Heritable genome editing: action needed to secure responsible way forward

An independent inquiry by the Nuffield Council on Bioethics has concluded that 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. If that is to happen, a number of measures would need to be put in place first to ensure that genome editing proceeds in ways that are ethically acceptable. The technique of genome editing – the deliberate alteration of a targeted DNA sequence in a living cell – could theoretically be used in assisted reproduction to alter the DNA of a human embryo, before it is transferred to the womb.

This is not currently lawful in the UK, but could, in time, become available as an option for parents who wish to influence the genetic characteristics of their future child (for example, to exclude a heritable disease or a predisposition to cancer in later life). The Council says that the possibilities raised by this radical new approach to reproductive choices could have significant implications for individuals and for all of society, and there must be action now to support public debate and to put in place appropriate governance.

The new report, Genome editing and human reproduction: social and ethical issues, 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. The Council recommends that two overarching principles should guide the use of ‘heritable genome editing interventions’ for them be ethically acceptable:

• they must be intended to secure, and be consistent with, the welfare of the future person; and
• they should not increase disadvantage, discrimination or division in society

The Council further recommends that heritable genome editing interventions should be permitted only when:

• there has been a sufficient opportunity for broad and inclusive public debate about its use and possible implications
• further research has been carried out to establish standards of clinical safety
• the risks of adverse effects for individuals, groups and society as a whole have been appropriately assessed and measures are in place to monitor and review these

It adds that, if it were to be permitted, it should be:

• strictly regulated (by the HFEA in the UK)
• introduced only in the context of a clinical study, with monitoring of the long-term effects on individuals and groups
• licensed on a case-by-case basis

Further recommendations In addition to these measures, the Council recommends the establishment of an independent body in the UK to promote broad and inclusive societal debate on heritable genome editing interventions and related scientific and medical developments.

Professor Karen Yeung, Chair of the working party and Professor of Law, Ethics, and Informatics at the University of Birmingham, said: “There is potential for heritable genome editing interventions to be used at some point in the future in assisted human reproduction, as a means for people to secure certain characteristics in their children. Initially, this might involve preventing the inheritance of a specific genetic disorder. However, if the technology develops it has potential to become an alternative strategy available to parents for achieving a wider range of goals.

Other reproductive options that are currently available to prospective parents who face the possibility of passing on an inherited genetic disorder, which genome editing might be considered alongside, include pre-implantation genetic diagnosis, which involves testing embryos for genetic characteristics and selecting one/s with preferred characteristics. Although the UK is one of the countries that permits research on human embryos, the law does not currently permit genome editing interventions on embryos that are to be placed in a womb. The law would therefore have to be changed in order to allow the use of genome editing embryos, sperm or eggs for reproduction.

The Council’s report sets out the ethical considerations raised by the prospect of heritable genome editing interventions in relation to the interests of the people who would be affected by its use, of others in society who may be indirectly affected, and of human beings in general. One of the main reasons heritable genome editing interventions are controversial is that changes may be passed on to future generations.

Professor Dave Archard, Chair of the Nuffield Council on Bioethics said: “Huge advances are happening in genomics research, and whilst we have to acknowledge that genes alone do not shape a person, the possibility of using genome editing in reproduction to secure or avoid a characteristic in a child offers a radically new approach that is likely to appeal to some prospective parents. There may be good reasons for allowing some parental preferences to be met, but we need to be careful that the use of genome editing to help parents to exercise these preferences doesn’t increase social disadvantage, discrimination or division and that close attention is paid to the welfare of those involved, especially any child born as a result.”

NOTES TO EDITORS

1. Copies of the report are available in advance, on request.

To request the report, or an advance interview, please contact: Sarah Walker-Robson, Communications Manager Nuffield Council on Bioethics swalker-robson@nuffieldbioethics.org (+44) 0207 681 9619 / (+44) 07551 159670 Genome editing and human reproduction: social and ethical issues will be published on the Council’s website on Tuesday 17 July 2018.

2. About genome editing

Genome editing is the deliberate alteration of a selected DNA sequence in a living cell. Genome editing techniques can be used to alter how a gene functions, for example, by changing a variant of a gene that may give rise to disease to one that does not. CRISPR-Cas9 is an example of a method of genome editing that is now widely used in research.Heritable genome editing interventions are interventions made to sperm, egg or embryo cells (or their precursors). The ‘edited’ DNA sequence would be present in all cells of any future person grown from those cells – including their own sperm or eggs – so may be passed on, in turn, to future generations).

3. About the project

This inquiry was initiated following publication of the Nuffield Council on Bioethics’ previous report Genome editing: an ethical review, in 2016. The development of genome editing applications in human reproduction was one of the areas identified in that review as requiring further ethical scrutiny.This inquiry was carried out by an interdisciplinary working party that included members with expertise in biology, human reproduction, genome editing, law, and ethics.To inform its deliberations, the working party received contributions from a wide range of people, including through an open call for evidence, an online questionnaire, and a series of fact-finding meetings and panel interviews.

4. About the working party

Members of the working party were appointed for their personal knowledge and expertise, and do not necessarily represent the views of their organisations.

Karen Yeung (Chair), Interdisciplinary Professorial Fellow in Law, Ethics and Informatics, University of Birmingham

Richard Ashcroft, Professor of Bioethics, Queen Mary University of London

Neva Haites, Professor of Medical Genetics, University of Aberdeen

Joyce Harper, Professor in Human Genetics and Embryology, University College London

Julian Hitchcock, Partner, Marriott Harrison LLP

Jackie Leach Scully, Professor of Social Ethics and Bioethics, PEALS (Policy, Ethics and Life Sciences) Research Centre, Newcastle University

Tony Perry, Professor of Mammalian Molecular Embryology, University of Bath

Christine Watson, Professor of Cell and Cancer Biology, University of Cambridge and Member of the Nuffield Council on Bioethics

5. About the Nuffield Council on Bioethics

The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. The Council has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics. https://www.nuffieldbioethics.org/