University expels scientist behind ‘illegal’ gene-editing of babies

The Chinese scientist behind the gene-edited babies scandal that caused a storm of condemnation from around the world on ethical grounds has been expelled from his university as the results of a preliminary official investigation into the case were made public this week.

He Jiankui, a scientist from the Southern University of Science and Technology (SUSTech) in Shenzhen in Southern Guangdong province, revealed in November that he had created the world’s first gene-edited twins using the gene-editing technology CRISPR, shocking the scientific community around the world.

SUSTech said in a brief statement on Monday that based on the conclusions of the official investigation “effective immediately, SUSTech will rescind the work contract with Dr Jiankui He and terminate any of his teaching and research activities at SUSTech”.

Investigators from Guangdong province, where the experiments were carried out, though not at SUSTECH which says it had no knowledge of the experiments, for the first time confirmed officially that the controversial births had taken place.

The Guangdong investigators said in a preliminary report on 21 January that He’s activities seriously violated ethical principles and scientific integrity and breached the relevant regulations of China.

The provincial-level investigation showed that He had defied government bans and “conducted the research in the pursuit of personal fame and gain”, the investigation team said, adding that He had intentionally dodged supervision, raised funds and organised researchers on his own to carry out gene-editing on human embryos “which is explicitly banned by relevant regulations”.

The state-run Xinhua news agency said on Monday that He would be “transferred to public security authorities” and any individuals involved in the experiment will be “severely dealt with according to the law”.

According to the Guangdong investigation, He started the project in June 2016 and organised a team that included some overseas researchers. “He conducted the gene-editing activities using technologies without safety and effectiveness guarantee,” the investigators said.

With a fake ethical review certificate, He recruited eight volunteer couples and carried out experiments from March 2017 to November 2018. One of the volunteers gave birth to twin girls Lulu and Nana; another is still pregnant, they confirmed.

Rushing to tighten up rules

In the wake of the scandal which made global headlines, the national and provincial authorities in China are rushing to tighten oversight and rules on the controversial technology.

According to a notice from the Department of Science and Technology under the Ministry of Education that was issued in December and posted on several university websites, all universities and research institutes are now required to report “illegal gene-editing experiments conducted after January 2013”. Illegal in this context refers to experiments that allow genes to survive more than 14 days, according to the guidelines.

In a campaign to implement stricter supervision of research according to ethical principles, while safeguarding the “healthy development of bioscience research”, the ministry now requires universities and research institutes to conduct strict investigations into experiments to ensure they are in accordance with ethical guidelines.

Universities and research institutes are also required to report the rules and procedures of their ethical review committees to the ministry as part of a complete self-inspection report which the ministry said had to be delivered by the end of 2018.

However, SUSTech would not have been able to detect He’s activities even under the stricter rules, as He was on leave from the university at the time and did not conduct the experiments there, experts note.

Academics in Guangdong province said national and provincial authorities had conducted “surprise inspections” on university and research centre laboratories in recent weeks.

New regulations in the pipeline

Official Chinese media said authorities in South China have held meetings to discuss new regulations on ethical biomedical research. The Health and Family Planning Commission of Shenzhen has said it is drawing up the regulations.

Ethics regulations for human-related research were previously issued by the commission in 2007 and renewed in 2016.

But Huang Jiefu, a former Chinese vice minister of health, told China’s official Global Times newspaper in November that science and technology in China has developed far beyond the purview of the law established decades ago.

"Even the law for organ donation and transplantation, which has improved a lot in recent years, is still imperfect, not to mention one for gene editing," Huang said.

Huang said a national authority was needed to take charge of the ethics review.

"I hope the country can start to pay attention to the problem after the occurrence of gene-edited babies. There is an urgent need for a national ethics review committee as well as a legal system to regulate bioscience," Huang stated.

In 2015, Shanghai released China's first regional rule – the Standards and Operational Guidance for Ethical Review of Biomedical Research Involving Human Participants.

The Shenzhen government established its own ethics review committee in April 2017, with all human research required to be examined by the committee. Xiao Ping, director of the committee, hosted several meetings last year to draft a regional standard for medical science ethics.

However, Zhai Xiaomei, a professor and deputy director of the Center for Bioethics of the Chinese Academy of Medical Sciences, said the national guidance on medical science ethics is already comprehensive, so the key for national and regional regulations is implementation and supervision.