On September 7, 2023, the Ministry of Science and Technology and nine other departments released the Trial Measures for Scientific and Technological Ethics Review, mandating ethics reviews for certain types of research.
Starting December 1, 2023, Chinese higher education institutions are required to conduct an ethics review any time they are carrying out certain scientific and technological activities, including those involving human research participants, experiments on animals, and activities involving data and algorithms (e.g., artificial intelligence).
On September 7, 2023, the Trial Measures for Scientific and Technological Ethics Review (“Trial Measures”) were jointly released by the Ministry of Science and Technology (“MOST”), the Ministry of Education, the Ministry of Industry and Information Technology, the Ministry of Agriculture and Rural Affairs, the National Health Commission, the Chinese Academy of Sciences, the Chinese Academy of Social Sciences, the Chinese Academy of Engineering, the China Association for Science and Technology, and the Science and Technology Commission of the Central Military Commission. The Trial Measures took effect December 1, 2023.
In recent years, China has promulgated a series of laws, regulations and policies on the ethics of science and technology, including artificial intelligence (AI), with the aim of mitigating any adverse impact on society. These laws date back to 2017, when the State Council issued the Development Plan on the New Generation of Artificial Intelligence, mandating that research on legal, ethical and social issues related to AI be strengthened and that a legal, regulatory and ethical framework be established to safeguard the healthy development of AI. Promulgated in 2021, the Code of Ethics for the New Generation of Artificial Intelligence stated that AI-related activities comply with a basic code of ethics that improves human welfare, promotes fairness and impartiality, protects privacy and security, ensures controllability and credibility, strengthens accountability, and improves ethical literacy. The Law of the People's Republic of China on Scientific and Technological Progress, as amended in 2021, requires scientific and technological research institutions, higher education institutions, corporations, and public institutions to establish and conduct ethics reviews of scientific and technological activities. The recently-issued Trial Measures provide affected entities with guidelines for the scientific and technological ethics review mechanism.
Scope of Ethics Review
The following scientific and technological activities are subject to the ethics review:
Scientific and technological activities involving human research participants, including human testing, investigation, observation, and other research activities, and scientific and technological activities utilizing human biological samples and personal information, among others;
Scientific and technological activities involving experimenting on animals;
Scientific and technological activities that do not directly involve humans or experimental animals, but may pose ethical risks and challenges to areas such as life and health, ecology and environment, public order, and sustainable development (such as AI); and
Other scientific and technological activities that are subject to scientific and technological ethics review in accordance with PRC laws, administrative regulations, and relevant rules.
Who Conducts the Ethics Review
The Trial Measures place the responsibility for managing the ethics review on affected higher education institutions, scientific and technological research institutions, medical and health institutions, and corporations. Any entity engaged in life science, medicine, AI, and other scientific and technological activities must establish a scientific and technological ethics review committee (“Ethics Review Committee”) if the research involves sensitive fields of scientific and technological ethics. The Ethics Review Committee must consist of at least seven members who possess relevant scientific and technological backgrounds or professional backgrounds in ethics and law. Other entities may also decide to establish an Ethics Review Committee, depending on their specific situations.
As its name suggests, the Ethics Review Committee is responsible for conducting the ethics review. Affected entities are required to register with the National Scientific and Technological Management Information Registration Platform within 30 days after the establishment of an Ethics Review Committee. If an affected entity does not establish an Ethics Review Committee, it must designate, in writing, another qualified Ethics Review Committee to carry out the ethics review on its behalf.
How to Conduct the Ethics Review
Depending on the type of activity and situation, Ethics Review Committee will apply one or more of four types of ethics review procedures: general procedures, simplified procedures, expert review procedures and emergency procedures.
General procedures include the application submission; review and decision on whether to accept the application; conducting the ethics review; declining or approving the application; and a follow-up review upon approval.
Simplified procedures apply to any of the following situations: the possibility and degree of occurrence of ethical risks in scientific and technological activities are minimal; minor modifications are made to an approved scientific and technological activity plan which do not affect the risk-benefit ratio; or a follow-up review of scientific and technological activities without material adjustments at an early stage of the activities.
A list of scientific and technological activities requiring expert review procedures will be established by the MOST. The panel, organized by the local or appropriate industry department, will be comprised of five or more external experts, “including experts with relatively high academic levels in fields relating to scientific and technological activities and experts in ethics, law, and other fields.”
Expert review procedures automatically apply if the activities involve any of the following: research on the synthesis of new species that have a significant impact on human life and health, value concepts, and ecology and the environment; related research on the introduction of human stem cells into animal embryos or fetuses and further development into individuals in the animal uterus; basic research on changing the genetic materials or genetic rules of human germ cells, fertilized eggs, and pre-implantation embryo cells; clinical research of invasive brain-computer interface for the treatment of neurological and psychiatric diseases; research and development of human-machine integration systems that have strong influences on human subjective behaviors, psychological emotions, and life and health, among others; research and development of algorithm models, applications, and systems with the ability to mobilize the public and guide social consciousness (e.g., AI); or research and development of highly autonomous decision-making systems for scenarios with security and personal health risks. Emerging scientific and technological activities that may pose significant ethical risks and challenges are also subject to these procedures.
Each Ethics Review Committee is required to develop emergency procedures for emergency scientific and technological ethics reviews that specify the review process and standard operating procedures applicable during emergencies, including public emergencies. Each Ethics Review Committee must also organize emergency ethics review training.
Implications for U.S. Higher Education Institutions
Currently, in order to comply with the Regulations on the Management of Human Genetic Resources and the related Implementation Rules, Chinese partners providing human genetic resources to U.S. higher education institutions are required to submit the human genetic resources to the MOST for recordation. If the research might affect China's public health, national security, or public interest, the Chinese partner must also pass a security review conducted by the MOST. After the Trial Measures take effect, if the research involves activities utilizing human biological samples and personal information, Chinese partners will now have the additional obligation of conducting an ethics review. Specifically, Article 12 of the Trial Measures states that if international cooperative scientific and technological activities fall under the scope of ethics review, all of the parties may proceed with the research only after passing the ethics review prescribed by the countries where the research partners are located.
U.S. higher education institutions with cooperative research projects with Chinese entities should consider reviewing whether their activities are likely to fall under the scope of the Trial Measures. If so, they should coordinate with their Chinese partners to ensure compliance with the Trial Measures in addition to considering how the ethics review process may affect the timeline for the research.