PaSAGE: PAtient Supported Approaches to Gene Editing

New methods for prenatal genetic editing in humans show promise for treating or even preventing the development of many genetic conditions. But recent events have shown that there are major gaps in systems for regulating and guiding research and implementation of human gene editing technologies. Since the 2018 discovery that a scientist in China conducted human experiments allegedly resulting in the birth of three genetically edited children, there has been strong pressure to build values-based governance for prenatal interventions, taking into account the views of many societal stakeholders. This is challenging in the United States context, which is among the few high-income countries that does not regulate research on embryos and assisted reproduction at the national level. Two important stakeholder voices have been largely left out of conversations around the future of prenatal gene editing: the patients and families that might benefit or be harmed by prenatal gene editing and the scientists and clinicians who would be on the front lines of clinical implementation. We are filling this gap by conducting empirical research with these key stakeholders, exploring potential governance approaches internationally, and considering how they may be implemented in an United States context. Our goal is to move past generalizations to explore the direct policy mechanisms that are feasible while incorporating the values and priorities of end users.