BThree government institutions in China, including the Ministry of Science of the Nation, may have funded a "CRISPR" study, which led to the birth of two genetically modified twin girls last November, according to documents reviewed by STAT.
These findings seem to support what many researchers inside and outside China are suspecting after scientist J. Jiankui revealed births in late November, causing international condemnation of breaking the scientific guidelines against the use of genetically-engineered human embryos for pregnancy. "I do not think he could do it without government support to go on with research that they thought would deserve the Nobel Prize," said Jing-Bao We, a bioethicist at Otago University in New Zealand.
If the papers are correct, they would assume that China supports the research that the US and other countries consider unethical and raises doubts about the preliminary conclusion of a government inquiry that it acted mostly alone. This investigation, led by the Guangdong Provincial Health Commission and including the Ministry of Science and the National Health Commission, found that He had raised funds for the experiment alone without formal approval. He also came to the conclusion that he had tampered with the form of informed consent and violated scientific ethics and Chinese regulations, according to the Xinhua news agency.
"They want him to be a scapegoat, so everyone else can be justified," he told us. "But that will hide serious institutional failures."
The papers examined by the STAT slide show, prepared by He's Chinese Language Consent and China Clinical Trials Register, list three sources of funding for the study that led to the birth of the twins: the Ministry of Science and technologies; Shenzhen Science and Technology Innovation Commission, part of the municipal government; and the South University of Science and Technology where he works.
However, it is not clear whether the institutions know how their subsidies will be used. Scientists applying for a grant in China usually have to describe in detail how they will use the money. But it is possible for CRISPR babies to use money that was given to him in the laboratory for earlier research. The Shenzhen Science and Innovation Commission funded He's preclinical research, which tested CRISPR's technology without generating pregnancies in humans.
The University and the government of Shenzhen denied any knowledge of the He CRISPR infants who are working shortly after their disclosure. In an e-mail Sunday, the ministry of science told STAT that "based on the preliminary investigation, he did not fund He's human genome editing activities." The Shenzhen Innovation Committee did not respond to a request for comment, nor was it Jiankui,
The STAT also found that five Chinese fertility clinics are linked to various studies of Gene gene editing based on references in the Chinese registry of clinical trials or in newspapers it has reported in magazines. It is not clear whether one of them has been involved in CRISPR's babies' work or, if so, whether they knew what he was doing; most of them have provided eggs and embryos for some of He's preclinical studies.
"It is unlikely that he will act alone," said Ley Ruiepen, executive director of the Center for Bioethics at the Huangong University of Wuhan. "I hope the ongoing investigation will look at the institutional issues that ended with the affair. Otherwise, the possibility of such scandals will remain open. "
Bioethics was not released in China a quarter century ago. Since then, she has been trying to make laws and struggle to regulate the rapid development of biotechnology. "It is difficult in the best cases and it is really difficult when you have 1.3 billion people spread over a large area," says Hank Grayley, a lawyer and bioethics at Stanford University.
"But China has to admit that this is a problem," he said. "To maintain our high standing and to be a reputed member of the international research community, China needs much better anti-abuse systems."
HJiankui is a rising star and has received generous financial support from the Chinese government after returning in 2012 after completing a PhD. and post-doctoral research in the United States.
Jia Ping, a human rights lawyer and founder of a non-governmental organization based in Beijing, a health management initiative, said he was a favorite of the ministry of science. In September 2017, he appeared on the Chinese state television channel CCTV13, which demonstrated a DNA sequencing device that he claims to have developed and sent shockwaves around the world.
"Not every scientific breakthrough can appear on television, not to mention such a profile," Jia said. "You will need government agencies to support you." Indeed, the TV program contained a statement issued by the Ministry of Science describing its work as a major achievement.
It then appears that the ministry of science has provided CRISPR baby care funding, which involves editing a gene called CCR5 in the embryos to protect children from HIV infection. This can be derived from a 14-slide Chinese Language Call for Volunteer Clinical Trial, which was provided to STAT by a Chinese scientist involved in the project. The sixth slide outlines the purpose of the study and claims that the source of funding is the state-run research program of the Chinese Ministry of Science.
The Chinese Register of Clinical Trials lists another forensic financier: the Shenzhen Science and Technology Innovation Project, which is funded by the Shenzhen Innovation Commission. It does not mention the ministry of science or the South University of Science and Technology.
On the issue of funding sources in November last year, after talking about his clinical study at the Second International Human Genome Editor's Summit in Hong Kong, he said the work had been partially paid out of his own savings, and partly from a generous start-up fund. from the university when he was hired for the first time. Indeed, the university is referred to as a source of funding for two forms of Chinese language awareness and consent provided to STAT that it has used to hire male and female volunteers respectively.
He may also have sought support from another government. A source close to the Chinese Ministry of Health told STAT that his team was lobbying the government of southern Hainan province to create in vitro clinics specializing in germline editing – changing DNA to embryos, eggs or semen.
Some Chinese researchers claim that He may have misinterpreted some of the government's donations to trust himself. "I would be very surprised if the government agencies officially fund the CRISPR infant project," says Mu-ming Poo, director of the Institute of Neurology at the Chinese Academy of Sciences in Shanghai. "But it is possible to use other government donations to fund CRISPR babies' work because there is some flexibility in how money can be spent."
WHere his team has done the work of in vitro fertilization and the editing of the genes remains a mystery. The CRISPR Infant Project website in the Chinese Register for Clinical Trials has an approval form from the Shenzhen Women's Medical Ethics Committee and the HarMoniCare Children's Hospital, which claims she has no knowledge of the project. Regardless of the authenticity of approval, in vitro and implantation of genetically modified embryos can not be carried out in the hospital because there is no in vitro clinic.
One trace can come from the manuscript he submitted to Nature last November, titled "The Birth of Twins After Editing the Genome for HIV Resistance." Luoyu District People's Hospital). And the only hospital related researcher in the author's list is Qin Jinzhou, who is the second author – after He, the lead author.
Qin was a key member of the project. He was named as his principal investigator in the clinical trial registry and the patient's presentation slider contact point. Kin has also co-authored He on two preclinical gene editing studies.
On the IVF website, the Qin hospital clinic was named last December as "an expert in laboratory research for in vitro" rather than as a "clinical expert" – suggesting he was an in vitro technician rather than a surgeon. Qin's role in CRISPR's babies' work is unclear. Since then, he has been removed from the website and neither he nor the hospital has responded to STAT's request to comment.
Four other IVF clinics are linked to He's pre-clinical gene editorial studies involving more than 300 embryos. Two of the clinics – Zhengzhou University's third linked hospital and the CITIC-Xiangya Genetics and Reproductive Hospital in Changsha – are listed as collaborating hospitals in the clinical trial registry projects. Both hospitals, along with the Guangdong General Hospital and Shenzhen Reproductive Health Center, are listed as contributing branches of the two pre-clinical papers that he and Kin co-authored.
"What is their role in CRISPR's babies? Did they follow the process properly when they were given eggs and embryos? Are they being investigated? Ley asked the Huazong University of Science and Technology. None of the in vitro clinics responded to STAT requests for an interview. Neither the National Health Commission, nor the Guangdong Provincial Health Commission.
OhOn the day of the Xinhua Report he was fired from his university. An unidentified employee who participated in the investigation told the news agency that suspected criminals would be handed over to the relevant public security bureaus.
"This would be a step forward from previous incidents," says Jia Human Rights Attorney. In China, ethics violations are mild, if any. "Few get the sack, not to mention the prison," Jia said.
But the punishment alone, no matter how strict, is far from enough, researchers say. "While it is important to sanction individuals, the focus should not be why they behave so badly, but why good people do bad things and why the system has allowed it to happen," says We, the New Zealand bioethics.
And "you need more than just a deterrent to have good quality control," said Stanford Gryll. "Even if he acted alone, which is great, if he had to have institutions that could prevent that. A good system creates unnecessary guarantees that limit the damage a bad participant can do. "
"China should turn this medical scandal into positive institutional reforms to prevent the recurrence of such incidents," Ley said. "Hopefully this will not be missed opportunity."