Framework for Advances in Reprogenomics Ethics & Regulation (FAIRER)

摘要 生殖背景下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。已经有很多关于以下婴儿健康的问题 实验性CRISPR基因修饰然而，另一个至关重要的因素却少得多 注意：孕妇和潜在孕妇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 让妇女参与，目的是让她们携带转基因胚胎或胚胎环境 在他们的身体里，最终怀孕并生下希望是健康的生命， 婴儿。有问题的是，关于担任孕妇的讨论如此之少， 生殖基因组学（再生组学）试验的研究参与者，如这些， 无论是在怀孕期间的短期内，还是在怀孕后的长期内， 怀孕这些问题的核心是如何实现再生组学研究的全部潜力， 改善儿童和母亲的结果，而不造成直接或代际伤害， 儿童以及作为个人和家庭成员的妇女。在第二波倡议的基础上， 概述了将妇女纳入药物临床试验的伦理框架，该项目将建立 一个伦理和社会指导再生组学研究的框架，特别关注 女性参与者沿着她们潜在的孩子。研究目的将（1）描述伦理挑战 通过对文献的系统回顾， 与主要利益相关者的访谈;（2）通过分析建立生殖组学研究的伦理框架 利益相关者访谈数据，并与主要利益相关者举行审议会议;以及（3）制定 指导IRB和研究人员制定、审查和实施 用于再生组学研究的协议。通过让关键利益攸关方参与生殖科学和医学， 包括研究人员，IRB成员，生物伦理学家和患者倡导者，该项目将开发强大的， 解决生殖组学研究伦理挑战的预期指导，沿着工具包， 为IRB、研究人员和研究机构提供具体指导。这项工作将与现有的相吻合 努力为科学和医学专业协会的基因组编辑制定道德指南， （b）在妇女参与研究期间， 研究）和患者（研究参与结束后）。这些战略将为更多的人创造一条途径， 一致关注再生组学的研究伦理，并扩大对这些技术的共识 在主要的专业机构中。

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.