Alcott Wei

Published: 9:00am

13 Jul 2024

All clinical research involving germline genome editing has been banned by China under a newly released ethics guideline.

Germline gene engineering relates to altering the DNA in sperm, eggs or early embryos to introduce changes that can be inherited.

“Any clinical research involving germline genome editing is irresponsible and not permitted,” according to the Ethical Guideline for Human Genome Editing Research, released earlier this week by China’s science and technology ministry.

The guideline marks the latest effort from China to tighten ethics reviews and regulations after bioscientist He Jiankui shocked the world in 2018 with the announcement that he had created twin gene-edited babies to make them less vulnerable to HIV/Aids.

“Only when benefits, risks and alternative options are fully understood and weighed, when issues of safety and efficacy are addressed, broad social consensus is reached and rigorous evaluation is conducted, could clinical research be considered with strict supervision in place,” the guideline adds.

It also strictly prohibits the use of genome editing research on germ cells, fertilised eggs, or human embryos for reproductive purposes.

“The potential detrimental impacts and risks of germline genome editing are still unpredictable,” Zhai Xiaomei, a member of the National Science and Technology Ethics Committee, was quoted as saying by the Science and Technology Daily.

Though it is necessary to carry out basic and preclinical research to understand human embryonic development and relevant diseases, ethics mattered as well, Zhai said.

Even if gene editing is performed on early human embryos or germ cells, the modified cells are banned from being used for reproduction, according to Zhai.

He’s case, involving the world’s first gene-edited babies, triggered huge criticism in China and beyond. He was released from prison in April 2022 after serving a three-year sentence for illegal medical practices.

Chinese scientist He Jiankui involved in gene-edited babies jailed for three years

The incident pushed China to tighten regulations relating to genome editing research, and set up the national ethics committee for science and technology in 2019.

In 2022, the committee issued the country’s first comprehensive guideline on boosting ethical governance in science and technology, including risk monitoring and punishment of violations.

China has since also issued a national regulation for ethics reviews of life sciences and medical research involving humans.

Britain, Canada, Australia, several Western European countries and South Korea have laws banning research into human genome editing technology for reproductive purposes.

The United States does not ban such research but prohibits researchers from using federal funds for related experiments.

“Human genome editing research involves changes to human genetic material and risks are difficult to predict. It not only matters to the dignity and well-being of individual humans but may also trigger a series of ethical, legal, and social issues and lead to a significant and far-reaching impact on human society,” the guideline says.

It also calls for extra attention to be paid to risks of accidental changes in germ cells during clinical research involving genome editing of somatic cells – that is, any cell of a body except reproductive cells. It is also necessary to evaluate the risks of heritable mutation, the guideline adds.