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

> **NIH NIH R01** · CASE WESTERN RESERVE UNIVERSITY · 2022 · $151,240

## Abstract

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.

## Key facts

- **NIH application ID:** 10593247
- **Project number:** 3R01HG011480-02S1
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Ruth Farrell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $151,240
- **Award type:** 3
- **Project period:** 2021-06-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10593247

## Citation

> US National Institutes of Health, RePORTER application 10593247, Supplement to Framework for Advances in Reprogenomics Ethics & Regulation (FAIRER) (3R01HG011480-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10593247. Licensed CC0.

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