China’s Ministry of Science and Technology has published ethical guidelines to regulate human genome editing research and promote its healthy development.
Human genome editing research should follow the principles of promoting human well-being, respecting individuals, maintaining prudence and responsibility, ensuring fairness and justice, and being open and transparent, according to the guidelines.
“The use of human genome editing technology in research must be carefully assessed, taking into full consideration its scientific and social value, as well as potential risks,” said the guidelines, formulated by the medical ethics subcommittee of the national science and technology ethics committee.
In clinical research, it is particularly necessary to fully evaluate and address the severity of the disease and potential risks to strike a balance between action and precaution, according to the guidelines.
Regarding human genome editing research on germ cells, fertilized eggs, or embryos, it is strictly prohibited to use edited germ cells, fertilized eggs, or embryos for pregnancy and reproduction, the guidelines stated.
“Currently, any clinical research involving germline genome editing is irresponsible and not allowed,” the guidelines added.
Clinical research can only be considered when benefits, risks and alternative options are fully understood and weighed, safety and effectiveness issues are addressed, and there is broad social consensus, rigorous evaluation and strict supervision in place, according to the guidelines.
The guidelines have also outlined general requirements for human genome editing research, which include having reasonable objectives, protecting research participants, possessing relevant qualifications and conditions, and obtaining informed consent.
Special requirements have been specified for handling leftover samples and the conditions for using somatic cell genome editing strategies at different stages of research, namely, basic research, preclinical research and clinical research.
