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| Notice by the Ministry of Science and Technology, the Ministry of Education, the Ministry of Industry and Information Technology, the Ministry of Agriculture and Rural Affairs, the National Health Commission, the Chinese Academy of Sciences, the Chinese Academy of Social Sciences, the Chinese Academy of Engineering, the China Association for Science and Technology, and the Science and Technology Commission of the Central Military Commission of Issuing the Measures for Scientific and Technological Ethics Review (for Trial Implementation) | | 科技部、教育部、工业和信息化部、农业农村部、国家卫生健康委、中国科学院、中国社科院、中国工程院、中国科协、中央军委科技委关于印发《科技伦理审查办法（试行）》的通知 |
| (No. 167 [2023] of the Ministry of Science and Technology) | | （国科发监〔2023〕167号） |
| The relevant departments of all provinces, autonomous regions, municipalities directly under the Central Government, cities under separate state planning, sub-provincial cities, and Xinjiang Production and Construction Corps; all relevant departments and all institutions directly under the State Council, and all relevant entities: | | 各省、自治区、直辖市及计划单列市、副省级城市有关部门，新疆生产建设兵团有关部门，国务院各有关部门、直属机构，各有关单位： |
| The Measures for Scientific and Technological Ethics Review (for Trial Implementation), as approved by the Science and Technology Commission of the Central Military Commission, are hereby issued to you for your compliance and implementation. | | 《科技伦理审查办法（试行）》已经中央科技委员会同意，现印发给你们，请遵照实施。 |
| Ministry of Science and Technology | | 科技部 |
| Ministry of Education | | 教育部 |
| Ministry of Industry and Information Technology | | 工业和信息化部 |
| Ministry of Agriculture and Rural Affairs | | 农业农村部 |
| National Health Commission | | 国家卫生健康委 |
| Chinese Academy of Sciences | | 中国科学院 |
| Chinese Academy of Social Sciences | | 中国社科院 |
| Chinese Academy of Engineering | | 中国工程院 |
| China Association for Science and Technology | | 中国科协 |
| Science and Technology Commission of the Central Military Commission | | 中央军委科技委 |
| September 7, 2023 | | 2023年9月7日 |
| Measures for Scientific and Technological Ethics Review (for Trial Implementation) | | 科技伦理审查办法（试行） |
| Chapter I General Provisions | | 第一章 总则 |
| Article 1 These Measures are developed in accordance with the Law of the People's Republic of China on Scientific and Technological Progress, the Opinions on Strengthening the Governance of Scientific and Technological Ethics, and other applicable laws and regulations and relevant provisions to regulate scientific and technological (“sci-tech”) ethics review in scientific research, technology development, and other scientific and technological activities, strengthen the prevention and control of sci-tech ethical risks, and promote responsible innovation. | | 第一条 为规范科学研究、技术开发等科技活动的科技伦理审查工作，强化科技伦理风险防控，促进负责任创新，依据《中华人民共和国科学技术进步法》、《关于加强科技伦理治理的意见》等法律法规和相关规定，制定本办法。 |
| Article 2 The following scientific and technological activities shall be subject to sci-tech ethics review in accordance with these Measures: | | 第二条 开展以下科技活动应依照本办法进行科技伦理审查： |
| (1) Scientific and technological activities involving human research participants, including human testing, investigation, observation, and other research activities, and scientific and technological activities utilizing human biological samples and personal information, among others. | | （一）涉及以人为研究参与者的科技活动，包括以人为测试、调查、观察等研究活动的对象，以及利用人类生物样本、个人信息数据等的科技活动； |
| (2) Scientific and technological activities involving experimental animals. | | （二）涉及实验动物的科技活动； |
| (3) Scientific and technological activities that do not directly involve humans or experimental animals, but may pose ethical risks and challenges to the aspects such as life and health, ecology and environment, public order, and sustainable development. | | （三）不直接涉及人或实验动物，但可能在生命健康、生态环境、公共秩序、可持续发展等方面带来伦理风险挑战的科技活动； |
| (4) Other scientific and technological activities that shall be subject to sci-tech ethics review in accordance with laws, administrative regulations, and relevant rules issued by the state. | | （四）依据法律、行政法规和国家有关规定需进行科技伦理审查的其他科技活动。 |
| Article 3 In conducting scientific and technological activities, people shall adhere to the unification of innovation promotion and risk prevention, objectively assess and prudently treat uncertainties and risks in technological application, follow the principles of improving human well-being, respecting the right to life, upholding fairness and impartiality, reasonably controlling risks, and maintaining open and transparent sci-tech ethics, and comply with the Constitution, laws and regulations, and relevant rules issued by the state, as well as sci-tech ethics standards. | | 第三条 开展科技活动应坚持促进创新与防范风险相统一，客观评估和审慎对待不确定性和技术应用风险，遵循增进人类福祉、尊重生命权利、坚持公平公正、合理控制风险、保持公开透明的科技伦理原则，遵守我国宪法、法律法规和有关规定以及科技伦理规范。 |
| Sci-tech ethics review shall adhere to the principles of being scientific, independent, impartial, and transparent, disclose to the public the review system and review procedures, objectively and prudently assess the ethical risks of scientific and technological activities, conduct reviews according to the applicable provisions, and consciously accept the supervision of relevant sides. If national security, state secrets, trade secrets, or sensitive issues are involved, relevant work shall be conducted effectively in accordance with the applicable laws and regulations. | | 科技伦理审查应坚持科学、独立、公正、透明原则，公开审查制度和审查程序，客观审慎评估科技活动伦理风险，依规开展审查，并自觉接受有关方面的监督。涉及国家安全、国家秘密、商业秘密和敏感事项的，依法依规做好相关工作。 |
| Chapter II Reviewers | | 第二章 审查主体 |
| Article 4 Institutions of higher learning, scientific research institutions, medical and health institutions, and enterprises, among others, are the parties responsible for administering their sci-tech ethics review. Entities engaged in life science, medicine, artificial intelligence, and other scientific and technological activities shall establish a sci-tech ethics (review) committee if the research content involves sensitive fields of sci-tech ethics. Other entities that need to conduct the sci-tech ethics review may establish a sci-tech ethics (review) committee according to their actual circumstances. | | 第四条 高等学校、科研机构、医疗卫生机构、企业等是本单位科技伦理审查管理的责任主体。从事生命科学、医学、人工智能等科技活动的单位，研究内容涉及科技伦理敏感领域的，应设立科技伦理（审查）委员会。其他有科技伦理审查需求的单位可根据实际情况设立科技伦理（审查）委员会。 |
| Entities shall provide the sci-tech ethics (review) committee with staffing, office premises, funds, and other conditions necessary for performing their duties and take effective measures to ensure that the sci-tech ethics (review) committee conducts ethics review independently. | | 单位应为科技伦理（审查）委员会履职配备必要的工作人员、提供办公场所和经费等条件，并采取有效措施保障科技伦理（审查）委员会独立开展伦理审查工作。 |
| The establishment of professional and regional sci-tech ethics review centers shall be explored. | | 探索建立专业性、区域性科技伦理审查中心。 |
| Article 5 The major duties of the sci-tech ethics (review) committee include: | | 第五条 科技伦理（审查）委员会的主要职责包括： |
| (1) developing and improving management rules and work standards of the sci-tech ethics (review) committee; | | （一）制定完善科技伦理（审查）委员会的管理制度和工作规范； |
| (2) providing sci-tech ethics consultation, guiding scientific and technological personnel to conduct the sci-tech ethics risk assessment of scientific and technological activities; | | （二）提供科技伦理咨询，指导科技人员对科技活动开展科技伦理风险评估； |
| (3) conducting sci-tech ethics review and tracking and supervising the entire process of relevant scientific and technological activities as required; | | （三）开展科技伦理审查，按要求跟踪监督相关科技活动全过程； |
| (4) making judgments on whether the proposed scientific and technological activities are included in the list determined in Article 25 of these Measures; | | （四）对拟开展的科技活动是否属于本办法第二十五条确定的清单范围作出判断； |
| (5) organizing training on sci-tech ethics review for committee members and training on sci-tech ethics knowledge for scientific and technological personnel; | | （五）组织开展对委员的科技伦理审查业务培训和科技人员的科技伦理知识培训； |
| (6) accepting and assisting in the investigation of complaints and reports involving sci-tech ethics issues in relevant scientific and technological activities; and | | （六）受理并协助调查相关科技活动中涉及科技伦理问题的投诉举报； |
| (7) registering and reporting in accordance with the requirements of Articles 43, 44, and 45 of these Measures, and cooperating with local and appropriate industry departments in conducting related work involving sci-tech ethics review. | | （七）按照本办法第四十三、四十四、四十五条要求进行登记、报告，配合地方、相关行业主管部门开展涉及科技伦理审查的相关工作。 |
| Article 6 The sci-tech ethics (review) committee shall develop its bylaws, and establish and improve the review, supervision, confidentiality management, archives management, and other rules and standards, work procedures, and the mechanism for the management of conflicts of interest to ensure that the sci-tech ethics review is compliant, transparent, and traceable. | | 第六条 科技伦理（审查）委员会应制定章程，建立健全审查、监督、保密管理、档案管理等制度规范、工作规程和利益冲突管理机制，保障科技伦理审查合规、透明、可追溯。 |
| Article 7 The sci-tech ethics (review) committee shall consist of at least seven members, including one chairman and several deputy chairmen. The committee shall consist of peer experts with relevant scientific and technological backgrounds, and experts with corresponding professional backgrounds in ethics and law, among others, and it shall have members of different genders and members who are not from the entity itself. In ethnic autonomous regions, there shall be members who are familiar with local conditions. The term of office of a member shall not exceed five years and a member may be re-elected. | | 第七条 科技伦理（审查）委员会人数应不少于7人，设主任委员1人，副主任委员若干。委员会由具备相关科学技术背景的同行专家，伦理、法律等相应专业背景的专家组成，并应当有不同性别和非本单位的委员，民族自治地方应有熟悉当地情况的委员。委员任期不超过5年，可以连任。 |
| Article 8 Members of the sci-tech ethics (review) committee shall have the corresponding ability and competence in sci-tech ethics review, good scientific research integrity, and comply with the following requirements: | | 第八条 科技伦理（审查）委员会委员应具备相应的科技伦理审查能力和水平，科研诚信状况良好，并遵守以下要求： |
| (1) Abiding by China's Constitution, laws, regulations, and rules and regulations on sci-tech ethics and the bylaws of the sci-tech ethics (review) committee. | | （一）遵守我国宪法、法律、法规和科技伦理有关制度规范及所在科技伦理（审查）委员会的章程制度； |
| (2) Attending sci-tech ethics review meetings on time and independently and impartially giving their review opinions. | | （二）按时参加科技伦理审查会议，独立公正发表审查意见； |
| (3) Strictly abiding by confidentiality provisions, and not divulging or using for other purposes any state secret, personal privacy, personal information, technical secret, and undisclosed information, among others, to which they have access during the sci-tech ethics review. | | （三）严格遵守保密规定，对科技伦理审查工作中接触、知悉的国家秘密、个人隐私、个人信息、技术秘密、未公开信息等，未经允许不得泄露或用于其他目的； |
| (4) Complying with the requirements for the management of conflicts of interest and withdrawing in accordance with the relevant provisions. | | （四）遵守利益冲突管理要求，并按规定回避； |
| (5) Regularly participating in training on sci-tech ethics review. | | （五）定期参加科技伦理审查业务培训； |
| (6) Completing other work assigned by the committee. | | （六）完成委员会安排的其他工作。 |
| Chapter III Review Procedures | | 第三章 审查程序 |
| Section 1 Application and Acceptance | | 第一节 申请与受理 |
| Article 9 Sci-tech ethical risk assessment shall be carried out in scientific and technological activities. The sci-tech ethics (review) committee shall, in accordance with the requirements of these Measures, develop measures for the assessment of sci-tech ethical risks and direct scientific and technological personnel to assess sci-tech ethical risks. If the activities fall within the scope specified in Article 2 of these Measures upon assessment, the person in charge of scientific and technological activities shall apply to the sci-tech ethics (review) committee for a sci-tech ethics review. The application materials shall mainly include: | | 第九条 开展科技活动应进行科技伦理风险评估。科技伦理（审查）委员会按照本办法要求制定本单位科技伦理风险评估办法，指导科技人员开展科技伦理风险评估。经评估属于本办法第二条所列范围科技活动的，科技活动负责人应向科技伦理（审查）委员会申请科技伦理审查。申请材料主要包括： |
| (1) an overview of scientific and technological activities, including but not limited to the name, purpose, significance, and necessity of scientific and technological activities, and previous sci-tech ethics reviews; | | （一）科技活动概况，包括科技活动的名称、目的、意义、必要性以及既往科技伦理审查情况等； |
| (2) the implementation plan for scientific and technological activities and relevant materials, including but not limited to the plan for scientific and technological activities, possible sci-tech ethical risks and prevention and control measures and emergency response plans, and the forms of release of achievements of scientific and technological activities; | | （二）科技活动实施方案及相关材料，包括科技活动方案，可能的科技伦理风险及防控措施和应急处理预案，科技活动成果发布形式等； |
| (3) the legal qualification materials of relevant institutions involved in scientific and technological activities, the relevant research experience of the participants and their participation in sci-tech ethics training, the sources of funds for scientific and technological activities, and the declaration of conflicts of interest in scientific and technological activities, among others; | | （三）科技活动所涉及的相关机构的合法资质材料，参加人员的相关研究经验及参加科技伦理培训情况，科技活动经费来源，科技活动利益冲突声明等； |
| (4) the informed consent, explanatory materials on the source of biological samples, data information, and experimental animals, among others; | | （四）知情同意书，生物样本、数据信息、实验动物等的来源说明材料等； |
| (5) a letter of commitment to comply with sci-tech ethics, scientific research integrity, and other requirements; and | | （五）遵守科技伦理和科研诚信等要求的承诺书； |
| (6) other materials as required by the sci-tech ethics (review) committee. | | （六）科技伦理（审查）委员会认为需要提交的其他材料。 |
| Article 10 The sci-tech ethics (review) committee shall decide whether to accept the application or not according to the application materials for sci-tech ethics (review) and notify the applicant of the result. If it decides to accept the application, it shall specify the applicable review procedures, and if the materials are incomplete, it shall inform the applicant of the required supplements at one time. | | 第十条 科技伦理（审查）委员会应根据科技伦理审查申请材料决定是否受理申请并通知申请人。决定受理的应明确适用的审查程序，材料不齐全的应一次性完整告知需补充的材料。 |
| Article 11 In principle, sci-tech ethics review shall be conducted through meetings, except as otherwise prescribed in these Measures. | | 第十一条 科技伦理审查原则上采取会议审查方式，本办法另有规定的除外。 |
| Article 12 Where international cooperative scientific and technological activities fall within the scope specified in Article 2 of these Measures, they may be carried out only after passing the sci-tech ethics review prescribed by the countries where all the cooperators are located. | | 第十二条 国际合作科技活动属于本办法第二条所列范围的，应通过合作各方所在国家规定的科技伦理审查后方可开展。 |
| Article 13 Where the sci-tech ethics (review) committee of an entity is unable to satisfy the requirements for the ethics review or an entity fails to establish a sci-tech ethics (review) committee or has no personnel to conduct scientific and technological activities, the entity shall entrust in writing another qualified sci-tech ethics (review) committee with the ethics review. | | 第十三条 单位科技伦理（审查）委员会无法胜任审查工作要求或者单位未设立科技伦理（审查）委员会以及无单位人员开展科技活动的，应书面委托其他满足要求的科技伦理（审查）委员会开展伦理审查。 |
| Section 2 General Procedures | | 第二节 一般程序 |
| Article 14 The sci-tech ethics review meeting shall be presided over by the chairman or the deputy chairman designated by the chairman. There shall be not less than five members present at the meeting, and it shall include members of different categories as listed in Article 7. | | 第十四条 科技伦理审查会议由主任委员或其指定的副主任委员主持，到会委员应不少于5人，且应包括第七条所列的不同类别的委员。 |
| As required for the review, the applicant may be required to explain the plan or explain specific issues at the meeting, and advisory experts, among others, who have no direct interest in the relevant fields may be invited to provide advice. Advisory experts shall not participate in the voting at the meeting. | | 根据审查需要，会议可要求申请人到会阐述方案或者就特定问题进行说明，可邀请相关领域不存在直接利益关系的顾问专家等提供咨询意见。顾问专家不参与会议表决。 |
| If a meeting is held in a video form, the requirements of the sci-tech ethics (review) committee on the conditions for the application of video meetings, meeting rules, and other relevant rules shall be complied with. | | 会议采用视频方式的，应符合科技伦理（审查）委员会对视频会议适用条件、会议规则等的有关制度要求。 |
| Article 15 The sci-tech ethics (review) committee shall carry out the review according to the following key contents and standards: | | 第十五条 科技伦理（审查）委员会应按照以下重点内容和标准开展审查： |
| (1) The scientific and technological activities to be carried out shall conform to the sci-tech ethical principles specified in Article 3 of these Measures, and the qualifications of scientific and technical personnel participating in scientific and technological activities, research foundations, and facilities and conditions, among others, shall satisfy the relevant requirements. | | （一）拟开展的科技活动应符合本办法第三条规定的科技伦理原则，参与科技活动的科技人员资质、研究基础及设施条件等符合相关要求。 |
| ．．．．．． | | ．．．．．． |
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