On April 4, the official website of the Ministry of Science and Technology released the " Announcement on Publicly Soliciting Opinions on the Measures for the Review of Science and Technology Ethics (Trial Implementation)".
The announcement stated that in order to implement the "Opinions on Strengthening the Ethical Governance of Science and Technology", strengthen the review and supervision of science and technology ethics, and promote responsible innovation, the Ministry of Science and Technology took the lead and worked with relevant departments to study and draft the "Measures for the Review of Science and Technology Ethics (Trial)" (hereinafter The “Review Measures” for short), are now open to the public for comments. The deadline for comments and feedback is May 3, 2023. The public can submit comments by e-mail, letter or fax.
The "Examination Measures" is divided into five chapters and fifty-seven articles. It mainly clarifies that scientific research institutions - colleges and universities, scientific research institutions, medical and health institutions, enterprises, etc. ) The establishment standards and organizational operation mechanism of the committee, and put forward specific requirements for the system construction, supervision and management of the committee.
The "Review Measures" pointed out that four categories of scientific and technological activities, including testing, surveys, observational studies, etc., involving human genes, human embryos, human biological samples, and personal information, should be reviewed for scientific and technological ethics; The unit shall equip the science and technology ethics (review) committee with full-time (part-time) staff, provide office space and funds and other conditions, and take effective measures to ensure that the science and technology ethics (review) committee independently conducts ethical review work.
The "Review Measures" respectively stipulate the procedures and requirements for general review, simplified review, emergency review, and expert review of scientific and technological activities included in the list management. Seven types of scientific and technological activities, such as "basic research on changing the genetic material of human germ cells, fertilized eggs, and pre-implantation embryo nuclei", are included in the list of scientific and technological activities that require expert review.
The "Review Measures" pointed out that the Ministry of Science and Technology is responsible for building a national scientific and technological ethics management information registration platform to provide corresponding support for local and relevant industry authorities to strengthen the supervision of scientific and technological ethics. Within 30 days after the unit establishes the Science and Technology Ethics (Review) Committee, it shall take the initiative to register through the National Science and Technology Ethics Management Information Registration Platform. Units should take the initiative to 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 are approved for ethical review. Units should submit the work report of the Science and Technology Ethics (Review) Committee of the previous year, the implementation status report of the scientific and technological activities included in the list management, etc. to the National Science and Technology Ethics Management Information Registration Platform before March 31 of each year.
On March 20, 2022, Xinhua News Agency announced that recently, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Strengthening the Governance of Science and Technology Ethics", pointing out that science and technology ethics should be followed in scientific research, technological development and other scientific and technological activities. The value concept and code of conduct require the establishment of a list system, the implementation of list management for scientific and technological activities with high ethical risks, and the establishment of an expert review mechanism for ethical review results.
The "Review Measures" takes the "List of Scientific and Technological Activities Requiring Expert Review" as an annex, and proposes seven types of scientific and technological activities in the three fields of life sciences, medicine and artificial intelligence, which will be dynamically adjusted in the future according to the development of scientific and technological innovation.
Attached is the full text of the Measures for the Review of Science and Technology Ethics (Trial) (draft for comments):
Chapter 1 General Provisions
Article 1 [Purpose basis] In order to standardize the scientific and technological ethics review of scientific and technological activities such as scientific research and technological development, strengthen the prevention and control of scientific and technological ethics risks, and promote responsible innovation, in accordance with the "Law of the People's Republic of China on Science and Technology Progress" and "On Strengthening the Ethics of Science and Technology" "Opinions on Governance" and other laws and regulations and relevant provisions, formulate these measures.
Article 2 [Ethical Requirements for Scientific and Technological Activities] Carrying out scientific and technological activities should adhere to the unity of promoting innovation and preventing risks, objectively assessing and prudently treating uncertainties and technological application risks, and following the principles of improving human well-being, respecting the right to life, adhering to fairness and justice, and reasonable control risk, maintain open and transparent scientific and technological ethical principles, and abide by scientific and technological ethical norms.
Article 3 [Scope of Application] 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 humans, including tests, surveys, observational studies, etc., involving humans as research participants, and involving the use of human genes, human embryos, human biological samples, personal information, 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 pose ethical risks and challenges in terms of life and health, ecological environment, public order, and sustainable development;
(4) Scientific and technological activities that require scientific and technological ethics review in accordance with laws, administrative regulations, and relevant state regulations.
Article 4 [Requirements for Review] 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, conduct reviews in accordance with regulations, and consciously accept the supervision of relevant parties.
Chapter II Examination Subject
Article 5 [Review subject] Universities, scientific research institutions, medical and health institutions, enterprises, etc. are responsible subjects for the management of scientific and technological ethics review. Units engaged in scientific and technological activities such as life sciences, medicine, artificial intelligence, etc., should set up a scientific and technological ethics (review) committee if the research content involves sensitive fields of scientific and technological ethics. Other units that need ethical review can set up a science and technology ethics (review) committee according to the actual situation.
The unit shall equip the science and technology ethics (review) committee with full-time (part-time) staff, provide office space and funds and other conditions, and take effective measures to ensure that the science and technology ethics (review) committee independently conducts ethical review work.
Article 6 [Committee Responsibilities] The main responsibilities of the Science and Technology Ethics (Review) Committee include:
(1) Formulating and improving 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 carry out scientific and technological ethics risk assessment for scientific and technological activities;
(3) Carrying out scientific and technological ethics review, tracking and supervising the entire process of relevant scientific and technological activities as required;
(4) Make a judgment on whether the proposed scientific and technological activities fall within the scope of the list determined in Article 31 of these Measures;
(5) Organizing and carrying out scientific and technological ethics review business training for committee members and scientific and technological ethics knowledge training for scientific and technological personnel;
(6) Accepting complaints and reports involving scientific and technological ethics issues in the scientific and technological activities of the unit;
(7) Register and report according to the requirements of the management department, and cooperate with the management department to carry out related work involving scientific and technological ethics review.
Article 7 [Institutional Construction] The Science and Technology Ethics (Review) Committee shall formulate a charter, establish system norms and working procedures for review, supervision, confidentiality management, and archives management, improve the conflict of interest management mechanism, and ensure compliance, transparency, and accountability of scientific and technological ethics review. backtracking.
Article 8 [Committee Composition] The Science and Technology Ethics (Review) Committee shall have no less than 7 members, including 1 chairman. Committee members should include peer experts with relevant scientific and technological backgrounds, members with corresponding professional backgrounds such as ethics, law, and sociology, members of different genders, and members who are not members of the unit. In minority areas, ethnic minority members should be considered. The term of office of members shall not exceed 5 years and may be re-elected.
Article 9 [Committee Requirements] Members of the Science and Technology Ethics (Review) Committee shall have corresponding ethics review capabilities, have good scientific research integrity, and abide by the following requirements:
(1) Abide by the laws and regulations of our country, the relevant systems and norms of scientific and technological ethics, and the rules and regulations of the scientific and technological ethics (review) committee;
(2) Participate in the scientific and technological ethics review meeting on time, and independently express review opinions;
(3) Strictly abide by the confidentiality regulations, and shall not disclose or use for other purposes without permission the personal privacy, technical secrets, and undisclosed information that are contacted and known during the ethical review work;
(4) Comply with the conflict of interest management requirements, and avoid as required;
(5) Regularly participate in professional training on scientific and technological ethics review and receive continuing education;
(6) Cooperate with other work arranged by the committee.
Chapter III Examination Procedures
Section 1 General Examination Procedures
Article 10 [Application Review] Conducting scientific and technological activities shall conduct ethical risk assessment. The Science and Technology Ethics (Review) Committee formulates procedures and standards for scientific and technological ethics risk assessments in accordance with the requirements of these Measures, and guides scientific researchers to conduct ethical risk assessments.
For scientific and technological activities that fall within the scope of Article 3 of these Measures, the person in charge of the scientific and technological activities shall apply for ethical review to the Science and Technology Ethics (Review) Committee of the unit. Application materials mainly include:
(1) An overview of scientific and technological activities, including the name, purpose, significance, necessity, and previous review of scientific and technological ethics of the scientific and technological activities;
(2) The implementation plan of scientific and technological activities and related materials, including the design of the scientific and technological activity plan, possible scientific and technological ethical risks and prevention and control measures and emergency response plans, and the release form of scientific and technological activities;
(3) Legal qualification materials of relevant institutions involved in scientific and technological activities, relevant research experience of participants in scientific and technological activities and participation in scientific and technological ethics training, source of funds for scientific and technological activities, statement of conflict of interest in scientific and technological activities, etc.;
(4) Informed consent, biological samples, explanatory materials on the source of information and data, explanatory materials on the source of experimental animals, etc.;
(5) A letter of commitment to abide by the requirements of scientific and technological ethics and scientific research integrity;
(6) Other materials deemed necessary by the Science and Technology Ethics (Review) Committee.
Article 11 [Acceptance of Application] The Science and Technology Ethics (Review) Committee shall put forward an opinion on whether to accept the application based on the application materials for the review of science and technology ethics and notify the applicant. Those that meet the requirements should be accepted, and those with incomplete materials should be notified at one time of the materials that need to be supplemented.
Article 12 [Examination method] In principle, the review of science and technology ethics adopts the method of meeting review, unless otherwise stipulated in these measures.
Article 13 [Conference review] The scientific and technological ethics review meeting shall be presided over by the chairman or a member designated by him. There shall be no less than 5 members present at the meeting, and shall include members of different categories listed in Article 8.
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 conflicts of interest in related fields to provide consulting opinions. Advisory experts do not participate in voting at the meeting.
If the video conference is used, it shall comply with the relevant system requirements of the Science and Technology Ethics (Review) Committee on the applicable conditions of video conferences and conference rules.
Article 14 [Review Content and Standards] The Science and Technology Ethics (Review) Committee shall carry out the review according to the following key contents and standards:
(1) The scientific and technological activities to be carried out should comply with the principles of scientific and technological ethics, and the qualifications of scientific and technological personnel participating in scientific and technological activities, research foundations, and facility conditions should meet relevant requirements.
(2) The scientific and technological activities to be carried out can generate new knowledge or effective information, have scientific and social value, and the realization of its research objectives will play a positive role in improving human well-being and realizing sustainable social development; the risk-benefit ratio of scientific and technological activities is within Within a reasonable range, the risk control plan and emergency plan are scientific, appropriate and operable.
(3) For scientific and technological activities involving human research participants, the recruitment plan formulated is fair and reasonable, the collection, storage and use of biological materials are legal and compliant, and the processing of personal privacy data, biometric information and other information complies with relevant regulations on the protection of personal information, The protection plan for the legitimate rights and interests of research participants such as compensation, injury treatment and compensation is reasonable, and special protection is given to vulnerable groups; the content of the informed consent form provided is complete, the risk disclosure is objective and sufficient, and the expression is clear and easy to understand. Appropriate methods and procedures.
(4) For scientific and technological activities involving experimental animals, the use of experimental animals conforms to the principles of reduction, substitution, and optimization, the source of experimental animals is reasonable, the technical operation requirements for breeding, use, and disposal meet animal welfare standards, and the safety of practitioners and the public environment, etc. Safeguards are in place.
(5) For scientific and technological activities involving data and algorithms, the data processing plan complies with the relevant national data security regulations, and the data security risk monitoring and emergency response plan is appropriate; the research and development of algorithms and systems conform to the principles of fairness, justice, transparency, reliability, and controllability.
(6) The declaration of the conflict of interest and the management plan formulated are reasonable; the release of scientific and technological achievements such as papers complies with the ethical norms of publishing and other industries, and the method and timing of the proposed release are appropriate.
(7) Other content that the Science and Technology Ethics (Review) Committee deems necessary to review.
Article 15 [Review Decision] The Science and Technology Ethics (Review) Committee may make decisions such as approval, approval after modification, review after modification, or disapproval of the scientific and technological activities reviewed. If it is approved after modification or re-examination after modification, a modification suggestion should be put forward and the modification requirements should be clarified; if it is not approved, the reasons should be explained.
The review decision made by the Science and Technology Ethics (Review) Committee shall be approved by more than two-thirds of the members present at the meeting.
Article 16 [Examination Time Limit] The Science and Technology Ethics (Examination) Committee shall generally make an examination decision within 30 days after the application is accepted, and may be appropriately extended in special circumstances. The review decision shall be delivered to the applicant in a timely manner.
Article 17 [Disagreement Appeal] If the applicant has any objection to the review decision, it 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 there are sufficient reasons for the appeal, the Science and Technology Ethics (Review) Committee shall make a new review decision in accordance with the provisions of these Measures, and the review decision shall be final.
Article 18 [Follow-up Review] The Science and Technology Ethics (Review) Committee shall carry out ethical follow-up review of scientific and technological activities reviewed and approved, and may make decisions such as suspending or terminating scientific and technological activities when necessary. The follow-up review is generally no less than once a year.
The main contents of the follow-up review include:
(1) The implementation and adjustment of the implementation plan for scientific and technological activities;
(2) The implementation of scientific and technological ethics risk prevention and control measures;
(3) Potential changes in scientific and technological ethics risks and conditions that may affect the rights and safety of research participants;
(4) Other content that needs to be tracked and reviewed.
According to 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 19 [Re-examination] If the risk of scientific and technological ethics may change due to the adjustment of the implementation plan of scientific and technological activities, the person in charge of the scientific and technological activities shall report to the Science and Technology Ethics (Review) Committee in a timely manner and cooperate with the Science and Technology Ethics (Review) Committee to carry out the risk and benefit review. situation assessment. When necessary, the Science and Technology Ethics (Review) Committee can re-conduct the ethics review, and scientific and technological activities should be carried out after passing the ethics review.
Article 20 [Examination Cooperation] Where multiple units cooperate to carry out scientific and technological activities, the leading unit shall establish a coordination mechanism for scientific and technological ethics review, strengthen the coordination and management of scientific and technological ethics review, and promote mutual recognition of review results. The cooperative unit shall submit the review decision or approval opinion to the lead unit in a timely manner.
Article 21 [International cooperative scientific and technological activities] International cooperative scientific and technological activities that fall within the scope listed in Article 3 of these Measures shall pass the scientific and technological ethics review stipulated by the countries where the parties to the cooperation are located before they can be carried out.
Article 22 [Entrusted Review] If the unit has not established a science and technology ethics (review) committee or the science and technology ethics (review) committee is unable to meet the requirements of the review work, it shall entrust in writing another scientific and technological ethics (review) committee that meets the requirements to conduct ethical review.
Section 2 Simplified Examination Procedures
Article 23 [Applicable Conditions] In any of the following circumstances, summary procedure review may be applied:
(1) The possibility and degree of the occurrence of ethical risks in scientific and technological activities are not higher than the minimum risk;
(2) Minor modifications to approved scientific and technological activities without affecting the risk-benefit ratio;
(3) Follow-up review of scientific and technological activities without major adjustments in the previous period.
The Science and Technology Ethics (Review) Committee shall formulate working procedures for the application of simplified procedures for review.
Article 24 [Requirements for Examination] Summary procedure examination shall be undertaken by two or more members designated by the chairman of the Science and Technology Ethics (Examination) Committee. During the review process, the applicant may be required to explain relevant issues. The summary procedure review decision shall state the reasons and basis.
If the simple procedure review is adopted, the Science and Technology Ethics (Review) Committee may adjust the follow-up review frequency according to the situation.
Article 25 [Adjustment of method] In case of any of the following circumstances during the summary procedure review, the review shall be terminated and adjusted to a conference review as required:
(1) The review result is a negative opinion;
(2) There is doubt about the content of the review;
(3) Disagreement among members;
(4) The committee member proposes that it needs to be adjusted to the meeting for review.
Section 3 Emergency Review Procedures
Article 26 [Emergency Review System] The Science and Technology Ethics (Review) Committee shall formulate an emergency review system for science and technology ethics, clarify the emergency review process and standard operating procedures in emergencies such as public emergencies, and organize emergency ethics review training.
Article 27 [Emergency Review Mechanism] The Science and Technology Ethics (Review) Committee conducts hierarchical management according to the urgency of scientific and technological activities, and can set up a fast channel for scientific and technological ethics review to carry out emergency reviews in a timely manner. The emergency review is generally completed within 72 hours.
Article 28 [Requirements for Review] Emergency review should be attended by professional committee members in the corresponding field. If there is no committee member in the corresponding field, expert consultants in the relevant field should be invited to participate in the meeting and provide consultation and guidance.
Article 29 [Follow-up Management] The Science and Technology Ethics (Review) Committee should strengthen the follow-up review and process supervision of scientific and technological activities for emergency review, and provide scientific and technological personnel with guidance and advice on scientific and technological ethics in a timely manner.
Article 30 [Examination and Supervision] No unit or individual may avoid scientific and technological ethics review or lower the standard of scientific and technological ethics review on the grounds of emergency.
Section 4 Expert Review Procedures
Article 31 [List Management] Establish a list system for ethical high-risk scientific and technological activities, and implement list management for emerging scientific and technological activities that may pose greater ethical risk challenges. The list is publicly released in an appropriate form and dynamically adjusted according to the situation.
Article 32 [Review method] To carry out scientific and technological activities included in the list management, after passing the preliminary review by the science and technology ethics (review) committee of the unit, it shall be reported to the local or relevant industry competent department 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 33 [Application for Review] To apply for review by experts, the undertaking unit of scientific and technological activities shall organize a scientific and technological ethics (review) committee and scientific and technological personnel to submit the following materials as required:
(1) Basic information on scientific and technological activities;
(2) The preliminary review opinions of the Science and Technology Ethics (Review) Committee;
(3) Relevant application materials for ethical review of scientific and technological activities;
(4) Review other relevant materials required by the organization unit.
Article 34 [Expert Requirements] The local or relevant industry authorities organize the establishment of a review expert group, which is composed of peer experts with high academic level in the field of scientific and technological activities, as well as experts in ethics, sociology, law, etc., many for 5 people. Members of the Science and Technology Ethics (Review) Committee shall not serve as review experts for the scientific and technological activities undertaken by the unit that are included in the list management.
Review experts shall abide by confidentiality regulations and recusal requirements, and those with conflicts of interest shall not participate in the review work.
Article 35 [Review Key Points and Standards] The review expert group shall carry out the review according to the following key contents and standards:
(1) Compliance with preliminary review opinions. Preliminary review opinions shall comply with Chinese laws, administrative regulations, relevant state regulations, and scientific and technological ethics requirements.
(2) The rationality of the preliminary review opinion. The preliminary review opinion should be based on the needs of technological development and the reality of my country's scientific and technological development, 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 panel deems needs to be reviewed.
Article 36 [Review Opinion] The review expert group shall carry out the review in an appropriate manner, and may ask the relevant science and technology ethics (review) committee and scientific and technical personnel to explain the relevant situation when necessary.
The review expert group shall make a review opinion of agreement or disagreement, which shall be agreed by more than two-thirds of all review experts.
Article 37 [Review time limit] The local or relevant industry authorities should generally give feedback to the applicant unit within 30 days after receiving the review application.
Article 38 [Review Decision] The scientific and technological ethics (review) committee of the unit shall make a scientific and technological ethics review decision based on the review opinions of experts.
Article 39 [Follow-up review and re-review] The scientific and technological ethics (review) committee of the unit shall 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, and the follow-up review frequency shall not be less than twice a year.
If there is a major change in the ethical risks of science and technology, the ethics review and expert review should be carried out again, and the implementation can only be continued after approval is obtained.
Article 40 [Exclusions] If the state implements regulatory measures such as administrative approval for the relevant scientific and technological activities included in the list management, and regards compliance with ethical requirements as the approval conditions and regulatory content, expert review may no longer be carried out. Approval and supervision departments and units undertaking scientific and technological activities should strictly implement ethical supervision responsibilities to prevent and control ethical risks.
Chapter IV Supervision and Management
Article 41 [Supervisory Responsibilities] Local and relevant industry authorities are responsible for the supervision and management of scientific and technological ethics reviews in their localities and systems in accordance with their responsibilities and affiliations, establish an expert review mechanism for scientific and technological activities included in the list management, and strengthen supervision of local , Coordination, guidance and supervision of emergency ethics review of major public emergencies that occur in this system.
Article 42 [Subject Responsibilities of Units] Universities, scientific research institutions, medical and health institutions, enterprises, etc. shall fulfill the main responsibility of science and technology ethics management, improve their own science and technology ethics supervision mechanism and ethics review quality control, supervision and evaluation mechanism, and carry out regular Education and training on scientific and technological ethics for unit employees, and strengthen the dynamic tracking and risk prevention and control of scientific and technological activities included in the list management.
Article 43 [Registration Platform] The Ministry of Science and Technology is responsible for the construction of a national scientific and technological ethics management information registration platform, providing corresponding support for local and relevant industry authorities to strengthen the supervision of scientific and technological ethics.
Article 44 [Committee Registration] Within 30 days after the unit establishes a science and technology ethics (examination) committee, it shall take the initiative to register through the National Science and Technology Ethics Management Information Registration Platform. The content of the registration includes the composition of the Science and Technology Ethics (Review) Committee, charter, work system, etc., and should be updated in time when the relevant content changes.
Article 45 [Registration of scientific and technological activities included in the list management] The unit shall actively register through the national scientific and technological ethics management information registration platform within 30 days after the scientific and technological activities included in the list management are approved for ethical review. The registration content includes the implementation plan of scientific and technological activities, ethics review and review, etc., and should be updated in time when the relevant content changes.
Article 46 [Annual Report] The unit shall submit the work report of the Science and Technology Ethics (Review) Committee of the previous year, the implementation report of the scientific and technological activities included in the list management, etc. to the National Science and Technology Ethics Management Information Registration Platform before March 31 each year.
Article 47 [Complaints and Reports] Any unit or individual has the right to complain and report to relevant departments and units in accordance with the law for violations of scientific and technological ethics norms and violations of scientific and technological ethical requirements in scientific and technological activities.
Article 48 [Punishment of Violations] Where scientific and technological activities undertaking units and scientific and technological personnel violate the provisions of these Measures and have one of the following circumstances, the competent authority shall impose punishment or punishment in accordance with laws, administrative regulations and relevant regulations; causing property losses or other damages, civil liability shall be borne according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
(1) Obtaining the approval of scientific and technological ethics review by falsification, or forging or tampering with the approval documents of scientific and technological ethics review;
(2) Failure to pass scientific and technological ethics review and expert review in accordance with regulations for scientific and technological activities included in the list management;
(3) Carrying out scientific and technological activities without obtaining the approval of scientific and technological ethics review in accordance with regulations;
(4) Carrying out scientific and technological activities beyond the scope approved by the scientific and technological ethics review;
(5) Other acts that violate the provisions of these Measures.
Article 49 [Punishment of Violations] If the Science and Technology Ethics Committee or its members violate the provisions of these Measures and have one of the following circumstances, the institution with jurisdiction shall impose punishment or punishment in accordance with laws, administrative regulations and relevant regulations; cause property damage or other If there is damage, civil liability shall be borne according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
(1) Facilitating the scientific and technological activities undertaking units to obtain the approval of scientific and technological ethics review by resorting to deceit;
(2) engaging in malpractice for personal gain, abusing power or neglecting duty;
(3) Other acts that violate the provisions of these Measures.
Article 50 [Division of Investigation and Punishment 1] Universities, scientific research institutions, medical and health institutions, enterprises, etc. are the primary subjects of internal investigation and handling of violations of scientific and technological ethics, and should promptly and proactively investigate violations of scientific and technological ethics, and pursue accountability in accordance with laws and regulations accountability.
If a unit or its person-in-charge is involved in violations of scientific and technological ethics, it shall be investigated and dealt with by the competent department at a higher level.
Article 51 [Investigation and Punishment Division 2] Local and relevant industry authorities, in accordance with their responsibilities and affiliation, strengthen guidance and supervision of the investigation and handling of violations of scientific and technological ethics in their localities and systems, and organize the investigation and handling of major scientific and technological ethics cases .
Article 52 [Investigation and Punishment Division 3] Where scientific and technological ethics violations involve scientific and technological planning projects established with fiscal funds, the project management department (unit) shall organize investigation and handling in accordance with relevant project management regulations. The project undertaking (participating) unit shall, in accordance with the requirements of the project management department (unit), actively carry out and actively cooperate with the investigation, and deal with the person responsible for the violation according to the authority.
Chapter V Supplementary Provisions
Article 53 [Concept and Scope Definition] The scientific and technological ethical risks referred to in these Measures refer to risks in scientific and technological activities such as scientific research and technological development identified from an ethical perspective. The lowest risk refers to the routine risk encountered in daily life or the risk equivalent to the health examination.
The terms "above" and "not less than" in these Measures include the original number. The provision concerning the time limit in these Measures, if it is not marked as a working day, it shall be a natural day.
The "local or relevant industry authorities" referred to in these Measures, where "local" generally refers to the provincial management departments determined by the local people's government at the provincial level to be responsible for the review and management of science and technology ethics in related fields, and the "relevant industry authorities" are Refers to the relevant national industry authorities.
Article 54 [Supporting detailed rules] Local and relevant industry authorities may formulate and revise the local and system's scientific and technological ethics review methods, detailed rules and other institutional norms in accordance with the provisions of these measures and in light of actual conditions. Science and technology social groups can formulate specific norms and guidelines for scientific and technological ethics review in this field.
Article 55 [Special regulations] 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 the requirements are not lower than these measures, the regulations shall be followed.
Article 56 [Interpretation of Measures] The Ministry of Science and Technology shall be responsible for the interpretation of these Measures.
Article 57 [Date of Implementation] These Measures shall come into force on the date of promulgation.
Attachment: List of scientific and technological activities requiring expert review
1. Research on the synthesis of new species that have a major impact on human life and health, values, and ecological environment.
2. Research on the introduction of human stem cells into animal embryos or fetuses and further breeding into individuals in the uterus of animals.
3. Basic research on changing the genetic material of human germ cells, fertilized eggs and pre-implantation embryo nuclei.
4. Clinical research on invasive brain-computer interface for 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, and 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 an automated decision-making system with a high degree of autonomy for scenarios where safety and personal health risks exist.
This list will be dynamically adjusted according to the development of technological innovation.
