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Hastings Bioethics Forum essays are the opinions of the authors, not of The Hastings Center.

  1. In December 2015, the organizing committee of the first International Summit on Human Gene Editing (of which I was a member) proposed a two-part ethics framework for decision-making about heritable human genome editing. I have previously described this framework as beautifully simple and exquisitely complex. It is simple insofar as there are only two elements: (i) safety and efficacy, and (ii) broad societal consensus. It is complex insofar as these elements are both subjective threshold concepts. At some time, someone will have to present and defend the following two claims: (i) that a proposed intervention is “safe enough” and “efficacious enough” to proceed with first-in-human trials; and (ii) that societal debate has been adequately settled and broad societal consensus has been achieved.

    Critics of this proposed standard frequently suggest that this framework cannot be operationalized because the second element – broad societal consensus – cannot be achieved. I am confident that such assertions are unnecessarily pessimistic. We have achieved broad societal consensus in the past and there is no ‘in principle’ reason why we can’t do so in the future. Current examples of broad societal consensus include the 14-day rule for embryo research and the prohibition on somatic cell human genome transfer for reproductive purposes.

    Broad societal consensus on heritable human genome editing is possible but will not be an easy feat. It will take considerable time, and frankly we should expect no less of an inclusive dialectical process aimed at achieving equilibrium between divergent interests, where ‘equilibrium’ is understood as a temporary and temporizing balance between uncertainty and certitude. It follows that broad societal consensus will always be fragile – it is no more than a state of equilibrium that can always be disturbed should some event or belief tip the balance, in which case equilibrium is lost to be negotiated anew.

    Françoise Baylis is University Research Professor at Dalhousie University and the author of Altered Inheritance: CRISPR and the Ethics of Human Genome Editing

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