Initial heritable genome editing: Mapping a responsible pathway from basic research to the clinic

Robert Ranisch*, Katharina Trettenbach, Garðar Ágúst Árnason

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Following the Second Summit on Human Gene Editing in Hong Kong in 2018, where the birth of two girls with germline genome editing was revealed, the need for a responsible pathway to the clinical application of human germline genome editing has been repeatedly emphasised. This paper aims to contribute to the ongoing discussion on research ethics issues in germline genome editing by exploring key issues related to the initial applications of CRISPR in reproductive medicine. Following an overview of the current discussion on bringing germline genome editing into clinical practice, we outline the specific challenges associated with such interventions and the features that distinguish them from conventional clinical testing of new medical treatments. We then review proposed ethical requirements for initial heritable genome editing, such as the absence of reasonable alternatives, the existence of sufficient and reliable preclinical data, appropriate informed consent, requirements related to safety, and long-term follow-up.

Original languageEnglish
JournalMedicine, Health Care and Philosophy
Publication statusPublished - 22 Nov 2022

Bibliographical note

Funding Information:
Gardar Arnason’s work was supported by the Dr. Kurt und Irmgard Meister-Stiftung.

Publisher Copyright:
© 2022, The Author(s).

Other keywords

  • First-in-human trials
  • Germline interventions
  • Heritable genome editing
  • Reproduction
  • Research ethics
  • Translational ethics


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