Incidental Enhancement: Addressing a Neglected Policy Issue in Human Genome Editing

附带增强：解决人类基因组编辑中被忽视的政策问题

• 批准号: 10565919
• 负责人: Rosemary Jean Cadigan
• 金额: $ 77.75万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10565919
• 关键词: Address; Affect; Agreement; Animal Experimentation; Animals; Asia; Authorization documentation; Automobile Driving; Basic Science; Binding; Case Study; Case/Control Studies; Categories; Clinical; Clinical Protocols; Communities; Consensus; Country; Data; Development; Diffusion; Disclosure; Disease; Empirical Research; Ethical Analysis; Ethics; Europe; Explosion; Future; Genes; Genome; Genomics; Goals; Health Benefit; Human; Human Genetics; Human Genome; Incentives; Influentials; Institution; International; Intervention; Interview; Judgment; Knowledge; Laws; Legal; Medical; Mission; Modeling; Modification; Morals; National Human Genome Research Institute; North America; Pathway interactions; Play; Policies; Policy Analysis; Policy Maker; Positioning Attribute; Posture; Prevention; Preventive; Process; Professional Role; Public Health; Qualifying; Reporting; Research; Research Design; Role; Science; Science Policy; Scientist; Shapes; Societies; Taxonomy; Translational Research; Translations; Weight; Work; authority; design; disorder prevention; experience; genome editing; interest; meetings; member; neglect; policy implication; pre-clinical; prevent; preventive intervention; social factors; theories; trait; translational pipeline

PROJECT SUMMARY/ ABSTRACT The increasing pace and international diffusion of developments in human genome editing research have prompted ongoing efforts to develop responsible governance for such research. One point of broad agreement across these efforts is that human genome editing research should prioritize medical applications over attempts to enhance human traits because of the moral concerns the latter would raise. What qualifies as human enhancement and how to address issues that may arise in this arena remain uncertain. Moreover, several influential reports expand their interpretation of medical applications beyond disease treatment to endorse disease prevention as a goal for genome editing research. Basic human genome research and animal studies aspiring to this goal are already underway. But preventing disease through human genome editing would incidentally facilitate human enhancement applications in a variety of ways. If these translational research efforts are penalized by policy concerns about those applications, then their preventive health benefits could be lost. Conversely, society could be caught off guard by the emergence of genome editing applications that evoke the very moral concerns that the policy line against enhancement is meant to forestall. To responsibly anticipate these challenges, science policymakers will need to know more about the salience of enhancement concerns in the context of preventive genome editing (PGE) research and how best to develop research governance to address them. This project addresses these needs through the following research questions: 1) How do the goals, incentives and values driving cases of preclinical PGE research affect the ways that its incidental enhancement implications are interpreted and addressed for governance purposes? 2) How well might different forms of research governance be expected to anticipate and address these different concerns? 3) Given the potential human health benefits of preventive genome editing research, what ethical weight should science policy give to the various enhancement concerns? Answering these questions requires both empirical research and ethical analysis. Aim 1 enlists scientists to examine the professional and social factors that shape the trajectory of basic research relevant to preventive genome editing. Their perspectives will inform a taxonomy of different ways of interpreting incidental enhancements for policy purposes, and preview of the governance challenges they will raise. Aim 2 follows national and global genome editing policy groups to capture the lessons of their experiences, in order to assess the relative merits of different approaches to governance in dealing with incidental enhancement concerns. Both of these efforts will be drawn together in Aim 3, to inform an empirically grounded ethical analysis of the policy choices facing those engaged in genome editing research governance in different cases. The product of this project will be a set of case studies designed to help science policy makers, the research community and the public anticipate the incidental enhancement concerns that preventive genome editing research will pose.

项目总结/摘要 人类基因组编辑研究进展的日益加快和国际扩散， 促使不断努力为此类研究制定负责任的治理。有一点达成广泛共识 在这些努力中，人类基因组编辑研究应该优先考虑医学应用，而不是尝试 因为后者会引起道德上的担忧。什么才算是人类 增强以及如何解决这一竞技场中可能出现的问题仍然不确定。此外，若干 有影响力的报告将他们对医学应用的解释扩展到疾病治疗之外， 疾病预防作为基因组编辑研究的目标。基础人类基因组研究和动物研究 正在朝着这个目标努力。但是通过人类基因组编辑来预防疾病 附带地以各种方式促进人类增强应用。如果这些转化研究 如果这些努力受到有关这些应用的政策关注的惩罚，那么它们的预防健康益处可能会被 迷路了相反，基因组编辑应用的出现可能会让社会措手不及， 反对增强的政策路线旨在阻止的道德担忧。责任地 为了应对这些挑战，科学决策者需要更多地了解增强的重要性， 预防性基因组编辑（PGE）研究背景下的问题以及如何最好地开展研究 治理来解决这些问题。本项目通过以下研究问题解决这些需求：1） 临床前PGE研究的目标、激励和价值驱动案例如何影响其 为了治理的目的，解释和处理了附带的增强含义？2)多好 不同形式的研究治理是否可以预期能够预见和解决这些不同的问题？ 3)鉴于预防性基因组编辑研究对人类健康的潜在益处， 科学政策是否应该考虑到各种增强的问题？回答这些问题需要 实证研究和伦理分析。目标1招募科学家研究专业和社会因素 这一点决定了与预防性基因组编辑相关的基础研究的轨迹。他们的观点将为 为策略目的解释附带增强功能的不同方法的分类，以及 他们将面临的治理挑战。Aim 2遵循国家和全球基因组编辑政策小组的要求， 总结经验教训，以评估不同方法的相对优点， 治理在处理附带的增强问题。这两方面的努力将在 目标3，为从事基因组研究的人所面临的政策选择提供基于经验的伦理分析 不同情况下的编辑研究治理。该项目的产品将是一组设计的案例研究 帮助科学政策制定者、研究界和公众预测附带的增强 预防性基因组编辑研究将带来的担忧。

项目成果

Public participation in human genome editing research governance: what do scientists think?

• DOI: 10.1007/s12687-024-00701-2
• 发表时间: 2024-02-14
• 期刊: JOURNAL OF COMMUNITY GENETICS
• 影响因子: 1.9
• 作者: Waltz，Margaret;Flatt，Michael A.;Cadigan，R. Jean
• 通讯作者: Cadigan，R. Jean

Scientists' Views on Scientific Self-Governance for Human Genome Editing Research.

• DOI: 10.1089/hum.2022.087
• 发表时间: 2022-07
• 期刊: Human gene therapy
• 影响因子: 4.2
• 作者: R. J. Cadigan;Margaret Waltz;J. M. Conley;G. Henderson;Arlene M Davis;Rami Major;E. Juengst

The View from the Benches: Scientists' Perspectives on the Uses and Governance of Human Gene-Editing Research.

工作台的观点：科学家对人类基因编辑研究的用途和治理的看法。

• DOI: 10.1089/crispr.2021.0038
• 发表时间: 2021
• 期刊: The CRISPR journal
• 作者: Waltz,Margaret;Juengst,EricT;Edwards,Teresa;Henderson,GailE;Kuczynski,KristineJ;Conley,JohnM;Della-Penna,Paige;Cadigan,RJean
• 通讯作者: Cadigan,RJean

Anticipating the ethical, legal, and social implications of human genome research: An ongoing experiment.

• DOI: 10.1002/ajmg.a.62405
• 发表时间: 2021-11
• 期刊: American journal of medical genetics. Part A
• 作者: Juengst ET