Nuffield report on heritable genome editing

An independent inquiry by the Nuffield Council on Bioethics has concluded that the editing the DNA of a human embryo, sperm, or egg to influence the characteristics of a future person (‘heritable genome editing’) could be morally permissible. The new report, Genome editing and human reproduction: social and ethical issues, (“the Report”), sets out the range of ethical issues that arise in relation to the prospect of genome editing becoming available as a reproductive option for prospective parents. In addition to the full report, the Press Release includes a summary of the  Key Findings and a Short Guide to the work.

Background

The Nuffield Council’s previous report Genome editing: an ethical review, published in September 2016, identified the development of genome editing applications in human reproduction as one of the areas identified as requiring further ethical scrutiny.

Genome editing could potentially be applied in the context of assisted reproduction to alter a DNA sequence(s) of an embryo, or of a sperm or egg cell prior to fertilisation. The aim would be to influence the inherited characteristics of the resulting person. This is referred to as ‘heritable genome editing interventions’ since the altered DNA may be passed to future generations.

The new inquiry was carried out by an interdisciplinary working party that included members with expertise in biology, human reproduction, genome editing, law, and ethics. Contributions were invited from a wide range of people through an open call for evidence, an on-line questionnaire, research interviews, factfinding meetings, and panel interviews.

The Report concluded that the use of heritable genome editing interventions to influence the characteristics of future generations could be ethically acceptable in some circumstances, provided:

  • it is intended to secure, and is consistent with, the welfare of a person who may be born as a consequence of interventions using genome edited cells; and
  • it upholds principles of social justice and solidarity, i.e. it should not be expected to increase disadvantage, discrimination, or division in society.

UK law currently prohibits genome editing interventions in human reproduction. This should only change after there has been an opportunity for broad and inclusive societal debate and the implementation of robust governance measures guided by the principles set out above. We reviewed the UK legislation in our post Genome editing of human cells, September 2015, including that relating to  the editing of human germ cells or embryos, and editing of somatic cells, (i.e. any cell of the body except sperm and egg cells). The later is not considered in the present Nuffield Council report (see paragraph 1.54).

The Report makes recommendations for four areas: research bodies; UK government; governments in the UK and elsewhere; and licensing and regulation. Those relating to the second and fourth of these are summarized below.

Recommendations for UK Government

  • before any move is made to amend UK legislation to permit heritable genome editing interventions there should be sufficient opportunity for a broad and inclusive societal debate.
  • without awaiting the opportunity for a thoroughgoing review, the Secretary of State for Health and Social Care should give consideration to bringing within the scope of licensing any heritable genome editing interventions that currently fall outside that scope.
  • heritable genome editing interventions should be permitted only provided that the impact on those whose vulnerability to adverse effects (including stigmatisation and discrimination) might thereby be increased has been assessed and mitigated (and, in any case, not without open and inclusive consultation with people in those positions).
  • heritable genome editing interventions should only be permitted provided that arrangements are in place to monitor the effects on those whose interests may be collaterally affected and on society more generally, and that effective mechanisms are in place to redress any such effects; this should include a clear regulatory measure to trigger a moratorium and a sunset provision, requiring review and an affirmative resolution to permit the practice to continue.
  • consideration should be given to the establishment of a separate body or commission in the UK, independent of Government and independent of existing regulatory agencies, which would have the function of helping to identify and produce an understanding of public interest(s) through promotion of public debate, engagement with publics and monitoring the effects of relevant technological developments on the interests of potentially marginalised subjects and on social norms.

Recommendations regarding licensing and regulation

If, as a result of the legislative review, heritable genome editing interventions are to be permitted, it was concluded that these should be subject to strict regulation and oversight by a national competent authority. The Report recommends that:

  • genome editing should be licensed for clinical use only once risks of adverse outcomes have been assessed by a national competent authority (in the UK, the Human Fertilisation and Embryology Authority).
  • heritable genome editing interventions should be licensed, initially, on a case-by-case basis.
  • heritable genome editing interventions should be introduced only within the context of well-designed and supervised studies, reporting regularly to a national coordinating authority, and that the effect on individuals and society, including over generations, should be closely monitored as far as possible, compatibly with the privacy of the individuals concerned.

Comment

UK Christian Today reports that Professor Fiona Watt, executive chair of Britain’s Medical Research Council, welcomed the Report’s call for wide debate and said it was vital that researchers “continue to assess safety and feasibility before gene edits that can be passed across generations are permitted in people'”. However, David King of the UK campaign group Human Genetics Alert “said the reports conclusions were a sign of approval of ‘designer babies’ and were ‘an absolute disgrace’. We must have an international ban on creating genetically engineered babies”.

Cite this article as: David Pocklington, "Nuffield report on heritable genome editing" in Law & Religion UK, 19 July 2018, https://lawandreligionuk.com/2018/07/19/nuffield-report-on-heritable-genome-editing/

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