An international collective of researchers and ethicists is calling for an urgent global moratorium on human germline gene editing, suggesting serious discussions on technical, scientific, medical, societal, ethical and moral issues need to be had before scientists move forward with the controversial technique.
Late last year Chinese scientist He Jiankui took to the stage at the Second International Summit on Human Genome Editing and permanently changed the world of science with one short presentation. He provided evidence of the first ever gene-edited babies to be born and was pretty quickly condemned by most around the world for violating conventional research safety and ethics.
A newly published editorial in the prestigious journal Nature has presented a case for an immediate international stop on any potential human germline editing for a fixed term while greater global conversations can be had to ascertain how the world of science should move forward. The editorial is co-signed by over a dozen influential scientists from Harvard, Stanford, MIT, Max Planck and Dalhousie University.
The proposal is not a formal treaty, but rather a voluntary pledge designed to allow time for some kind of global coordinating body to be established. The international governmental body could be instituted under the auspices of the World Health Organization, or an entirely new entity, but the authors of this new proposal suggest the implications of gene editing technology could so fundamentally change humanity that it is vitally urgent scientists consider some kind of oversight framework.
The voluntary nature of the proposal has been criticized by some as relatively pointless, especially in light of the fact that many scientists believe current laws and regulations already make it impossible to deploy germline editing in clinical situations. Helen O'Neill, from University College London, suggests the moratorium is essentially irrelevant as it won't stop rogue scientists and will ultimately shed a negative light on the technology in general.
"Currently, there are (as there was in China) legal and ethical measures in place globally which regulate the use of gametes and embryos," says O'Neill. "Let's not forget that He Jiankui broke many rules, and was aware of this by choosing to do his work outside of the auspices of the university (and taking unpaid leave). It was not that he did this because the law allowed it."
The scientists behind this new proposal counter that argument by claiming the moratorium will stimulate an open and transparent conversation which is vital in managing the progress of this new technology.
"… we think that this approach would be effective, because it would encourage nations to commit to transparency, to public engagement, to international consultation and to policing behavior within their own borders," the scientists write in their proposal. "It would also provide opportunities for other nations to dissuade a country from proceeding with ill conceived uses. And it would provide a mechanism for flagging nations that refuse to commit to – or live up to – these self imposed obligations."
The proposal is relatively nuanced, specifying allowances for research into germline editing, and only really calling for a prohibition in transferring gene edited embryos into a person's uterus. Gene editing in human somatic cells to treat disease is still allowed. The big concern here is gene editing babies and permanently altering heritable DNA.
"Will it hamper research and use in the clinic? No – the moratorium will not apply to germline editing for research purposes or to the editing of somatic cells," explains Hillary Sheppard, from the University of Auckland. "The call to limit the clinical use of germline editing is proposed for a fixed and limited time of perhaps five years. This is warranted as many technical issues still need to be resolved to allow this method to be safely used in the clinic. In addition, it is still debatable whether there is a sufficient unmet need to warrant its use in the clinic. It is clear that many issues, both technical and ethical, remain to be resolved."
All this conversation may be resolutely hypothetical, with voluntary proposals such as this obviously not functioning to overtly ban types of research. The big important takeaway from the new proposal is the pressing urgency for this debate to happen right now. In an accompanying comment published by the editors of the journal Nature, it is suggested all stakeholders, from governments to universities to journals, need to act now and find a consensus on the issue.
"The right decisions on human germline modification can be reached only through frank and open discussion, followed by swift action," the editors of Nature write. "With so much at stake, that must happen now."
The proposal was published in the journal Nature.