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

生殖基因组学伦理进展框架的补充

• 批准号: 10593247
• 负责人: Ruth Farrell
• 金额: $ 15.12万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593247
• 关键词: Address; Administrative Supplement; Advocate; Area; Assisted Reproductive Technology; Bioethics; Bioethics Consultants; Biomedical Research; Child; Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data Collection; Development; Ensure; Ethical Issues; Ethics; Family; Feedback; Focus Groups; Funding; Future; Genetic; Genomics; Health; Health Care Research; Healthcare; Heterosexuals; Human; Human Genome; Individual; Institutional Review Boards; Intervention; Interview; Literature; Medical; Modification; Motivation; Output; Parents; Participant; Patients; Personal Satisfaction; Persons; Physiological; Policy Maker; Population Heterogeneity; Pregnancy; Privacy; Qualitative Methods; Regulation; Reproduction; Reproductive Medicine; Reproductive Sciences; Research; Research Ethics; Research Methodology; Research Personnel; Review Literature; Safety; Science; Scientist; Sexual Development; Social Sciences; Societies; Structure; Trust; Underrepresented Populations; Work; cisgender; community based research; design; epigenome; experience; gender minority; gender minority community; gender minority group; gender minority health; insight; interest; meetings; member; microbiome; minority healthcare; offspring; parent project; pregnant; reproductive; sexual minority; sexual minority group; social; social exclusion; social movement; transgender; trial design

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.

摘要 FAIRER研究旨在为生殖健康临床试验的伦理行为制定一个框架， 基因组干预措施，特别注重有怀孕能力的个人参与研究。 FAIRER研究的补充将解决涉及研究的试验中的独特伦理和社会问题 性和/或性别少数群体（SGM）。SGM的动机和考虑 关于生殖基因组干预，同时与顺性别和 异性恋的参与者，可能也有很大的不同。生理、遗传和社会差异 在顺性别参与者、跨性别参与者和性发育差异者之间 (DSD)可能需要改变试验设计和安全性考虑。最后，SGM在历史上 在医疗环境中经历边缘化，特别是在获得和利用援助方面， 生殖技术，影响生物医学研究中的信任关系。为了建立一个道德的 该框架考虑了再生组学临床试验中所有潜在参与者的需求和利益， 这个项目有以下目标：（1）纳入对性取向的个人的独特考虑 和/或性别少数群体（SGM）纳入生殖组学研究的伦理框架，重点是 怀孕和潜在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SGM医疗保健专家的观点和专业知识，以及对我们 伦理框架和知情的工具包，以指导IRB和研究人员参与 再生组学为了实现这些目标，我们将对SGM的文献进行范围审查 家庭建设中的考虑因素;采访具有SGM健康专业知识的专业人士， 解决SGM临床参与相关问题的框架;并开展两个焦点小组， 来自SGM社区的个人讨论框架草案并听取反馈意见。这些策略 将加强我们的大型项目，并提高其成果和交付成果与所有利益相关者的相关性 他可能会参与未来人类的再生组学研究。