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.