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Trial Measures for Science and Technology Ethics Review

📑 Legal hierarchy: Level 3 · Departmental rule | Issuance: MOST-led, ten-ministry joint issuance (MOST / MOE / MIIT / MARA / NHC / CAS / CASS / CAE / CAST / CMC S&T Commission) | Effective: 2023-12-01 | Character: hard law

⚠️ Hierarchy note: This instrument is a departmental rule, jointly issued by ten ministries. It is not a State Council administrative regulation. “Trial” (试行), like “Interim” (暂行), reflects the legislator’s decision to reserve room for adjustment — it is not a hierarchy marker. See Index of Chinese Rules.

The Trial Measures for Science and Technology Ethics Review, issued jointly by ten ministries led by MOST on 2023-09-07 and effective 2023-12-01, establish China’s framework for ethics review of R&D activities. For AI, the Measures require (i) the establishment of ethics review committees at research institutions performing “sensitive” R&D, (ii) review of projects on a negative list (“审查清单”) that explicitly includes autonomous decision-making AI with significant safety/ethics risks, algorithms capable of steering public opinion, and large-scale generative models with certain characteristics, and (iii) expert ethics review — a precursor oversight layer sitting above the CAC’s filing-based regime.

This is China’s first cross-ministerial implementing rule for science-and-technology ethics review. Its key roles in AI governance:

  1. A pre-emptive review layer: CAC’s algorithm filing (备案) is a pre-launch review, whereas science-and-technology ethics review operates at the project-initiation stage.
  2. List-based approach: Article 25 sets out an “expert re-review list of science-and-technology activities.” AI-related entries include:
    • research and development of algorithmic models, applications, and systems with the capacity to shape public opinion and mobilize society;
    • research and development of automated decision-making systems for scenarios involving safety or human-health risks;
    • research and development of human-machine fusion systems with significant psychological or emotional impact on human subjects.
  3. Internal institutional committees: research institutions shall establish science-and-technology ethics (review) committees; review → file with the competent S&T authority.
  • Promote human well-being;
  • Respect the right to life;
  • Uphold fairness and justice;
  • Reasonably control risks;
  • Maintain openness and transparency.

Articles 9–10 · Internal Institutional Committees

Section titled “Articles 9–10 · Internal Institutional Committees”

Units conducting ethically sensitive R&D shall establish a science-and-technology ethics (review) committee. Committees shall have at least seven members, including members from different disciplines, external ethics / legal experts, and not fewer than two external members.

Key areas:

  1. Involving human life and health;
  2. Involving data and algorithms: algorithms with capacity to steer public opinion, automated decision-making for safety / health scenarios, and human-machine fusion systems with strong psychological or emotional impact;
  3. Synthetic biology, neuroscience, gene editing, and the like.
  • institutional self-review → listed projects submitted for expert re-review → filed with the competent S&T authority;
  • material changes trigger fresh review;
  • periodic follow-up review.
  • Precedes CAC filing: ethics review at the project-initiation stage; CAC filing at the pre-launch stage.
  • Generative AI Interim Measures: do not expressly cite these Measures, but “large model + capability frontier” projects in fact engage Article 25.
  • TC260-003: technical-level assessment vs. ethics review — different layers, but potential intersection.

Primary authority: the MOST-led Ethics Committee Office; sector regulators coordinate within their mandates.

Penalties:

  • failure by institutions to establish an ethics review committee: order to rectify, public reprimand, refusal to approve projects;
  • non-compliant R&D: termination of projects, clawback of funding, pursuit of institutional and individual responsibility.
LanguageSourceLink
Chinese (original)MOSTmost.gov.cn
EnglishDigiChina / Carnegie analysishttps://digichina.stanford.edu/
DateEvent
2023-04Draft for public comment
2023-09-07Joint issuance by ten ministries
2023-12-01Effective