China’s Ministry of Science and Technology (MOST) has issued the Ethical Guidelines for Human Genome Editing Research, establishing a framework to regulate such activities and ensure their responsible development. The guidelines place a stringent prohibition on germline editing, which involves genetic modifications that could be passed down to future generations.
According to the guidelines, human genome editing research must possess significant scientific and societal value. Clinical research should be confined to medical interventions for treatment or prevention purposes. Making genomic alterations for non-medical reasons is strictly prohibited. Research can only proceed if the necessary qualifications are met, subjects are safeguarded, and informed consent is obtained.
The document explicitly states that using edited germ cells, fertilized eggs, or human embryos for pregnancy and reproduction during germline, fertilized egg, or human embryo genome editing research is strictly forbidden. For research involving human embryonic and fetal somatic cell genome editing, the potential risks of heritable variations must be thoroughly considered, particularly during the early stages of human embryonic development, to prevent the risk of heritable genome editing.
The guidelines emphasize that any clinical research on reproductive system genome editing is considered irresponsible and is not allowed. Clinical research may only be contemplated after a comprehensive understanding of benefits, risks, and alternatives, resolution of safety and efficacy concerns, and broad societal consensus, under strict and prudent evaluation, and with stringent oversight.
In the case of genome editing research involving somatic cells, germ cells, fertilized eggs, and in vitro human embryos, the guidelines mandate that sample sources must be legally obtained and used only when necessary and irreplaceable. The handling of residual biological materials, including in vitro human embryo culture, must adhere to internationally and domestically recognized ethical and technical standards.- Flcube.com
