PROJECT SUMMARY/ABSTRACT The development of new methods for prenatal genetic editing in humans has accelerated the translation of technologies designed to disrupt disease mechanisms or remove disease-causing mutations entirely. These technologies show promise for preemptively addressing previously intractable genetic conditions. However, recent events have demonstrated considerable gaps in the governance structure surrounding human gene editing and its translation to clinical practice. Since the discovery that a scientist in China had conducted human experiments allegedly resulting in the birth of three genetically edited children, numerous calls have been made for a novel governance structure for prenatal human gene editing, frequently framed around moratoria or other forms of suppression, and several international bodies have convened. There has been strong pressure towards a values-based governance approach that moves beyond traditional technocratic considerations of safety and efficacy and takes into account collective normative deliberation about the ethics of prenatal intervention. This is challenging in the United States context, which is among the few high-income countries without centralized regulation of research on embryos and/or translational assisted reproductive technologies. As such, two important stakeholder voices have been largely left out of conversations around the future of prenatal gene editing in the US context: the patients and families that might be benefitted or harmed by the translation of prenatal gene editing and the scientists and clinicians who would be on the front lines of clinical translation were it to move forward. We propose to fill this gap by conducting empirical research with these key stakeholders that assesses potential governance approaches internationally and explores how they may be implemented in an United States context. The goal is to move past generalizations to explore the direct policy mechanisms that are feasible while incorporating the values and priorities of end users. This study consists of three aims. The first two, contemporaneous, aims will consist of qualitative research with two sets of stakeholders: patients and families affected by genetic conditions potentially addressable through prenatal gene editing and clinicians and scientists involved in relevant translational and clinical activities in this space. In Aim 1, We will begin by conducting a review of the international science policy landscape to gather policy mechanisms that have been proposed or implemented to manage emerging technologies in the reproductive science, genetics, and regenerative medicine spaces. We will identify policies that fall into a spectrum from permissive to restrictive. These policies will be shared with stakeholders during qualitative interviews to assess their concordance with stakeholder values and priorities. We will recruit a diverse cohort of clinicians and scientist leaders from 20 key professional s...