The National Health Commission, Ministry of Science and Technology, Ministry of Education, and eight other bureaus have jointly issued the “Measures for the Review of Science and Technology Ethics (Trial)”, which came into effect on December 1, 2023. These measures are designed to ensure that scientific and technological activities are conducted in accordance with ethical standards, particularly those involving humans, experimental animals, and activities that may pose ethical risks.
Ethical Review Requirements
The document mandates that scientific and technological activities that could challenge life, health, the ecological environment, public order, and sustainable development must undergo a rigorous ethics review. For research involving sensitive areas of scientific and technological ethics, relevant units are required to establish a scientific and technological ethics (review) committee. This committee should consist of no fewer than seven members, including a chairman and several vice chairmen.
Conducting Ethical Risk Assessments
Scientific and technological activities should be accompanied by a risk assessment of scientific and technological ethics. The review process should, in principle, be conducted through meetings. The technology ethics review meeting should be chaired by the chairman or a designated vice chairman, with at least five members present, representing different categories. The review content includes assessing the reasonableness of risks and benefits, the scientific appropriateness and operability of ethical risk control plans and emergency plans, and whether the qualifications of relevant personnel and facility conditions meet the required standards.
Review Timeline and Special Procedures
The technology ethics (review) committee should generally make a review decision within 30 days after the application is accepted, with possible extensions in special circumstances. In addition to the general review procedures, technology activities with low ethical risks and no significant adjustments in the early stage can adopt a simplified review procedure if they meet the conditions. Emerging technology activities that may pose significant ethical risks and challenges require list management and expert review. In emergency situations such as public emergencies, a fast track for scientific and ethical review can be established to carry out emergency reviews, which are usually completed within 72 hours.
Conclusion
The introduction of the “Measures for the Review of Science and Technology Ethics (Trial)” underscores China’s commitment to ensuring that scientific and technological advancements are pursued in an ethically responsible manner. These measures provide a framework for ethical review and risk assessment, helping to safeguard against potential ethical breaches in scientific research and development.-Fineline Info & Tech
