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

> **NIH NIH R01** · CASE WESTERN RESERVE UNIVERSITY · 2022 · $604,126

## Abstract

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)....

## Key facts

- **NIH application ID:** 10408663
- **Project number:** 5R01HG011480-02
- **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:** $604,126
- **Award type:** 5
- **Project period:** 2021-06-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10408663

## Citation

> US National Institutes of Health, RePORTER application 10408663, Framework for Advances in Reprogenomics Ethics & Regulation (FAIRER) (5R01HG011480-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10408663. Licensed CC0.

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