University Hospitals to Help Establish Ethical Frameworks for Reprogenomics Research

Innovations in Obstetrics & Gynecology | Fall 2021

Reprogenomics holds the promise of early intervention on embryos and their environments, with an ultimate goal of reducing maternal and fetal morbidity and mortality.

 Rebecca Flyckt, MD

Today, leaders in reproductive medicine are investigating how modifying the hormonal environment of the uterus can affect gene expression in embryos, and some studies have even involved direct alterations of the genes of embryos. While these avenues of exploration are enormously promising, they do raise many ethical questions that have yet to be answered by a structured and robust ethical framework.

“Right now, there's no clear or uniform ethical guidance about how to structure these human trials of genomic interventions; ultimately, we must ensure that these trials are being performed according to the highest ethical standards, and in ways that mitigate possible harms to potential mothers and babies,” says Rebecca Flyckt, MD, Division Chief, Reproductive Endocrinology and Infertility at University Hospitals Cleveland Medical Center, Lilian Hanna Baldwin Chair in Obstetrics and Gynecology at University Hospitals MacDonald Women's Hospital and Medical Director of the University Hospitals Fertility Center.

University Hospitals is part of a multicenter collaborative National Institutes of Health-funded effort to develop this necessary framework to guide reprogenomics research as it progresses. Dr. Flyckt is a co-investigator on this multidisciplinary study — the FAIRER R01 — which brings a wide variety of experts together with this shared purpose. Stakeholders will determine the ethical challenges associated with reprogenomics, develop a framework for reprogenomics research that prioritizes the health of the women and children involved and establish a toolkit to guide researchers and institutional review boards involved in reprogenomics research.

“The idea is to get all of the right people to the table for this conversation, because it hasn’t happened in the past in a large or coordinated way,” Dr. Flyckt says. The NIH-funded study will bring together a diverse range of experts, including obstetrician/gynecologists, bioethicists, social scientists, maternal fetal medicine specialists, clinical geneticists, human subject research specialists and more.

The grant has a three-year timeline and the process has just begun, but the potential impact of the project’s end goal is clear. “If the framework becomes widely adopted, then we can ensure that we are holding all research to the same defined and high-level ethical standards,” Dr. Flyckt says.

While this is the immediate goal of the funded study, research is never a static process. As the field of reprogenomics evolves, so will the ethics surrounding it. “We might have to come up with a completely new framework someday based on information gained, and I think that's just an essential part of work in bioethics. You have to constantly evolve as new information, new procedures and new science come up,” she says.

University Hospitals' participation puts it at the core of an exciting field of study. “We have such strong obstetrics and fertility divisions, so this kind of research is a natural fit here,” Dr. Flyckt says. UH researchers like Sam Mesiano, PhD, Vice Chair of Research at University Hospitals Cleveland Medical Center and Rachel Weinerman, MD, an assistant professor at Case Western Reserve University School of Medicine and Fellowship Program Director in the Division of Reproductive Endocrinology and Infertility at the UH Fertility Center, are studying areas like the early hormone environment in pregnancy and how embryo transfers affect neonatal outcomes.

“Although individual research studies are essential, at UH, we are also participating in answering broader questions about alterations in the early fetal environment with some of the preeminent ethicists and geneticists around the country,” Dr. Flyckt says.

Participating in this NIH-funded study allows UH a foundational role in shaping ethical standards for reprogenomics research. “This is one of the final frontiers in reproductive medicine, and to be at institution that allows us to ask and answer some of these questions … it's truly exciting,” she says. 

If you are interested in learning more about this NIH-funded research, reach out Dr. Flyckt at rebecca.flyckt2@uhhospitals.org.

Contributing Expert:
Rebecca Flyckt, MD
Division Chief, Reproductive Endocrinology and Infertility
UH Cleveland Medical Center
Lilian Hanna Baldwin Chair in Obstetrics and Gynecology
UH MacDonald Women's Hospital
Medical Director, UH Fertility Center
Associate Professor of Reproductive Biology
Case Western Reserve University School of Medicine