Researchers have raised concerns after South Africa updated its health research ethics code to include a new section on heritable (or germline) human genome editing.

Scientists say this could move the country a step closer to accepting the controversial technique, which involves making genetic changes to sperm, eggs or embryos and passing those changes on to successive generations. The research ethics code was updated in May, but the news became more widely known last month.

Currently, no country explicitly allows heritable human genome editing in clinical settings. It is unclear to what extent the South African scientific community was consulted on the changes.

Nature It sought comment from South Africa’s health ministry, which published the revised guidelines, and the National Health Research Ethics Council, a statutory body under the National Health Act that prepared them. No comments were received at the time this article was published.

“The decision to amend the South African Health Research Ethics Guidelines to facilitate research to create genetically modified children is puzzling,” says bioethicist Françoise Baylis of Dalhousie University in Halifax, Canada, who has written about the change. in an article inside Speech.

“I don’t know of any other country that has openly permitted this type of research, and I can’t understand why South Africa would want to be the first to do so,” adds Baylis, who is also a member of the World Health Organization’s advisory committee on development. Global standards for the management and oversight of human genome editing.

There is an international consensus among researchers that the practice is not acceptable in the clinical setting. Such regulation could prevent inherited diseases such as cystic fibrosis and sickle cell disease, but raises significant ethical concerns and safety issues.

He Jiankui in 2018The scientist, then a biophysicist at the Southern University of Science and Technology of China in Shenzhen, claimed to have helped create the world’s first genome-edited babies. This caused a global outcry. Jailed in 2020 for “illegal medical practice”.

An international group of ethicists and researchers in 2019 called for a moratorium On the clinical use of heritable human genome editing supported by US National Institutes of Health. The organizing committee of the third international summit on human genome editing said heritable human genome editing in 2023 “is currently unacceptable”.

before and after

South Africa’s previous Guidelines from 2015 It had a relatively small section on genomic research. In the latest versionAdded a new section on the regulation of the hereditary human genome.

The updated text says heritable human genome editing must have “a clear and convincing scientific and medical rationale focused on the prevention of serious genetic disorders and immunity against serious diseases,” be transparent, obtain informed consent from all parties, and have strict ethical oversight. . “The potential benefits to individuals and society must outweigh the risks and uncertainties,” the guidance states.

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Furthermore, researchers are required to “commit to ongoing monitoring of individuals resulting from (heritable human genome editing) to assess their health, well-being and possible unforeseen consequences.”

The guidelines state that researchers must comply with all relevant laws governing this type of research. However, there are different opinions as to whether South African law is valid. National Health Act It actually allows editing of the hereditary human genome.

Is it legal?

Jantina De Vries, director of the EthicsLab at the University of Cape Town, is among those who say heritable human genome editing is illegal in clinical settings. He warns against reading too much into the changed guidelines. “What has changed are the rules of research ethics, not the legality of heritable human genome editing in any sense beyond research,” he says.

By contrast, Bonginkosi Shozi, a bioethicist and health law expert at Stanford Law School’s Center for Law and Bioscience in California, takes the view that the law already allows for heritable human genome editing, and the revised research ethics guidelines have now reached that level. by law.

In a study conducted in 2020 South African Journal of Science¹, “Given its potential to improve the lives of South African people, human germline editing should be regulated, not banned,” Shozi and four co-authors wrote.

Shozi told Nature: “The (updated) guidelines should be seen as recognition of the legal reality in South Africa and providing guidance to health research ethics committees that are aware of this reality,” he says.

Baylis says he is concerned that proponents of heritable genome editing may use the new guidelines to push for more legal changes that would explicitly allow the creation of genetically modified children.

“Globally, there is a reluctance to accept heritable genome editing at this point,” says Michael Pepper, director of the Institute of Cellular and Molecular Medicine at the University of Pretoria. “We need to examine in more detail why our guidelines are published in this way.”