Editing babies’ genes likely to lead to charges
Scientist’s work raised ethical issues about gene altering.
A Chinese scientist HONG KONG — who claimed to have created the world’s first genetically edited babies “seriously violated” state regulations, according to the results of an initial government investigation reported Monday by Chinese state media.
The investigators’ findings indicate that the scientist, He Jiankui, and his collaborators are likely to face criminal charges.
He shocked the world in November when he announced that he had used Crispr, a powerful gene-editing technique, to alter the genes of human embryos. He produced some data but no definitive proof during his presentation at an international conference in Hong Kong.
The investigation found that He and his team had edited the genes of human embryos and then implanted the embryos in female volunteers, as he claimed last year. One volunteer gave birth to twin girls in November, and another volunteer is now pregnant, according to Xinhua, the Chinese state news agency.
His announcement raised ethical concerns about the long-term effects of such genetic alterations, which if successful would be inherited by the child’s progeny, and whether other scientists would be emboldened to try their own gene-editing experiments.
Scientists inside and outside China criticized He’s work, which highlighted fears that the country has overlooked ethical issues in the pursuit of scientific achievement. Chinese authorities placed He under investigation, during which time he has been kept under guard at a guesthouse at the Southern University of Science and Technology in the city of Shenzhen.
The university announced Monday that it was rescinding He’s contract and canceling all of his teaching and research activities there.
In countries including the United States, such a clinical trial would be banned. But China has laxer regulations on such research, and it was not immediately clear which specific laws He was accused of breaking.
This case has served as a warning that China needs to enact tough laws on gene editing, said Wang Yue, a professor at Peking University who researches health law in China.
“Even though the Ministry of Health has issued ethical rules, the legal responsibility is unclear and the penalties are very light,” he said.
The government investigation found that starting in 2016, He had deliberately evaded supervision, used unsafe and ineffective methods, and forged ethical review materials, Xinhua reported.
“This behavior seriously violated ethics, scientific research integrity and relevant state regulations causing adverse effects at home and abroad,” Xinhua said.
He and other personnel and institutions involved “will be dealt with seriously according to the law,” the report said, citing an unidentified lead investigator. The case will be handed over to public security organs, the report said, indicating the likelihood of criminal charges.
The investigation also found that He had raised funds on his own “in pursuit of personal fame and fortune.” The allegations that he forged documents and financed his work independently could shield from punishment his university, local authorities and the hospital where the trial was carried out.
Still, some critics have asked how He could have perpetrated such a scheme without some knowledge of the authorities. After his announcement, speculation swirled that the Shenzhen government had funded his work. Local officials have denied it.
At the core of He’s legal problems is informed consent. Chinese medical ethics guidelines require that researchers obtain verbal consent from the subjects of their work. Civil charges can be brought against researchers who exaggerate the benefits of a particular experiment while playing down the risks.
He said he had recruited couples in which the man had HIV, the virus that causes AIDS. He then used in vitro fertilization to create human embryos genetically altered to be resistant to HIV infection. But there are simpler ways of preventing HIV infection that do not involve the risks of such a trial.
Bai Hua, the head of Baihualin, an AIDS support group that helped He recruit the couples, said that he now regretted doing so and was deeply worried about the families. In a statement posted on the social media platform WeChat, Bai, who uses a pseudonym, said he felt “deceived.”
One HIV-infected man whom He’s team tried to recruit said he was not told of the ethical concerns about editing human embryos, according to Sanlian Life Weekly, a Chinese newsmagazine.