China’s Ministry of Science and Technology has unveiled a comprehensive set of ethical guidelines aimed at regulating human genome editing research, marking a significant step toward ensuring responsible scientific advancement in this cutting-edge field.
According to the newly released guidelines, human genome editing research must adhere to core principles that prioritize human well-being, respect for individuals, prudence and responsibility, fairness and justice, and transparency. The Ministry emphasizes that any use of genome editing technology requires careful assessment of its scientific merit and social value, fully considering potential risks associated with such research.
“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,” state the guidelines, formulated by the Medical Ethics Subcommittee of the National Science and Technology Ethics Committee.
A key aspect of the guidelines is the strict prohibition of using edited germ cells, fertilized eggs, or embryos for the purpose of pregnancy and reproduction. “Currently, any clinical research involving germline genome editing is irresponsible and not allowed,” the document asserts, underscoring China’s commitment to preventing ethically contentious practices.
For clinical research, the guidelines call for a thorough evaluation of disease severity and potential risks to achieve a balance between action and precaution. Clinical applications can only be considered when benefits, risks, and alternative options are fully understood and weighed. Moreover, safety and effectiveness issues must be addressed, accompanied by broad social consensus, rigorous evaluation, and strict supervision.
The guidelines also outline general requirements for human genome editing research, including establishing reasonable objectives, ensuring the protection of research participants, securing relevant qualifications and conditions, and obtaining informed consent. Special requirements are specified for handling leftover samples and for the use of somatic cell genome editing strategies at various stages of research, such as basic research, preclinical studies, and clinical trials.
By setting these ethical standards, China aims to promote the healthy development of human genome editing research while safeguarding against potential abuses. The guidelines reflect an awareness of the profound scientific and social implications of genome editing technologies and a commitment to guiding their application responsibly.
Reference(s):
China publishes ethical guidelines for human genome editing research
cgtn.com
