Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future.
Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future.
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DOI：
10.1089/crispr.2021.0043
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Adashi EY
中科院分区：
文献类型：
--
作者：
Walters L;Cook-Deegan RM;Adashi EY
自2015年以来，可遗传的人类基因组编辑（HHGE）已经成为一个引起公众强烈兴趣的话题。在20世纪80年代早期，一个相关的话题——人类基因工程——是公众持续讨论的主题。人们特别关注生殖系基因干预。在20世纪80年代的辩论中，美国国立卫生研究院（NIH）院长的一个咨询委员会——重组DNA咨询委员会（RAC）——同意对有意将DNA引入人类的建议进行初步的公开审查。1984年和1985年，RAC制定了涉及DNA转移到患者体内的研究指南。该委员会还评论了故意改变人类生殖系的可能性。我们跟踪文本的变化随着时间的推移，在RAC的反应，生殖系遗传干预的可能性在人类。2019年，NIH RAC被废除。基因组编辑的新技术，包括基于crispr的技术，使体细胞和种系的改变变得更加可行。这些新功能再次引发了对监管的质疑。我们建议创建一个新的结构，以便公众监督执行HHGE的提案。在由监管机构进行技术审查的同时，这些建议也应该由总统任命的生物伦理咨询委员会进行公开评估。
Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic—human genetic engineering—was the subject of sustained public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)—the Recombinant DNA Advisory Committee (RAC)—agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.
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