The Human Fertilisation and Embryology Authority (HFEA) has made history this week by approving an application to begin gene-editing on human embryos. Dr Kathy Niakan, of the Francis Crick Institute in London, applied for approval in order to understand the processes behind unexplained miscarriages and infertility.

Although similar research has been undertaken previously in China to correct a gene which causes a blood disorder, but the research had not been taken through a proper regulatory system.

Surplus embryos will be donated by couples who have undergone IVF treatment and will be studied over the first two weeks of embryonic development. This will encompass a journey from the single-cell of an embryo to a mass of around 250 cells. During this period, Dr Niakan will use Crispr-Cas9 to manipulate the DNA within the cells of the embryo.

Crispr-Cas9 is a gene-editing technology first developed by Martin Jinek and his team in 2012 to investigate bacterial immunity. The technique allows for the precise manipulation of DNA within the nucleus of any cell. It works by essentially swapping out the ‘faulty’ section of DNA with a ‘healthy’ section, attached to an enzyme called Cas9. Think of it like swapping out a faulty battery in an electronic device.

By using this technology at the embryonic stage of foetal development, Dr Niakan hopes that any changes made to the DNA will become sealed within the ‘germ-line’, the next generations of cells to develop from the original embryo. This technique is far and away the most advanced gene-editing to date.

The modifications made by Dr Niakan will turn certain genes on or off within the embryo; she will then analyse the development of new cells to assess any changes the modifications may have made. This will help her to identify whether any faulty genes may be responsible for both infertility and unexplained miscarriages.

Despite the promise this research holds for people who suffer from these problems, there has been a significant backlash against the HFEA’s decision. The most prominent concern seems to be public fear that genetically modified ‘designer’ babies are becoming a likely prospect for the future. Consumer Eugenics describes the study of improving the human genome by artificially modifying genetic information to create people with desirable traits.

Dr David King from the Human Genetics Alert watchdog group has voiced his concerns:

“This research will allow the scientists to refine the techniques for creating GM babies, and many of the Government’s scientific advisers have already decided that they are in favour of allowing that. This is the first step in a well mapped-out process leading to GM babies, and a future of consumer eugenics.”

There are also complaints from pro-life organisations, such as Josephine Quintavalle of Comment on Reproductive Ethics (CORE), who has accused the HFEA of arrogance:

“This is a very contentious and extremely dangerous area of embryo manipulation which is eliciting worldwide concern, and at the very least the HFEA should have waited until Nuffield had had a chance to examine responses.”

Nuffield refers to an internationally renowned independent council of experts who examines and reports on ethical issues within medicine and biology.

In order to maintain an ethical basis to the research and to satisfy these concerns, the HFEA have outlined very strict rules and regulations surrounding the research. For instance, after two weeks of research the embryos cannot be studied further, and under no circumstances can they ever be implanted into a woman’s womb.

Despite the clear public outcry at the decision by HFEA, there are many indiviudals and organisations who are equally pleased.

A professor of genetics at the University of Kent has called the decision a ‘triumph of common sense’ and strongly believes that the research is worth undertaking:

“While it is certain that the prospect of gene editing in human embryos raised a series of ethical issues and challenges, the problem has been dealt with in a balanced manner. It is clear that the potential benefits of the work proposed far outweigh the foreseen risks.”

Others have shared this sentiment; Sarah Norcross of Process Educational Turst called it a ‘victory for level-headed regulation over moral panic’, and Dr Sarah Chan from the Usher Institute reminds the public that the research will be heavily monitored and regulated:

“We should feel confident that our regulatory system in this area is functioning well to keep science aligned with social interests.”

Dr Niakan hopes to begin the research within the year.