Present situation and trend of ethical governance in life sciences

2. In recent years, there has been an increasing number of research papers related to life science ethics in China

By August 2021, Chinese scholars have participated in 96 English literature articles on life Science ethics published in the core collection of Web of Science, and a total of 1,290 relevant Chinese papers published on CNKI; The main research institutions include the Institute of Science and Technology Strategy Consulting of the Chinese Academy of Sciences, the Research Center of Science and Technology Ethics of Beijing Academy of Stem Cell and Regenerative Medicine, the Research Center of Bioethics of Huazhong University of Science and Technology, and the School of Philosophy of Fudan University, etc. The main research contents include ethical disputes, ethical reflection, ethical review, and legal regulation related to new technologies, new ideas and new applications in the field of life sciences.

3. All sectors of society constantly call for the ethical issues in the field of life sciences to be faced squarely and ethical supervision to be strengthened

In 2018, the Association of Life Sciences Societies of the China Association for Science and Technology issued a statement firmly opposing scientific research and biotechnology applications that violate the spirit of science and ethics. In May 2019, four Chinese ethicists published a commentary on Nature, calling for the strengthening of the ethical supervision of biomedical research and putting forward six policy suggestions for the reconstruction of China's science and technology ethical governance system. In 2019 and 2021, many representatives of the National Two Sessions stressed the importance of bioethics norms, suggesting that legislation should be strengthened to guide and restrict scientific research activities in the field of life sciences, and increase penalties.

Laws and regulations on ethics have been promulgated, and the regulatory system has kept pace with The Times

1 China gradually attaches importance to ethical supervision in the field of life sciences, and has introduced a number of ethical supervision measures for the application of emerging technologies

Ethical Guidelines for Human Embryonic Stem Cell Research (2003), Ethical Review Measures for Biomedical Research Involving Humans (2016), Regulations on Human Organ Transplantation (2017), Administrative Measures for Clinical Application of Medical Technology (2018), Regulations on the Prevention and Handling of Medical Disputes (2018) Policies and regulations such as the Regulations on the Management of Clinical Application of New Biomedical Technologies (Draft for Comment) (2019) place ethical constraints on relevant research and clinical activities, and prohibit research and practice activities that do not meet ethical norms.

2. The level of ethics-related legislation in the field of life sciences has gradually improved

In recent years, relevant ethical norms in the field of life sciences have been gradually written into the Law of the People's Republic of China on the Promotion of Basic Medical Care and Health, the Civil Code of the People's Republic of China, the Biosafety Law of the People's Republic of China, the Criminal Law of the People's Republic of China and other laws and regulations.  Under the overall national security legal system, these legal provisions provide macro-guidance and norms for ethical supervision and governance in the field of life sciences, and set clear ethical requirements for biotechnology research, development and application activities, and biomedical clinical research - not to endanger human health, not to violate ethics, and not to harm public interests.

The regulations on ethical review have been constantly updated, and the construction of multi-level ethical review bodies has gradually improved

1. The ethical review system of life science and biomedical research involving humans has been continuously updated

The Measures for Ethical Review of Biomedical Research Involving Humans (2016) has established a relatively systematic ethical review system for biomedical research involving humans, specifying the principles for ethical review of biomedical research involving humans, the setting and duties of ethics committees at all levels, the procedures and methods of ethical review, as well as the supervision and management of the review. In April 2021, in light of the new situation and requirements, the National Health Commission, together with relevant departments, drafted the Measures for the Ethical Review of Life Science and Medical Research Involving Humans (Draft for Comments), extending the applicable objects from biomedical research to life science and medical research; Updating the legislative basis, emphasizing human dignity, privacy protection, and strengthening informed consent; And emphasized the protection of the public interest.

2. The construction of multi-level ethical review bodies has been gradually improved

With the promulgation of relevant policies and management measures, the construction of China's life science ethics review committee and related independent institutions has gradually improved. For the field of biomedical research involving human beings, a three-level medical ethics review structure has been formed: the national Medical Ethics Expert Committee, the provincial medical ethics Expert Committee and the institutional Ethics Committee. In addition, the provincial health administration departments set up their own administrative areas of ethical review guidance and advisory organizations, resulting in the emergence of new types of ethics committees, such as reproductive medicine ethics committee, human organ transplantation technology clinical application and ethics committee; Various provinces and regions have set up a number of regional ethics committees successively to meet the requirements of organizations that do not have ethical review to carry out commissioned review, so as to improve the ethics committee mechanism in China.