Are IRBs prepared to govern reprogenomics research? Building stakeholder-informed guidance and testing the limits of US research regulation
Friday, September 20, 2024
10:15 AM – 11:15 AM CT
Location: Midway 5 (First Floor)
Abstract: Reproductive applications of genome editing are on the horizon, including modifying human gametes, embryos, or fetuses. The design of reprogenomic clinical trials entails considering risks and potential benefits, not just for the offspring, but also the person who will carry a genomically modified pregnancy. Clinical trials of these reprogenomic interventions will involve people who are pregnant or will become pregnant through research interventions, and may also involve people who may provide reproductive tissue for these interventions. Germline modifications, including unanticipated germline effects when targeting somatic interventions in fetuses, are of particular interest as they have implications for future generations. In the US landscape of research regulation, IRBs are the most obvious oversight bodies to govern individual clinical trials of reprogenomics. However, the expertise required and the considerations to be weighed may exceed the present capabilities of many local IRBs, raising critical questions about how well IRBs will be situated to take on the unique aspects of studies of genomic interventions. What resources and guidance do IRBs need to effectively govern these novel trials and the complex issues they raise? And is the regulatory purview of US IRBs broad enough to take on the ethical considerations at stake? We will discuss findings of a multi-year study developing an ethical framework for reprogenomics research via expert interviews and a structured literature review, and provide an overview of both the wide-ranging ethical/regulatory issues and the practical, on-the-ground resources IRBs will need when they soon find themselves reviewing reprogenomics protocols.
Learning Objectives:
After participating in this conference, attendees should be able to:
To understand the unique ethical challenges associated with trials that will modify the germline.
To examine how those challenges present additional considerations for pregnant persons participating in these trials, their offspring, and society.
To determine whether and how the current regulatory structure must evolve in conjunction with innovative genomic interventions being researched in the reproductive context.
Christina Collart, MEd – Cleveland Clinic; Ruth Farrell, MD, MA – Cleveland Clinic; Holly Fernandez Lynch, JD, MBE – University of Pennsylvania; Marsha Michie – Case Western Reserve University School of Medicine; Kelly Ormond – ETH- Zurich; Roselle Ponsaran – Case Western Reserve University School of Medicine
