Science

China gives the go-ahead to create a national scientific ethics board


China is set to establish a national scientific ethics board in the wake of disgraced academic He Jiankui’s experiments with editing the genes of babies.

President Xi Jinping’s most powerful policy making body will oversee the formation of the regulatory panel, according to reports in Chinese news media.

Its primary goal is to close a variety of loopholes which allow questionable experiments to be conducted in the country.  

Dr He stunned the world when he announced the use of gene-editing technology CRISPR-Cas9 to alter the embryonic genes of twin girls, nicknamed ‘Lulu’ and ‘Nana’.

The disgraced researcher’s justification for the experiment was to confer HIV immunity to the embryos to avoid infection from their father, who is HIV positive.

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Pictured: In a video he released in November 2018, He Jiankui explained his rationale for CRISPR editing embryos in vitro and then implanting the embryos in a Chinese woman. China is now establishing a formal ethics board to stop such a scandal happening again

Pictured: In a video he released in November 2018, He Jiankui explained his rationale for CRISPR editing embryos in vitro and then implanting the embryos in a Chinese woman. China is now establishing a formal ethics board to stop such a scandal happening again 

HOW DID DR HE DESCRIBE THE WORK? 

‘The gene editing occurred during IVF, or lab dish fertilisation.

‘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 three to five 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.’

Details of exactly how the board will work and who will be appointed are scant.

Bioethicist Qiu Renzong, who works at the Chinese Academy of Social Science in Beijing, claims the board will close regulatory loopholes that allowed Dr He to conduct his work, according to reports in the scientific journal Nature.

The National Health Commission (NHC) currently oversees research on humans to ensure that it meets ethical standards.

For all other ethical issues, the Ministry of Science and Technology (MOST) is charged with oversight.

The proposed body is intended to be separate from both existing bodies and will ensure no studies slip through the gaps. 

It comes after Dr He announced to the world via YouTube that he attempted gene editing for HIV immunity in twin girls because infections are rising in China. 

The fathers had their infections suppressed by standard HIV medicines and there are simple ways to keep them from infecting offspring without altering genes.

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

Dr He has since been fired from his university post and is under investigation by Chinese authorities.

Scientists around the world were quick to condemn Dr He’s experiments when news of them emerged.

Whether China’s actions will be enough to placate the international outcry over the debacle remains to be seen. 

The true scale of the fallout from Dr He’s research is still unfolding.

Last month, it transpired a third baby whose DNA was edited as part of a series of the ‘monstrous’ experiments may already have been born, experts fear.

Pictured: He Jiankui speaks during an interview at a laboratory in Shenzhen in southern China's Guangdong province in October, 2018

Pictured: He Jiankui speaks during an interview at a laboratory in Shenzhen in southern China’s Guangdong province in October, 2018

Physician and ethicist William Hurlbut spoke out in January over revelations that He had altered the genes of a third embryo, expected to be born in June or July.

With June now behind us, Professor Hurlbut fears that the child may already have been delivered – or, if it hasn’t, that China may decide to keep it quiet when it has.

‘A normal birth is 38 to 42 weeks, and it’s pretty close to the center of that,’ the Stanford University professor told MIT Technology Review.  

Professor Hurlbut is not alone in his fears, with some researchers predicting that the secretive Chinese regime will never announce the child’s birth.

Given the controversy surrounding the announcement of the birth of the first two gene-edited infants in November 2018, that seems like a fairly safe bet.

Among the scientists raising their heads above the parapet on the issue is Rosario Isasi, a health and human rights lawyer at the University of Miami whose research and work focuses on the regulation of human genetic technologies.

Ms Isasi says she has been working to encourage scientists in China to speak out and limit the damage from the country’s unethical human experimentation.

She fears that experts in the country are reluctant to speak out, however, and that Beijing is keen to avoid any further publicity over the issue.

‘The government is extremely aware of any transgressions,’ Ms Isasi said in an in-depth article by MIT Technology Review’s Antonio Regalado.

‘They have the Tiananmen anniversary, they have the Hong Kong protests, and they have the CRISPR babies.’ 
    

WHAT ARE SOME OF THE DOUBTS SURROUNDING DR HE’S CLAIMS?

Several scientists reviewed materials that Dr 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, famed Harvard University geneticist Professor George Church said.

Church and Dr Kiran Musunuru, a University of Pennsylvania gene editing expert, 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,’ Dr 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, Dr Musunuru said.

There also are questions about the way Dr He said he proceeded.

He gave official notice of his work long after he said he started it – on November 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 hospital linked to the controversial project denied approving the procedure and accused Dr He of forgery.

This graphic reveals how, theoretically, an embryo could be 'edited' using the powerful tool Crispr-Cas9 to defend humans against HIV infection

This graphic reveals how, theoretically, an embryo could be ‘edited’ using the powerful tool Crispr-Cas9 to defend humans against HIV infection



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