On the 8th, the "Science and Technology Ethics Review Measures (Trial)" (hereinafter referred to as the "Review Measures") jointly issued by ten departments including the Ministry of Science and Technology, the Ministry of Education, and the Ministry of Industry and Information Technology was officially announced, aiming to regulate scientific research, technology development, etc. Ethical review of scientific and technological activities, strengthening the prevention and control of scientific and technological ethical risks, and promoting responsible innovation.
The "Review Measures" point out that scientific and technological ethics review should adhere to the principles of science, independence, impartiality and transparency, make the review system and review procedures public, objectively and prudently assess the ethical risks of scientific and technological activities, and conduct reviews in accordance with regulations.
The "Review Measures" clarify the scientific and technological activities that should be included in the scope of scientific and technological ethics review: scientific and technological activities involving human research participants, including the use of human biological samples, personal information data, etc.; scientific and technological activities involving experimental animals. In addition, scientific and technological activities that do not directly involve humans or experimental animals, but may bring ethical risks and challenges to life and health, ecological environment, public order, sustainable development, etc.; as well as scientific and technological ethics that need to be conducted in accordance with laws, administrative regulations and relevant national regulations Other scientific and technological activities reviewed.
The "Review Measures" put forward specific measures in terms of review subjects, review procedures, and supervision and management. Specifically, colleges and universities, scientific research institutions, medical and health institutions, enterprises, etc. are the responsible entities for the science and technology ethics review and management of their own units. Units engaged in scientific and technological activities such as life sciences, medicine, and artificial intelligence, if the research content involves sensitive areas of scientific and technological ethics, should establish a scientific and technological ethics (review) committee.
The review procedures include application and acceptance, general procedures, simplified procedures, expert review procedures, and emergency procedures. The "Review Measures" mention that the Science and Technology Ethics (Review) Committee should conduct ethical follow-up reviews of approved scientific and technological activities, and can make decisions such as suspending or terminating scientific and technological activities when necessary. The follow-up review interval generally does not exceed 12 months.
The "Review Methods" stipulate that a list system of scientific and technological activities that require expert review shall be established, and list management shall be implemented for emerging scientific and technological activities that may pose greater ethical risk challenges. The list is dynamically adjusted according to work needs and is publicly released by the Ministry of Science and Technology. While clarifying the expert review procedures, the "Review Methods" also mention emergency procedures. For example, the Science and Technology Ethics (Review) Committee should develop a science and technology ethics emergency review system and implement hierarchical management according to the urgency of science and technology activities. It can set up a science and technology ethics review rapid Channel, emergency review is carried out in a timely manner, and the emergency review is generally completed within 72 hours.
It is worth noting that the "Review Methods" also lists a list of scientific and technological activities that require ethical review, including: research related to introducing human stem cells into animal embryos or fetuses and further gestating them into individuals in the uterus of animals, changing human germ cells , basic research on the genetic material or genetic rules of the nucleus of fertilized eggs and pre-implantation embryos, clinical research on the use of invasive brain-computer interfaces for the treatment of neurological and psychiatric diseases, algorithm models and applications with the ability to mobilize public opinion and social awareness and guide social awareness. R&D of programs and systems, etc.
The "Review Measures" also pointed out that the state promotes the establishment of a science and technology ethics (review) committee certification mechanism and encourages relevant units to carry out science and technology ethics review and certification.
Attached: Science and Technology Ethics Review Methods (Trial)
Chapter 1 General Provisions
Article 1 is to regulate the scientific and technological ethics review work for scientific research, technology development and other scientific and technological activities, strengthen the prevention and control of scientific and technological ethics risks, and promote responsible innovation, in accordance with the "Science and Technology Progress Law of the People's Republic of China" and "Opinions on Strengthening the Governance of Science and Technology Ethics" and other laws, regulations and relevant provisions to formulate these Measures.
Article 2 The following scientific and technological activities shall be subject to scientific and technological ethics review in accordance with these Measures:
(1) Scientific and technological activities involving human research participants, including scientific and technological activities that use human beings as subjects of research activities such as testing, investigation, observation, etc., as well as scientific and technological activities that use human biological samples, personal information data, etc.;
(2) Scientific and technological activities involving experimental animals;
(3) Scientific and technological activities that do not directly involve humans or experimental animals, but may bring ethical risks and challenges in terms of life and health, ecological environment, public order, sustainable development, etc.;
(4) Other scientific and technological activities that require scientific and technological ethics review in accordance with laws, administrative regulations and relevant national regulations.
Article 3 When carrying out scientific and technological activities, we should adhere to the unity of promoting innovation and preventing risks, objectively assess and prudently treat uncertainties and technology application risks, and follow the principles of promoting human welfare, respecting the right to life, adhering to fairness and justice, reasonably controlling risks, and maintaining openness and transparency. The principles of science and technology ethics, abide by our country's constitution, laws, regulations and relevant provisions as well as the ethics of science and technology.
Science and technology ethics review should adhere to the principles of science, independence, fairness and transparency, make the review system and procedures public, objectively and prudently assess the ethical risks of scientific and technological activities, conduct reviews in accordance with regulations, and consciously accept supervision from relevant parties. For matters involving national security, state secrets, commercial secrets and sensitive matters, relevant work shall be done in accordance with laws and regulations.
Chapter 2 Review Subject
Article 4 Universities, scientific research institutions, medical and health institutions, enterprises, etc. are the responsible entities for the science and technology ethics review and management of their own units. Units engaged in scientific and technological activities such as life sciences, medicine, and artificial intelligence, if the research content involves sensitive areas of scientific and technological ethics, should establish a scientific and technological ethics (review) committee. Other units with needs for science and technology ethics review may establish science and technology ethics (review) committees based on actual circumstances.
The unit should equip the Science and Technology Ethics (Review) Committee with necessary staff, provide office space and funding and other conditions for the Science and Technology Ethics (Review) Committee to perform its duties, and take effective measures to ensure that the Science and Technology Ethics (Review) Committee can independently carry out ethical review work.
Explore the establishment of a professional and regional science and technology ethics review center.
Article 5 The main responsibilities of the Science and Technology Ethics (Review) Committee include:
(1) Formulate and improve the management system and work specifications of the Science and Technology Ethics (Review) Committee;
(2) Provide scientific and technological ethics consultation and guide scientific and technological personnel to conduct scientific and technological ethical risk assessments on scientific and technological activities;
(3) Carry out scientific and technological ethics review and track and supervise the entire process of relevant scientific and technological activities as required;
(4) Make a judgment on whether the planned scientific and technological activities fall within the scope of the list determined in Article 25 of these Measures;
(5) Organize and carry out scientific and technological ethics review business training for committee members and scientific and technological ethics knowledge training for scientific and technological personnel;
(6) Accept and assist in the investigation of complaints and reports involving scientific and technological ethics issues in relevant scientific and technological activities;
(7) Register and report in accordance with the requirements of Articles 43, 44, and 45 of these Measures, and cooperate with local and relevant industry authorities to carry out relevant work involving science and technology ethics review.
Article 6 The Science and Technology Ethics (Review) Committee shall formulate charters, establish and improve institutional norms, work procedures, and conflict of interest management mechanisms for review, supervision, confidentiality management, and file management to ensure that science and technology ethics review is compliant, transparent, and traceable.
Article 7 The Science and Technology Ethics (Review) Committee shall have no less than 7 members, including one chairman and several vice-chairmen. The committee shall be composed of experts with relevant scientific and technological backgrounds, as well as experts with corresponding professional backgrounds such as ethics and law. It shall have members of different genders and members from outside the unit. Ethnic autonomous areas shall have members who are familiar with local conditions. The term of a member shall not exceed 5 years and may be re-elected.
Article 8 Members of the Science and Technology Ethics (Review) Committee should have corresponding science and technology ethics review capabilities and levels, have good scientific research integrity, and comply with the following requirements:
(1) Comply with my country’s constitution, laws, regulations and relevant institutional norms on science and technology ethics, as well as the charter and system of the science and technology ethics (review) committee;
(2) Participate in science and technology ethics review meetings on time and issue review opinions independently and impartially;
(3) Strictly abide by confidentiality regulations, and shall not disclose or use for other purposes without permission any state secrets, personal privacy, personal information, technical secrets, undisclosed information, etc. that are exposed or learned during the scientific and technological ethics review work;
(4) Comply with the requirements for conflict of interest management and avoid as required;
(5) Regularly participate in scientific and technological ethics review business training;
(6) Complete other work assigned by the committee.
Chapter 3 Review Procedure
Section 1 Application and Acceptance
Article 9 When carrying out scientific and technological activities, a scientific and technological ethics risk assessment shall be conducted. The Science and Technology Ethics (Review) Committee shall formulate the unit's science and technology ethics risk assessment methods in accordance with the requirements of these Measures, and guide scientific and technological personnel to conduct science and technology ethics risk assessments. If it is assessed that the scientific and technological activities fall within the scope listed in Article 2 of these Measures, the person in charge of the scientific and technological activities shall apply to the Science and Technology Ethics (Review) Committee for a science and technology ethics review. Application materials mainly include:
(1) Overview of scientific and technological activities, including the name, purpose, significance, necessity of scientific and technological activities, and previous scientific and technological ethics review status, etc.;
(2) Implementation plans and related materials for scientific and technological activities, including scientific and technological activity plans, possible scientific and technological ethical risks, prevention and control measures and emergency response plans, release forms of scientific and technological activity results, etc.;
(3) Legal qualification materials of relevant institutions involved in scientific and technological activities, relevant research experience and participation in scientific and technological ethics training of participants, sources of funding for scientific and technological activities, statement of conflicts of interest in scientific and technological activities, etc.;
(4) Informed consent form, source description materials of biological samples, data information, experimental animals, etc.;
(5) A letter of commitment to comply with requirements such as scientific and technological ethics and scientific research integrity;
(6) Other materials that the Science and Technology Ethics (Review) Committee deems necessary to submit.
Article 10 The Science and Technology Ethics (Review) Committee shall decide whether to accept the application based on the Science and Technology Ethics Review application materials and notify the applicant. Those who decide to accept the application should clarify the applicable review procedures. If the materials are incomplete, the materials that need to be supplemented should be fully informed at once.
Article 11 In principle, scientific and technological ethics review shall take the form of meeting review, unless otherwise provided for in these Measures.
Article 12 If international cooperative scientific and technological activities fall within the scope listed in Article 2 of these Measures, they must pass the scientific and technological ethics review stipulated by the countries where the cooperation parties are located before they can be carried out.
Article 13 If the unit’s science and technology ethics (review) committee is unable to meet the review work requirements or the unit has not established a science and technology ethics (review) committee and has no unit personnel to carry out scientific and technological activities, it shall entrust in writing other science and technology ethics (review) committees that meet the requirements to carry out ethics review.
Section 2 General Procedures
Article 14 The science and technology ethics review meeting shall be chaired by the chairman or his designated deputy chairman. There shall be no less than 5 members present, and shall include members of different categories listed in Article 7.
According to the needs of the review, the meeting may require the applicant to attend the meeting to explain the plan or explain specific issues, and may invite consultants and experts who do not have direct interests in the relevant fields to provide advisory opinions. Consultants do not participate in voting at the meeting.
If the meeting uses video conference, it should comply with the relevant institutional requirements of the Science and Technology Ethics (Review) Committee on the applicable conditions for video conferences, meeting rules, etc.
Article 15 The Science and Technology Ethics (Review) Committee shall conduct review in accordance with the following key contents and standards:
(1) The scientific and technological activities to be carried out shall comply with the scientific and technological ethical principles stipulated in Article 3 of these Measures, and the qualifications, research infrastructure and facilities of the scientific and technological personnel participating in the scientific and technological activities shall meet relevant requirements.
(2) The scientific and technological activities to be carried out have scientific and social value, and the realization of its research goals will have a positive effect on improving human welfare and achieving sustainable social development. The risks and benefits of scientific and technological activities are reasonable, and ethical risk control plans and emergency plans are scientific, appropriate and operable.
(3) Involving scientific and technological activities involving human research participants, the recruitment plan formulated is fair and reasonable, the collection, storage, use and disposal of biological samples are legal and compliant, and the processing of personal privacy data, biometric information and other information complies with the protection of personal information. Relevant regulations stipulate that the protection plan for the legitimate rights and interests of research participants such as compensation, injury treatment or compensation is reasonable, and special protection is given to vulnerable groups; the informed consent form provided is complete in content, the risk notification is objective and sufficient, the statement is clear and easy to understand, and the individual The method and process of informed consent were compliant and appropriate.
(4) For scientific and technological activities involving experimental animals, the use of experimental animals conforms to the principles of substitution, reduction, and optimization, the sources of experimental animals are legal and reasonable, and technical operation requirements such as breeding, use, and disposal comply with animal welfare standards, and are harmful to the safety of employees and the public environment, etc. appropriate safeguards.
(5) Scientific and technological activities involving data and algorithms, data collection, storage, processing, use and other processing activities, as well as research and development of new data technologies, etc. comply with relevant national data security and personal information protection regulations, data security risk monitoring and emergency response plans Appropriate; the design, implementation, and application of algorithms, models, and systems adhere to the principles of fairness, justice, transparency, reliability, and controllability, comply with relevant national requirements, ethical risk assessment reviews and emergency response plans are reasonable, and user rights protection measures are comprehensive and appropriate.
(6) The declaration of conflicts of interest and management plan formulated are reasonable.
(7) Other content that the Science and Technology Ethics (Review) Committee deems necessary to review.
Article 16 The Science and Technology Ethics (Review) Committee may make decisions such as approval, approval after modification, reexamination after modification, or disapproval of the scientific and technological activities under review. If it is approved after modification or re-examined after modification, suggestions for modification should be made and the modification requirements should be made clear; if it is not approved, the reasons should be explained.
The review decision made by the Science and Technology Ethics (Review) Committee must be approved by more than two-thirds of the members present at the meeting.
Article 17 The Science and Technology Ethics (Review) Committee shall generally make a review decision within 30 days after the application is accepted. In special circumstances, it may be appropriately extended and the time limit may be clearly extended. The review decision should be sent to the applicant promptly.
Article 18 If the applicant has objections to the review decision, he or she may submit a written appeal to the Science and Technology Ethics (Review) Committee that made the decision, explaining the reasons and providing relevant supporting materials. If the grounds for appeal are sufficient, the Science and Technology Ethics (Review) Committee shall make a new review decision in accordance with the provisions of these Measures.
Article 19 The Science and Technology Ethics (Review) Committee shall conduct ethical follow-up reviews of approved scientific and technological activities, and may make decisions such as suspending or terminating scientific and technological activities when necessary. The follow-up review interval generally does not exceed 12 months.
The main contents of the follow-up review include:
(1) Implementation and adjustment of the implementation plan for scientific and technological activities;
(2) Implementation of scientific and technological ethics risk prevention and control measures;
(3) Potential changes in scientific and technological ethical risks and situations that may affect the rights and safety of research participants;
(4) Other content that requires follow-up review.
Based on the needs of follow-up review, the Science and Technology Ethics (Review) Committee may require the person in charge of scientific and technological activities to submit relevant materials.
Article 20 If adjustments to the implementation plan of scientific and technological activities, changes in the external environment, etc. may lead to changes in scientific and technological ethical risks, the person in charge of scientific and technological activities shall report to the Science and Technology Ethics (Review) Committee in a timely manner. The Science and Technology Ethics (Review) Committee should evaluate the risks and benefits, propose opinions on continuation of implementation, suspension of implementation, etc., and if necessary, re-open the ethics review.
Article 21 If multiple units cooperate to carry out scientific and technological activities, the leading unit may establish a mechanism for collaboration and mutual recognition of scientific and technological ethics review results based on the actual situation, and strengthen the coordination and management of scientific and technological ethics review.
Section 3 Simple Procedures
Article 22 The simplified procedure review may be applied to any of the following circumstances:
(1) The possibility and degree of ethical risks in scientific and technological activities are not higher than the minimum risk;
(2) Make minor modifications to the approved science and technology activity plan without affecting the risk-benefit ratio;
(3) Follow-up review of scientific and technological activities that have no major adjustments in the early stage.
The Science and Technology Ethics (Review) Committee should formulate work procedures that apply to the simplified procedure review.
Article 23 The summary procedure review shall be undertaken by two or more members designated by the chairman of the Science and Technology Ethics (Review) Committee. During the review process, the applicant may be asked to explain relevant issues. The review decision shall state the reasons and basis for adopting the simplified procedure review.
If a simplified procedure is adopted for review, the Science and Technology Ethics (Review) Committee may adjust the frequency of follow-up reviews according to the situation.
Article 24 If one of the following circumstances occurs during the review of simplified procedures, it shall be adjusted to a meeting review according to regulations, and general procedures shall apply:
(1) The review result is a negative opinion;
(2) There is doubt about the content of the review;
(3) There is disagreement among members;
(4) The committee member proposes that it needs to be adjusted to a meeting for review.
Section 4 Expert Review Procedure
Article 25: Establish a list of scientific and technological activities that require expert review, and implement list management of emerging scientific and technological activities that may pose greater ethical risk challenges. The list is dynamically adjusted according to work needs and is publicly released by the Ministry of Science and Technology.
Article 26 If any scientific and technological activities included in the list management are carried out, after passing the preliminary review by the Science and Technology Ethics (Review) Committee, the unit shall report to the local or relevant industry authorities to organize expert review. If multiple units participate, the leading unit shall summarize and apply to the local or relevant industry authorities for expert review.
Article 27 When applying for expert review, the unit responsible for scientific and technological activities shall organize a science and technology ethics (review) committee and scientific and technological personnel to submit the following materials as required:
(1) Materials listed in Article 9 of these Measures;
(2) Preliminary review opinions of the Science and Technology Ethics (Review) Committee;
(3) Review other relevant materials required by the organizational unit.
Article 28 The local or relevant industry authorities shall organize and establish a review expert group, consisting of no less than 5 experts in the field with higher academic levels in the fields related to scientific and technological activities, as well as experts in ethics, law, etc. Members of the Science and Technology Ethics (Review) Committee shall not participate in the review of scientific and technological activities by the Committee.
Review experts should proactively declare whether they have a direct interest relationship with the review matter and strictly abide by confidentiality regulations and avoidance requirements.
Article 29 The review expert group shall conduct the review in accordance with the following key contents and standards:
(1) Compliance of preliminary review opinions. Preliminary review opinions should comply with my country's laws, administrative regulations, relevant national regulations and scientific and technological ethics requirements.
(2) The rationality of the preliminary review opinions. The preliminary review opinions should be based on the needs of technological development and the actual development of science and technology in my country, and conduct a comprehensive, adequate, appropriate and reasonable assessment of the potential ethical risks and prevention and control measures of scientific and technological activities.
(3) Other content that the review expert group deems necessary to review.
Article 30 The review expert group shall conduct the review in an appropriate manner, and may request the relevant science and technology ethics (review) committee and scientific and technological personnel to explain the relevant situation when necessary.
The review expert group shall make a review opinion of agreement or disagreement, and the review opinion shall be agreed by more than two-thirds of all review experts.
Article 31 The local or relevant industry authorities shall generally provide feedback on the review opinions to the applicant within 30 days after receiving the review application.
Article 32 The unit’s science and technology ethics (review) committee shall make science and technology ethics review decisions based on expert review opinions.
Article 33 The unit’s science and technology ethics (review) committee should strengthen the follow-up review and dynamic management of the scientific and technological activities carried out by the unit that are included in the list management. The follow-up review interval generally does not exceed 6 months.
If there are major changes in the ethical risks of science and technology, the ethics review shall be carried out again and an application for expert review shall be made in accordance with Article 20 of these Measures.
Article 34: If the state implements administrative approval and other regulatory measures for scientific and technological activities included in the list management and uses compliance with ethical requirements as an approval condition and regulatory content, expert review may no longer be carried out. Approval and regulatory departments and units responsible for scientific and technological activities should strictly implement ethical supervision responsibilities and prevent and control ethical risks.
Section 5 Emergency Procedures
Article 35 The Science and Technology Ethics (Review) Committee shall formulate a science and technology ethics emergency review system, clarify the emergency review process and standard operating procedures in emergencies such as public emergencies, and organize emergency ethics review training.
Article 36 The Science and Technology Ethics (Review) Committee implements hierarchical management based on the urgency of scientific and technological activities, etc., and may establish a fast track for science and technology ethics review to conduct emergency reviews in a timely manner. Emergency reviews are generally completed within 72 hours. For scientific and technological activities that are subject to expert review procedures, the expert review time will be included in the emergency review time.
Article 37 The emergency review shall include the participation of committee members from relevant professional fields. If there are no committee members in relevant professional fields, consultants and experts in relevant fields should be invited to attend the meeting and provide advisory opinions.
Article 38 The Science and Technology Ethics (Review) Committee shall strengthen the follow-up review and process supervision of scientific and technological activities for emergency review, and provide scientific and technological ethics guidance and consultation suggestions to scientific and technological personnel in a timely manner.
Article 39: No unit or individual may use emergencies as an excuse to avoid scientific and technological ethics review or lower the standards of scientific and technological ethics review.
Chapter 4 Supervision and Management
Article 40 The Ministry of Science and Technology is responsible for coordinating and guiding the national science and technology ethics supervision work. Important matters related to science and technology ethics review and supervision should be subject to professional and academic advisory opinions from the National Science and Technology Ethics Committee. Local and relevant industry authorities shall be responsible for the supervision and management of science and technology ethics review in their locality and system in accordance with their responsibilities, powers and affiliations, establish an expert review mechanism for scientific and technological activities included in the list management, and strengthen the supervision of major public emergencies that occur in this locality and system. Coordination, guidance and supervision of incident emergency ethics review.
Article 41 Colleges and universities, scientific research institutions, medical and health institutions, enterprises, etc. should fulfill the main responsibilities of science and technology ethics management, improve their unit's science and technology ethics supervision mechanism and review quality control, supervision and evaluation mechanism, and regularly carry out science and technology ethics education for unit staff Provide training to strengthen the dynamic tracking of scientific and technological activities included in list management and the prevention and control of ethical risks.
The state promotes the establishment of a science and technology ethics (review) committee certification mechanism and encourages relevant units to carry out science and technology ethics review and certification.
Article 42 The Ministry of Science and Technology is responsible for building a national science and technology ethics management information registration platform to provide corresponding support for local and relevant industry authorities to strengthen science and technology ethics supervision.
Article 43 The unit shall register through the National Science and Technology Ethics Management Information Registration Platform within 30 days after establishing the Science and Technology Ethics (Review) Committee. The registration content includes the composition, charter, working system, etc. of the Science and Technology Ethics (Review) Committee, etc., and should be updated in a timely manner when relevant content changes.
Article 44: Units shall register through the National Science and Technology Ethics Management Information Registration Platform within 30 days after the scientific and technological activities included in the list management receive ethics review approval. Registration content includes implementation plans for scientific and technological activities, ethics review and review status, etc., and should be updated in a timely manner when relevant content changes.
Article 45 The unit shall submit the work report of the Science and Technology Ethics (Review) Committee of the previous year, the implementation report of the science and technology activities included in the list management, etc. to the National Science and Technology Ethics Management Information Registration Platform before March 31 of each year.
Article 46: Any unit or individual has the right to complain and report to the unit responsible for scientific and technological activities or the local or relevant industry authorities in accordance with the law any behavior that violates scientific and technological ethics norms or violates the requirements of scientific and technological ethics in scientific and technological activities.
Article 47 If units or scientific and technological personnel responsible for scientific and technological activities violate the provisions of these Measures and fall under any of the following circumstances, they shall be punished or dealt with by the competent authority in accordance with laws, administrative regulations and relevant provisions; if they cause property losses or other damage , bear civil liability in accordance with the law; if it constitutes a crime, criminal liability shall be pursued in accordance with the law.
(1) Obtaining science and technology ethics review approval by fraudulent means, or forging or tampering with science and technology ethics review approval documents;
(2) Carrying out scientific and technological activities included in the list management without passing the scientific and technological ethics review and expert review in accordance with regulations;
(3) Carrying out scientific and technological activities without obtaining scientific and technological ethics review approval in accordance with regulations;
(4) Carrying out scientific and technological activities beyond the scope approved by scientific and technological ethics review;
(5) Interfere with or hinder scientific and technological ethics review work;
(6) Other behaviors that violate the provisions of these Measures.
Article 48 If the Science and Technology Ethics (Review) Committee or its members violate the provisions of these Measures and fall under any of the following circumstances, they shall be punished or dealt with by the competent authority in accordance with laws, administrative regulations and relevant provisions; resulting in property losses or other damages. If it constitutes a crime, it shall bear civil liability in accordance with the law; if it constitutes a crime, it shall be investigated for criminal liability in accordance with the law.
(1) Practicing fraud to facilitate the units responsible for scientific and technological activities to obtain scientific and technological ethics review approval;
(2) Engage in malpractice for personal gain, abuse of power or neglect of duty;
(3) Other behaviors that violate the provisions of these Measures.
Article 49: Universities, scientific research institutions, medical and health institutions, enterprises, etc. are the first responsible entities for internal investigation and handling of violations of scientific and technological ethics. They should proactively investigate violations of scientific and technological ethics in a timely manner and pursue accountability in accordance with laws and regulations.
If a unit or its person in charge is suspected of violating scientific and technological ethics, it shall be investigated and handled by its superior authority. If there is no superior authority, the provincial science and technology administrative department where it is located shall be responsible for organizing the investigation and handling.
Article 50: Local and relevant industry authorities shall, in accordance with their responsibilities, powers and affiliations, strengthen guidance and supervision on the investigation and handling of scientific and technological ethics violations in their localities and systems, and organize the investigation and handling of major scientific and technological ethics cases.
Article 51 If any violation of scientific and technological ethics involves a science and technology plan project established with fiscal funds, the project management department (unit) shall organize an investigation and handling in accordance with the relevant provisions of project management. The project undertaking (participating) unit shall take the initiative to carry out and actively cooperate with the investigation in accordance with the requirements of the project management department (unit), and deal with those responsible for violations according to their responsibilities and authority.
Chapter 5 Supplementary Provisions
Article 52 The term “scientific and technological ethical risks” as mentioned in these Measures refers to risks identified from an ethical perspective in scientific research, technology development and other scientific and technological activities. Minimum risk refers to routine risks encountered in daily life or risks equivalent to a health check-up.
The terms "above" and "not less than" mentioned in these Measures include the original number. These Measures involve provisions on time limits. If they are not marked as working days, they shall be natural days.
The term "local" as mentioned in these Measures refers to the provincial administrative department responsible for the review and management of science and technology ethics in relevant fields determined by the provincial local people's government. "Relevant industry authorities" refers to the relevant industry authorities of the State Council.
Article 53: Local and relevant industry authorities may formulate or revise local and system science and technology ethics review methods, detailed rules and other institutional norms in accordance with the provisions of these Measures and based on actual conditions. Science and technology social groups can formulate specific norms and guidelines for science and technology ethics review in this field.
Article 54 If the relevant industry authorities have special regulations on the establishment of science and technology ethics (review) committees or science and technology ethics review in this field and they are consistent with the spirit of these measures, those regulations shall prevail.
If there are no provisions in these Measures, other existing relevant provisions shall apply.
Article 55 The Ministry of Science and Technology is responsible for the interpretation of these Measures.
Article 56 These Measures will come into effect on December 1, 2023.
Attachment: List of scientific and technological activities that require ethical review
1. Research on the synthesis of new species that has a significant impact on human life and health, values, and the ecological environment.
2. Research related to introducing human stem cells into animal embryos or fetuses and further developing them into individuals in the uterus of animals.
3. Basic research on changing the genetic material or genetic rules of the nucleus of human germ cells, fertilized eggs and pre-implantation embryos.
4. Invasive brain-computer interfaces are used in clinical research on the treatment of neurological and psychiatric diseases.
5. Research and development of human-machine fusion systems that have a strong impact on human subjective behavior, psychological emotions, life and health.
6. Research and development of algorithm models, applications and systems with the ability to mobilize public opinion and guide social awareness.
7. Research and development of automated decision-making systems with a high degree of autonomy for scenarios involving safety and personal health risks.
This list will be dynamically adjusted based on work needs.
