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管理非常规基因实验。

Governing nonconventional genetic experimentation.

作者信息

Mehlman Maxwell J, Conlon Ronald A, Pearlman Alex

机构信息

Case Western Reserve University, Cleveland, OH 44106, USA.

Concentric by Ginkgo, Boston, Massachusetts, USA.

出版信息

J Law Biosci. 2023 Mar 9;10(1):lsad003. doi: 10.1093/jlb/lsad003. eCollection 2023 Jan-Jun.

Abstract

A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic research has been limited, and therefore these activities have attracted little regulatory attention. New technologies such as CRISPR/Cas9, however, give nonconventional experimenters more extensive gene editing abilities at an unprecedented level of accessibility. The affordability and accessibility of these powerful technologies are raising questions about whether the current largely laissez-faire governance approach is adequate. This article recommends steps to enhance self-governance, including establishing umbrella organizations to represent community interests, creating a community IRB modelled on the DIYBio Ask a Safety Expert Service, and adopting an ethical obligation to report rogue experiments.

摘要

大量高度多样化的个体群体在传统企业和学术环境之外开展基因和基因组研究。他们可能是创新的重要来源,但其活动大多发生在现有促进安全和道德实践的监管体系范围之外。从历史上看,可用于非传统基因组研究的基因靶向技术一直有限,因此这些活动很少受到监管关注。然而,诸如CRISPR/Cas9等新技术,以前所未有的可及性赋予了非传统实验者更广泛的基因编辑能力。这些强大技术的可承受性和可及性引发了人们对当前基本上自由放任的治理方式是否足够的质疑。本文建议采取加强自我治理的措施,包括建立代表社区利益的伞状组织,创建一个以DIY生物“询问安全专家服务”为蓝本的社区机构审查委员会,并承担报告违规实验的道德义务。

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