Bioethics Council Rules Heritable Genome Editing "Ethically Acceptable" In Certain Circumstances

A leading UK bioethics advisory body has weighed in on the debate around human genetic modification, concluding that heritable genome editing – modifying the DNA of an egg, sperm or embryo with changes that will be passed on to future generations – could be ‘morally permissible’ in humans, provided key ethical tests are met.

The Nuffield Council on Bioethics began an inquiry, entitled Genome editing and human reproduction: social and ethical issues, in September 2016. The report was prompted by the emergence of genome editing technology, such as CRISPR-Cas9, which has become extensively used in modern genetics research.

The report arrived at two key findings; that heritable genome editing could be ethically acceptable if it is intended to secure and is consistent with the welfare of a person who might be born with an edited genome, and that the changes are consistent with social justice and solidarity, meaning it should not be expected to to increase disadvantage, discrimination, or division in society.

These findings were backed up with six key recommendations for future research and policy in the area – 

• That research should be carried out on the safety and feasibility of heritable genome editing interventions to establish standards for clinical use. 

• That social research should be carried out to develop greater understanding of the implications of genome editing for the welfare of the future person. 

• That before any move is made to amend UK legislation to permit heritable genome editing interventions, there should be sufficient opportunity for broad and inclusive societal debate.

• That an independent UK body is established to promote public debate on the use of genomic and related technologies to respond to societal challenges; to help to identify and understand the public interests at stake; and to monitor social, cultural, legal, and health impacts. 

• That governments in the UK and elsewhere should work with international human rights institutions, such as the Council of Europe and UNESCO, to promote international dialogue and to develop a framework for international governance of heritable genome editing interventions.  

• That heritable genome editing interventions should only be licensed on a case-by case basis subject to assessment of the risks of adverse clinical outcomes for the future person by a national competent authority (in the UK, the HFEA); and strict regulation and oversight, including long-term monitoring of the effects on individuals and social impacts.

The scientific community’s ability to edit genomes has greatly advanced in recent years, and tools like CRISPR-Cas9 have been tested on human embryos. The technology allows targeted editing of base pairs in genomic material, and has applications far beyond heritable genome editing, including in diagnostics platforms and monitoring cancer progression.

The reaction from the scientific community and press was understandably mixed. Speaking to the Guardian, the chair of the report’s working group, and professor of law, ethics and informatics at the University of Birmingham, Karen Yeung said, “It is our view that genome editing is not morally unacceptable in itself. There is no reason to rule it out in principle.”

In an opinion article, also in the Guardian, Marcy Darnovsky, executive director of the US non-profit the Center for Genetics and Society, called heritable genome editing an “unnecessary threat to society”.

The report follows on from Nuffield’s guidelines on mitochondrial replacement therapy, which has now been used clinically in the UK. In a similar theme as the “three-parent babies” headlines that accompanied that development, a few outlets have interpreted the report as giving the “green light” to “designer babies”. This would appear to ignore the above recommendations of the report, which suggest that far more consultation and research is needed before such editing can be clinically used.

Speaking to the Independent, Professor Jackie Leach Scully said, “It’s not often that you’re in a position where you can see a development like that coming towards you and have enough time to think very carefully about how to go ahead with it – or not.” The Nuffield report, which touches on genome editing as radical as that which could enhance senses and abilities, is clearly looking into the distant future, far beyond our current understanding of how our DNA affects our genome. With the pace of advancement in gene editing technologies, perhaps that is a prudent approach.