In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to tighten oversight, there are worries that the rules could impose a burden on areas of genetic research that are not so controversial.
“I am happy to see the national regulations regarding new biomedical technologies; I think this makes relevant policy more clear,” says Wei Jia, a medical oncologist who is involved with an ongoing trial using gene editing to modify cancer patient T-cells at the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China.
The regulations are in response to the late November 2018 claim by He Jiankui, then of Southern University of Science and Technology in Shenzhen, China, that he had altered the DNA embryos in a way that would give the babies and their descendants resistance to HIV. This approach is called germline engineering—it can involve changing DNA in embryos or sperm or eggs—and is banned in many countries, by law or regulation. He’s effort, using a technique called CRISPR, resulted in twin girls born last fall; one more baby, he said, is on the way. The experiment earned He worldwide condemnation for prematurely using a still glitchy technique that might negatively affect the babies’ development and health in a medically unnecessary and unjustified intervention.
In January, a preliminary investigation found that He deliberately sidestepped regulations, dodged oversight, and used fake ethical review documents, according to Chinese media. (No official report was ever publicly released.) But as the scandal unfolded over the past 3 months, many Chinese ethicists and researchers noted that the most relevant regulations date back to 2003 and need updating in light of CRISPR’s emergence and other research advances.
The new rules cover experiments that involve gene editing, the transfer of genes or attempts to regulate gene expression, the use of stem cells, and other “high-risk” technologies in humans or in human organs or embryos that would be implanted in a person. All would require approval by a yet-to-be-specified agency under the State Council, the country’s highest administrative authority. Research involving human subjects using low- or medium-risk technologies—which will be defined later—will need institutional and provincial approval. The 16-page document also gives requirements for informed consent by trial participants and the information needed on applications. It also states that conflicts of interest or lack of clarity on funding sources will be grounds for rejecting a proposed trial.
The regulations specify a range of legal penalties, including warnings, fines, a lifetime ban on participating in clinical research, and criminal charges, depending on the seriousness of the infraction. The National Health Commission posted the draft regulations on its website on Tuesday and will accept comments from the public until 27 March. There is no date given for when the new rules might take effect.
Wei Wensheng, a molecular biologist at Peking University in Beijing, says regulation of what is now “a chaotic situation” in China gene editing has been needed. In particular, he adds, it is “very reasonable to set tight regulations on germline editing.” But Wei notes that the same national approval will now be required for clinical research relying on editing somatic cells, such as those in the blood, that are not passed on to future generations. “On paper, there is basically nothing wrong” with this requirement. “But in a practical sense, if it takes too long to get permissions, it could be a bottleneck that will slow down research,” he says. “It depends on execution, on how they handle each case.”