Establish a science and technology ethics (review) committee and secure its independence
Severity High第四条、第五条
An entity engaged in life sciences, medicine, artificial intelligence or similar activities whose research touches ethically sensitive areas must establish a science and technology ethics (review) committee. The entity must provide the committee with the necessary staff, premises and funding, and take effective measures to secure its independence. The committee’s duties include adopting management systems and working rules; providing ethics advice and guiding risk assessment; conducting reviews and monitoring the activity throughout; determining whether an activity falls within the Art. 25 list; organising training for members and researchers; receiving and assisting in investigating complaints; and completing the registration and reporting required by Arts. 43–45.
- Applies when
- AI companies whose R&D touches human-machine integration, opinion-mobilising algorithms or highly autonomous decision systems, or that use personal information data or human research participants. The committee should be built once and shared with the ethics-review systems required by Art. 7 of the Deep Synthesis Provisions and Art. 7 of the Algorithmic Recommendation Provisions.
- Evidence to retain
- · Resolution establishing the ethics committee, the member roster and terms of appointment
- · Committee charter, management systems and working rules
- · Description of the independence safeguards: staffing, premises, funding and recusal rules
- · Ethics training records and test results for members and researchers
- · Note recording the joint build with the ethics-review systems required by the Deep Synthesis and Algorithmic Recommendation rules
Estimated first-time effort: 15–35 person-days (estimate, not a commitment)
Run an ethics risk assessment before the activity and file the review application
Severity High第九条、第十五条、第十六条
Every science and technology activity requires an ethics risk assessment. Where the assessment places it within Art. 2, the activity lead applies to the ethics committee, submitting: an overview (name, purpose, significance, necessity and prior review history); the implementation plan and supporting materials, including the potential ethical risks with controls and a contingency plan, and how results will be published; the participating institutions’ qualifications, the researchers’ experience and ethics training, the funding source and conflict-of-interest declarations; the informed-consent form and documentation on the provenance of biological samples, data and laboratory animals; an undertaking to observe research ethics and integrity; and any other material the committee requires. The committee reviews against the seven focus areas in Art. 15, and a decision requires the agreement of at least two-thirds of the members present.
- Applies when
- Every AI R&D activity within Art. 2. Art. 15(5) speaks directly to activities involving data and algorithms, requiring that data processing comply with national data-security and personal-information rules, that the design, implementation and application of algorithms, models and systems observe fairness, impartiality, transparency, reliability and controllability, and that there be a sound ethics risk assessment and contingency plan together with comprehensive user-protection measures.
- Evidence to retain
- · The entity’s ethics risk assessment methodology and the per-project assessment records
- · Complete review application pack, including the informed-consent form, provenance documentation for data and samples, conflict-of-interest declarations and the integrity undertaking
- · Committee meeting minutes and voting records evidencing the two-thirds majority
- · The review decision (approved, approved subject to modification, re-review after modification, or refused) and evidence that required modifications were made
- · Assessment conclusions on algorithmic fairness, reliability and controllability corresponding to Art. 15(5)
Estimated first-time effort: 10–25 person-days (estimate, not a commitment)
Listed activities must clear expert re-review organised by the competent authority
Severity Critical第二十五条、第二十六条、第二十七条、第三十条、第三十一条、第三十二条；附件《需要开展伦理审查复核的科技活动清单》
For an activity on the managed list, after clearing the committee’s initial review the entity applies to its local or sector authority to organise an expert re-review; where several entities participate, the lead entity consolidates the application. The submission comprises the Art. 9 materials, the committee’s initial opinion and anything else the organising body requires. The expert panel issues an agree or disagree opinion requiring at least a two-thirds majority of all panel experts; the local or sector authority should normally respond within 30 days of receiving the application; and the entity’s committee then makes its review decision in light of that opinion. The list is published and dynamically adjusted by MOST, and its three AI-relevant items are: research and development of human-machine integrated systems with a strong influence on human subjective behaviour, psychological emotions and life and health; research and development of algorithmic models, applications and systems capable of mobilising public opinion and society and guiding social consciousness; and research and development of highly autonomous automated decision systems for scenarios involving safety or personal-health risks.
- Applies when
- Entities developing public-facing large models, brain-computer interfaces and affective-computing products, and highly autonomous systems such as autonomous driving and surgical robots. The 30-day response window must be built into the development schedule, and a negative opinion means the activity cannot proceed.
- Deadline: The local or sector authority should normally provide the re-review opinion within 30 days of receiving the application.
- Evidence to retain
- · Determination records mapping each R&D project against the seven annexed items
- · The committee’s initial review opinion
- · Re-review application submitted to the local or sector authority and the acceptance record
- · The expert panel’s written opinion and voting record
- · The final review decision made in light of that opinion, with records of any required changes
- · Monitoring records for MOST’s dynamic adjustments to the list
Estimated first-time effort: 20–50 person-days (estimate, not a commitment)
File the annual report with the national ethics management information platform by 31 March
Severity Medium第四十五条
By 31 March each year, the entity must submit to the national science and technology ethics management information platform the previous year’s report of its ethics committee and reports on the implementation of any listed activities. This is a hard annual deadline, and the reports feed into subsequent inspections and eligibility for research funding.
- Applies when
- Entities that have established an ethics committee, including AI companies holding government research contracts.
- Deadline: By 31 March each year.
- Evidence to retain
- · The ethics committee’s annual work report for the previous year
- · Implementation reports for any activities under list management
- · Submission records and receipts from the national ethics management information platform
- · Archived annual reports and the internal approval records
Estimated first-time effort: 3–8 person-days (estimate, not a commitment)