Ethical Review of Science and Technology in China: Draft Trial Measures
With ongoing efforts in China to strengthen the oversight of ethical reviews in science and technology, we analyze the latest proposed measures to provide valuable insights for industry and other interested parties. The Draft Trial Measures for Ethical Review of Science and Technology was open to public feedback from April 4 to May 3, this year.
On April 4, 2023, the Ministry of Science and Technology (MOST) released the Trial Measures for Ethical Review of Science and Technology (Draft for Soliciting Opinions), soliciting feedback from the public until May 3, 2023.
The Trial Measures’ Draft is part of a larger effort from the Chinese government to “strengthen the research on relevant laws in key areas such as life sciences, medicine, and artificial intelligence” by 2025.
As such, the proposed regulations mandate that organizations establish a committee with the objective of reviewing research that involves humans and animals based on the principles of scientific, independent, just, and transparent standards.
Additionally, they also urge universities to include ethics courses as a significant part of undergraduate and graduate education.
All these indicate that the government is paying increased attention to ethical review work.
In this article, we highlight key points from the Draft relevant to industry stakeholders.
In recent years, Chinese regulators and policymakers have become more serious about ethical review work, especially in scientific and technological fields.
The latest amendment to the Law on Scientific and Technological Progress, which was released in 2023, explicitly calls for improvements to the country’s science and technology ethics regulatory system.
To achieve this, the Central Committee of the Communist Party of China and the State Council jointly issued the Opinions on Strengthening the Governance of Science and Technology Ethics, in March 2022, providing guidance and planning for science and technology ethics governance at the national policy level.
Against this backdrop, in April 2023, the MOST released its latest Trial Measures’ Draft to better prepare for the construction of a regulatory system for the ethical review of science and technology.
The primary areas of ethical regulation in science and technology are centered around life sciences, medicine, and artificial intelligence – all regulatory fields which have continuously been updated. For instance, the Ethical Review Measures for Life Science and Medical Research involving Humans were just updated with the introduction of new regulations in February 2023. Meanwhile, in the field of artificial intelligence, many companies have voluntarily established science and technology ethics committees and are actively exploring practical approaches to ethical challenges.
What are the key measures included in the draft?
Activities that need to undergo science and technology ethics review
The list of activities that should undergo science and technology ethics review includes (but is not limited to) the following:
- Activities involving humans, including tests, surveys, observational studies involving humans as research participants, and those involving the use of human genes, human embryos, human biological samples, and personal information.
- Experimental activities involving animals.
- Activities that do not directly involve humans or animals but may pose ethical risks in areas, such as life and health, ecological environment, public order, and sustainable development.
- Other activities that need to undergo science and technology ethics review in accordance with laws, administrative regulations, and relevant national regulations.
Obligations for the establishment of ethics review committee
Building on the 2022 Opinion on Strengthening Ethics and Governance in Science and Technology, which assigned healthcare institutions, universities, scientific research institutes, and other organizations as the primarily responsible bodies for ethical review work, the new Draft proposes that enterprises engaged in life sciences, medicine, artificial intelligence, and other technology activities should also be included as responsible entities for ethical review.
The Draft recommends that units, such as universities, scientific research institutions, medical and health institutions, and enterprises, should be responsible for managing science and technology ethics. For “ethically sensitive” science and technology activities related to life sciences, medicine, artificial intelligence, and other areas, units must establish a science and technology ethics (review) committee, also known as an ethics review committee.
Other units with ethical review needs may establish an ethics review committee based on their actual situation. The Draft also mandates that companies involved in sensitive areas of technology ethics must establish ethics review committees for their research activities.
Within 30 days of establishing the ethics review committee, the unit must proactively register the committee through the National Science and Technology Ethics Management Information Registration Platform. The registration contents should include the composition of the ethics review committee, articles of association, working system, and other relevant information, which should be updated promptly when changes occur.
Different kinds of science and technology ethics review procedures
According to the Draft, there can be several types of review procedures, such as the following:
- General review procedures
- Simplified review procedures for activities with relatively low ethical risks
- Emergency review procedures for sudden public events
- Expert review procedures for those activities included in the list of high-risk science and technology ethics management
Expert review requirements
The list of high-risk science and technology ethics management and expert review procedures are special regulatory systems created under the Draft. The focus of the expert review procedure is to examine the compliance and rationality of the preliminary review results.
The list of high-risk science and technology ethics includes the following activities (subject to dynamic adjustment):
- Research on the synthesis of new species that have a significant impact on human life and health, values, and ecological environment
- Research related to the introduction of human stem cells into animal embryos or fetuses and their further development into individuals in the animal uterus
- Fundamental research on changing the genetic material of human reproductive cells, fertilized eggs, and pre-implantation embryos
- Clinical research on invasive brain-machine interfaces for the treatment of neurological and psychiatric diseases
- Research and development of human-machine fusion systems that have a strong impact on human subjective behavior, psychological emotions, and life and health
- Research and development of algorithm models, applications, and systems with the ability to mobilize public opinion and guide social awareness
- Research and development of highly autonomous decision-making systems for scenarios that pose safety and personal health risks
For the activities included in the above list, the preliminary review of the ethics review committee of the unit should be submitted for expert review by the local or relevant industry-competent department. The Draft also stipulates requirements for the expert panel.
It is worth noting that the Draft provides specific exemptions from the expert review procedure. As per the Draft, if the state implements administrative approval or other regulatory measures for relevant technology activities included in the list of management, and requires compliance with ethical requirements as a condition for approval or regulatory content, the expert review may not be necessary.
In addition, clinical trial activities, collection and preservation of human genetic resources, and international cooperative research activities may be subject to special provisions that do not require expert review – if administrative approval and other regulatory procedures are applicable. Industry and research stakeholders should keep a close watch on the specific application scope provided in the final version of the measures and how these are implemented.
For technology activities included in the list of high-risk science and technology ethics management, the entity shall take the initiative to register the science and technology activities included in the list management through the National Science and Technology Ethics Management Information Registration Platform within 30 days after the approval of the ethical review. The registration contents should include the implementation plan of scientific and technological activities, etc., and should be updated in time when the relevant contents change.
The unit shall submit the work report of the ethics review committee for the previous year and the report on the implementation of the science and technology activities included in the list management to the National Science and Technology Ethics Management Information Registration Platform before March 31 of each year.
How will the measures affect businesses?
The release of the Draft is a significant development that could potentially impact businesses operating in many related areas. The Draft seeks to establish a list system for science and technology activities with ethical considerations and to implement list management for emerging technology activities that may pose significant ethical risks.
Further, China has recently introduced several laws related to research ethics, including the Biosecurity Law (2020), the Science and Technology Progress Law (2021), and various data regulations (between 2021 and 2023). As a result, foreign companies and institutions operating in China should anticipate increased scrutiny, particularly if their research and development are considered high-risk and listed in the latest guidelines.
The impact of these measures will be felt particularly by enterprises whose operations involve sensitive areas of science and technology. They will need to establish ethical review committees to manage ethical review compliance. For other companies, the establishment of such committees will depend on their own business conditions, research content, and technology ethical review needs.
Overall, the release of these trial measures is a step towards improving research ethics in China and will likely result in a more principled approach to the development of science and applied technology innovation.
Businesses operating in the field are advised to take audit of their exposure to risk of incompliance and take the appropriate steps to comply with the ethical review requirements set out in the Draft Trial Measures.
China Briefing is written and produced by Dezan Shira & Associates. The practice assists foreign investors into China and has done so since 1992 through offices in Beijing, Tianjin, Dalian, Qingdao, Shanghai, Hangzhou, Ningbo, Suzhou, Guangzhou, Dongguan, Zhongshan, Shenzhen, and Hong Kong. Please contact the firm for assistance in China at email@example.com. Dezan Shira & Associates has offices in Vietnam, Indonesia, Singapore, United States, Germany, Italy, India, and Russia, in addition to our trade research facilities along the Belt & Road Initiative. We also have partner firms assisting foreign investors in The Philippines, Malaysia, Thailand, Bangladesh.
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