Abstract

BackgroundClustered Regularly Interspaced Short Palindromic Repeats-associated (CRISPR-Cas) technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.Main bodyAgainst this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline editing measures be therapeutically legitimized? For this purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.ConclusionThese findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards.

Highlights

  • Risk and uncertainty Ethical and legal arguments so far CRISPR-Cas, raising hopes and expectations regarding the safe and effective treatment of severe, hitherto incurable hereditary human diseases, has provoked intense ethical and legal debates with a view to possible risks associated with the technology

  • We show that if the accuracy of CRISPR-Cas mediated genome editing can be improved and germline transmission to future generations be excluded, the editing of human single-cell embryos appears to be no matter of categorical arguments, but rather one of safety aspects

  • The renunciation of any reference to diagnosis in combination with the revised concept of therapeutic benefit in the alternative concept of therapy comes at the cost of therapeutically justifying germline editing in human single-cell embryos even though, like in our scenarios, 50% of the treated embryos would be phenotypically healthy without such intervention

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Summary

Conclusion

These findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards.

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