The Chinese authorities are holding scientist He Jiankui wholly responsible for creating the world’s first gene-edited babies.

He had announced their birth in November, after which the authorities announced an investigation into the matter.

A team of investigators told the official Xinhua news agency on Monday that a preliminary investigation had concluded that He had “organised a project team that included foreign staff, which intentionally avoided surveillance and used technology of uncertain safety and effectiveness to perform human embryo gene-editing activity with the purpose of reproduction, which is officially banned in the country”.

Between March 2017 and November 2018, He forged ethical review papers and recruited eight couples to participate in his experiment, resulting in two pregnancies.

Chinese scientist He Jiankui says he is proud of genetic experiments



One of the mothers gave birth to twins nicknamed “Lulu” and “Nana”, the investigators said. Another woman is still carrying a gene-edited fetus.

They also said that He, his staff and organisations related to his project would be punished according to laws and regulations.

The Guangdong government will keep the twins under medical observation. </s> A Chinese hospital has denied involvement in the alleged delivery of the world’s first genetically-edited babies and experts worldwide have voiced outrage at such use of the technology.

The push back comes amid claims made online by scientist He Jiankui that twin girls had been born with DNA altered to make them resistant to HIV, a ground-breaking move that could potentially spark huge scientific and ethical dilemmas.

He, a professor at Southern University of Science and Technology in Shenzhen, claims that his lab had been editing embryos’ genetic codes for seven couples undergoing in-vitro fertilization (IVF).

In a video posted to YouTube Monday, the Chinese researcher said that one of the pregnancies had been successful, and that ostensibly healthy twin girls Lulu and Nana had been born “a few weeks ago.”

He claims that he used a tool known as CRISPR-cas9, which can insert or deactivate certain genes. In his YouTube video, He describes the procedure as having “removed the doorway through which HIV enters.”

But the hospital named in He’s ethical approval documents, Shenzhen Harmonicare Women’s and Children’s Hospital, has denied involvement in the procedures.

“We can ensure that the research wasn’t conducted in our hospital nor were the babies born here,” a hospital spokesperson told CNN. The hospital confirmed that two of the doctors named in He’s documents work at the hospital, and suggested that an internal investigation was underway.

The Shenzhen Health and Family Planning Commission denounced the legitimacy of the hospital ethics committee and the review process that approved the application. It confirmed an investigation was launched Monday to “verify the authenticity of the ethical review of the research reported by media.”

He’s University, Southern University of Science and Technology, said in a statement that the researcher has been on leave since February 1, 2018.

“The research work was carried out outside the school by Associate Professor He Jiankui. He did not report to the school or the department of biology. The university and the biology department are not aware of it,” the institution said, adding that “the Academic Committee of the Department of Biology believes that it seriously violates academic ethics and academic norms.”

He’s claims have neither been independently verified nor peer-reviewed. But if true, the procedure would raise significant ethical questions around gene-editing and so-called “designer” babies.

Editing the genes of embryos intended for pregnancy is banned in many counties, including the US. In the UK editing of embryos may be permitted for research purposes with strict regulatory approval. It is unknown whether the procedure is safe or, if used in pregnancy, whether it can have unintended consequences for the babies later in life, or for future generations.

A joint statement has been issued by more than 120 Chinese scientists on the Chinese social media site Wiebo condemning the human genome-editing research.

“The medical ethics review exists in the name only. Directly experimenting on human is nothing but crazy… as soon as a living human is produced, no one could predict what kind of impact it will bring, as the modified inheritable substance will inevitably blend into human genome pool,” they wrote, adding that the trial is a “huge blow” to the reputation of Chinese biomedical research. “It’s extremely unfair to Chinese scientist who are diligent, innovative and defending the bottom line of scientific ethics.”

Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics at the University of Oxford, described the alleged births as “genetic Russian Roulette.”

“If true, this experiment is monstrous,” he said. “The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

“There are many effective ways to prevent HIV in healthy individuals: For example, protected sex. And there are effective treatments if one does contract it,” Savulescu said.

Joyce Harper, a professor in genetics and human embryology at the Institute for Women’s Health, UCL, described the alleged research “premature, dangerous and irresponsible,” calling for public debate and legislation.

“Before this procedure comes anywhere near clinical practice, we need years of work to show that meddling with the genome of the embryo is not going to cause harm to the future person,” she said in a statement.

Yalda Jamshidi, senior lecturer in human genetics, St George’s, University of London pointed out that such controversial research is not necessary for preventing HIV. “We already have ways to prevent HIV infection and available treatments should it occur. We also do not need gene editing to ensure it isn’t passed on to offspring,” she said. “We know very little about the long term effects, and most people would agree that experimentation on humans for an avoidable condition just to improve our knowledge is morally and ethically unacceptable.

Despite ethical concerns in the West, a recent study suggested that the Chinese public is broadly in favor of using gene-editing for medical purposes. An online survey conducted by Sun Yat-Sen University in Guangzhou found that more than two-thirds of the 4,771 people surveyed (575 of whom reportedly have HIV), supported its use in treating diseases, according to the state-run tabloid Global Times.

“(Chinese people) have a high willingness to use of gene in disease prevention and treatment,” Liang Chen, a professor at Sun Yat-Sen University is quoted as saying. “This suggests that the research of gene editing in China not only has a promising potential, but also is responding to the public’s needs.” </s> A Chinese investigation into reports of the world's first gene-edited babies seems to have confirmed their existence, and investigators say the scientist responsible acted on his own and will be punished for any violations of law.

China's official news agency said Monday that investigators in Guangdong province determined that the scientist, He Jiankui (HUH JEEN-qway), for the sake of fame evaded supervision of his work and violated research norms. It did not say what laws or regulations he may have broken.

The scientist stunned the world in November by claiming that he had altered the DNA of twin girls at conception to try to help them resist infection with the AIDS virus.

The claim has been widely criticized as medically risky and unethical. A second pregnancy also reportedly is underway.

FILE - In this Oct. 10, 2018, file photo, He Jiankui is reflected in a glass panel as he works at a computer at a laboratory in Shenzhen in southern China's Guangdong province. A Chinese investigation says Chinese scientist He, behind the reported birth of two babies whose genes had been edited in hopes of making them resistant to the AIDS virus, acted on his own and will be punished for any violations of the law. (AP Photo/Mark Schiefelbein, File)

FILE - In this Oct. 9, 2018, file photo, a microplate containing embryos that have been injected with Cas9 protein and PCSK9 sgRNA is seen in a laboratory in Shenzhen in southern China's Guangdong province. A Chinese investigation says Chinese scientist He Jiankui, behind the reported birth of two babies whose genes had been edited in hopes of making them resistant to the AIDS virus, acted on his own and will be punished for any violations of the law. (AP Photo/Mark Schiefelbein, File) </s> After rocking the scientific community by helping to create ‘AIDS-resistant’ children using banned gene-editing techniques, Chinese investigators have confirmed that Dr He Jiankui will be punished for his experiment.

“This behavior seriously violates ethics and the integrity of scientific research, is in serious violation of relevant national regulations, and creates a pernicious influence at home and abroad,” a report by Chinese state news agency Xinhua stated.

The scientist made headlines across the world in 2018 by claiming to have helped make the world’s first gene-edited babies, flouting scientific consensus regarding the ethical implications of manipulating genes that would have intergenerational and somewhat unknown consequences.

The investigating team set up by the Health Commission of China in southern Guangdong province found that He had self-funded and privately organized a team to carry out the procedure using CRISPR-Cas9 gene-editing techniques to “seek personal fame and profit,” according to the report.

He reportedly assembled a team that included foreign staff, all of whom intentionally evaded surveillance and used “technology of uncertain safety and effectiveness to perform human embryo gene-editing activity with the purpose of reproduction, which is officially banned in the country.”

Authorities also confirmed that He forged an ethical review between March 2017 and November 2018, and recruited eight couples to participate in the experiments, two of which achieved fertilization; twins Lulu and Nana are currently under observation by Chinese medical experts, while another embryo has yet to be born.

In the aftermath of the initial announcement, there was widespread condemnation of He’s actions among the scientific and broader international communities. Gene editing for reproductive purposes is effectively banned in the US, most of Europe and many other nations around the world, including China.

READ MORE: ‘Chinese Frankenstein’ missing? Whereabouts of scientist who created gene-edited babies unknown

He defended his actions at a conference in Hong Kong last November, stating that he was “proud” of what he had done, doubling down by stating that he had helped protect the twin girls from possible infection with HIV later in life.

Like this story? Share it with a friend! </s> Chinese authorities appear to have confirmed a scientist’s unpublished claim that he helped make the world’s first gene-edited babies and that a second pregnancy is underway, and say he could face consequences for his work.

China’s official Xinhua News Agency said Monday that investigators in Guangdong province determined that the scientist, He Jiankui (HUH JEEN-qway), evaded supervision of his work and violated research norms because he wanted to be famous.

The report said He acted alone and will be punished for any violations of the law, although it didn’t say which regulations he may have broken.

The scientist stunned the world in November by claiming that he had altered the DNA of twin girls at conception to try to help them resist infection with the AIDS virus.

He’s work has been widely criticized as unethical because of questions about whether the participants truly understood the risks.

It is also considered medically dangerous because of possible harm to other genes and the DNA changes can be passed to future generations.

There has been no independent verification of his claim, first reported by The Associated Press, and it has not yet been published, although He gave details at an international gene editing conference in Hong Kong.

Some have even speculated that it could be a hoax.

But the Chinese investigation appears to confirm it.

The Xinhua report says the twins and those involved in the second pregnancy will remain under medical observation with regular visits supervised by government health departments.

“It does sound like they have confirmed the existence of the babies,” said Dr. Kiran Musunuru, a genetics journal editor from the University of Pennsylvania who reviewed materials He provided at the AP’s request.

Given that the Chinese investigation alleged ethical lapses, He’s work might not be published by a scientific journal, but “the information needs to be made available so we know exactly what was done,” Musunuru said. “It could be as simple as putting it on the web.”

The scientist, He, could not be reached for comment.

It’s unclear how many edited embryos remain from He’s experiment and what will become of them.

He’s school, Southern University of Science and Technology of China in Shenzhen, and the Chinese ministries of health and science also have said they are investigating and have put a halt to his work.

Gene editing for reproductive purposes is effectively banned in the U.S. and most of Europe.

In China, ministerial guidelines prohibit embryo research that “violates ethical or moral principles.” </s> Chinese officials this week denounced the actions of a scientist who claims his lab made the world’s first genetically edited babies.

As reported by the Xinhua News Agency, researcher He Jiankui defied government bans and conducted the experiment “in pursuit of personal fame and gain.”

An investigation by the Guangdong Province Task Force suggests that He intentionally dodged supervision, raising funds and organizing lab techs to carry out the human embryo revision that is “explicitly banned” by regulations, Xinhua said.

In late November, He announced the birth of twin girls whose DNA was modified to protect against future HIV infection.

The project allegedly dates back to June 2016, when He began organizing a team (which included overseas members).

According to results of the investigation, He used a fake ethical review certificate to lure eight volunteer couples for procedures between March 2017 and November 2018.

Most famously, parents Grace and Mark welcomed “two beautiful Chinese girls” last month.

Grace began her pregnancy via in vitro fertilization (IVF)—but with a twist: After inseminating her eggs, an embryologist sent in “a little bit of protein,” plus instructions for a gene surgery intended to protect the girls from future HIV infection.

The news set the scientific community alight: an angry mob of researchers carried proverbial pitchforks and torches, calling He’s conduct unethical—a feeling echoed by the independent committee assigned to investigate the incident.

“The activities seriously violated ethical principles and scientific integrity and breached relevant regulations of China,” the probe said, as reported by Xinhua.

The Southern University of Science and Technology in Shenzhen, from which the scientist was on non=paid leave from teaching through January 2021, made it very clear the project was conducted off campus and without official approval.

On Monday, the institution released a statement announcing that, effective immediately, SUSTech “will rescind the work contract with Dr. He Jiankui and terminate any of his teaching and research activities.”

He—apparently MIA since making an appearance at the second International Summit on Human Genome Editing in early December—as well as other relevant personnel and organizations, are expected to face undisclosed punishment for their actions.

The babies and pregnant volunteer, meanwhile, will receive medical observation and follow-up visits.
• None Can This Gene-Edited Wild Plant Become the Next Strawberry? </s> Chinese authorities answered one of the lingering questions in the case of rogue scientist He Jiankui on Monday by confirming the twin girls he claims to have genetically edited as embryos were born and are currently under medical supervision.

He Jiankui rocked the medical community, and enraged Chinese officials, by announcing in November that he modified the DNA of the twins to make them immune to the HIV virus carried by their father. Monday’s announcement was the first official confirmation of He’s claim that the girls were born alive and healthy.

The South China Morning Post on Monday reported concerns for both the safety of the children and the future of the human race:

A biologist, who asked not to be identified, said: “This is a result I’m happy to see,” he said. ”This should be the way. There needs to be protection of the babies too.” He said he had also researched gene-editing but all experiments were done on lab rats only. In an interview with Beijing Youth Daily on Sunday, Shao Feng, from the Chinese Academy of Sciences and deputy director of the National Institute of Biological Sciences, said the whole incident would need to be investigated thoroughly. “If I were to handle the matter, I would never tell [the twins] they’ve been gene-edited and allow them to live their lives like normal people,” he said. “I think that’s for the best.” An expert in the field, Shao is worried about potential health risks the children will face as well as the incident’s effect on the human race. “Once the gate of gene-editing is wide open, the human race will be finished,” he said. “The technology is strong but the terrifying fact is that anyone slightly trained in a lab can perform it.”

He Jiankui may or may not be under house arrest at the university that employs him, but his work is clearly under intense investigation, and all of his projects have been suspended. In addition to the troubling questions about genetic engineering raised by his work, he has been accused of violating ethical standards, including a challenge to his claim that he submitted the gene-editing project to review by a hospital ethics committee before proceeding.

Investigators in Guangdong province stated on Monday that He acted alone, evading oversight by privately raising funds for the project, and will be punished for violating unspecified laws.

“This behavior seriously violates ethics and the integrity of scientific research, is in serious violation of relevant national regulations and creates a pernicious influence at home and abroad,” said the authorities. </s> Hong Kong (CNN) The Chinese government has ordered an "immediate investigation" into the alleged delivery of the world's first genetically edited babies, as experts worldwide voiced outrage at such use of the technology.

The pushback comes amid claims made online by Chinese scientist He Jiankui that twin girls had been born with DNA altered to make them resistant to HIV, a groundbreaking move that is likely to spark significant ethical questions around gene editing and so-called designer babies.

He, a professor at Southern University of Science and Technology in Shenzhen, claims that his lab had been editing embryos' genetic codes for seven couples undergoing in-vitro fertilization.

In a video posted to YouTube on Monday , the Chinese researcher said that one of the pregnancies had been successful and that ostensibly healthy twin girls Lulu and Nana had been born "a few weeks ago."

He claims that he used a tool known as CRISPR-cas9, which can insert or deactivate certain genes. In his YouTube video, He describes the procedure as having "removed the doorway through which HIV enters."

He's claims have neither been independently verified nor peer-reviewed. Editing the genes of embryos intended for pregnancy is banned in many counties, including the United States. In the UK, editing of embryos may be permitted for research purposes with strict regulatory approval. It is unknown whether the procedure is safe or, if used in pregnancy, whether it can have unintended consequences for the babies later in life or for future generations.

China has invested heavily in gene-editing technology, with the government bankrolling research into a number of world "firsts," including the first use of the gene-editing tool CRISPR-Cas9 in humans in 2016 and the first reported use of gene editing technology to modify nonviable human embryos in 2015.

More recently researchers in China claimed to have bred healthy mice from same-sex parents, using gene editing technology.

But in a statement posted Tuesday morning, China's National Health Commission said that it had "immediately requested the Guangdong Provincial Health Commission to seriously investigate and verify" the claims made by He Jiankui.

The statement follows moves by the Chinese hospital named in He's ethical approval documents, Shenzhen Harmonicare Women's and Children's Hospital, to distance itself from involvement in the procedures.

"We can ensure that the research wasn't conducted in our hospital nor were the babies born here," a hospital representative told CNN. The hospital confirmed that two of the doctors named in He's documents work at the hospital and suggested that an internal investigation was underway.

An initial investigation by the hospital said that signatures on He's ethics review form are suspected to be forged. The hospital has never convened an ethics committee meeting on it, according to a statement on its WeChat account , and the facility will ask police to intervene and investigate it and hold related people accountable by law.

The Shenzhen Health and Family Planning Commission denounced the legitimacy of the hospital ethics committee and the review process that approved the application. It confirmed that an investigation was launched Monday to "verify the authenticity of the ethical review of the research reported by media."

He's University, Southern University of Science and Technology, said in a statement that the researcher has been on leave since February 1.

"The research work was carried out outside the school by Associate Professor He Jiankui. He did not report to the school or the department of biology. The university and the biology department are not aware of it," the institution said, adding that "the Academic Committee of the Department of Biology believes that it seriously violates academic ethics and academic norms."

A 'huge blow' to Chinese research

A joint statement issued by more than 120 Chinese scientists on the Chinese social media site Weibo condemns the human genome-editing research.

"The medical ethics review exists in the name only. Directly experimenting on human is nothing but crazy ... as soon as a living human is produced, no one could predict what kind of impact it will bring, as the modified inheritable substance will inevitably blend into human genome pool," they wrote, adding that the trial is a "huge blow" to the reputation of Chinese biomedical research. "It's extremely unfair to Chinese scientist who are diligent, innovative and defending the bottom line of scientific ethics."

Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics at the University of Oxford, described the alleged births as "genetic Russian Roulette."

"If true, this experiment is monstrous," he said. "The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

"There are many effective ways to prevent HIV in healthy individuals: For example, protected sex. And there are effective treatments if one does contract it," Savulescu said.

Joyce Harper, a professor in genetics and human embryology at the Institute for Women's Health at University College London, described the alleged research "premature, dangerous and irresponsible," calling for public debate and legislation.

Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

"Before this procedure comes anywhere near clinical practice, we need years of work to show that meddling with the genome of the embryo is not going to cause harm to the future person," she said in a statement.

Despite ethical concerns in the West, a recent study suggested that the Chinese public is broadly in favor of using gene-editing for medical purposes. An online survey conducted by Sun Yat-Sen University in Guangzhou found that more than two-thirds of the 4,771 people surveyed (575 of whom reportedly have HIV), supported its use in treating diseases, according to the state-run tabloid Global Times.

"(Chinese people) have a high willingness to use of gene in disease prevention and treatment," Liang Chen, a professor at Sun Yat-Sen University was quoted as saying. "This suggests that the research of gene editing in China not only has a promising potential, but also is responding to the public's needs." </s> In this Oct. 10, 2018 photo, He Jiankui is reflected in a glass panel as he works at a computer at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist He claims he helped make world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark Schiefelbein)

In this Oct. 10, 2018 photo, He Jiankui is reflected in a glass panel as he works at a computer at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist He claims he helped make world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark Schiefelbein)

HONG KONG (AP) — A Chinese researcher claims that he helped make the world’s first genetically edited babies — twin girls born this month whose DNA he said he altered with a powerful new tool capable of rewriting the very blueprint of life.

If true, it would be a profound leap of science and ethics.

A U.S. scientist said he took part in the work in China, but this kind of gene editing is banned in the United States because the DNA changes can pass to future generations and it risks harming other genes.

Many mainstream scientists think it’s too unsafe to try, and some denounced the Chinese report as human experimentation.

The researcher, He Jiankui of Shenzhen, said he altered embryos for seven couples during fertility treatments, with one pregnancy resulting thus far. He said his goal was not to cure or prevent an inherited disease, but to try to bestow a trait that few people naturally have — an ability to resist possible future infection with HIV, the AIDS virus.

He said the parents involved declined to be identified or interviewed, and he would not say where they live or where the work was done.

There is no independent confirmation of He’s claim, and it has not been published in a journal, where it would be vetted by other experts. He revealed it Monday in Hong Kong to one of the organizers of an international conference on gene editing that is set to begin Tuesday, and earlier in exclusive interviews with The Associated Press.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” He told the AP. “Society will decide what to do next” in terms of allowing or forbidding such science.

Some scientists were astounded to hear of the claim and strongly condemned it.

It’s “unconscionable ... an experiment on human beings that is not morally or ethically defensible,” said Dr. Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal.

“This is far too premature,” said Dr. Eric Topol, who heads the Scripps Research Translational Institute in California. “We’re dealing with the operating instructions of a human being. It’s a big deal.”

However, one famed geneticist, Harvard University’s George Church, defended attempting gene editing for HIV, which he called “a major and growing public health threat.”

“I think this is justifiable,” Church said of that goal.

In recent years scientists have discovered a relatively easy way to edit genes, the strands of DNA that govern the body. The tool, called CRISPR-cas9, makes it possible to operate on DNA to supply a needed gene or disable one that’s causing problems.

It’s only recently been tried in adults to treat deadly diseases, and the changes are confined to that person. Editing sperm, eggs or embryos is different — the changes can be inherited. In the U.S., it’s not allowed except for lab research. China outlaws human cloning but not specifically gene editing.

He Jiankui (HEH JEE’-an-qway), who goes by “JK,” studied at Rice and Stanford universities in the U.S. before returning to his homeland to open a lab at Southern University of Science and Technology of China in Shenzhen, where he also has two genetics companies. The university said He’s work “seriously violated academic ethics and standards” and planned to investigate. A spokesman for He confirmed that he has been on leave from teaching since early this year, but he remains on the faculty and has a lab at the school.

The U.S. scientist who worked with him on this project after He returned to China was physics and bioengineering professor Michael Deem, who was his adviser at Rice in Houston. Deem also holds what he called “a small stake” in — and is on the scientific advisory boards of — He’s two companies.

The Chinese researcher said he practiced editing mice, monkey and human embryos in the lab for several years and has applied for patents on his methods.

He said he chose embryo gene editing for HIV because these infections are a big problem in China. He sought to disable a gene called CCR5 that forms a protein doorway that allows HIV, the virus that causes AIDS, to enter a cell.

All of the men in the project had HIV and all of the women did not, but the gene editing was not aimed at preventing the small risk of transmission, He said. The fathers had their infections deeply suppressed by standard HIV medicines and there are simple ways to keep them from infecting offspring that do not involve altering genes.

Instead, the appeal was to offer couples affected by HIV a chance to have a child that might be protected from a similar fate.

He recruited couples through a Beijing-based AIDS advocacy group called Baihualin. Its leader, known by the pseudonym “Bai Hua,” told the AP that it’s not uncommon for people with HIV to lose jobs or have trouble getting medical care if their infections are revealed.

Here is how He described the work:

The gene editing occurred during IVF, or lab dish fertilization. First, sperm was “washed” to separate it from semen, the fluid where HIV can lurk. A single sperm was placed into a single egg to create an embryo. Then the gene editing tool was added.

When the embryos were 3 to 5 days old, a few cells were removed and checked for editing. Couples could choose whether to use edited or unedited embryos for pregnancy attempts. In all, 16 of 22 embryos were edited, and 11 embryos were used in six implant attempts before the twin pregnancy was achieved, He said.

Tests suggest that one twin had both copies of the intended gene altered and the other twin had just one altered, with no evidence of harm to other genes, He said. People with one copy of the gene can still get HIV, although some very limited research suggests their health might decline more slowly once they do.

Several scientists reviewed materials that He provided to the AP and said tests so far are insufficient to say the editing worked or to rule out harm.

They also noted evidence that the editing was incomplete and that at least one twin appears to be a patchwork of cells with various changes.

“It’s almost like not editing at all” if only some of certain cells were altered, because HIV infection can still occur, Church said.

Church and Musunuru questioned the decision to allow one of the embryos to be used in a pregnancy attempt, because the Chinese researchers said they knew in advance that both copies of the intended gene had not been altered.

“In that child, there really was almost nothing to be gained in terms of protection against HIV and yet you’re exposing that child to all the unknown safety risks,” Musunuru said.

The use of that embryo suggests that the researchers’ “main emphasis was on testing editing rather than avoiding this disease,” Church said.

Even if editing worked perfectly, people without normal CCR5 genes face higher risks of getting certain other viruses, such as West Nile, and of dying from the flu. Since there are many ways to prevent HIV infection and it’s very treatable if it occurs, those other medical risks are a concern, Musunuru said.

There also are questions about the way He said he proceeded. He gave official notice of his work long after he said he started it — on Nov. 8, on a Chinese registry of clinical trials.

It’s unclear whether participants fully understood the purpose and potential risks and benefits. For example, consent forms called the project an “AIDS vaccine development” program.

The Rice scientist, Deem, said he was present in China when potential participants gave their consent and that he “absolutely” thinks they were able to understand the risks.

Deem said he worked with He on vaccine research at Rice and considers the gene editing similar to a vaccine.

“That might be a layman’s way of describing it,” he said.

Both men are physics experts with no experience running human clinical trials.

The Chinese scientist, He, said he personally made the goals clear and told participants that embryo gene editing has never been tried before and carries risks. He said he also would provide insurance coverage for any children conceived through the project and plans medical follow-up until the children are 18 and longer if they agree once they’re adults.

Further pregnancy attempts are on hold until the safety of this one is analyzed and experts in the field weigh in, but participants were not told in advance that they might not have a chance to try what they signed up for once a “first” was achieved, He acknowledged. Free fertility treatment was part of the deal they were offered.

He sought and received approval for his project from Shenzhen Harmonicare Women’s and Children’s Hospital, which is not one of the four hospitals that He said provided embryos for his research or the pregnancy attempts.

Some staff at some of the other hospitals were kept in the dark about the nature of the research, which He and Deem said was done to keep some participants’ HIV infection from being disclosed.

“We think this is ethical,” said Lin Zhitong, a Harmonicare administrator who heads the ethics panel.

Any medical staff who handled samples that might contain HIV were aware, He said. An embryologist in He’s lab, Qin Jinzhou, confirmed to the AP that he did sperm washing and injected the gene editing tool in some of the pregnancy attempts.

The study participants are not ethicists, He said, but “are as much authorities on what is correct and what is wrong because it’s their life on the line.”

“I believe this is going to help the families and their children,” He said. If it causes unwanted side effects or harm, “I would feel the same pain as they do and it’s going to be my own responsibility.”

___

AP science writer Christina Larson, video journalist Emily Wang and researcher Fu Ting contributed to this report from Beijing and Shenzhen, China.

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This Associated Press series was produced in partnership with the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
China confirms the 2018 birth of the world's first genetically edited babies, Lulu and Nana, saying He Jiankui forged ethical review papers and organised a project team with foreign staff, which intentionally avoided surveillance, and that He and his staff will be punished according to laws and regulations. The Guangdong government will keep the twins under medical observation with the support of the national departments.