Earlier today, regulators from the United Kingdom’s Human Fertilisation and Embryology Authority (HFEA) approved an application by researchers at London’s Francis Crick Institute to use a new and powerful gene altering tool called CRISPR-Cas9 in human embryos for fertility research. It’s the first time a regulatory agency has approved genetic modification in human embryos.
According to the HFEA’s decision, researchers led by Kathy Niakan, a developmental biologist at the Crick Institute, will be allowed to genetically modify human embryos for a study on how they develop during the first few days after fertilization.
“I am delighted that the HFEA has approved Dr Niakan’s application,” Crick Institute director Paul Nurse said in a statement. “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.”
Per the HFEA’s decision, Niakan will be restricted to studying the modified embryos for the first seven days as they grow from a single cell to about 250 cells. The decision does not allow the embryos to be implanted into a female, and they must be destroyed a week after being fertilized.
Niakan and her colleagues hope that their research will help scientists understand why some women lose their babies before term. They hope it could also lead to new conventional treatments for infertility, Haroon Siddique reports for The Guardian.
In the study, Niakan will use the CRISPR-Cas9 tool to switch certain genes off and on to see how they affect a human embryo’s earliest development stages. The powerful tool, which was invented three years ago, uses enzymes to slice and replace segments of DNA more precisely than scientists have ever been able to before, Siddique reports. But while some researchers say CRISPR-Cas9 could be useful in treating genetic diseases by isolating and replacing faulty genes, others worry that it could open the door to future experimentation and genetic modification.
"By the end of this century, I am absolutely confident that we will have the tools for someone with the means to use this information to change the child they can have through this process," Dartmouth professor Ronald Green, a member of the National Institutes of Health's human embryo research panel tells Sheena McKenzie for CNN.
This isn't the first time that scientists have used CRISPR-Cas9 to modify human embryos, though it is the first time a regulatory agency has allowed it. Last year, a group of scientists in China announced that they had used the tool to modify the genomes of several non-viable human embryos, sparking an ethical debate in the scientific community.
The HFEA previously granted Niakan’s group permission to study human embryos donated by patients who have had in-vitro fertilization. Last September, Niakan announced that her group was applying for permission to genetically modify some of the embryos, Ewen Callaway reports for Nature. The researchers are still waiting for the experiment to be granted ethical approval, but hope to begin testing within months.
While some experts have their concerns about the ethical ramifications of genetically modifying human embryos, others are hailing the decision as a triumph of rationality whose effects could ripple beyond the United Kingdom.
“I think this will be a good example to countries who are considering their approach to regulating this technology,” University of Edinburgh bioethicist Sarah Chan tells Callaway. “We can have a well-regulated system that is able to make that distinction between research and reproduction,” she says.