Measures for Scientific and Technological Ethics Review (for Trial Implementation)
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)
Document Number：No. 167 [2023] of the Ministry of Science and Technology
Area of Law： General Provisions and System Reform of Science and Technology
Level of Authority： Departmental Regulatory Documents
Issuing Authority： Ministry of Science & Technology Ministry of Education Ministry of Industry & Information Technology Ministry of Agriculture and Rural Affairs National Health Commission Chinese Academy of Sciences Chinese Academy of Social Sciences Chinese Academy of Engineering China Association for Science and Technology Science and Technology Committee of the Central Military Commission
Date Issued：09-07-2023
Effective Date：12-01-2023
Status： Effective
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
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)
（国科发监〔2023〕167号）
(No. 167 [2023] of the Ministry of Science and Technology)
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 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:
《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。
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.
科技部
Ministry of Science and Technology
教育部
Ministry of Education
工业和信息化部
Ministry of Industry and Information Technology
农业农村部
Ministry of Agriculture and Rural Affairs
国家卫生健康委
National Health Commission
中国科学院
Chinese Academy of Sciences
中国社科院
Chinese Academy of Social Sciences
中国工程院
Chinese Academy of Engineering
中国科协
China Association for Science and Technology
中央军委科技委
Science and Technology Commission of the Central Military Commission
2023年9月7日
September 7, 2023
科技伦理审查办法（试行）
Measures for Scientific and Technological Ethics Review (for Trial Implementation)
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 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.
Article 2 The following scientific and technological activities shall be subject to sci-tech ethics review in accordance with these Measures:
（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.
（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；
（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。
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。
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。
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.
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.
Article 5 The major duties of the sci-tech ethics (review) committee include:
（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；
（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；
（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；
（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；
（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。
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 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 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：
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:
（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；
（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；
(5) Regularly participating in training on sci-tech ethics review.
(6) Completing other work assigned by the committee.
Section 1 Application and Acceptance
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：
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:
（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；
（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；
（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；
（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；
(6) other materials as required by the sci-tech ethics (review) committee.
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 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 11 In principle, sci-tech ethics review shall be conducted through meetings, except as otherwise prescribed in these Measures.
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 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。
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。
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.
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。
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。
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：
Article 15 The sci-tech ethics (review) committee shall carry out the review according to the following key contents and standards:
（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。
（二）拟开展的科技活动具有科学价值和社会价值，其研究目标的实现对增进人类福祉、实现社会可持续发展等具有积极作用。科技活动的风险受益合理，伦理风险控制方案及应急预案科学恰当、具有可操作性。
（四）涉及实验动物的科技活动，使用实验动物符合替代、减少、优化原则，实验动物的来源合法合理，饲养、使用、处置等技术操作要求符合动物福利标准，对从业人员和公共环境安全等的保障措施得当。
(7) Other content that shall be reviewed as required by the sci-tech ethics (review) committee.
第十六条 科技伦理（审查）委员会对审查的科技活动，可作出批准、修改后批准、修改后再审或不予批准等决定。修改后批准或修改后再审的，应提出修改建议，明确修改要求；不予批准的，应说明理由。
Article 16 The sci-tech ethics (review) committee may make decisions such as approval, approval after modification, review after modification, or disapproval of the scientific and technological activities under review. If the committee makes the decision to grant approval after modification or to conduct a review after modification, it shall offer modification recommendations and specify modification requirements and shall explain the reasons for disapproval if it makes the disapproval decision.
科技伦理（审查）委员会作出的审查决定，应经到会委员的三分之二以上同意。
第十七条 科技伦理（审查）委员会一般应在申请受理后的30日内作出审查决定，特殊情况可适当延长并明确延长时限。审查决定应及时送达申请人。
Article 17 The sci-tech ethics (review) committee shall generally make a review decision within 30 days after accepting the application, which may be properly extended under special circumstances and the extension shall be specified. The review decision shall be served upon the applicant in a timely manner.
第十八条 申请人对审查决定有异议的，可向作出决定的科技伦理（审查）委员会提出书面申诉，说明理由并提供相关支撑材料。申诉理由充分的，科技伦理（审查）委员会应按照本办法规定重新作出审查决定。
Article 18 Where an applicant has any objection to the review decision, he or she may file a written complaint with the sci-tech ethics (review) committee that makes the decision, explain the reasons therefor, and provide relevant supporting materials. If the reasons for the complaint are sufficient, the sci-tech ethics (review) committee shall make a new review decision in accordance with the provisions of these Measures.
第十九条 科技伦理（审查）委员会应对审查批准的科技活动开展伦理跟踪审查，必要时可作出暂停或终止科技活动等决定。跟踪审查间隔一般不超过12个月。
Article 19 The sci-tech ethics (review) committee shall carry out follow-up ethics review of scientific and technological activities approved upon review, and may make a decision to suspend or terminate scientific and technological activities when necessary. The interval between follow-up reviews shall generally not exceed 12 months.
The main content of the follow-up review includes:
(2) the implementation of measures for the prevention and control of sci-tech ethical risks;
（三）科技伦理风险的潜在变化及可能影响研究参与者权益和安全等情况；
(4) other content that needs to be subject to follow-up review.
根据跟踪审查需要，科技伦理（审查）委员会可以要求科技活动负责人提交相关材料。
第二十条 因科技活动实施方案调整、外部环境变化等可能导致科技伦理风险发生变化的，科技活动负责人应及时向科技伦理（审查）委员会报告。科技伦理（审查）委员会应对风险受益情况进行评估，提出继续实施、暂停实施等意见，必要时，重新开展伦理审查。
Article 20 Where adjustments to the implementation plan for scientific and technological activities or changes in the external environment, among others, may lead to changes in sci-tech ethical risks, the person in charge of scientific and technological activities shall report to the sci-tech ethics (review) committee in a timely manner. The sci-tech ethics (review) committee shall assess the risks and benefits, propose opinions on whether to continue or suspend implementation, among others, and if necessary, carry out an ethics review again.
第二十一条 多个单位合作开展科技活动的，牵头单位可根据实际情况建立科技伦理审查协作与结果互认机制，加强科技伦理审查的协调管理。
Article 21 Where many entities cooperate to carry out scientific and technological activities, the leading entity may establish a mechanism for cooperation and mutual recognition of results of sci-tech ethics review according to actual circumstances and strengthen the coordinated administration of sci-tech ethics review.
Article 22 Summary procedure may apply under any of the following circumstances:
第二十三条 简易程序审查由科技伦理（审查）委员会主任委员指定两名或两名以上的委员承担。审查过程中，可要求申请人就相关问题进行说明。审查决定应载明采取简易程序审查的理由和依据。
Article 23 The chairman of the sci-tech ethics (review) committee shall appoint two or more members to conduct the review under the summary procedure. During the review process, the applicant may be required to explain relevant issues. The review decision shall indicate the grounds and basis for conducting a review under the summary procedure.
采取简易程序审查的，科技伦理（审查）委员会可根据情况调整跟踪审查频度。
第二十四条 简易程序审查过程中出现下列情形之一的，应按规定调整为会议审查，适用一般程序：
Article 24 Under any of the following circumstances in the course of review under the summary procedure, the procedure shall be adjusted to meeting review in accordance with the applicable provisions, and the general procedure shall apply:
(1) The review result is negative.
(2) There is any doubt about the review content.
(3) Committee members have different opinions.
(4) Any committee member proposes the need to adjust to meeting review.
Section 4 Expert Review Procedures
第二十五条 建立需要开展专家复核的科技活动清单制度，对可能产生较大伦理风险挑战的新兴科技活动实施清单管理。清单根据工作需要动态调整，由科技部公开发布。
Article 25 A system of list of scientific and technological activities requiring review by experts shall be established, and emerging scientific and technological activities that may pose significant challenges in ethical risks shall be subject to list management. The list shall be dynamically adjusted according to work needs and shall be released to the public by the Ministry of Science and Technology.
第二十六条 开展纳入清单管理的科技活动的，通过科技伦理（审查）委员会的初步审查后，由本单位报请所在地方或相关行业主管部门组织开展专家复核。多个单位参与的，由牵头单位汇总并向所在地方或相关行业主管部门申请专家复核。
Article 26 To carry out scientific and technological activities subject to list management, the entity shall, after passing the preliminary review by the sci-tech ethics (review) committee, report to the local or appropriate industry department at the place where it is located for expert review. If many entities participate in the review, the leading entity shall summarize the review results and apply to the local or appropriate industry department for expert review.
第二十七条 申请专家复核的，科技活动承担单位应组织科技伦理（审查）委员会和科技人员按要求提交以下材料：
Article 27 To apply for expert review, the entity undertaking scientific and technological activities shall organize the sci-tech 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 sci-tech ethics (review) committee.
(3) Other relevant materials required by the review organizer.
第二十八条 地方或相关行业主管部门组织成立复核专家组，由科技活动相关领域具有较高学术水平的同行专家以及伦理学、法学等方面的专家组成，不少于5人。科技伦理（审查）委员会委员不得参与本委员会审查科技活动的复核工作。
Article 28 The local or appropriate industry department shall organize the formation of a review expert group, which shall be composed of not less than five persons including experts with relatively high academic levels in fields relating to scientific and technological activities and experts in ethics, law, and other fields. Members of the sci-tech ethics (review) committee shall not participate in the review of scientific and technological activities under review by this committee.
复核专家应主动申明是否与复核事项存在直接利益关系，严格遵守保密规定和回避要求。
Article 29 The review expert group shall carry out the review according to the following key contents and standards:
（一）初步审查意见的合规性。初步审查意见应当符合我国法律、行政法规、国家有关规定和科技伦理要求。
（二）初步审查意见的合理性。初步审查意见应当结合技术发展需求和我国科技发展实际，对科技活动的潜在伦理风险和防控措施进行全面充分、恰当合理的评估。
(3) Other contents that shall be subject to review as required by the review expert group.
第三十条 复核专家组采取适当方式开展复核，必要时可要求相关科技伦理（审查）委员会、科技人员解释说明有关情况。
Article 30 The review expert group shall conduct the review in an appropriate manner and may require the relevant sci-tech ethics (review) committee and scientific and technological personnel to make explanations when necessary.
复核专家组应当作出同意或不同意的复核意见，复核意见应经全体复核专家的三分之二以上同意。
第三十一条 地方或相关行业主管部门一般应在收到复核申请后30日内向申请单位反馈复核意见。
Article 31 The local or appropriate industry department shall generally provide feedback on the review opinion to the applicant within 30 days after receiving the review application.
第三十二条 单位科技伦理（审查）委员会应根据专家复核意见作出科技伦理审查决定。
Article 32 The sci-tech ethics (review) committee of an entity shall make a sci-tech ethics review decision based on the expert review opinion.
第三十三条 单位科技伦理（审查）委员会应加强对本单位开展的纳入清单管理的科技活动的跟踪审查和动态管理，跟踪审查间隔一般不超过6个月。
Article 33 The sci-tech ethics (review) committee of an entity shall strengthen the follow-up review and dynamic management of scientific and technological activities carried out by the entity subject to list management, and the interval between such follow-up reviews shall generally not exceed six months.
科技伦理风险发生重大变化的，应按照本办法第二十条规定重新开展伦理审查并申请专家复核。
第三十四条 国家对纳入清单管理的科技活动实行行政审批等监管措施且将符合伦理要求作为审批条件、监管内容的，可不再开展专家复核。审批、监管部门和科技活动承担单位应严格落实伦理监管责任，防控伦理风险。
Article 34 Where the state takes regulatory measures such as administrative approval for scientific and technological activities subject to list management, and takes compliance with ethical requirements as approval conditions and regulatory content, it is not necessary to conduct expert review again. Approval and regulatory departments and entities undertaking scientific and technological activities shall strictly fulfill their ethical supervision responsibilities to prevent and control ethical risks.
Section 5 Emergency Procedures
第三十五条 科技伦理（审查）委员会应制定科技伦理应急审查制度，明确突发公共事件等紧急状态下的应急审查流程和标准操作规程，组织开展应急伦理审查培训。
Article 35 The sci-tech ethics (review) committee shall develop rules for the emergency sci-tech ethics review, specify the emergency review process and standard operating procedures under emergencies such as public emergencies, and organize emergency ethics review training.
第三十六条 科技伦理（审查）委员会根据科技活动紧急程度等实行分级管理，可设立科技伦理审查快速通道，及时开展应急审查。应急审查一般在72小时内完成。对于适用专家复核程序的科技活动，专家复核时间一并计入应急审查时间。
Article 36 The sci-tech ethics (review) committee shall carry out level-by-level administration according to the degree of urgency of scientific and technological activities, among others, and may set up rapid channels for sci-tech ethics review, and conduct emergent review in a timely manner. Emergency review shall generally be completed within 72 hours. The time required for expert review shall be included in the time for emergency review if the expert review procedure applies to scientific and technological activities.
第三十七条 应急审查应有相关专业领域的委员参会。无相关专业领域委员的，应邀请相关领域顾问专家参会，提供咨询意见。
Article 37 Emergency review shall be attended by committee members from the relevant professional fields. If there is no committee member in the relevant professional field, advisory experts in relevant fields shall be invited to attend the meeting to provide advisory opinions.
第三十八条 科技伦理（审查）委员会应加强对应急审查的科技活动的跟踪审查和过程监督，及时向科技人员提供科技伦理指导意见和咨询建议。
Article 38 The sci-tech ethics (review) committee shall strengthen the follow-up review and process supervision of scientific and technological activities subject to emergency review and provide sci-tech ethics guidance and advice to scientific and technological personnel in a timely manner.
第三十九条 任何单位和个人不得以紧急情况为由，回避科技伦理审查或降低科技伦理审查标准。
Article 39 No entity or individual may evade sci-tech ethics review or lower the standards for sci-tech ethics review on the grounds of an emergency.
Chapter IV Supervision and Administration
第四十条 科技部负责统筹指导全国科技伦理监管工作，有关科技伦理审查监管的重要事项应听取国家科技伦理委员会的专业性、学术性咨询意见。地方、相关行业主管部门按照职责权限和隶属关系负责本地方、本系统科技伦理审查的监督管理工作，建立对纳入清单管理科技活动的专家复核机制，加强对本地方、本系统发生的重大突发公共事件应急伦理审查的协调、指导和监督。
Article 40 The Ministry of Science and Technology shall be responsible for coordinating and guiding the supervision and administration of sci-tech ethics review nationwide and shall listen to the professional and academic advisory opinions of the National Scientific and Technological Ethics Commission on important issues concerning the supervision and administration of sci-tech ethics review. Local and appropriate industry departments shall, according to their duties, authorities, and affiliations, be responsible for the supervision and administration of sci-tech ethics review in their respective regions and systems, establish expert review mechanisms for scientific and technological activities subject to list management, and strengthen the coordination, guidance, and supervision of ethics review of major public emergencies in their respective regions and systems.
第四十一条 高等学校、科研机构、医疗卫生机构、企业等应履行科技伦理管理主体责任，健全本单位科技伦理监管机制和审查质量控制、监督评价机制，经常性开展单位工作人员科技伦理教育培训，加强对纳入清单管理的科技活动的动态跟踪和伦理风险防控。
Article 41 Institutions of higher learning, scientific research institutions, medical and health institutions, and enterprises, among others, shall perform their primary responsibilities for sci-tech ethics management, improve their mechanisms for the supervision and administration of sci-tech ethics review and review quality control and supervision and evaluation mechanisms, regularly provide sci-tech ethics education and training for their staff, and strengthen the dynamic tracking and ethical risk prevention and control of scientific and technological activities subject to list management.
国家推动建立科技伦理（审查）委员会认证机制，鼓励相关单位开展科技伦理审查认证。
第四十二条 科技部负责建设国家科技伦理管理信息登记平台，为地方、相关行业主管部门加强科技伦理监管提供相应支撑。
Article 42 The Ministry of Science and Technology shall be responsible for building a national sci-tech ethics management information registration platform to provide local and appropriate industry departments with corresponding support in strengthening the supervision and administration of sci-tech ethics review.
第四十三条 单位应在设立科技伦理（审查）委员会后30日内，通过国家科技伦理管理信息登记平台进行登记。登记内容包括科技伦理（审查）委员会组成、章程、工作制度等，相关内容发生变化时应及时更新。
Article 43 An entity shall, within 30 days after the establishment of the sci-tech ethics (review) committee, make registration through the national sci-tech ethics management information registration platform. The registration information includes the composition, bylaws, and work rules, among others, of the sci-tech ethics (review) committee, and the relevant information shall be updated in a timely manner in case of any modification.
第四十四条 单位应在纳入清单管理的科技活动获得伦理审查批准后30日内，通过国家科技伦理管理信息登记平台进行登记。登记内容包括科技活动实施方案、伦理审查与复核情况等，相关内容发生变化时应及时更新。
Article 44 An entity shall register its scientific and technological activities subject to list management through the national sci-tech ethics management information registration platform within 30 days after the approval of the ethics review. The registration information shall include but not be limited to the implementation plan for scientific and technological activities, information on ethics review and review, and shall be updated in a timely manner in case of any change in the relevant information.
第四十五条 单位应于每年3月31日前，向国家科技伦理管理信息登记平台提交上一年度科技伦理（审查）委员会工作报告、纳入清单管理的科技活动实施情况报告等。
Article 45 An entity shall, before March 31 each year, submit the work report of the sci-tech ethics (review) committee and the report on the implementation of scientific and technological activities subject to the list management for the previous year to the national sci-tech ethics management information registration platform.
第四十六条 对科技活动中违反科技伦理规范、违背科技伦理要求的行为，任何单位或个人有权依法向科技活动承担单位或地方、相关行业主管部门投诉举报。
Article 46 Any entity or individual shall have the right to legally file a complaint or report with the entity that undertakes scientific and technological activities or the local or appropriate industry department against any violation of sci-tech ethics standards or ethical requirements in scientific and technological activities.
第四十七条 科技活动承担单位、科技人员违反本办法规定，有下列情形之一的，由有管辖权的机构依据法律、行政法规和相关规定给予处罚或者处理；造成财产损失或者其他损害的，依法承担民事责任；构成犯罪的，依法追究刑事责任。
Article 47 Where any entity undertaking scientific and technological activities or any scientific and technological person falls under any of the following circumstances in violation of these Measures, the violator shall be punished or dealt with by the organ having jurisdiction in accordance with laws, administrative regulations, and relevant provisions; if any property loss or other damage is caused, the violator shall assume civil liability in accordance with the law; and if it is criminally punishable, the violator shall be held criminally liable in accordance with the law.
（一）以弄虚作假方式获得科技伦理审查批准，或者伪造、篡改科技伦理审查批准文件的；
（二）未按照规定通过科技伦理审查和专家复核擅自开展纳入清单管理的科技活动的；
(5) Interfering in or obstructing the sci-tech ethics review.
(6) Otherwise violating the provisions of these Measures.
第四十八条 科技伦理（审查）委员会、委员违反本办法规定，有下列情形之一的，由有管辖权的机构依据法律、行政法规和相关规定给予处罚或者处理；造成财产损失或者其他损害的，依法承担民事责任；构成犯罪的，依法追究刑事责任。
Article 48 The sci-tech ethics (review) committee or any of its members that falls under any of the following circumstances in violation of the provisions of these Measures shall be punished or dealt with by the authority having jurisdiction in accordance with laws, administrative regulations, and relevant provisions; if any property loss or other damage is caused, shall assume civil liability in accordance with the law; and if it is criminally punishable, the violator shall be held criminally liable in accordance with the law.
（一）弄虚作假，为科技活动承担单位获得科技伦理审查批准提供便利的；
(2) Practicing favoritism, making falsification, abusing power, or neglecting duty.
(3) Otherwise violating the provisions of these Measures.
第四十九条 高等学校、科研机构、医疗卫生机构、企业等是科技伦理违规行为单位内部调查处理的第一责任主体，应及时主动调查科技伦理违规行为，依法依规追责问责。
Article 49 Institutions of higher learning, scientific research institutions, medical and health institutions, and enterprises, among others, are the primary parties responsible for the internal investigation and handling of sci-tech ethics violations, and shall promptly and actively investigate sci-tech ethics violations and hold violators liable in accordance with the applicable laws and regulations.
单位或其负责人涉嫌科技伦理违规行为的，由其上级主管部门调查处理，没有上级主管部门的，由其所在地的省级科技行政管理部门负责组织调查处理。
第五十条 地方、相关行业主管部门按照职责权限和隶属关系，加强对本地方、本系统科技伦理违规行为调查处理的指导和监督，组织开展对重大科技伦理案件的调查处理。
Article 50 Local and appropriate industry departments shall, according to their duties, authorities, and affiliations, strengthen the guidance to and supervision of the investigation and handling of sci-tech ethics violations in their respective regions and systems, and organize the investigation and handling of major cases on sci-tech ethics.
第五十一条 科技伦理违规行为涉及财政性资金设立的科技计划项目的，由项目管理部门（单位）按照项目管理有关规定组织调查处理。项目承担（参与）单位应按照项目管理部门（单位）要求，主动开展并积极配合调查，依据职责权限对违规行为责任人作出处理。
Article 51 Where the sci-tech ethics violation involves a scientific and technological plan project established with fiscal funds, the project management department (entity) shall organize investigation and handling in accordance with the provisions on project management. An entity undertaking (or participating in) a project shall, according to the requirements of the project management department (entity), take the initiative to carry out and actively cooperate in the investigation, and punish the person liable for the regulatory violation according to its duties and authority.
Chapter V Supplemental Provisions
第五十二条 本办法所称科技伦理风险是指从伦理视角识别的科学研究、技术开发等科技活动中的风险。最低风险是指日常生活中遇到的常规风险或与健康体检相当的风险。
Article 52 For the purpose of these Measures, “scientific and technological ethical risks” means the risks in scientific research, technology development, and other scientific and technological activities identified from an ethical perspective. Minimum risk means the normal risks encountered in daily life or risks equivalent to physical examination.
本办法所称“以上”、“不少于”均包括本数。本办法涉及期限的规定，未标注为工作日的，为自然日。
本办法所称“地方”是指省级地方人民政府确定的负责相关领域科技伦理审查和管理工作的省级管理部门，“相关行业主管部门”是指国务院相关行业主管部门。
第五十三条 地方、相关行业主管部门可按照本办法规定，结合实际情况制定或修订本地方、本系统的科技伦理审查办法、细则等制度规范。科技类社会团体可制定本领域的科技伦理审查具体规范和指南。
Article 53 Local and appropriate industry departments may, in accordance with these Measures and in light of actual circumstances, develop or revise their respective rules and standards, including the measures and detailed rules for sci-tech ethics review in their respective regions and systems. Scientific and technological social groups may develop specific standards and guidelines for sci-tech ethics review in their respective fields.
第五十四条 相关行业主管部门对本领域科技伦理（审查）委员会设立或科技伦理审查有特殊规定且符合本办法精神的，从其规定。
Article 54 Where the appropriate industry department has special provisions on the establishment of the sci-tech ethics (review) committee or sci-tech ethics review in the field and complies with the guidelines of these Measures, such provisions shall prevail.
Article 55 These Measures shall be subject to interpretation by the Ministry of Science and Technology.
Article 56 These Measures shall come into force on December 1, 2023.
List of Scientific and Technological Activities Subject to Ethics Review
1.对人类生命健康、价值理念、生态环境等具有重大影响的新物种合成研究。
2.将人干细胞导入动物胚胎或胎儿并进一步在动物子宫中孕育成个体的相关研究。
3.改变人类生殖细胞、受精卵和着床前胚胎细胞核遗传物质或遗传规律的基础研究。
