A group of ethicists and scientists – including some of the inventors of CRISPR – have called for a moratorium on all clinical uses of germline editing. But the leaders of the US National Academy of Sciences, the US National Academy of Medicine and the UK Royal Society have come out in opposition.
The World Health Organization (WHO) should create a global registry of studies that involve editing the human genome, and research funders and publishers should require scientists to participate in it, a group advising the WHO said on 19 March, reports Nature.
The WHO created panel in December after a scientist in China used the gene-editing tool CRISPR to modify the genomes of twin baby girls. In its statement, the panel also opposed the clinical application of research that alters the genome of human eggs, sperm or embryos – called the germ line – in ways that can be passed to future generations.
“The committee agrees it is irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing,” said Margaret Hamburg, the panel’s co-chair and foreign secretary of the US National Academy of Medicine, according to Nature.
But she emphasised that the WHO panel is not calling for a permanent moratorium on such research. “We are trying to look at the broader picture and a framework for responsible stewardship,” said Hamburg, a former commissioner of the US Food and Drug Administration. “I don’t think a vague moratorium is the answer for what needs to be done.”
The advisory committee, which is developing an international framework to govern the use of gene-editing technologies in people, will issue final recommendations to WHO director-general Tedros Adhanom Ghebreyesus in 18 months.
Hamburg did not offer hints as to whether the WHO is considering ways to create a binding international agreement governing gene editing, or to ensure that governments enforce existing laws. The advisory committee’s charge includes understanding the differences between how countries govern such research, she said: “It’s a daunting task, but it’s the beginning of a process and we don’t really know all the strategies that might be used.”
The WHO decided to weigh in on genome editing after Chinese biophysicist He Jiankui said in November that he had modified the genomes of two girls to make them resistant to HIV. His use of the technology was nearly universally condemned, and the Southern University of Science and Technology in Shenzhen fired him in January. Late last month, China’s Health Ministry issued draft regulations to restrict the use of gene editing in people.
But scientists are split on whether a complete moratorium on the clinical use of germline editing is appropriate. Last week, a group of ethicists and scientists – including some of the inventors of CRISPR – published an opinion piece in Nature calling for “a fixed period during which no clinical uses of germline editing whatsoever are allowed”.
In an accompanying response, the leaders of the US National Academy of Sciences, the US National Academy of Medicine and the UK Royal Society opposed such a moratorium, arguing that “we must achieve broad societal consensus before making any decisions, given the global implications of heritable genome editing”.
The registry recommended by the WHO committee is an attempt to bridge the gap until the world agrees on a framework to govern gene editing in people. The panel says that it should cover studies of the clinical applications of human genome editing – including both changes to the germline and techniques that alter a person’s genes in ways that won’t be inherited. The latter has not generally been controversial.
Several companies and research teams are conducting clinical trials to test whether CRISPR and other gene-editing techniques can treat genetic diseases such as β-thalassaemia, which affects the production of haemoglobin.
Representatives of several scientific publishers said they support the concept of a registry for studies of gene editing in people. “We applaud the WHO for addressing this important issue and look forward to seeing what their deliberations add to the ongoing societal debate about responsible application of genome editing,” says Deborah Sweet, vice president of editorial for Cell Press.
And Jeremy Berg, editor-in-chief of Science, says that his employer “would support transparency through the development of an appropriate registry and the requirement of timely registration of studies as a prerequisite for publication in our journals”.
Asked whether Nature would support the WHO proposal, a journal spokesperson pointed to a recent Nature editorial to stating that “proposals for ethically vetted and approved basic research studies that use gene-editing tools in human embryos and gametes, including those aimed at assessing efficacy and safety, should be deposited in an open registry”. (Nature’s news team is editorially independent of its journal team.) “We keep all of our editorial and publishing policies under regular review to ensure that they are aligned with the needs and expectations of the research community and remain rigorous and effective to safeguard the integrity of the research we publish,” the spokesperson added.
The transparency recommended by the WHO panel is the right approach, says Helen O’Neill, a molecular geneticist at University College London who works on CRISPR. “Speaking to researchers about their research and being very open is the best way forward, to open it to discussion rather than polarising the debate,” she says. “It just says who is doing what and how can we talk about this.”
O’Neill would like to see the WHO committee take its time developing recommendations for international governance, rather than rush to produce a framework. She says that the negative reaction to He’s work, and the media attention, should deter any other rogue scientists from undertaking similar experiments before the governance question is settled.