Responsible Translational Pathways for Germline Gene Editing?

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GENOME EDITING (Y FAN & J CHAN, SECTION EDITORS)

Responsible Translational Pathways for Germline Gene Editing? Bryan Cwik 1

# Springer Nature Switzerland AG 2020

Abstract Purpose of Review Continued development of gene editing techniques has raised the real possibility of clinical application of germline gene editing. These results, as well as reports of an unethical experiment which resulted in the birth of at least two children from edited embryos in 2018, have highlighted the urgency and importance of ethical issues about translational pathways for editing of human germline cells. Charting responsible translational pathways for germline gene editing requires tackling some significant and complex ethical issues. Recent Findings A literature on development of clinical applications of germline gene editing is emerging, and several key ethical issues are coming into focus as major challenges for responsible translational pathways. Summary Potential clinical utility, clinical justification, and human subjects research for germline gene editing raise outstanding ethical questions. Work on these questions will help provide guidance to researchers and clinicians and direct translational projects toward justifiable applications. Keywords Gene editing . Germline . Ethics . Clinical utility . Human subjects research . Reproductive medicine

Introduction Making heritable changes to the genome of prospective persons by editing germline cells has held enduring fascination for scientists and non-scientists alike, but until very recently the prospects for actually doing it seemed squarely in the realm of science fiction. The continuous development of powerful, accurate, and efficient gene editing techniques over the past decade has now taken this from science fiction to medical possibility [1–3]. Some vivid research results within the past 5 years have raised real questions about translation of gene editing tools for clinical use. This research has raised serious questions about the ethics of translational pathways for germline gene editing [4–6]. The questions addressed by this literature were given new urgency by the revelations in November 2018 that He Jiankui, a biophysicist working at Southern University of Science and Technology in China, used edited embryos to start This article is part of the Topical Collection on Genome Editing * Bryan Cwik [email protected] 1

Philosophy and University Studies, Portland State University, Fourth Ave Building Suite 175, 1900 SW 4th Ave, Portland, OR 97201, USA

pregnancies that resulted in the birth of at least two children, twin girls nicknamed “Lulu” and “Nana” [7, 8, 9••]. He Jiankui was attempting to disable the CCR5 gene in these embryos in order to prevent HIV transmission to prospective persons where the male progenitor was HIV positive, a clinical goal for which there are multiple other existing mechanisms [9••]. Without question, He’s experiment was deeply unethical, and given the availability of other means for preventing vertical transmission of HIV, had little to no clinical