At the core of research on reproductive genomic interventions is a fundamental question: whether and how to involve pregnancy-capable people in clinical trials. Human participants will need to 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 people 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.

We lack ethical guidance about how to conduct these human trials without causing undue harm, especially in regard to the women and other pregnancy-capable participants who are a necessary part of clinical research. By building an ethical framework and a toolkit to guide researchers and institutional review boards, this project is creating robust guidance for research in reprogenomics and a broadened consensus on these technologies among key professional bodies.

The FAIRER study (Framework for Advances In Reprogenomics Ethics & Regulation) is funded by the US National Institutes of health, and is led in partnership by Marsha Michie of Case Western Reserve University and Ruth Farrell of the Cleveland Clinic.