More than a decade after a fraud scandal in stem-cell science rocked South Korea, scientists in the field are ramping up pressure on the government to relax the country’s strict regulations on human-embryo research — which many researchers label a ban.
On 30 August, the nation’s bioethics committee held a public forum with the Ministry of Health and Welfare in Seoul, inviting 11 researchers and scholars to discuss possible changes to the country’s bioethics policies on research.
“We need to revise the relevant laws and institutions urgently,” Jin-Soo Kim, a genome engineer at the Institute for Basic Science in Daejeon, South Korea, said at the forum. He says the regulations were made before researchers started using gene-editing tools such as CRISPR–Cas9. In South Korea, such tools cannot be used in embryos, and only in extremely limited cases can they be inserted into the body, under conditions that researchers say are impossible to meet. Given the technology’s potential to treat a range of diseases, clinical and embryo testing will be needed, he says. Gene editing experiments on human embryos have been undertaken in a number of countries including China, the United States, the United Kingdom and Sweden.
But some bioethicists are warning the government against making rash changes to the law without public consultation. Ahead of the forum, local media reported that a separate, government-convened panel of researchers, ethicists and religious scholars was on the verge of recommending to the government that it lift its restrictions on human-embryo research. But the health ministry’s bioethics division told Nature’s news team that there is no plan to revise the current regulations.
In 2004, Woo Suk Hwang, then at Seoul National University, claimed to have produced human stem cell lines from cloned human embryos. In response to public debate, South Korea's Bioethics and Biosafety Act came into effect a year later in 2005, restricting research on human embryos to scientists who are granted a licence from the national bioethics committee. Initially, Hwang’s was the only team granted approval. Then, in 2006, Hwang’s results were found to be fabricated and he was later convicted of embezzlement and bioethics violations, such as buying human eggs in violation of the bioethics law.
Although regulations for human-embryo research were in place before the scandal, approvals for new research efforts effectively ceased after it, amounting to a de facto ban, say many researchers. Since then, the only team to have received a licence for embryonic-stem-cell projects is one led by Dong Ryul Lee, a developmental biologist at CHA University in Seoul.
Lee says the rules forced him to look abroad to continue his research. In South Korea, his team is limited to using surplus eggs from in vitro fertilization that have been cryogenically frozen. Freezing eggs can reduce the effectiveness of the cloning technique in which the egg is inserted with DNA from another person, says Lee, making it harder to obtain stem cells from the resulting embryo. Researchers prefer to use fresh eggs sourced directly from donors, he says.
In 2014, Lee’s group reported1 the cloning of human embryonic stem cells. But the work was carried out at CHA’s satellite facilities in Los Angeles, California, using eggs collected for research purposes from donors in the United States, where there are no federal legal restrictions on embryonic stem cell research. Lee wants South Korea’s laws to be amended so that Korean researchers can work with fresh eggs from donors.
Removing barriers to using eggs from Korean donors is more than a matter of convenience, says Bonghee Lee, a proteomicist at Gachon University. It would also encourage scientists to study the developmental mechanisms of genetic illnesses that are more likely to affect east Asian populations. Because Lee cannot work on Korean embryos, he collaborates with researchers in Tehran to study illnesses that are specific to the local population, using surplus eggs from the infertility clinic at the city’s Royan Institute.
Kim acknowledges that it could take years to make changes to the regulations, which would require new legislation to pass through South Korea’s parliament. “It seems that the public hearing is a step forward for a long journey.”
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