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Clinical research involving gene editing, gene transfer, or gene regulation could be considered high-risk and overseen by China’s national cabinet, the State Council, if draft regulations posted yesterday (February 26) on the National Health Commission’s website (in Chinese) are adopted.
“The guidelines would require clinical trials involving gene-editing and other experimental life science technologies to be classified as high or low risk, and to obtain approval from government authorities before proceeding,” Bloomberg reports. “Researchers and hospitals found to have flouted the rules will be subject to penalties including a lifetime ban on research work, a revoking of business licenses and criminal investigation, said the draft.”
The proposal comes in the wake of international attention to scientist He Jiankui’s claim to have directed the production of two genetically edited babies. Investigations have revealed that He used banned techniques and may have used government funds to do so.
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