Framework for Advances in Reprogenomics Ethics & Regulation (FAIRER)

摘要 生殖领域的基因组研究正在从筛查和诊断转向干预： 确定改变人类基因组、表观基因组或微生物组的方法，以改善产科、新生儿、 和儿科结果。关于以下出生的孩子的健康问题已经比比皆是 实验性CRISPR基因改造。然而，另一个至关重要的因素却少得多。 注意：怀孕和潜在怀孕妇女参与生殖基因组研究 干预措施。基因组干预研究的核心是一个基本问题：是否以及如何 让有意携带转基因胚胎或胚胎环境的女性参与 在他们的身体里，最终怀孕并生下希望是健康的生活 婴儿。有问题的是，关于怀孕妇女担任 生殖基因组学(再生殖基因组学)试验的研究参与者，以及关于保护的研究 这对她们来说必须到位--无论是在怀孕期间的短期内，还是在怀孕后很长一段时间内 怀孕的事。这些问题的核心是如何充分发挥生殖基因组学研究的潜力 改善儿童和母亲的结果，而不会造成直接或代际伤害，而不仅仅是 不仅对儿童，而且对作为个人和家庭成员的妇女也是如此。在第二波倡议的基础上， 概述了将女性纳入药理学临床试验的伦理框架，该项目将建立 伦理和社会指导生殖基因组学研究的框架，特别关注利益 女性参与者及其可能的孩子。研究目标将(1)描述道德挑战 通过对文献和文献的系统回顾，对生殖基因组学研究进行综述，包括优势和差距。 与主要利益相关者的访谈；(2)通过分析建立生殖基因组研究的伦理框架 与利益攸关方面谈数据并与关键利益攸关方举行审议会议；以及(3)制定 利益相关者知情的工具包，用于指导IRBs和正在开发、审查和实施的研究人员 生殖基因组学研究的协议。通过让生殖科学和医学领域的主要利益攸关方参与进来， 包括研究人员、IRB成员、生物伦理学家和患者权益倡导者在内，该项目将发展壮大， 解决生殖基因组研究的伦理挑战的前瞻性指导，以及一个工具包 为研究所、研究人员和研究机构提供具体指导。这项工作将与现有的工作相吻合 努力在科学和医学专业学会中制定基因组编辑的伦理指导，并 各组织，同时提请特别注意妇女作为研究参与者的利益(在 研究)和患者(在研究参与结束后)。这些战略将创造一条途径， 一致关注生殖基因组学中的研究伦理并就这些技术达成更广泛的共识 在关键的专业团体中。

ABSTRACT Genomic research in the reproductive context is shifting from screening and diagnosis to interventions: identifying ways to alter the human genome, epigenome, or microbiome in order to improve obstetric, neonatal, and pediatric outcomes. Already, questions abound regarding the health of children born following experimental CRISPR genetic modification. However, another critically important factor has received far less attention: the involvement of pregnant and potentially-pregnant women in studies of reproductive genomic interventions. At the core of research on genomic interventions is a fundamental question: whether and how to involve women with the intention that they will carry a genetically modified embryo or embryonic environment within their bodies, ultimately becoming pregnant and giving birth to what, is hoped, will be a healthy, live infant. It is problematic that there has been so little discussion about the pregnant women who serve as research participants in reproductive genomics (reprogenomics) trials such as these, and about protections that must be in place for them—either in the short term while they are pregnant or in the long term, well after the pregnancy. At the core of these questions is how to achieve the full potential of reprogenomics research to improve outcomes for children and mothers without causing immediate or generational harms, not just for children but also for women as individuals and members of families. Building on the Second Wave Initiative, which outlined an ethical framework for inclusion of women in pharmacologic clinical trials, this project will build a framework to ethically and socially guide research in reprogenomics, with particular concern for the interests of women participants along with their potential children. Study aims will (1) characterize the ethical challenges of reprogenomics research, including strengths and gaps, through a systematic review of the literature and interviews with key stakeholders; (2) build an ethical framework for reprogenomics research through analyzing stakeholder interview data and holding a deliberative meeting with key stakeholders; and (3) develop a stakeholder-informed toolkit to guide IRBs and researchers who are developing, reviewing and implementing protocols for reprogenomics research. By engaging key stakeholders in reproductive science and medicine, including researchers, IRB members, bioethicists, and patient advocates, this project will develop robust, anticipatory guidance for addressing the ethical challenges of reprogenomics research, along with a toolkit to provide concrete guidance for IRBs, researchers, and research institutions. This work will dovetail with existing efforts to develop ethical guidance for genome editing among scientific and medical professional societies and organizations, while drawing particular attention to the interests of women as research participants (during studies) and patients (after study participation has ended). These strategies will create a pathway for more concerted attention to research ethics in reprogenomics and a broadened consensus on these technologies among key professional bodies.