Conley John M, Davis Arlene M, Henderson Gail E, Juengst Eric T, Meagher Karen M, Walker Rebecca L, Waltz Margaret, Cadigan Jean
John M. Conley is the William Rand Kenan, Junior Professor at the University of North Carolina School of Law, and the corresponding author for this Article.Arlene M. Davis is an Associate Professor of Social Medicine at the University of North Carolina School of Medicine. Gail E. Henderson is the Director of the Center for Genomic and Society, and a professor in in the Department of Social Medicine at the University of North Carolina School of Medicine. Eric T. Juengst is the Director of the Center for Bioethics, a Professor of Social Medicine, and a Professor of Genetics in the University of North Carolina School of Medicine. Karen M. Meagher is an Assistant Professor in the Biomedical Ethics Research Program at the Mayo Clinic. Rebecca L. Walker is a professor in the Department of Social Medicine, Department of Philosophy, and Center for Bioethics at the University of North Carolina at Chapel Hill. Margarete Waltz is a Research Assistant in the Department of Social Medicine at University of North Carolina School of Medicine. Jean Cadigan is an Associate Professor in the Department of Social Medicine, and a part of the core faculty at the Center for Bioethics at the University of North Carolina at Chapel Hill.
N C J Law Technol. 2020 Dec;22(2):107-141.
For years, genomic medicine-medicine based on the growing understanding of the genetic contribution to many diseases and conditions-has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations. In the wake of ethically dubious experiments with human embryos in China, the international governance of human genome editing is emerging as an urgent topic for scientists, regulators, and the public. Efforts to develop a governance model are underway at national and international levels. These efforts are the subject of multiple initiatives by national and international health and science organizations and are topics of discussion at scientific conferences, summits, and meetings. This Article reports on the Authors' multi-year, interdisciplinary project to identify and investigate the practical, ethical, and policy considerations that are emerging as the greatest concerns about human genome editing, and ultimately to develop policy options. The project involves monitoring the discussions of groups, both government-sponsored and private, that are considering how genome editing should be governed; observing conferences where the topic is discussed; analyzing emerging policy reports by national and international bodies; and interviewing a wide range of stakeholders, including scientists, ethicists, and those who make and comment on public policy. The Article identifies several stakeholder concerns that are especially prominent in the research to date and begins to explore the implications of these concerns for alternative models of governance. There are current indications that, for practical purposes, a focus on "soft," hybrid forms of governance based on networks of multiple public and private stakeholders may turn out to be the most promising course to pursue. The "new governance" paradigm developed in the corporate and financial sectors offers a useful model for understanding the dynamics of this approach.
多年来，基因组医学——基于对许多疾病和病症的遗传因素的日益深入了解而发展起来的医学——一直被誉为医疗治疗的未来，但迄今为止，它对日常医疗实践的影响有限。基因组医学的最终目标一直不仅是识别危险的基因突变，而且是修复这些突变。现在，CRISPR及相关的基因组编辑技术可能有潜力提供一种安全有效的方法来修复危险突变。在中国进行了有伦理问题的人类胚胎实验之后，人类基因组编辑的国际治理正成为科学家、监管机构和公众的一个紧迫话题。国家和国际层面都在努力制定治理模式。这些努力是国家和国际卫生与科学组织多项倡议的主题，也是科学会议、峰会和会议的讨论话题。本文报道了作者多年的跨学科项目，旨在识别和研究作为对人类基因组编辑最为关注的实际、伦理和政策考量，并最终制定政策选项。该项目包括监测政府发起和私人组织关于基因组编辑应如何治理的讨论；观察讨论该话题的会议；分析国家和国际机构发布的新政策报告；以及采访广泛的利益相关者，包括科学家、伦理学家以及制定和评论公共政策的人士。本文确定了在迄今为止的研究中特别突出的几个利益相关者关切，并开始探讨这些关切对替代治理模式的影响。目前有迹象表明，出于实际目的，关注基于多个公共和私人利益相关者网络的“软性”、混合治理形式可能是最有前途的做法。企业和金融领域发展起来的“新治理”范式为理解这种方法的动态提供了一个有用的模型。
