UK fertility regulator approves research project to gene-edit human embryos


A research project to gene-edit human embryos has been given the go-ahead by the UK’s Human Fertilisation and Embryology Authority (HFEA). The approval, which allows early-stage embryos to be modified by the CRISPR/Cas9 gene-editing tool, has been granted to the Francis Crick Institute for research into the genes needed for embryos to develop successfully.


Henry (Hank) Greely, Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine (webpage):

Expertise: ethical, legal, and social implications of new biomedical technologies, particularly those related to neuroscience, genetics, or stem cell research.

“The decision of the British Human Fertilisation and Embryology Authority (HFEA) to accept a specific application for genome editing on human embryos for only research purposes should be applauded.  The ruling applies to embryos created initially for IVF but then donated by the parents for research uses. The approval specifically requires that these embryos not be transferred into a woman’s womb for possible implantation, pregnancy, and birth.  It also requires that the parents’ informed consent should include discussion of genomic editing and that these new activities be approved by the institution’s Research Ethics Committee (the British equivalent to an American IRB).

“The goal of the researcher, Dr. Kathy Niakan of the Francis Crick Institute, is to study what genes are essential for the successful development of an embryo from fertilization through the seventh day (the blastocyst stage).  She will use CRISPR/Cas9 to disrupt genes thought to be important in the development process to see which ones really are crucial. Mice, which are the usual laboratory animal, do not have all the same genes and genetic variations seen in humans, so mouse work would not be sufficient. Dr. Niakan’s hope is to better understand early human embryonic development and, as a result, to understand and treat some causes of infertility.

“If you are morally opposed to any destruction of human embryos for research purposes, you should oppose this research. Otherwise, you should support it.  This is important research that can only be done with human embryos, it is being done with surplus IVF embryos whose prospective parents agreed to this kind of use, and the researchers are forbidden to try to produce human gene-edited babies.  The proposal has gone through a long and very specific approval process, including a parliamentary vote and lengthy and thoughtful review by the relevant regulatory body – a much better process than anything in place in the United States. Anyone comfortable with any research that destroys human embryos should support this HFEA decision.”


Dr. Perry Hackett, Professor, Center for Genome Engineering, University of Minnesota (webpage):

Expertise: Gene-editing techniques applied to both humans and animals.

“The decision looks entirely proper, and in fact a bit conservative, but I fully understand the baby steps given the abysmal ignorance, both public and scientific, surrounding the field of study in early human development. The researchers are looking at genes involved in very early embryo development, and while every period in development is important, the first few weeks are critical since all that follows builds on proper early cell function.

“The global goal is to better understand how early human development progresses. This is an incredibly important area as we now know more than half of conceptions may result in spontaneous abortion. The intricacies of how a single human cell following fertilization is able to develop into a living human is staggering and understanding the process requires years of painstaking research.

“The promise of research like this is for more parents to have the opportunity to birth healthier babies and raise healthier children. Decisions like that of the HFEA to allow investigations of site-specific, gene editing techniques in early human development may eventually lead to treatments of children before genetic deficiencies result in uncorrectable problems. Its really hard for me to imagine how anyone could be against such work. Anyone who is should visit some of the clinics that work with such kids (and adults).”


Dr. Kyle Orwig, Professor of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine (webpage):

Expertise: stem cells and regenerative medicine; fertility and infertility; germline development; genetic engineering 

“The initiative by Dr. Niakan and colleagues to genetically modify human embryos is a game changer.  Not only will it broaden scientific knowledge about the safety and feasibility of human gene editing, it will reduce barriers to more expansive thinking about human gene therapy applications.  Britain’s Human Fertilisation and Embryology Authority continues to provide valuable international leadership in the responsible conduct of research on human embryos. 

“I am not concerned about ‘slippery slope’ arguments against gene editing in human embryos.  The immediate objectives of Dr. Niakan’s research are clearly fundamental in nature and will be a valuable contribution to the genome editing field.”


Dr. Dana Carroll, Professor of Biochemistry, University of Utah (webpage):

Expertise: Gene targeting; use of ZFNs, TALENs and CRISPR-Cas for targeted mutagenesis and sequence replacement.

“While this project to employ CRISPR-based editing in human embryos is, in several ways, the first of its kind, it is not as radical as it might seem at first glance. The project falls completely within the guidelines established by the HFEA, including the use of surplus embryos, limiting culture of the embryos to no more than 14 days, and the prohibition against using them to initiate a pregnancy. This is also the kind of research that was called for in the statement issued at the end of the International Summit on Human Gene Editing held in December.

“The work published by Chinese researchers last year was directed simply at demonstrating the use of CRISPR methods in embryos, not at any biological function of the embryos. The current proposal by Dr. Niakan is aimed at specific aspects of human embryo development that affect spontaneous miscarriage. Niakan will also focus on surplus normal embryos, whereas the inviable tripronuclear embryos used by the Chinese group are abnormal in ways that very likely negatively affect the outcome of CRISPR editing.

“When I talked with Kathy Niakan at the Summit, my chief concern was how compelling her justification was for this human embryo experimentation. In reviewing the HFEA document, I see that she is not only proposing to learn about early human embryo development (which is demonstrably different from that in mouse), but also to derive embryonic and extra-embryonic stem cells that can be used for research without returning to intact embryos. The project seems to me like it promises to produce very useful information that will, in the long run, aid in ensuring successful pregnancies.

“It should also be noted that the HFEA approval is conditional, awaiting review and approval by an appropriate ethics committee.”


Dr. Paul Root Wolpe, Asa Griggs Candler Professor of Bioethics & Director, Center for Ethics, Emory University (webpage):

Expertise: The social, religious, ethical, and ideological impact of technology on the human condition.

“While I understand and am in sympathy with the fear and nervousness that this announcement brings, it does not make much sense for the UK to allow research using early human embryos, but draw the line at CRISPR. The technology can answer many important questions about health, and the embryos in question will not be developed beyond 14 days.  The decisions does, however, open the larger conversation that we should be having about how we will apply these technologies if and when they have been shown to be useful in curing or preventing disease. These are some of the most pressing ethical questions of our time, and we need to be discussing them widely and thoughtfully.”


Dr. Debra Mathews, Assistant Director of Science Programs, Johns Hopkins Berman Institute of Bioethics (webpage):

Expertise: Bioethics and policy issues related emerging biotechnologies.

“It is important to be clear that what the UK has approved is basic science research, and not the editing of the genes of a future person, which was not part of the application and is not permitted under UK law. The proposed research is aimed at better understanding the earliest stages of human development, which could lead to improvements in IVF that do not involve genome-editing. Any steps beyond basic research and toward the use of genome-editing technologies for reproductive purposes will require further data, debate and public engagement.”


Dr. Peter Donovan, Professor of Biological Chemistry and of Developmental and Cell Biology, UC Irvine (webpage):

Expertise: molecular genetics of germ cell and stem cell development.

“The use of gene-editing technology in human embryos will advance our understanding of development in our own species in ways that could not be achieved using animal models. Such experiments will no doubt advance our understanding of human health in a way that is regulated and responsible and should not be alarming to the lay public.”


Dr. Jacob Corn, Scientific Director, Innovative Genomics Initiative &  Assistant Adjunct Professor of Biochemistry, Biophysics and Structural Biology, University of California, Berkeley (webpage):

Expertise: Next-generation genome editing; clinical and commercial applications of the technology.

“The HFEA decision is well thought out and a positive step to advance  fundamental understanding of human health. The research uses only surplus embryos donated from in vitro fertilization procedures and will halt studies after only a few days, when the embryo is only about 250 cells in size. No edited humans will result from this research.”


Declared interests (see GENeS register of interests policy):

Dr. Perry Hackett: Dr. Hackett is Chief Scientific Officer at Recombinetics, a company that uses gene-editing techniques in animals but not humans.

No further interests declared



HFEA licence committee minutes:

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