Scientists in Britain have applied for permission to genetically modify human embryos as part of a research project into the earliest stages of human development.
The work marks a controversial first for the UK and comes only months after Chinese researchers became the only team in the world to announce they had altered the DNA of human embryos.
Kathy Niakan, a stem cell scientist at the Francis Crick Institute in London, has asked the government’s fertility regulator for a licence to perform so-called genome editing on human embryos. The research could see the first genetically modified embryos in Britain created within months.
GM embryos: time for ethics debate, say scientists
Donated by couples with a surplus after IVF treatment, the embryos would be used for basic research only. They cannot legally be studied for more than two weeks or implanted into women to achieve a pregnancy.
Though the modified embryos will never become children, the move will concern some who have called for a global moratorium on the genetic manipulation of embryos, even for research purposes. They fear a public backlash could derail less controversial uses of genome editing, which could lead to radical new treatments for disease.
Niakan wants to use the procedure to find genes at play in the first few days of human fertilisation, when an embryo develops a coating of cells that later form the placenta. The basic research could help scientists understand why some women lose their babies before term.
“The knowledge we acquire will be very important for understanding how a healthy human embryo develops, and this will inform our understanding of the causes of miscarriage. It is not a slippery slope [towards designer babies] because the UK has very tight regulation in this area,” she told the Guardian.
The Human Fertilisation and Embryology Authority (HFEA) has yet to review her application, but is expected to grant a licence under existing laws that permit experiments on embryos provided they are destroyed within 14 days. In Britain, research on embryos can only go ahead under a licence from an HFEA panel that deems the experiments to be justified.
“If we receive a licence, I would hope to start work as soon as possible,” Niakan said. “However, it is difficult to know how long it will take to carry out the project. In particular, we need to obtain sufficient embryos.” Those will come from a number of IVF clinics whose identities are kept confidential.
Niakan is one of a growing band of scientists working with a powerful new genome editing procedure called Crispr-Cas9. Invented three years ago, it has revolutionised biomedical research. It allows scientists to make precise changes to DNA, and has the potential to transform the treatment of genetic disorders by correcting faulty genes.
Niakan will use Crispr-Cas9 to switch genes on and off in early stage human embryos. She will then look for the effects the modifications have on the development of the cells that go on to form the placenta. “It is essential to study the function of these human genes in the context of the embryo in order to fully understand their roles,” she said.
Genome editing is cheap, easy and effective and has been adopted by scientists at breakneck speed. But the pace of change has made some researchers uneasy. They warn that the field is moving too fast for its ethical implications to be fully considered. Some fear that the procedure could be used to modify human sperm, eggs and embryos for clinical uses before it is safe to do so.
Earlier this year, two groups of scientists called for a voluntary ban on genome editing of human embryos, sperm and eggs. One urged scientists to rule out the procedure for clinical treatments because it is not safe. The other, led by Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington DC, took a harder line, and pushed for a global moratorium on modifying human embryos, sperm and eggs, even if it was only for research.
Analysis Genome editing: how to modify genetic faults – and the human germline
Is it time for a debate on whether there are any circumstances where there is an ethical case for ‘editing’ human embryos?
The potential applications of genome editing can be broken down into three broad categories. The first, and by far the largest, is widely supported by scientists. It aims to treat blood disorders, lung diseases, muscle wastage and so on. The second category, into which Niakan’s work falls, involves genetic changes to human eggs, sperm and embryos for basic research. The third and most controversial category would see genome editing used in IVF clinics to correct faulty genes that cause devastating diseases.
For now, the idea of editing embryos to treat diseases is futuristic, and no scientists have proposed to do such work. The procedure is simply not safe enough to use in clinics yet. One major concern is that changes to an embryo’s DNA could have unknown harmful consequences throughout a person’s body. Worse, that genetic damage would be passed on for generations to come, through the affected person’s sperm or eggs. Another concern is the prospect of designer babies, where a child’s DNA is modified to suit their parents’ wishes.
Earlier this month, leading UK funders called for a national debate on whether editing human embryos could ever be justified in the clinic. Weeks later, international experts belonging to the Hinxton Group said it did not yet approve of GM babies being born, but added that “when all safety, efficacy and governance needs are met, there may be morally acceptable uses of this technology in human reproduction.”
Robin Lovell-Badge, head of stem cell biology at the Francis Crick Institute and a member of the Hinxton Group, said: “There is clearly lots of interesting and important research you can do with these techniques which has nothing to do with clinical applications.” But, he added: “We are absolutely not ready for clinical applications yet.”
The US National Institutes of Health will not fund any genome editing research on human embryos, and its head, Francis Collins, has said that altering the DNA of embryos for clinical purposes was “viewed almost universally as a line that should not be crossed.” But if the procedure is made safe enough in coming years, IVF embryos could, in principle, be modified to boost public health, by reducing people’s risk of Alzheimer’s disease, or to make them resistant to HIV, malaria or influenza.
“There are suggestions that the methods could be used to correct genetic defects, to provide disease resistance, or even to introduce novel traits that are not found in humans,” said Niakan. “However, it is up to society to decide what is acceptable: science will merely inform what may be possible.”
An HFEA spokesperson said: “Genome editing of embryos for use in treatment is illegal. It has been permissible in research since 2009, as long as the research project meets the criteria in the legislation and it is done under an HFEA licence. We have recently received an application to use Crispr-Cas9 in one of our licensed research projects, and it will be considered in due course.”