Hastings Cent Rep. 2019 May;49(3):30-42. doi: 10.1002/hast.1006.
A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one.
遗传性 germline 基因编辑的国际治理面临的一个核心问题是,全世界在态度和价值观以及伦理和医疗保健方面存在重要差异。这些差异反映在复杂多样的监管格局中。有几篇出版物讨论了生殖用途在个别国家是否合法,以及在监管空白和灰色地带的情况下,临床应用是否可能出现。需要进行系统的比较研究,从不同的国家和国际角度探讨与该技术治理相关的问题,以弥补这一领域的知识空白。在本研究报告中,我们通过介绍英国利益相关者对遗传性基因组编辑治理的挑战的看法,为填补这一空白做出了贡献。我们展示了 2016 年 10 月至 2018 年 1 月期间在英国进行的一项多利益攸关方研究的结果,该研究由惠康信托基金会资助。这项研究包括访谈、文献分析和一次研讨会。我们邀请了英国领先的科学家、体外受精临床医生以及监管机构、患者组织和其他民间社会组织以及生育公司的代表参加。本文的第一部分探讨了利益相关者对遗传性基因组编辑可能的全球发展以及相关风险和治理挑战的看法。第二部分介绍了在研讨会期间针对第一部分讨论的挑战提出的一系列政策选择。