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Resources for IRBs: Meeting the Challenges Presented by Reproductive Applications of Genomics Research

Purchase Recording

Overview

As the field of genomic science advances, there is growing interest in applications of genomic interventions in the reproductive context. This includes genomic modification of embryos, fetuses, and gametes with the goal of avoiding serious disease in offspring. Germline modifications, including possible unintended effects of somatic interventions, are of particular interest as changes induced in the present will have implications for future generations.
The design and review of these studies entails considering risks and potential benefits not just for the offspring but also the pregnant person who will carry the genomically modified embryo within their body. Given the unique aspects of trials genomic interventions, it will be critical for IRBs to provide guidance regarding the conduct of these studies and the protections that must be in place for both pregnant individuals (during and after the pregnancy) and offspring.

Cost:

Members: Free Nonmembers: $190

What Will I Learn?

  • Identify the unique ethical considerations associated with reproductive applications of genomic interventions.
  • Explain the risk/benefit considerations for pregnant persons participating in trials of genomic modification and offspring that result from genomic modification in vitro or in utero.
  • Assess current IRB practices to regulate reproductive applications of genomic interventions and the role of novel resources to support those efforts.
CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
CIP Credit
CIP CreditCourse participants who hold the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.

Contributors

Marsha Michie, PhD

Associate Professor of Bioethics at the Case Western Reserve University School of Medicine
Marsha Michie, PhD: Dr. Marsha Michie is Associate Professor of Bioethics at the Case Western Reserve University School of Medicine, where she co-directs the PhD in Bioethics. Dr. Michie is an anthropologist and empirical bioethicist who received her PhD in Anthropology from University of North Carolina-Chapel Hill. Before coming to Case Western Reserve University in 2017, she held postdoctoral fellowships at UNC-Chapel Hill and Stanford University and was a faculty member at the University of California, San Francisco Institute for Health and Aging. Dr. Michie’s research primarily focuses on ethical and social issues in genetics and reproduction, with particular interests in research ethics, health equity, and disability. Her recent research includes work in the areas of reproductive genomic interventions, the ethics of research with pregnant populations, the ethical and equitable translation of gene editing technologies such as CRISPR, the delivery and support of prenatal genetic information from screening and testing, and the ways that ethical concerns in reproductive and genomic technologies disproportionately impact people from racial, ethnic, sex and/or gender minorities. Her work has been funded by NIH and private foundations.

Ruth M. Farrell, MD, MA, FACOG

Physician-scientist, Cleveland Clinic
Dr. Ruth Farrell is a physician-scientist at the Cleveland Clinic, whose mission is to provide patients with the highest-quality, equitable, and innovative healthcare. She is a board-certified obstetrician-gynecologist with a primary appointment in the Cleveland Clinic OB/GYN Institute and secondary appointments in the Genomic Medicine Institute and the Center for Bioethics. Dr. Farrell serves as the Vice Chair of Research at the Cleveland Clinic OB/GYN Institute, where she leads the institute's research strategy and academic performance across a spectrum of clinical, basic, translational, and health services research. She is Professor of OB/GYN and Reproductive Biology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Farrell's medical practice specializes in women's health, gynecology, and reproductive medicine, with a focus on the medical management of benign gynecologic conditions, contraception, cervical cancer prevention, and gynecologic ultrasound. Her research investigates the translation of new biomedical science and technology into women's health and reproductive medicine. She has been successfully funded by the NIH, March of Dimes, and the Templeton Foundation to pursue this line of research. Dr. Farrell received an M.A. in Bioethics and an M.D. from Case Western Reserve University. Following residency in OB/GYN at University Hospitals of Cleveland, she completed the Greenwall Fellowship in Bioethics and Health Policy, a joint program of the Johns Hopkins Berman Bioethics Institute and Georgetown University Kennedy Institute of Ethics. During this time, she also served as the J. Benjamin Younger Fellow of Policy at ASRM in Washington, DC.