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

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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.