China’s science and technology ministry has prohibited all clinical research involving germline genome editing, describing the approach as ‘irresponsible’.
Germline genome editing involves making edits to DNA in egg, sperm or early embryos to introduce changes that can be inherited by future generations.
The South China Morning Post reports that the new Ethical Guideline for Human Genome Editing Research are China’s latest effort to tighten regulations following the case of Chinese researcher, He Jiankui, who claimed to have created the world’s first gene-edited babies.
Jiankui announced his work – which used Crispr–Cas9 technology – and the subsequent birth of the twin girls at a presentation at a conference in Hong Kong in November 2018, causing widespread shock in the scientific community.
He was later sentenced to three years in prison for illegal medical practices and fined Yuan3 million (£327,000) by a Chinese court. It was feared his actions would unleash a global regulatory backlash against gene editing.
The guidelines, published on 8 July, don’t completely close the door to germline editing further down the line, however. They state that clinical research in this area would only be considered – with strict supervision – once the benefits, risks and alternative options were fully understood and weighed, the issues of safety and efficacy addressed, a broad social consensus achieved, and only after the study protocol had been subjected to rigorous assessment.
The guidelines also strictly prohibit the use of genome editing research on germ cells, fertilised eggs or human embryos for reproductive purposes.
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