Key policy statement on germline editing informed by Wellcome Genome Campus Connecting Science

Date: 3 August 2017

An international group of 11 organisations with clinical genetics expertise has issued a policy statement on germline genome editing in humans.

An international group of 11 organisations with clinical genetics expertise has issued a policy statement on germline genome editing in humans. The counselling, medical and research groups urge a cautious but proactive approach to gene editing.

Published today (3rd August) in The American Journal of Human Genetics, the statement recommends against genome editing that culminates in human implantation and pregnancy; supports publicly funded, in vitro research into its potential clinical applications; and outlines scientific and societal steps necessary before implementation of such clinical applications is considered.

Kelly E. Ormond, MS, CGC, lead author of the statement and Professor of Genetics at Stanford University, said: “Our workgroup on genome editing included experts in several subfields of human genetics as well as from countries with varying health systems and research infrastructure. Given this diversity of perspective, we are encouraged by the agreement we were able to reach and hope it speaks to the soundness and wider acceptability of our recommendations.”

Dr Anna Middleton, Head of the Society and Ethics Research group at Wellcome Genome Campus Connecting Science, and Vice-Chair of the Association of Genetic Nurses and Counsellors was the UK consultee for this policy. She said:

This is the first time that the international genetic counselling community has come together to issue a statement about the ethics of genetic research. They work at the coal face of genetics, helping people make sense of the science. It is vital that their voice is heard in policy and we at the Wellcome Genome Campus are extremely pleased to be supporting the views of British genetic counsellors
Anna Middleton, Society and Ethics Research, Connecting Science

The CRISPR/Cas9 system, a genome editing tool introduced in 2013, has quickly become widely used in genetics research due to the ease with which it can be customised and its effectiveness across cell types and species. There is considerable interest in using this tool to develop cell-based therapeutics in both somatic cells – cells you have in the body that are not passed onto the next generation – and germline cells, which are passed onto children. This policy statement focuses on the ethically more complex issue of editing germline cells (eggs, sperm or embryos) due to potential effects on not just the treated individual but also future generations.

Derek T. Scholes, PhD, ASHG Director of Science Policy, said: “While germline genome editing could theoretically be used to prevent a child being born with a genetic disease, its potential use also raises a multitude of scientific, ethical, and policy questions. These questions cannot all be answered by scientists alone, but also need to be debated by society.”

After considering these issues and the current state of the science in germline genome editing, the statement authors* agreed that at this time, it is inappropriate to perform germline gene editing that culminates in human pregnancy. They also agreed there is currently no reason to prohibit in vitro (outside of a living organism) germline genome editing research, with appropriate oversight and consent, or to prohibit public funding for such research.

Further, the authors of the statement agreed that before any future clinical application of germline genome editing takes place, there should be:

  • A compelling medical rationale to use this approach
  • An evidence base to support its clinical use
  • An ethical justification, and
  • A transparent and public process to solicit and incorporate stakeholder input

Professor Ormond said: “As basic science research into genome editing progresses in the coming years, we urge stakeholders to have these important ethical and social discussions in tandem.”

* The statement was jointly authored by the American Society of Human Genetics (ASHG), the Association of Genetic Nurses and Counsellors, the Canadian Association of Genetic Counsellors, the International Genetic Epidemiology Society, and the National Society of Genetic Counselors. It was also endorsed by the American Society for Reproductive Medicine, the Asia Pacific Society of Human Genetics, the British Society for Genetic Medicine, the Human Genetics Society of Australasia, the Professional Society of Genetic Counselors in Asia, and the Southern African Society for Human Genetics.

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