Promulgated by: Ministry of Science and Technology (科技部), Ministry of Education, Ministry of Industry and Information Technology, Ministry of Agriculture and Rural Affairs, National Health Commission, Chinese Academy of Sciences, Chinese Academy of Social Sciences, Chinese Academy of Engineering, China Association for Science and Technology, Science and Technology Commission of the Central Military Commission.
Document No.: 国科发监〔2023〕167号 (Guo Ke Fa Jian [2023] No. 167).
Issued September 7, 2023. Effective December 1, 2023.
Translation note — DCC. Translated in full from the official Chinese text of the issuing notice, the Measures and the annexed expert re-review list. Terminology follows DCC’s bilingual glossary. 科技伦理（审查）委员会 is rendered “science and technology ethics (review) committee” — the parenthesis is in the original. The sector-specific counterpart for healthcare and life-science research is the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans; the AI-specific counterpart is the AI Science and Technology Ethics Review and Service Measures (Trial).
Notice on Issuing the Measures for the Ethical Review of Science and Technology (Trial)
To the relevant departments of all provinces, autonomous regions, municipalities directly under the Central Government, cities specifically designated in the State plan and sub-provincial cities; the relevant departments of the Xinjiang Production and Construction Corps; the relevant departments and directly affiliated institutions of the State Council; and all relevant units:
The Measures for the Ethical Review of Science and Technology (Trial) have been approved by the Central Science and Technology Commission and are hereby issued to you. Please comply with and implement them.
Ministry of Science and Technology · Ministry of Education · Ministry of Industry and Information Technology
Ministry of Agriculture and Rural Affairs · National Health Commission · Chinese Academy of Sciences
Chinese Academy of Social Sciences · Chinese Academy of Engineering · China Association for Science and Technology
Science and Technology Commission of the Central Military Commission
September 7, 2023
Measures for the Ethical Review of Science and Technology (Trial)
Chapter I General Provisions
Article 1. These Measures are formulated in accordance with the Law of the People’s Republic of China on Progress of Science and Technology, the Opinions on Strengthening the Governance of Science and Technology Ethics and other laws, regulations and relevant provisions, in order to regulate the ethical review of scientific research, technological development and other science and technology activities, strengthen the prevention and control of science and technology ethics risks, and promote responsible innovation.
Article 2. The following science and technology activities shall undergo science and technology ethics review in accordance with these Measures:
(1) science and technology activities involving humans as research participants, including activities in which humans are the subjects of testing, surveys, observation or other research, and activities that use human biological samples, personal information data and the like;
(2) science and technology activities involving laboratory animals;
(3) science and technology activities that do not directly involve humans or laboratory animals but may pose ethical risks and challenges to life and health, the ecological environment, public order, sustainable development or the like;
(4) other science and technology activities that require science and technology ethics review under laws, administrative regulations and relevant national provisions.
Article 3. Science and technology activities shall adhere to the unity of promoting innovation and preventing risk, objectively assess and prudently treat uncertainty and the risks of technology application, follow the science and technology ethics principles of enhancing human well-being, respecting the right to life, upholding fairness and justice, reasonably controlling risk and maintaining openness and transparency, and comply with China’s Constitution, laws, regulations and relevant provisions and with science and technology ethics norms.
Science and technology ethics review shall adhere to the principles of science, independence, impartiality and transparency; review systems and review procedures shall be made public; the ethical risks of science and technology activities shall be assessed objectively and prudently; review shall be conducted in accordance with the rules; and supervision by the relevant parties shall be accepted voluntarily. Where national security, State secrets, trade secrets or sensitive matters are involved, the relevant work shall be carried out in accordance with laws and regulations.
Chapter II Review Bodies
Article 4. Institutions of higher education, research institutions, healthcare institutions, enterprises and the like are the entities responsible for the management of science and technology ethics review in their units. Units engaged in life sciences, medicine, artificial intelligence and other science and technology activities whose research content involves ethically sensitive fields shall establish a science and technology ethics (review) committee. Other units with a need for science and technology ethics review may establish a science and technology ethics (review) committee according to actual conditions.
Units shall provide the necessary staff, office premises, funding and other conditions for the science and technology ethics (review) committee to perform its duties, and shall take effective measures to ensure that the committee conducts ethics review independently.
The establishment of specialized and regional science and technology ethics review centers shall be explored.
Article 5. The main duties of a science and technology ethics (review) committee include:
(1) formulating and improving the committee’s management systems and working norms;
(2) providing science and technology ethics consultation and guiding science and technology personnel in conducting ethics risk assessments of science and technology activities;
(3) conducting science and technology ethics review and, as required, tracking and supervising the whole process of the relevant science and technology activities;
(4) determining whether a proposed science and technology activity falls within the scope of the list established under Article 25 of these Measures;
(5) organizing training in science and technology ethics review for committee members and training in science and technology ethics knowledge for science and technology personnel;
(6) accepting and assisting in the investigation of complaints and reports involving science and technology ethics issues in the relevant activities;
(7) registering and reporting in accordance with Articles 43, 44 and 45 of these Measures and cooperating with local and relevant industry competent departments in work relating to science and technology ethics review.
Article 6. A science and technology ethics (review) committee shall formulate a charter and establish and improve systems, norms, working procedures and conflict-of-interest management mechanisms for review, supervision, confidentiality management and records management, ensuring that science and technology ethics review is compliant, transparent and traceable.
Article 7. A science and technology ethics (review) committee shall have no fewer than seven members, with one chair and several vice-chairs. The committee shall be composed of peer experts with the relevant scientific and technological background and experts with corresponding professional backgrounds in ethics, law and the like, and shall include members of different genders and members from outside the unit; in ethnic autonomous areas it shall include members familiar with local conditions. A member’s term shall not exceed five years and may be renewed.
Article 8. Members of a science and technology ethics (review) committee shall possess the corresponding capability and competence in science and technology ethics review and be in good standing as to research integrity, and shall comply with the following requirements:
(1) comply with China’s Constitution, laws, regulations and the relevant systems and norms on science and technology ethics, and with the charter and rules of the committee;
(2) attend science and technology ethics review meetings on time and express review opinions independently and impartially;
(3) strictly comply with confidentiality provisions and not, without permission, disclose or use for other purposes State secrets, personal privacy, personal information, technical secrets, undisclosed information or the like accessed or learned in the course of review;
(4) comply with conflict-of-interest management requirements and recuse themselves as required;
(5) participate regularly in science and technology ethics review training;
(6) complete other work assigned by the committee.
Chapter III Review Procedure
Section 1 Application and Acceptance
Article 9. Science and technology activities shall undergo a science and technology ethics risk assessment. The science and technology ethics (review) committee shall, in accordance with these Measures, formulate its unit’s science and technology ethics risk assessment measures and guide science and technology personnel in conducting the assessment. Where the assessment finds that an activity falls within the scope listed in Article 2, the person in charge of the activity shall apply to the committee for science and technology ethics review. The application materials shall mainly include:
(1) an overview of the activity, including its name, purpose, significance, necessity and any previous science and technology ethics review;
(2) the implementation plan and related materials, including the activity plan, the possible science and technology ethics risks and the prevention and control measures and emergency-response plans, and the form in which the results will be released;
(3) materials on the lawful qualifications of the institutions involved, the research experience of the participating personnel and their participation in science and technology ethics training, the sources of funding, and the conflict-of-interest declaration;
(4) the informed-consent form and materials explaining the sources of biological samples, data and information, laboratory animals and the like;
(5) an undertaking to comply with science and technology ethics and research-integrity requirements;
(6) other materials the committee considers necessary.
Article 10. The science and technology ethics (review) committee shall decide, on the basis of the application materials, whether to accept the application and shall notify the applicant. Where it decides to accept, it shall specify the applicable review procedure; where the materials are incomplete, it shall inform the applicant in full and at one time of the materials to be supplemented.
Article 11. Science and technology ethics review shall in principle be conducted by meeting review, except as otherwise provided in these Measures.
Article 12. International cooperative science and technology activities that fall within the scope listed in Article 2 may be carried out only after passing the science and technology ethics review prescribed by the countries in which the cooperating parties are located.
Article 13. Where a unit’s science and technology ethics (review) committee is unable to meet the requirements of the review, or the unit has not established a committee, or the science and technology activity is carried out by persons without a unit, another qualified science and technology ethics (review) committee shall be entrusted in writing to conduct the ethics review.
Section 2 General Procedure
Article 14. A science and technology ethics review meeting shall be chaired by the chair or a vice-chair designated by the chair; no fewer than five members shall attend, and the attending members shall include members of the different categories listed in Article 7.
According to the needs of the review, the meeting may require the applicant to attend to present the plan or explain specific issues, and may invite consulting experts in the relevant fields who have no direct interest to provide advisory opinions. Consulting experts shall not take part in the vote.
Where the meeting is held by video, it shall comply with the committee’s rules on the conditions for and conduct of video meetings.
Article 15. The science and technology ethics (review) committee shall conduct review according to the following key contents and standards:
(1) the proposed activity complies with the science and technology ethics principles set out in Article 3, and the qualifications, research foundation and facilities of the participating science and technology personnel meet the relevant requirements;
(2) the proposed activity has scientific and social value, and the achievement of its research objectives will play a positive role in enhancing human well-being and achieving sustainable social development; the activity’s risks and benefits are reasonable, and the ethical-risk control plan and emergency plan are scientific, appropriate and operable;
(3) for activities involving humans as research participants: the recruitment plan is fair and reasonable; the collection, storage, use and disposal of biological samples are lawful and compliant; the processing of personal privacy data, biometric information and other information complies with the relevant provisions on personal information protection; the plan for safeguarding participants’ lawful rights and interests — compensation, treatment of injury, damages — is reasonable; vulnerable groups are given special protection; the informed-consent form is complete in content, objective and sufficient in its disclosure of risks, and clear and understandable in expression; and the manner and process of obtaining individual informed consent are compliant and appropriate;
(4) for activities involving laboratory animals: the use of laboratory animals complies with the principles of replacement, reduction and refinement; the sources of the animals are lawful and reasonable; the technical requirements for husbandry, use and disposal comply with animal-welfare standards; and the measures safeguarding the safety of practitioners and the public environment are appropriate;
(5) for activities involving data and algorithms: the collection, storage, processing, use and other handling of data and the research and development of new data technologies comply with the relevant national provisions on data security and personal information protection, and the data-security risk-monitoring and emergency-response plans are appropriate; the design, implementation and application of algorithms, models and systems comply with the principles of fairness, justice, transparency, reliability and controllability and with the relevant national requirements; the ethical-risk assessment and review and the emergency-response plan are reasonable; and the measures protecting users’ rights and interests are comprehensive and appropriate;
(6) the conflict-of-interest declaration and management plan are reasonable;
(7) other contents the committee considers necessary to review.
Article 16. The science and technology ethics (review) committee may decide to approve, approve subject to modification, re-review after modification, or not approve the activity under review. Where approval is subject to modification or re-review after modification, the committee shall put forward modification proposals and specify the modification requirements; where approval is refused, reasons shall be given.
A review decision of the committee shall be agreed by more than two-thirds of the members present.
Article 17. The science and technology ethics (review) committee shall generally make its review decision within 30 days of accepting the application; in special circumstances the period may be appropriately extended, with the extension specified. The review decision shall be delivered to the applicant promptly.
Article 18. An applicant that objects to a review decision may submit a written appeal to the committee that made the decision, stating the reasons and providing supporting materials. Where the grounds of appeal are sufficient, the committee shall make a new review decision in accordance with these Measures.
Article 19. The science and technology ethics (review) committee shall conduct follow-up ethics review of activities it has approved and may, where necessary, decide to suspend or terminate the activity. The interval between follow-up reviews shall generally not exceed 12 months.
The main contents of follow-up review include:
(1) the implementation and adjustment of the activity’s implementation plan;
(2) the implementation of the science and technology ethics risk prevention and control measures;
(3) potential changes in science and technology ethics risks and circumstances that may affect the rights, interests and safety of research participants;
(4) other contents requiring follow-up review.
According to the needs of follow-up review, the committee may require the person in charge of the activity to submit relevant materials.
Article 20. Where an adjustment to the implementation plan, a change in the external environment or the like may cause the science and technology ethics risks to change, the person in charge of the activity shall report promptly to the committee. The committee shall assess the risks and benefits, give its opinion on whether to continue or suspend implementation, and, where necessary, conduct a fresh ethics review.
Article 21. Where several units cooperate in a science and technology activity, the lead unit may, according to actual conditions, establish a mechanism for collaboration in ethics review and mutual recognition of results, and strengthen the coordinated management of the review.
Section 3 Simplified Procedure
Article 22. Simplified-procedure review may apply in any of the following circumstances:
(1) the likelihood and degree of ethical risk of the activity are not higher than minimal risk;
(2) a minor modification to an approved activity plan that does not affect the risk–benefit ratio;
(3) follow-up review of an activity that has undergone no major prior adjustment.
The science and technology ethics (review) committee shall formulate working procedures for the application of simplified-procedure review.
Article 23. Simplified-procedure review shall be undertaken by two or more members designated by the committee chair. In the course of the review, the applicant may be required to explain relevant issues. The review decision shall state the reasons and basis for adopting the simplified procedure.
Where the simplified procedure is adopted, the committee may adjust the frequency of follow-up review according to circumstances.
Article 24. Where any of the following arises in the course of simplified-procedure review, the review shall be converted to meeting review under the general procedure as prescribed:
(1) the review outcome is negative;
(2) there is doubt about the content under review;
(3) the members disagree;
(4) a member requests conversion to meeting review.
Section 4 Expert Re-Review Procedure
Article 25. A list system shall be established for science and technology activities requiring expert re-review, applying list management to emerging science and technology activities that may pose significant ethical risks and challenges. The list shall be adjusted dynamically according to the needs of the work and published by the Ministry of Science and Technology.
Article 26. Where a science and technology activity subject to list management is to be carried out, after passing the preliminary review of the science and technology ethics (review) committee, the unit shall request the local or relevant industry competent department to organize expert re-review. Where several units are involved, the lead unit shall consolidate the application and apply to the local or relevant industry competent department for expert re-review.
Article 27. When applying for expert re-review, the unit undertaking the activity shall organize the science and technology ethics (review) committee and the science and technology personnel to submit the following materials as required:
(1) the materials listed in Article 9;
(2) the preliminary review opinion of the science and technology ethics (review) committee;
(3) other relevant materials required by the unit organizing the re-review.
Article 28. The local or relevant industry competent department shall organize a re-review expert group composed of peer experts of high academic standing in the fields concerned and experts in ethics, law and the like, numbering no fewer than five. Members of the science and technology ethics (review) committee shall not take part in the re-review of activities reviewed by their own committee.
Re-review experts shall proactively declare whether they have a direct interest in the matter under re-review and shall strictly comply with confidentiality provisions and recusal requirements.
Article 29. The re-review expert group shall conduct re-review according to the following key contents and standards:
(1) the compliance of the preliminary review opinion — the opinion shall comply with China’s laws, administrative regulations, relevant national provisions and science and technology ethics requirements;
(2) the reasonableness of the preliminary review opinion — the opinion shall, in light of the needs of technological development and the actual state of China’s science and technology, comprehensively, sufficiently, appropriately and reasonably assess the potential ethical risks of the activity and the prevention and control measures;
(3) other contents the re-review expert group considers necessary to re-review.
Article 30. The re-review expert group shall conduct re-review in an appropriate manner and may, where necessary, require the relevant science and technology ethics (review) committee and science and technology personnel to explain the relevant circumstances.
The re-review expert group shall issue a re-review opinion of agreement or disagreement, which shall be agreed by more than two-thirds of all re-review experts.
Article 31. The local or relevant industry competent department shall generally provide the re-review opinion to the applying unit within 30 days of receiving the re-review application.
Article 32. The unit’s science and technology ethics (review) committee shall make its science and technology ethics review decision on the basis of the expert re-review opinion.
Article 33. The unit’s science and technology ethics (review) committee shall strengthen the follow-up review and dynamic management of activities under list management carried out by the unit; the interval between follow-up reviews shall generally not exceed six months.
Where the science and technology ethics risks change materially, a fresh ethics review shall be conducted and expert re-review applied for in accordance with Article 20.
Article 34. Where the State applies administrative approval or other regulatory measures to an activity under list management and makes compliance with ethical requirements a condition of approval or a matter of regulation, expert re-review need not be conducted. The approving and regulatory departments and the unit undertaking the activity shall strictly implement their ethics-regulation responsibilities and prevent and control ethical risks.
Section 5 Emergency Procedure
Article 35. The science and technology ethics (review) committee shall formulate an emergency science and technology ethics review system, specifying the emergency review process and standard operating procedures for emergencies such as sudden public events, and shall organize training in emergency ethics review.
Article 36. The committee shall apply tiered management according to the urgency of the activity and may establish a fast track for science and technology ethics review so as to conduct emergency review promptly. Emergency review shall generally be completed within 72 hours. For activities subject to the expert re-review procedure, the time taken for expert re-review shall be counted within the emergency review period.
Article 37. Members from the relevant professional field shall attend emergency reviews. Where there is no member from the relevant field, consulting experts in that field shall be invited to attend and provide advisory opinions.
Article 38. The committee shall strengthen the follow-up review and process supervision of activities that have undergone emergency review, and shall promptly provide science and technology ethics guidance and advice to science and technology personnel.
Article 39. No unit or individual shall, on the ground of an emergency, evade science and technology ethics review or lower the standards of review.
Chapter IV Supervision and Administration
Article 40. The Ministry of Science and Technology shall be responsible for coordinating and guiding science and technology ethics supervision nationwide and shall seek the professional and academic advisory opinions of the National Science and Technology Ethics Committee on important matters concerning the supervision of science and technology ethics review. Local and relevant industry competent departments shall, according to their duties, powers and lines of affiliation, be responsible for the supervision and administration of science and technology ethics review in their localities and systems, establish expert re-review mechanisms for activities under list management, and strengthen the coordination, guidance and supervision of emergency ethics review of major sudden public events occurring in their localities and systems.
Article 41. Institutions of higher education, research institutions, healthcare institutions, enterprises and the like shall perform their primary responsibility for the management of science and technology ethics, improve their internal mechanisms for science and technology ethics supervision and for review quality control and supervision and evaluation, regularly conduct science and technology ethics education and training for their staff, and strengthen the dynamic tracking and ethical-risk prevention and control of activities under list management.
The State shall promote the establishment of a certification mechanism for science and technology ethics (review) committees and encourage relevant units to obtain certification of their science and technology ethics review.
Article 42. The Ministry of Science and Technology shall be responsible for building the national science and technology ethics management information registration platform, providing corresponding support for local and relevant industry competent departments in strengthening science and technology ethics supervision.
Article 43. A unit shall, within 30 days of establishing a science and technology ethics (review) committee, register it through the national science and technology ethics management information registration platform. The registration shall cover the committee’s composition, charter and working systems, and shall be updated promptly when the relevant content changes.
Article 44. A unit shall, within 30 days of an activity under list management obtaining ethics review approval, register it through the national science and technology ethics management information registration platform. The registration shall cover the activity’s implementation plan and the ethics review and re-review, and shall be updated promptly when the relevant content changes.
Article 45. A unit shall, by March 31 each year, submit to the national science and technology ethics management information registration platform the previous year’s work report of its science and technology ethics (review) committee and its report on the implementation of activities under list management.
Article 46. Any unit or individual has the right, in accordance with law, to complain about or report to the unit undertaking the activity or to the local or relevant industry competent department any conduct in a science and technology activity that violates science and technology ethics norms or contravenes science and technology ethics requirements.
Article 47. Where a unit undertaking a science and technology activity or science and technology personnel violate these Measures in any of the following ways, the body with jurisdiction shall impose penalties or take action in accordance with laws, administrative regulations and relevant provisions; where property loss or other harm is caused, civil liability shall be borne in accordance with law; where a crime is constituted, criminal liability shall be pursued in accordance with law:
(1) obtaining science and technology ethics review approval by fraud, or forging or altering approval documents;
(2) carrying out an activity under list management without passing science and technology ethics review and expert re-review as prescribed;
(3) carrying out a science and technology activity without obtaining science and technology ethics review approval as prescribed;
(4) carrying out a science and technology activity beyond the scope of the ethics review approval;
(5) interfering with or obstructing science and technology ethics review;
(6) other acts in violation of these Measures.
Article 48. Where a science and technology ethics (review) committee or its members violate these Measures in any of the following ways, the body with jurisdiction shall impose penalties or take action in accordance with laws, administrative regulations and relevant provisions; where property loss or other harm is caused, civil liability shall be borne in accordance with law; where a crime is constituted, criminal liability shall be pursued in accordance with law:
(1) engaging in fraud to facilitate a unit’s obtaining of science and technology ethics review approval;
(2) practising favoritism, abusing power or neglecting duty;
(3) other acts in violation of these Measures.
Article 49. Institutions of higher education, research institutions, healthcare institutions, enterprises and the like are the primary entities responsible for the internal investigation and handling of science and technology ethics violations, and shall promptly and proactively investigate such violations and pursue accountability in accordance with laws and regulations.
Where a unit or its person in charge is suspected of a science and technology ethics violation, the matter shall be investigated and handled by its superior competent department; where there is no superior competent department, the provincial science and technology administrative department of the place where it is located shall organize the investigation and handling.
Article 50. Local and relevant industry competent departments shall, according to their duties, powers and lines of affiliation, strengthen the guidance and supervision of the investigation and handling of science and technology ethics violations in their localities and systems, and organize the investigation and handling of major science and technology ethics cases.
Article 51. Where a science and technology ethics violation involves a science and technology program project established with fiscal funds, the project management department (unit) shall organize the investigation and handling in accordance with the relevant project-management provisions. The unit undertaking (participating in) the project shall, as required by the project management department (unit), proactively conduct and actively cooperate with the investigation and take action against those responsible for the violation according to its duties and powers.
Chapter V Supplementary Provisions
Article 52. “Science and technology ethics risk” as used in these Measures means risk in scientific research, technological development and other science and technology activities identified from an ethical perspective. “Minimal risk” means the routine risks encountered in daily life or risks comparable to those of a health check-up.
“Or more” and “no fewer than” as used in these Measures include the number stated. Time limits in these Measures not marked as working days are calendar days.
“Local” as used in these Measures means the provincial administrative department determined by the provincial people’s government to be responsible for science and technology ethics review and administration in the relevant field; “relevant industry competent department” means the relevant industry competent department of the State Council.
Article 53. Local and relevant industry competent departments may, in accordance with these Measures and in light of actual conditions, formulate or revise the science and technology ethics review measures, detailed rules and other norms for their localities and systems. Science and technology social organizations may formulate specific norms and guidelines for science and technology ethics review in their fields.
Article 54. Where a relevant industry competent department has special provisions on the establishment of science and technology ethics (review) committees or on science and technology ethics review in its field that are consistent with the spirit of these Measures, those provisions shall prevail.
Matters not provided for in these Measures shall be handled in accordance with other existing relevant provisions.
Article 55. The Ministry of Science and Technology shall be responsible for the interpretation of these Measures.
Article 56. These Measures shall come into force on December 1, 2023.
Annex: List of Science and Technology Activities Requiring Ethics Review Re-Review
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Research on the synthesis of new species that have a major impact on human life and health, values, the ecological environment or the like.
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Research involving the introduction of human stem cells into animal embryos or fetuses and their further gestation into individuals in an animal uterus.
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Basic research that alters the nuclear genetic material or the laws of inheritance of human germ cells, fertilized eggs or pre-implantation embryonic cells.
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Clinical research using invasive brain–computer interfaces for the treatment of neurological or psychiatric diseases.
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Research and development of human–machine fusion systems with a strong influence on human subjective behavior, psychological emotions, life and health or the like.
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Research and development of algorithmic models, applications and systems with the capability of public-opinion social mobilization and of guiding social consciousness.
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Research and development of highly autonomous automated decision-making systems for scenarios involving safety, personal-health or similar risks.
This list will be adjusted dynamically according to the needs of the work.