China Releases New Guidelines for Human Genome Editing Research Implications and Requirements
TapTechNews July 8th news, according to the official website of the Ministry of Science and Technology on July 8th, in order to regulate the behavior of human genome editing research and promote the healthy development of human genome editing research, the Medical Ethics Sub-committee of the National Committee on Science and Technology Ethics has studied and compiled the Ethical Guidelines for Human Genome Editing Research (hereinafter referred to as the Guidelines), for the reference and use of relevant research institutions and researchers.
The Guidelines state that genome editing technology has developed rapidly and is now widely used in biomedical research and provides new means for the diagnosis, treatment and prevention of hereditary diseases. Human genome editing research involves changes to human genetic material, with unpredictable risks, not only related to the dignity and well-being of individual humans, but also likely to trigger a series of ethical, legal and social issues, having a significant and far-reaching impact on human society.
TapTechNews summarizes the key information of the Guidelines as follows:
Conducting human genome editing research should adhere to scientific standards and professional norms, ensure high-quality research design, effective risk control measures, and risk monitoring throughout the process, and be subject to appropriate supervision.
The transformation of research results should give priority to the accessibility and affordability of new technologies in the medical field, and should not be determined solely by the market.
Conducting human genome editing research should be open and transparent, and establish a reasonable participation mechanism for stakeholders and the public.
On the premise of protecting privacy and personal information, strengthen information sharing, objectively and accurately disclose research information and research results to reduce duplicate research and improve research quality.
When conducting genome editing research on germ cells, fertilized eggs or human embryos, it is strictly prohibited to use the edited germ cells, fertilized eggs or human embryos for pregnancy and reproduction.
The main purpose of somatic cell genome editing clinical research is to treat or prevent diseases.
Somatic cell clinical research should be based on basic research evidence and conduct necessary animal experiments and pre-clinical in vitro experiments to obtain the safety and effectiveness evidence required for clinical research.
Involving genome editing research on human embryos and fetal somatic cells, careful consideration and assessment of the possible risks of heritable variation is also necessary, especially in the early stages of human embryo development, avoiding the risk of editable heritable genomes.