BEIJING — A powerful new national medical ethics committee, which will approve all clinical trials involving high-risk biomedical technologies, is at the center of a regulatory shakeup Chinese authorities are planning in the aftermath of the widely condemned “CRISPR babies” experiment, STAT has learned.
The technologies that will be regulated by the ethics committee are often new and are deemed risky either because of safety or moral concerns. They will include not only gene editing, but also cloning, cell therapy, xenotransplantation, mitochondrial replacement, and nanotechnology.
With a planned 30-member staff, the national ethics committee — personally approved by President Xi Jinping — will report to the State Council, China’s cabinet, and have regulatory jurisdiction over nearly a dozen ministry-level agencies that fund or regulate medical research and applications. The agencies include the health commission, the science ministry, the education ministry, the China Food and Drug Administration, the National Natural Science Foundation, the Chinese Academy of Medical Sciences, the Chinese Academy of Sciences, and the Chinese Academy of Engineering, a researcher involved in the initiative told STAT.
