In wake of gene-edited baby scandal, China sets new ethics rules for human studies

Nearly 5 years after a Chinese scientist sparked worldwide outrage by announcing he had helped create genetically edited babies, China has unveiled new rules aimed at preventing a repeat of such ethically problematic research on humans.

Many researchers welcome the new regulations, which set requirements for ethics reviews of research involving humans and human materials such as tissue, fertilized eggs, and embryos. The new rules extensively revise regulations adopted in 2016 and aim to close loopholes exposed by biophysicist He Jiankui in 2018 when he claimed his team had made heritable alterations to the DNA of human embryos that were later born as twin girls. He spent 3 years in prison for conducting “illegal medical practices.”

The new measures, which were developed by four government agencies, “are much more comprehensive and systematic” and “strike a good balance” between protecting people who participate in studies and allowing science to move forward, says Linqi Zhang, a virologist at Tsinghua University.

But some researchers worry they don’t go far enough, given China’s surging biomedical innovation. The revision is “very significant, but I don’t think it is sufficient,” says Joy Zhang, a China-born sociologist at the University of Kent who studies China’s research establishment. A notable shortcoming, she says, is that the rules don’t apply to companies, foundations, and other private entities.

The Chinese government unveiled the new rules on 27 February, and observers say the timing was no coincidence. The sweeping policy arrived 1 week before the opening of this week’s Third International Summit on Human Genome Editing in London, which featured a session on how China now regulates human genome editing.

Work on the new rules began in 2019, just months after He claimed to have altered the twin girls’ DNA to make them resistant to HIV infection. Prior to He’s claim, some countries had already outlawed such germline alterations pending further discussion of safety and ethics. And some major research agencies, including the U.S. National Institutes of Health, would not fund the use of any gene-editing technologies in human embryos.

In the wake of He’s announcement, numerous scientific organizations called on researchers and governments to strengthen governance of human genome editing research. China answered that call in 2020 with new civil penalties for researchers who violate ethical norms surrounding gene editing. In 2021, China also made human germline editing for clinical use a crime. Last year, the government called on all institutions conducting research involving humans and animals to establish review committees but did not provide details.

The new rules, formally called the Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, aim to strengthen a host of existing guidelines and rules, says Ruipeng Lei, a bioethicist at Huazhong University of Science and Technology. For example, the update includes wording changes that reflect a greater emphasis on protecting people enrolled in studies, says bioethicist Renzong Qiu of the Chinese Academy of Social Sciences’s Institute of Philosophy. They are now called “research participants” instead of “research objects” or “receiving human subjects.” Participants “are treated as making contributions to science equal [to those of] investigators,” Qiu says.

Researchers must now inform participants about alternatives to the drug or treatment they are investigating—something He neglected to do for his work. And they must give participants a way to contact an ethics review committee with any concerns. Scientists must also disclose potential conflicts of interest, the sources of biological samples, and how they will share study results. Unlike the 2016 version, the new rules specify that they apply to “institutions of higher learning, scientific research institutes, etc.” and not just hospitals and health care institutions.

The changes are expected to have little impact at China’s major research universities, Zhang says. His institution, he notes, has had rigorous ethics reviews “for quite a long time now.”

The fact that the rules don’t apply to the private sector, however, “is scary,” says Robin Lovell-Badge, a stem cell biologist at the Francis Crick Institute. For example, He, after leaving prison last year, set up a nonprofit institute to work on Duchenne muscular dystrophy and other topics. The institute is not covered by the rules, but He told Science that he intends to “set up an international ethics committee to oversee my work.”

The challenge of regulating private entities is not unique to China, notes bioethicist Françoise Baylis, now retired from Dalhousie University in Canada. The United States, Canada, and other nations also apply different rules to publicly and privately funded research, often giving private entities greater latitude.

The next challenge will be to ensure compliance with the new rules, says Jing-Bao Nie, a Chinese medical ethicist at the University of Otago, Dunedin. Often, he says, the problem “is not the lack of guidelines or regulations on paper, but how to realize them in practice.”

With reporting by Kai Kupferschmidt and Bian Huihui.