Supplement to Framework for Advances in Reprogenomics Ethics & Regulation (FAIRER)

摘要 这项更公平的研究旨在为生殖临床试验的伦理行为制定一个框架。 基因组干预，特别侧重于有怀孕能力的个人的研究参与。 这项更公平的研究的补充将解决涉及研究的试验中独特的伦理和社会问题。 来自性和/或性别少数群体(SGM)的参与者。SGM产生的动因及考虑 在生殖基因组干预方面，虽然与顺性和 异性恋参与者在很大程度上也可能存在差异。生理、遗传和社会差异 顺性参与者、变性者和性发育差异者之间的关系 (DSD)可能需要改变试验设计和安全考虑因素。最后，从历史上看，SGM 在医疗环境中经历边缘化，特别是在获得和利用援助的机会方面 生殖技术，影响生物医学研究中的信任关系。为了建立一种道德的 考虑到再生基因组学临床试验中所有潜在参与者的需求和利益的框架， 该项目有以下目标：(1)纳入个人识别为性的独特考虑因素 和/或性别少数群体(SGM)纳入生殖基因组研究的伦理框架，重点是 怀孕和可能怀孕的参与者及其未来后代的健康和福祉；以及(2)建立 SGM个人和专家在SGM医疗保健和研究方面的观点和专业知识 道德框架和利益攸关方知情工具包，以指导IRBs和研究人员参与 生殖基因组学。为了实现这些目标，我们将对关于SGM的文献进行范围回顾 在家庭建设中的考虑；采访具有SGM卫生专业知识的专业人员，以起草一份伦理报告 解决与SGM临床参与相关的问题的框架；并开展两个焦点小组 来自特别工作组社区的个人讨论并接受对框架草案的反馈。这些策略 将加强我们更大的项目，并提高其结果和交付成果与所有利益相关者的相关性 他们可能参与未来人类生殖基因组学的研究。

ABSTRACT The FAIRER study is designed to develop a framework for the ethical conduct of clinical trials of reproductive genomic interventions, particularly focusing on the research participation of pregnancy-capable individuals. This supplement to the FAIRER study will address unique ethical and social issues in trials involving research participants from sexual and/or gender minorities (SGM). The motivations and considerations of SGM regarding reproductive genomic interventions, while sharing common features with those of cisgender and heterosexual participants, likely also differ in significant ways. Physiological, genetic, and social differences between cisgender participants, transgender participants, and those with differences of sexual development (DSD) may necessitate changes in trial design and safety considerations. Finally, SGM have historically experienced marginalization in medical settings, particularly with respect to access to and utilization of assisted reproductive technologies, that impact trust relationships in biomedical research. In order to build an ethical framework that considers the needs and interests of all potential participants in reprogenomics clinical trials, this project has the following Aims: (1) Incorporate considerations unique to individuals identifying as sexual and/or gender minorities (SGM) into an ethical framework for reprogenomics research, with emphasis on the health and well-being of pregnant and potentially pregnant participants and their future offspring; and (2) Build the perspectives and expertise of SGM individuals and experts in SGM healthcare and research into our ethical framework and the stakeholder-informed toolkit to guide IRBs and researchers engaged with reprogenomics. To accomplish these Aims, we will conduct a scoping review of literature on SGM considerations in family-building; interview professionals with expertise in SGM health to draft an ethical framework that addresses issues relevant to SGM clinical participation; and conduct two focus groups with individuals from SGM communities to discuss and receive feedback on the draft framework. These strategies will enhance our larger project and increase the relevance of its results and deliverables to all stakeholders who may be involved in future human research in reprogenomics.