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Gene editing, assisted reproduction, and xenotransplantation have national regulations

Gene editing, xenotransplantation, assisted reproductive technologies... The scientific and technological ethics challenges of related new technology research and development have attracted everyone's attention. The General Office of the CPC Central Committee and the General Office of the State Council recently issued the "Opinions on Strengthening the Governance of Science and Technology Ethics", which pointed out that it is necessary to strengthen the institutional guarantee of scientific and technological ethics governance, and formulate scientific and technological ethics norms and guidelines in key areas such as life sciences, medicine, and artificial intelligence.

This is another landmark event in the governance of science and technology ethics in the mainland after the establishment of the National Science and Technology Ethics Committee.

In this regard, Huang Guoning, chairman of the Reproductive Medicine Branch of the Chinese Medical Association and chief physician of Chongqing Maternal and Child Health Hospital, told the People's Daily health client that the development and clinical transformation of assisted reproduction, gene editing and other technologies have been managed from the source, and the ethical system of assisted reproduction, gene editing and other technologies and technologies has been established at the national level, and the review and supervision mechanism of science and technology has been improved. At the same time, through the scientific and technological ethical risk monitoring and early warning mechanism, the effective risk management and control of new technologies of assisted reproduction and gene editing that may have a major impact is conducive to the benign and standardized development of assisted reproduction and gene editing technologies. ”

Gene editing, assisted reproduction, and xenotransplantation have national regulations

"In recent years, cutting-edge technologies such as gene editing technology, artificial intelligence technology, and assisted reproductive technology have developed rapidly, bringing new risks and uncertainties to society while bringing well-being to human beings, and constantly challenging the ethical bottom line and value scale of human beings." Huang Guoning pointed out that in 2019, the National Health Commission promulgated the "Regulations on the Administration of Clinical Application of New Biomedical Technologies (Draft for Solicitation of Comments)", which clarified that the clinical research of new biomedical technologies should be managed at two levels according to the risk level, the medium and low risk research projects should be approved by the provincial health authorities, and the high-risk research projects should be examined and approved by the health departments of the State Council after review by the provincial health authorities And the technology involving assisted reproductive technology and gene editing technology are listed as high-risk biomedical new technologies approved by the competent health department under the State Council; the transformation and application of research results are the responsibility of the health department under the State Council.

On March 23, 2022, Gu Jinhui, deputy director of the Department of Science and Education of the National Health Commission, pointed out at the press conference of the "Opinions on Strengthening the Governance of Scientific and Technological Ethics" held by the Ministry of Science and Technology that medical and health institutions are places where clinical research is relatively concentrated, and medical ethics research is also an important aspect of scientific and technological ethics, and it is also a forerunner of scientific and technological ethics.

Gu Jinhui said that in recent years, the National Health Commission has also attached great importance to medical ethics. First, the medical and health system has taken the lead in establishing an ethical review system and a regulatory system. In 2007, the former Ministry of Health issued the Measures for the Ethical Review of Medical Research Involving Human Life (Trial), which was revised in October 2016 and officially upgraded to departmental regulations. The second is to establish a technical guidance system for the ethical review of medical research. The third is the establishment of a national medical research registration and filing information system. The fourth is to formulate the "Administrative Measures for Clinical Research Initiated by Researchers in Medical and Health Institutions", which will be piloted in four provinces such as Beijing, Shanghai, Guangdong and Hainan, and the system for protecting the rights and interests of subjects will be further improved.

As more and more Chinese scientific and technological workers brave the "no man's land", Huang Guoning reminds that it is necessary to predict the ethical risks that scientific and technological innovation may bring, systematically foresee, weigh and deal with ethical conflicts at the forefront of science and technology, and beware of accidentally rushing into the ethical "forbidden area". Improve the review and supervision mechanism: delineate the "red line" and "bottom line".

Reporter Kong Tianjiao

Gene editing, assisted reproduction, and xenotransplantation have national regulations

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