Revised regulations require greater disclosure by scientists and more protections for study participants

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.