Assignment of responsibility for creating persons using germline genome-editing

Abstract

The 2018 announcement regarding safe childbirths via germline genome-editing (GGE) with parental consent shocked the world. This minireview examines the predictable risks, burdens, and potential harms of human GGE and explores the question of responsibility for using GGE in human reproduction. Although there is currently no international consensus on proving the absence of harmful off-target mutations in the genome, preclinical GGE study can demonstrate the non-existence under specific conditions. Initially, the clinical application will be limited to small studies without controls. In any case, individuals born via GGE should be followed up for long period. However, such persons can decline follow-up. Due to limited screening, an overlooked off-target mutation may harm the entire body. Some persons suffering such harm might claim damages on the ground that their life is less valuable. However, most jurisdictions will reject such claims. Practitioners are responsible for proving there are no harmful off-target mutations in each GGE case, although the appropriateness of proof is currently difficult to accept. Parents who consented to GGE, as well as practitioners, assume responsibility for the safety of genome-edited offspring; however, the fulfillment of responsibility ultimately depends on the offspring's autonomy. Meanwhile, practitioners and parents may be exempt from some damage claims by offspring harmed by unsafe GGE. The uncertainty of assigning responsibility may underpin GGE's prohibition in light of the unacceptable risks, burdens and potential harms for persons born via GGE; or it may oppositely underpin its permission if an acceptable risk-benefit balance is reached for parents and society.