Studying embryos may ultimately lead to cures for debilitating congenital diseases Adapted from John Finn

In a world first, this April, the UK Human Fertility and Embryology Authority (HFEA), approved an application to use the newest and most accurate gene-editing technique on human embryos. This new technique, named CRSIPR/Cas9 is currently touted for the Nobel Prize in Medicine and has been creating a monopoly in genome modification technologies since its discovery in 2012. Developmental biologist Kathy Niakan at the Francis Crick Institute plans to use this technique in healthy human embryos to investigate how genes act during the first few days of development. Regulators in Japan have now taken a step further, allowing research into a clinical setting only last week. These events follow worldwide outrage at research published last year describing unregulated attempts by Chinese scientists to modify human embryos. However in the growing age of biological manipulation with success stories such as IVF (in vitro fertilisation), how much of this reactionary scepticism is rightfully earned?

The potential use of genetic editing techniques in human embryos has long been a source of contention due to ethical and safety fears. The main safety risks of using modified embryos in a clinical setting include the unpredictable side-effects of changing the genome for therapeutic use. There are also on-going ethical concerns about the ‘slippery slope’ that begins with remedial gene-editing and concludes with non-therapeutic modifications: the heavily-debated ‘designer babies’. However, it is important to note the presence of other non-clinical research in this field which makes use of the same toolkit, as Dr Niakan plans to do, investigating early human development. The ethical concerns surrounding the potential future applications do not apply in this area. Although advances in the technique are transferable between these different avenues of research, we are still too far from being able to use the relatively new CRISPR technology in a clinical environment for this to be a real issue.

The remaining ethical considerations are the broad concerns about the use of human embryos in research in the first place; the HFEA approval marks a turning point in the official opinions on this matter. Dr Niakan’s research will not be the first to use CRISPR in human embryo cells, but it is the first to receive specific approval from a regulatory government body, ushering in a new wave of momentum for gene-editing research in human embryos. When the decision was announced, it was predicted to encourage more applications from other scientists to work on this type of research. Already, these predictions are being fulfilled, with a government bioethics panel in Japan approving the use of the technology on 22nd April for research into developmental genes as well as baby-steps towards clinical therapeutics - congenital (present from birth) disease treatment and improving reproductive technologies.

This new view of acceptance (although not without reservations) of embryo-editing is in stark contrast to the reception of related work only a year ago. In April 2015, a Chinese team from Sun Yat-Sen University in Guangzhou published their attempts to modify the gene responsible for the blood disorder beta-thalassemia. Their efforts were conducted without the need for approval from a regulatory body as China has particularly unrestrictive embryonic stem cell research policies.

Their efforts revealed serious obstacles that would have to be overcome before the technique is suitable for use in medical applications, including low efficiency and more unwanted off-target effects than expected. Although the team only used non-viable embryos, their research caused considerable controversy, sparking an international outcry, including a call for a self-imposed research moratorium in a commentary published in Nature.

The lead author of this Nature article, elaborated on his position further in interviews: "Humans are not rats of other (experimental) organisms, and this is not something we want to do." This opinion reveals the persistent view of humans as separated from other animals by some impassable rift. However, this distinct separation of human and other has emerged from socio-cultural attitudes; it has no grounding in scientific comparisons. All animals exist on a continuous scale of relatedness and similarity, not a discrete grouping of human and other. This is important for considerations of the significance assigned to research embryos, especially as those used are at such an early stage – and are often non-viable or surplus from fertility clinics.

Of course the cultural objections to human embryo research have personal significance for many people so we should not avoid taking them into account, but it should be remembered that these are not objective values, and are not in fact culturally universal. For example, according to accepted Confucian philosophy, a person begins at birth, so a human embryo does not represent the beginning of life. This cultural attitude is significantly different from that in the West and may be one of the reasons for China’s less restrictive human embryo research policies.

As such, the newly emerging adjustment of attitudes among regulatory bodies is a welcome change. It reflects the development of gene-editing techniques and acknowledges the potential CRISPR has to bring to research into early human development and congenital diseases. With the recommendations to minimise ethical concerns that formed part of both the UK and Japanese approvals, this could be a promising step towards removing the taboo of embryo modification.