Further progress in “gene editing” emphasizes the pressing need for a wider debate
On 1 February 2016, the Francis Crick Institute announced that the Human Fertilisation and Embryology Authority (HFEA) had approved a research application to use new “gene editing” techniques known as “Crispr/Cas9” to modify human embryos.
The Press Release states:
“The aim of the research, led by Dr Kathy Niakan, a group leader at the Crick, is to understand the genes human embryos need to develop successfully. The work carried out at the Crick will be for research purposes and will look at the first seven days of a fertilised egg’s development (from a single cell to around 250 cells). The knowledge acquired from the research will be important for understanding how a healthy human embryo develops. This knowledge may improve embryo development after in vitro fertilisation (IVF) and might provide better clinical treatments for infertility, using conventional medical methods.
Paul Nurse, director of the Crick, said: ‘… Dr Niakan’s proposed research is important for understanding how a healthy human embryo develops and will enhance our understanding of IVF success rates, by looking at the very earliest stage of human development – one to seven days.’
In line with HFEA regulations, any donated embryos will be used for research purposes only and cannot be used in treatment. These embryos will be donated by patients who have given their informed consent to the donation of embryos which are surplus to their IVF treatment. The genome editing research now needs to gain ethical approval and, subject to that approval, the research programme will begin within the next few months.”
In September 2015, the Human Fertilisation & Embryology Authority (HFEA), stated that it had received the application from researchers at The Francis Crick Institute for the use of a new genetic technique to carry out research into infertility; at that time HFEA indicated the application would be looked at “in due course” and the February Press Release indicates that its approval has now been given. Whilst no new legislation is required – existing measures permit the use of gene editing for non-clinical research purposes in germ cells, including human embryos up to 14 days old – there are ethical considerations to be taken into account. The Francis Crick Institute Press Release indicated that the research programme was dependent upon “gaining ethical approval”, although it is unclear whether this refers to that addressed by the HFEA Code of Practice or to a broader consideration of broader issues, infra.
In our post Genome editing of human cells we reported that on 2 September 2015, a group of leading UK research funders had issued a statement calling for an urgent national debate on the ethics of genetically modifying human embryos and other tissues to prevent serious diseases. The group, comprising the Wellcome Trust, the Medical Research Council, the Academy of Medical Sciences, the Association of Medical Research Charities and the Biotechnology and Biological Sciences Research Council, called for “widespread discussion among scientists, ethicists and the wider public about how these emerging techniques may in future be applied clinically, in human reproductive cells and early embryos, to treat or prevent serious genetic disease.”
In view of the rapid development of these techniques, such a discussion is urgently needed. As Dame Catherine Wybourne commented on the recent announcement: “For anyone who believes that life begins at conception, irrespective of whether that life lasts for only a few hours or many years, is born or is not born, … it is a decision of enormous consequence”. Prior to 24 weeks gestation, an embryo or foetus does not have legal personality and the European Citizens’ Initiative (ECI) “One of Us” sought to end EU financing of “activities which presuppose the destruction of human embryos, in particular in the areas of research, development aid and public health”. Although achieving well in excess of the 1 million expressions of support required under ECI regulations, the demands of the “One of Us” campaign were rejected by the European Commission.