j.issn.1000-7857.2022.15.011

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.

参考文献

[1] Nambisan P. An introduction to ethical, safety and intellectual property rights issues in biotechnology[M]. Boston:Academic Press, 2017:83-126.
[2] Kane E M. Human genome editing:An evolving regulatory climate[J]. Jurimetrics, 2017, 57(3):301-323.
[3] 魏星.基因编辑[J].中国科技术语, 2018, 20(5):79.
[4] Bibikova M, Beumer K, Trautman J K, et al. Enhancing gene targeting with designed zinc finger nucleases[J]. Science, 2003, 300(5620):764.
[5] Office of the Federal Register. Meeting 58 Fed. Reg. 197[R]. Washington, DC:Office of the Federal Register, 1993.
[6] Liang P, Xu Y, Zhang X, et al. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes[J]. Protein&Cell, 2015, 6(5):363-372.
[7] 世界首例免疫艾滋病的基因编辑婴儿在中国诞生[EB/OL].(2018-11-26)[2021-09-01]. https://baijiahao.baidu.com/s?id=1618174995628718470&wfr=spider&for=pc.
[8] Jackson D A, Symons R H, Berg P. Biochemical method for inserting new genetic information into DNA of simian virus 40:Circular SV40 DNA molecules containing lambda phage genes and the galactose operon of escherichia coli[J]. Proceedings of the National Academy of Sciences, 1972, 69(10):2904-2909.
[9] Singer M, Soll D. Guidelines for DNA hybrid molecules[J]. Science, 1973, 181(4105):1114.
[10] Berg P, Baltimore D, Boyer H W, et al. Potential biohazards of recombinant DNA molecules[J]. Science, 1974, 185(4148):303.
[11] Wivel N A. Historical perspectives pertaining to the NIH Recombinant DNA Advisory Committee[J]. Human Gene Therapy, 2014, 25(1):19-24.
[12] Talbot B. Development of the national institutes of health guidelines for recombinant DNA research[J]. Public Health Reports, 1983, 98(4):361-368.
[13] Swazey J P, Sorenson J R, Wong C B. Risks and benefits, rights and responsibilities:A history of the recombinant DNA research gontroversy[J]. Southern California Law Review, 1978, 51(6):1019-1078.
[14] Dworkin R B. Science, society, and the expert town meeting:Some comments on Asilomar[J]. Southern California Law Review, 1978, 51(6):1471-1482.
[15] Berg P, Baltimore D, Brenner S, et al. Summary statement of the Asilomar conference on recombinant DNA molecules[J]. Proceedings of the National Academy of Sciences, 1975, 72(6):1981-1984.
[16] Perpich J G. Formulation of the NIH guidelines for recombinant DNA research as an exercise in due process[J]. Proceedings of the ASIL Annual Meeting, 1979, 73:219-232.
[17] Paradise J. U.S. regulatory challenges for gene editing[J]. The SciTech Lawyer, 2016, 13(1):10-13.
[18] U.S. National Institutes of Health. Recombinant DNA research guidelines[J]. Federal Register, 1976, 41(131):27902-27943.
[19] Kane E M. Human genome editing:An evolving regulatory climate[J]. Jurimetrics, 2017, 57(3):301-323.
[20] Holtzman N A. Correcting the code:Inventing the genetic cure for the human body[J]. JAMA, 1995, 273(16):1304.
[21] Grant E. FDA regulation of clinical applications of CRISPR-CAS gene-editing technology[J]. Food&Drug Law, 2016, 71(4):608-633.
[22] President's Commission. Summary from'splicing life':A report on the social and ethical issues of genetic engineering with human beings[J]. Recombinant DNA Technical Bulletin, 1983, 6(1):10-12.
[23] OTA. Human Gene Therapy:Background paper[R]. Washington, DC:US Congress, Office of Technology Assessment, 1984.
[24] Committee on Science and Technology. Hearing on human genetic engineering before the subcommittee on investigations and oversight of the H. comm. on science and technology[R]. Washington, DC:US Congress, Committee on Science and Technology, 1982.
[25] US House of Representatives, US Congresss. Human genetic engineering[R]. Washington, DC:Government Printing Office, 1982.
[26] U S House of Representatives. Testimony at a hearing before the subcommittee on investigations and oversight of the committee on science and technology[R]. Washington, DC:US House of Representatives, 1982.
[27] Cook-Deegan R M. Human gene therapy and congress[J]. Human Gene Therapy, 1990, 1(2):163-170.
[28] Walters L R. Human gene therapy:Ethics and public policy[J]. Human Gene Therapy, 1991, 2(2):115-122.
[29] Areen J, King P. Legal regulation of human gene therapy[J]. Human Gene Therapy, 1990, 1(2):151-161.
[30] Recombinant DNA Advisory Committee. Meeting 44 Fed. Reg. 17[R]. Washington, DC:Recombinant DNA Advisory Committee, 1984.
[31] Recombinant DNA Advisory Committee. Meeting 50 Fed. Reg. 2940[R]. Washington, DC:Recombinant DNA Advisory Committee, 1985.
[32] Office of the Federal Register. Meeting 50 Fed. Reg. 160[R]. Washington, DC:Office of the Federal Register, 1985.
[33] Recombinant DNA Advisory Committee. Meeting 57 Fed. Reg. 316[R]. Washington, DC:Recombinant DNA Advisory Committee, 1992.
[34] Korwek E L. The NIH guidelines for recombinant DNA research and the authority of FDA to require compliance with the guidelines[J]. Jurimetrics, 1981, 21(3):264-283.
[35] Recombinant DNA Advisory Committee. Meeting 49 Fed. Reg. 50[R]. Washington, DC:Recombinant DNA Advisory Committee, 1984.
[36] Recombinant DNA Advisory Committee. Meeting 51 Fed. Reg. 23[R]. Washington, DC:Recombinant DNA Advisory Committee, 1986.
[37] Kessler D A, Siegel J P, Noguchi P D, et al. Regulation of somatic-cell therapy and gene therapy by the Food and Drug Administration[J]. New England Journal of Medicine, 1993, 329(16):1169-1173.
[38] Listed N. Guidance for human somatic cell therapy and gene therapy. March 1998. Center for biologics evaluation and research, Food and Drug Administration[J]. Human Gene Therapy, 1998, 9(10):1513-1524.
[39] The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report[EB/OL].(1979-04-18)[2021-09-01]. https://www.hhs.gov/ohrp/sites/default/files/the-belmontreport-508c_FINAL.pdf.
[40] Office for Human Research Protections. Federal policy for the protection of human subjects (Common Rule)[EB/OL].(2018-03-18)[2021-09-01]. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.
[41] Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee. Oversight and review of clinical gene transfer protocols:Assessing the role of the Recombinant DNA Advisory Committee[EB/OL].(2014-03-27)[2021-09-01]. https://pubmed.ncbi.nlm.nih.gov/24354033/.
[42] CenterWatch. Overview of clinical trials[EB/OL].(2021-03-15)[2021-09-15]. https://www.centerwatch.com/clinical-trials/overview/.
[43] Rainsbury J M. Biotechnology on the RAC——FDA/NIH regulation of human gene therapy[J]. Food&Drug Law, 2000, 55(4):575-600.
[44] Anderson W F. Human gene therapy[J]. Science, 1992, 256(5058):808-813.
[45] Carmen I H. Debates, divisions, and decisions:Recombinant DNA Advisory Committee (RAC) authorization of the first human gene transfer experiments[J]. The American Journal of Human Genetics, 1992, 50(2):245-260.
[46] US National Library of Medicine. The Paul Berg papers:Recombinant DNA technologies and researchers'responsibilities, 1973-1980[EB/OL].[2021-09-05]. https://profiles.nlm.nih.gov/spotlight/cd/feature/dna.
[47] Institute of Medicine. Oversight and review of clinical gene transfer protocols:Assessing the role of the Recombinant DNA Advisory Committee[M]. Washington, DC:The National Academies Press, 2014:41-116.
[48] Beach J E. The new RAC:Restructuring of the National Institutes of Health Recombinant DNA Advisory Committee[J]. Food&Drug Law Journal, 1999, 54(1):49.
[49] Goldner J A. Dealing with conflicts of interest in biomedical research:IRB oversight as the next best solution to the abolition approach[J]. Journal of Law Medicine&Ethics, 2001, 28(4):379-404.
[50] Sibbald B. Death but one unintended consequence of gene-therapy trial[J]. Canadian Medical Association Journal, 2001, 164(11):1612.
[51] Breakefield, Xandra O. Refocus the Recombinant DNA Advisory Committee[J]. Nature Medicine, 2012, 18(7):1007.
[52] Francis S C. Statement by the NIH director on the IOM report addressing the role of the Recombinant DNA Advisory Committee in oversight of clinical gene transfer protocols[EB/OL].(2014-05-21)[2021-09-01]. https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-director-iom-report-addressing-role-recombinant-dna-advisory-committee-oversight-clinical-gene-transfer-protocols.
[53] Francis S C, Gottlieb S. The next phase of human gene-therapy oversight[J]. New England Journal of Medicine, 2018, 379(10):1393-1395.
[54] Francis S C. Statement on modernizing human gene therapy oversight[EB/OL].(2018-08-16)[2021-09-01]. https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-modernizing-human-gene-therapy-oversight.
[55] Francis S C. NIH streamlines gene therapy oversight and charts a course for considering emerging technology[EB/OL].(2019-04-25)[2021-09-01]. https://www. nih. gov/about-nih/who-we-are/nih-director/statements/nih-streamlines-gene-therapy-oversight-charts-course-considering-emerging-technology.
[56] National Institutes of Health. NIH guidelines[EB/OL].(2019-04-29)[2021-09-01]. https://osp.od.nih.gov/wpcontent/uploads/NIH_Guidelines.pdf.
文章导航

/