Genome editing in humans: A survey of law, regulation and governance principles

Genome editing is a powerful new tool allowing precise additions, deletions and substitutions in the genome. The development of new approaches has made editing of the genome much more precise, efficient, flexible, and less expensive, relative to previous strategies. As with other medical advances, each such application comes with its own set of benefits, risks, ethical issues and societal implications, which may require new regulatory frameworks. Important questions raised with respect to genome editing include how to balance potential benefits against the risk of unintended harms; how to govern the use of these technologies, and how to incorporate societal values into salient clinical and policy considerations. This STOA study provides an overview of human genome editing applications and a review of the principles that guide the governance of genome editing in humans, at EU level and worldwide. The study also formulates a series of policy options targeted at basic research and to clinical applications, both somatic and germline.