| | |
| Notice by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine of Issuing the Measures for Ethical Review of Life Science and Medical Research Involving Human Being | | 国家卫生健康委、教育部、科技部、国家中医药局关于印发涉及人的生命科学和医学研究伦理审查办法的通知 |
| (No. 4 [2023] of the National Health Commission) | | （国卫科教发〔2023〕4号） |
| The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council and all institutions directly under the State Council; and the China Association for Science and Technology: | | 各省、自治区、直辖市人民政府，国务院各部委、各直属机构，中国科学技术协会： |
| The Measures for Ethical Review of Life Science and Medical Research Involving Human Being, as deliberated and adopted by the National Science and Technology Ethics Committee, are hereby issued for your diligent implementation in light of the work reality, with the consent of the State Council. | | 《涉及人的生命科学和医学研究伦理审查办法》已经国家科技伦理委员会审议通过。经国务院同意，现印发给你们，请结合工作实际，认真组织实施。 |
| National Health Commission | | 国家卫生健康委 |
| Ministry of Education | | 教育部 |
| Ministry of Science and Technology | | 科技部 |
| National Administration of Traditional Chinese Medicine | | 国家中医药局 |
| February 18, 2023 | | 2023年2月18日 |
| Measures for Ethical Review of Life Science and Medical Research Involving Human Being | | 涉及人的生命科学和医学研究伦理审查办法 |
| Chapter I General Principles | | 第一章 总 则 |
| Article 1 For the purposes of protecting the life and health of human being, safeguarding personal dignity, respecting and protecting the legitimate rights and interests of research participants, promoting the sound development of life science and medical research, and regulating the ethical review of life science and medical research involving human being, these Measures are developed in accordance with the Civil Code of the People's Republic of China, the Basic Healthcare and Health Promotion Law of the People's Republic of China, the Law of the People's Republic of China on Scientific and Technological Progress, the Law of the People's Republic of China on Biosecurity, and the Regulation of the People's Republic of China on the Administration of Human Genetic Resources, etc. | | 第一条 为保护人的生命和健康，维护人格尊严，尊重和保护研究参与者的合法权益，促进生命科学和医学研究健康发展，规范涉及人的生命科学和医学研究伦理审查工作，依据《中华人民共和国民法典》《中华人民共和国基本医疗卫生与健康促进法》《中华人民共和国科学技术进步法》《中华人民共和国生物安全法》《中华人民共和国人类遗传资源管理条例》等，制定本办法。 |
| Article 2 These Measures shall apply to the ethical review of life science and medical research involving human being in medical and health institutions, institutions of higher learning and research institutes, among others, in the territory of the People's Republic of China. | | 第二条 本办法适用于在中华人民共和国境内的医疗卫生机构、高等学校、科研院所等开展涉及人的生命科学和医学研究伦理审查工作。 |
| Article 3 For the purpose of these Measures, “life science and medical research involving human being” refers to the following research activities carried out with biological samples and information data (including health records, behavior, etc.) with human beings as subjects or users (collectively referred to as “research participants”): | | 第三条 本办法所称涉及人的生命科学和医学研究是指以人为受试者或者使用人（统称研究参与者）的生物样本、信息数据（包括健康记录、行为等）开展的以下研究活动： |
| (1) Carrying out activities of research on human reproduction, growth, development and senescence by physics, chemistry, biology and traditional Chinese medicine and other means. | | （一）采用物理学、化学、生物学、中医药学等方法对人的生殖、生长、发育、衰老等进行研究的活动； |
| (2) Carrying out activities of research on human physiological and psychological behavior, pathological phenomena, etiology and pathogenesis of diseases, as well as prevention, diagnosis, treatment of diseases and rehabilitation by physics, chemistry, biology, traditional Chinese medicine, psychology and other means. | | （二）采用物理学、化学、生物学、中医药学、心理学等方法对人的生理、心理行为、病理现象、疾病病因和发病机制，以及疾病的预防、诊断、治疗和康复等进行研究的活动； |
| (3) Carrying out activities of experimental research on human subjects by using new technologies or new products. | | （三）采用新技术或者新产品在人体上进行试验研究的活动； |
| (4) Carrying out activities of collecting, recording, using, reporting or storing biological samples, information data (including health records, behavior, etc.) and other scientific research materials on life science and medical problems involving human being by epidemiology, sociology, psychology, and other means. | | （四）采用流行病学、社会学、心理学等方法收集、记录、使用、报告或者储存有关人的涉及生命科学和医学问题的生物样本、信息数据（包括健康记录、行为等）等科学研究资料的活动。 |
| Article 4 The ethical review work and relevant personnel shall comply with the Constitution, laws and relevant regulations of the People's Republic of China. In life science and medical research involving human being, participants shall be respected, the principles of benefiting, non-harm and justice shall be followed, and the right to privacy and personal information shall be protected. | | 第四条 伦理审查工作及相关人员应当遵守中华人民共和国宪法、法律和有关法规。涉及人的生命科学和医学研究应当尊重研究参与者，遵循有益、不伤害、公正的原则，保护隐私权及个人信息。 |
| Chapter II Ethical Review Committee | | 第二章 伦理审查委员会 |
| Article 5 As subjects assuming the management responsibilities for the work of ethical review, medical institutions at or above Grade II and health institutions at or above the level of districted cities (including disease prevention and control, maternal and child health care, blood collection and supply institutions, etc.) carrying out life science and medical research involving human being, institutions of higher learning, scientific research institutes and other institutions shall set up ethical review committees to conduct ethical review of life science and medical research involving human being, and provide bioethics education and training for researchers, students, scientific research managers and other relevant personnel carrying out life science and medical research involving human being on a regular basis. | | 第五条 开展涉及人的生命科学和医学研究的二级以上医疗机构和设区的市级以上卫生机构（包括疾病预防控制、妇幼保健、采供血机构等）、高等学校、科研院所等机构是伦理审查工作的管理责任主体，应当设立伦理审查委员会，开展涉及人的生命科学和医学研究伦理审查，定期对从事涉及人的生命科学和医学研究的科研人员、学生、科研管理人员等相关人员进行生命伦理教育和培训。 |
| Article 6 Institutions shall take effective measures and provide resources to ensure the independence of the ethical review committees. | | 第六条 机构应当采取有效措施、提供资源确保伦理审查委员会工作的独立性。 |
| Article 7 An ethical review committee shall conduct ethical review of life science and medical research involving human being, including initial review and follow-up review; accept and coordinate complaints of research participants to ensure that the research will not make research participants face unreasonable risk; and organize and provide relevant ethical review training, and provide ethical consultation. | | 第七条 伦理审查委员会对涉及人的生命科学和医学研究进行伦理审查，包括初始审查和跟踪审查；受理研究参与者的投诉并协调处理，确保研究不会将研究参与者置于不合理的风险之中；组织开展相关伦理审查培训，提供伦理咨询。 |
| Article 8 Members of an ethical review committee shall be selected from experts in the fields of life science, medicine, bioethics, law and other fields as well as from the public who are not of the institution. The number of members shall not be less than seven, and there shall be members of different genders. Ethnic minority members shall be considered for regions inhabited by ethnic groups. | | 第八条 伦理审查委员会的委员应当从生命科学、医学、生命伦理学、法学等领域的专家和非本机构的社会人士中遴选产生，人数不得少于7人，并且应当有不同性别的委员，民族地区应当考虑少数民族委员。 |
| Members of an ethical review committee shall have appropriate capacity for ethical review and receive training on ethical knowledge on life science and medical research as well as relevant laws and regulations on a regular basis. | | 伦理审查委员会委员应当具备相应的伦理审查能力，定期接受生命科学和医学研究伦理知识及相关法律法规知识培训。 |
| If necessary, an ethical review committee may retain independent consultants to provide professional advice on particular issues under review and research. Independent consultants shall neither participate in voting and nor have conflict of interest. | | 必要时，伦理审查委员会可以聘请独立顾问，对所审查研究的特定问题提供专业咨询意见。独立顾问不参与表决，不得存在利益冲突。 |
| Article 9 The term of office of a member of an ethical review committee shall not exceed five years and a member may be reappointed. An ethical review committee shall have one chairman and several deputy chairmen, who shall be recommended or elected through consultation by members of the ethical review committee and appointed by the institution. | | 第九条 伦理审查委员会委员任期不超过5年，可以连任。伦理审查委员会设主任委员1人，副主任委员若干人，由伦理审查委员会委员协商推举或者选举产生，由机构任命。 |
| Article 10 Members of an ethical review committee, independent consultants and their staff members shall enter into confidentiality agreements, pledging to keep confidential the sensitive information known during the ethical review. | | 第十条 伦理审查委员会委员、独立顾问及其工作人员应当签署保密协议，承诺对伦理审查工作中获知的敏感信息履行保密义务。 |
| Article 11 An ethical review committee shall accept management of the institution and supervision by the research participants. | | 第十一条 伦理审查委员会应当接受所在机构的管理和研究参与者的监督。 |
| Article 12 An ethical review committee shall establish the working system and standard operating procedures for ethical review, improve the management mechanism for conflict of interest and the quality control mechanism for ethical review, and ensure the independence, objectivity and fairness of the ethical review process. | | 第十二条 伦理审查委员会应当建立伦理审查工作制度、标准操作规程，健全利益冲突管理机制和伦理审查质量控制机制，保证伦理审查过程独立、客观、公正。 |
| An ethical review committee shall establish an ethical review system in advance for emergencies such as epidemic outbreaks and specify the time limit for review. | | 伦理审查委员会应预先制定疫情暴发等突发事件紧急情况下的伦理审查制度，明确审查时限。 |
| Article 13 An institution shall undergo the recordation formalities within three months from the date of formation of an ethical review committee, and upload the information to the National Medical Research Registration and Recordation Information System. Medical and health institutions shall undergo the recordation formalities with their practicing registries. Other institutions shall undergo the recordation formalities with competent authorities at higher levels according to their administrative affiliations. An ethical review committee shall submit the work report of the ethical review committee for the previous year to the recordation authority before March 31 of each year. | | 第十三条 机构应当在伦理审查委员会设立之日起3个月内进行备案，并在国家医学研究登记备案信息系统上传信息。医疗卫生机构向本机构的执业登记机关备案。其他机构按行政隶属关系向上级主管部门备案。伦理审查委员会应当于每年3月31日前向备案机关提交上一年度伦理审查委员会工作报告。 |
| The recordation documents of an ethical review committee shall include: | | 伦理审查委员会备案材料包括： |
| (1) the list of members and their resumes; | | （一）人员组成名单和委员工作简历； |
| (2) the bylaws of the ethical review committee; | | （二）伦理审查委员会章程； |
| (3) the working system or relevant working rules; and | | （三）工作制度或者相关工作规程； |
| (4) other relevant materials required by the recordation authority. | | （四）备案机关要求提供的其他相关材料。 |
| In the event of any change in the aforesaid information, an institution shall update the information with the recordation authority in a timely manner. | | 以上信息发生变化时，机构应当及时向备案机关更新信息。 |
| Article 14 If an institution fails to establish an ethical review committee for carrying out life science and medical research involving human being or the ethical review committee is incompetent for the review, the institution may entrust ethical review to a competent ethical review committee of an institution or a regional ethical review committee in writing. The entrusted ethical review committee shall conduct follow-up review of the research reviewed. A medical and health institution shall entrust ethical review to an ethical review committee of a medical and health institution at a level not lower than its level or a regional ethical review committee. | | 第十四条 机构开展涉及人的生命科学和医学研究未设立伦理审查委员会或者伦理审查委员会无法胜任审查需要的，机构可以书面形式委托有能力的机构伦理审查委员会或者区域伦理审查委员会开展伦理审查。受委托的伦理审查委员会应当对审查的研究进行跟踪审查。医疗卫生机构应当委托不低于其等级的医疗卫生机构的伦理审查委员会或者区域伦理审查委员会开展伦理审查。 |
| The provincial competent health departments shall, in conjunction with the relevant departments, develop measures for the formation and administration of regional ethical review committees. Regional ethical review committees shall undergo recordation formalities with provincial competent health departments and upload the information to the National Medical Research Registration and Recordation Information System. | | 省级卫生健康主管部门会同有关部门制定区域伦理审查委员会的建设和管理办法。区域伦理审查委员会向省级卫生健康主管部门备案，并在国家医学研究登记备案信息系统上传信息。 |
| Chapter III Ethical Review | | 第三章 伦理审查 |
| Article 15 Ethical review shall be generally conducted by meeting of the ethical review committee. | | 第十五条 伦理审查一般采取伦理审查委员会会议审查的方式。 |
| Article 16 An ethical review committee shall require researchers to provide necessary materials for the review, and carry out ethical review and issue review opinions within 30 days after the acceptance. | | 第十六条 伦理审查委员会应当要求研究者提供审查所需材料，并在受理后30天内开展伦理审查并出具审查意见。 |
| In case of emergency, the ethical review shall be conducted in a timely manner. In the case of an epidemic outbreak and other emergencies, ethical reviews shall be carried out and review opinions shall be issued generally within 72 hours, and the requirements for and quality of the ethical review shall not be lowered. | | 情况紧急的，应当及时开展伦理审查。在疫情暴发等突发事件紧急情况下，一般在72小时内开展伦理审查、出具审查意见，并不得降低伦理审查的要求和质量。 |
| Article 17 Life science and medical research involving human being shall have scientific and social value without violating relevant laws and regulations of the state, follow internationally recognized ethical norms, without harming public interests, and satisfy the following basic requirements: | | 第十七条 涉及人的生命科学和医学研究应当具有科学价值和社会价值，不得违反国家相关法律法规，遵循国际公认的伦理准则，不得损害公共利益，并符合以下基本要求： |
| (1) Risk control. The scientific and social benefits of the research shall not override considerations of personal safety and health rights of research participants. The risk-benefit ratio of a research shall be reasonable to minimize the possible risks of research participants. | | （一）控制风险。研究的科学和社会利益不得超越对研究参与者人身安全与健康权益的考虑。研究风险受益比应当合理，使研究参与者可能受到的风险最小化； |
| (2) Informed consent. The right of research participants or their guardians to know and independently decide to participate in a research shall be respected and protected, the informed consent procedure shall be strictly implemented, deception, inducement, coercion and other methods shall not be allowed to be used to make research participants or their guardians agree with participating in a research, and research participants or their guardians shall be allowed to exit from a research unconditionally at any stage. | | （二）知情同意。尊重和保障研究参与者或者研究参与者监护人的知情权和参加研究的自主决定权，严格履行知情同意程序，不允许使用欺骗、利诱、胁迫等手段使研究参与者或者研究参与者监护人同意参加研究，允许研究参与者或者研究参与者监护人在任何阶段无条件退出研究； |
| (3) Fairness and impartiality. Research participants shall be selected in a fair and reasonable manner, the inclusion and exclusion criteria shall be based on clear scientific evidence, and the benefits, risks and burdens of research shall be distributed in a fair and reasonable manner. | | （三）公平公正。应当公平、合理地选择研究参与者，入选与排除标准具有明确的科学依据，公平合理分配研究受益、风险和负担； |
| (4) Free of charge and remedy and compensation. No research-related fees shall be collected from any research participants, and appropriate compensation for reasonable expenses incurred by the research shall be paid to research participants. Research participants shall receive timely and free medical treatment and receive remedy and compensation in accordance with laws and regulations and mutual agreements if they suffer research-related damage. | | （四）免费和补偿、赔偿。对研究参与者参加研究不得收取任何研究相关的费用，对于研究参与者在研究过程中因参与研究支出的合理费用应当给予适当补偿。研究参与者受到研究相关损害时，应当得到及时、免费的治疗，并依据法律法规及双方约定得到补偿或者赔偿； |
| (5) Protecting privacy and personal information. The privacy of research participants shall be effectively protected, research participants shall be truthfully notified of the collection, storage, use and confidentiality measures for their personal information and permission shall be obtained, and their personal information shall not be disclosed to any third party without their authorization. | | （五）保护隐私权及个人信息。切实保护研究参与者的隐私权，如实将研究参与者个人信息的收集、储存、使用及保密措施情况告知研究参与者并得到许可，未经研究参与者授权不得将研究参与者个人信息向第三方透露； |
| (6) Special protection. Special protection shall be given to participants in research on specific groups such as children, pregnant and lying-in women, senior citizens, persons with intellectual disabilities and persons with mental disabilities; and special attention shall be paid to those involving fertilized eggs, embryos, foetuses or those who may be affected by assisted reproductive technology. | | （六）特殊保护。对涉及儿童、孕产妇、老年人、智力障碍者、精神障碍者等特定群体的研究参与者，应当予以特别保护；对涉及受精卵、胚胎、胎儿或者可能受辅助生殖技术影响的，应当予以特别关注。 |
| Article 18 Researchers of life science and medical research involving human being shall submit the following materials to the ethical review committee when applying for initial ethical review: | | 第十八条 涉及人的生命科学和医学研究的研究者在申请初始伦理审查时应当向伦理审查委员会提交下列材料： |
| (1) The letter of commitment on integrity of research materials. | | （一）研究材料诚信承诺书； |
| (2) The application form for ethical review. | | （二）伦理审查申请表； |
| (3) The information on researchers, the legal qualification certificates of relevant institutions involved in the research and the explanations for sources of research funds. | | （三）研究人员信息、研究所涉及的相关机构的合法资质证明以及研究经费来源说明； |
| ．．．．．． | | ．．．．．． |
Dear visitor,you are attempting to view a subscription-based section of lawinfochina.com. If you are already a subscriber, please login to enjoy access to our databases . If you are not a subscriber, please subscribe . Should you have any questions, please contact us at:
+86 (10) 8268-9699 or +86 (10) 8266-8266 (ext. 153)
Mobile: +86 133-1157-0713
Fax: +86 (10) 8266-8268
database@chinalawinfo.com
| |
您好：您现在要进入的是北大法律英文网会员专区，如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户，请注册并交纳相应费用成为我们的英文会员 。如有问题请来电咨询；
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail: database@chinalawinfo.com
|
| | | |
| | | |