China has issued a set of ethical rules on human genome editing, reiterating a strict ban on altering germ cells and embryos and clarifying standard ethical practices for gene editing research.

The guideline was formulated by the medical ethics subcommittee of the National Science and Technology Ethics Committee and released on the website of the Ministry of Science and Technology on Wednesday.

"At present, any clinical research involving germline genome editing is irresponsible and not permitted," it said. "Only when there is a full understanding and considering of benefits, risks and alternative options, when the safety and efficacy issues are addressed, broad consensus achieved and rigorous assessment completed can the possibility of carrying out such research under tight supervision be evaluated."

The document highlights that using edited germ cells, fertilized eggs or human embryos for pregnancy or reproduction is strictly prohibited.

Regarding clinical research involving genome editing of somatic cells — which are cells in the body other than sperm and egg cells — it said that such research should be aimed at preventing or treating diseases and should be carried out after animal tests or preclinical, in vitro experiments have offered basic evidence of safety and efficacy.

"When conducting clinical research on somatic cells, special attention should be paid to whether it might trigger alterations in germ cells," it added.

In terms of conducting genome editing of human embryos or fetal somatic cells, it is also necessary to carefully evaluate the risk of potential heritable variations.

The fast development of gene-editing technologies in recent years has brought about innovations in medicine, but has also raised ethical questions and concerns about the reckless alteration of human DNA.

The guideline stresses that advancing human well-being and prosperity is the fundamental force behind genome editing research. It is important to rigorously evaluate the scientific and societal value of such research, be alert to potential risks, and implement whole-process risk monitoring and adequate supervision.

When considering transforming research outcomes into practical use, researchers should prioritize the affordability and accessibility of new technologies, rather than solely focus on market needs, it said.

The guideline also proposes setting up a mechanism to invite participation of all stakeholders and the public, and enhance information sharing while ensuring protection of personal information.

Shi Jiayou, a professor at Renmin University of China's Law School, said that the guideline has laid out clear standard practices for researchers to follow.

"As the genome editing technology is still developing, the conditions are not ripe for establishing a law on regulating the industry," he said. "So it is appropriate at present to publish industry guidelines and regulations to rein in unprincipled and unethical actions."

In late 2018, He Jiankui, a Chinese researcher, announced the creation of the world's first gene-edited babies to make them less vulnerable to HIV/AIDS. His research attracted a wave of condemnation from the domestic and international science community.

Shi said that the incident prompted authorities to tighten oversight on genome editing studies.

For instance, China's Civil Code, adopted in May 2020, includes tightened provisions on human gene editing to minimize the threats the technology poses to personality rights, ethics and public interests. An amendment to the Law on Scientific and Technological Progress in 2021 and a guideline released by top authorities in 2022 also stress prioritizing the review of research ethics.

"The new rule represents a meaningful addition to the current governance system by demonstrating best practices and offering practical guidance to researchers," Shi said.

In addition to existing rules, Shi also called for setting up a whistleblowing mechanism to help identify potentially concerning research and protect whistleblowers who report violations of research integrity.

It is also important to explore feasible measures to strike a balance between guaranteeing the privacy of research participants, confidentiality of research, and promoting openness and transparency, he said.

wangxiaoyu@chinadaily.com.cn

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