汇业评论

随着适用范围的扩大，管理对象也由“各级各类医疗卫生机构”拓展为“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”。相应的，《办法》根据行政隶属关系明确伦理审查的管理机构及监管职责。

As the scope of application expands, the management subjects have also been extended from “medical and health institutions at all levels and of all types” to “medical and health institutions, universities, research institutes, etc. within the territory of the People's Republic of China”. Accordingly, the “Measures” specify the ethical review management agency and regulatory responsibilities based on administrative affiliation.

就管理部门而言，国家卫生健康委负责全国医疗卫生机构开展的涉及人的生命科学和医学研究伦理审查监督；国家中医药局负责涉及人的中医药学研究伦理审查监督；教育部负责全国高等学校开展的涉及人的生命科学和医学研究伦理审查监督，并管理教育部直属高等学校相关工作；其他高等学校和科研院所开展的涉及人的生命科学和医学研究伦理审查的监督管理按行政隶属关系由相关部门负责。

Regarding the management department, the National Health Commission shall be responsible for the supervision of ethical review of life science and medical research involving humans conducted by medical and health institutions nationwide; the National Administration of Traditional Chinese Medicine shall be responsible for the supervision of ethical review of TCM research involving humans; the Ministry of Education shall be responsible for the supervision of ethical review of life science and medical research involving humans conducted by institutions of higher learning nationwide and administration of the relevant work of the institutions of higher learning directly under it; and the relevant authorities shall be in charge of the supervision and administration of the ethical review of the life science and medical research involving humans conducted by other institutions of higher learning and scientific research institutes according to the relationship of administrative subordination.

就管理层级而言，国家卫生健康委会同有关部门共同负责全国涉及人的生命科学和医学研究伦理审查的监督管理。县级以上地方人民政府卫生健康、教育等部门依据职责分工负责本辖区涉及人的生命科学和医学研究伦理审查的监督管理。

Regarding the management level, the National Health Commission shall, jointly with the relevant authorities, be responsible for the supervision and administration of ethical review of life science and medical research involving humans nationwide. The departments of health, education and other departments of the local people’s governments at the county level or above shall, according to the division of their duties, be responsible for the supervision and administration of the ethical review of the life science and medical research involving humans within their respective jurisdictions.

《办法》规定，开展涉及人的生命科学和医学研究的二级以上医疗机构、设区的市级以上卫生机构（包括疾病预防控制机构、妇幼保健、采供血机构等）、高等学校、科研院所等应当设立伦理审查委员会。

According to the “Measures”, Medical institutions at or above Grade II, health agencies at or above the level of the city with districts (including disease prevention and control, maternal and child health care, blood collection and supply centers, etc.), institutions of higher learning, scientific research institutes and other organizations that carry out life science and medical research involving humans shall set up an ethics review committee.

《办法》将“伦理委员会”的名称更新为“伦理审查委员会”，意在对于伦理委员会审查责任进行明确，强调伦理审查委员会对负责的研究的伦理审查需要包括初始审查和跟踪审查。[ii]除伦理审查之外，《办法》进一步明确伦理审查委员会的伦理审查培训及伦理咨询的职责。

The “Measures” updated the name of “Ethics Committee” to “Ethics Review Committee” to clarify the committee’s responsibility for conducting ethical reviews, emphasizing that the ethics review committee should conduct both initial and follow-up reviews of the research it oversees. In addition to the ethical review process, the “Measures”  also outline the responsibilities of the ethics review committee in providing ethical review training and consultation.

为实现对人的生命科学和医学研究伦理审查的全面覆盖，《办法》允许委托有能力的伦理审查委员会开展伦理审查。委托伦理审查制度对未建立伦理审查委员会或缺乏伦理审查能力的机构提供了解决方案与积极指引。具体而言：

To achieve comprehensive coverage of ethics review for human life science and medical research, the “Measures” allow competent ethics review committee to be entrusted to carry out the ethical review. The system of entrusting ethics review provides a solution and positive guidance for institutions that have not established ethics review committees or lack the ability to conduct ethics review. Specifically，

1.明确未设立伦理审查委员会的机构或者伦理审查委员会无法胜任审查需要的机构可以书面委托区域伦理审查委员会或者有能力的机构伦理审查委员会开展伦理审查。

i. Institutions without an ethics review committee or those whose ethics review committee is unable to conduct the necessary review may entrust a regional ethics review committee or competent institutional ethics review committee in writing to carry out an ethics review.

2.企业独立开展研究的，可以委托机构伦理审查委员会或区域伦理审查委员会，并通过跟踪审查实现延伸监管。

ii. For enterprises conducting independent research, they may entrust in writing a competent institutional ethics review committee or regional ethics review committee to conduct an ethical review.

3.企业和机构合作开展研究的，机构应当充分了解研究的整体情况，通过伦理审查、开展跟踪审查。

iii. In research collaborations between enterprises and institutions, the institutions shall fully understand the overall conditions of the research, pass an ethical review and conduct a follow-up review.

考虑到医疗卫生机构主要开展临床研究，对风险控制较高。《办法》要求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。

iv. Given that medical and health institutions mainly engage in clinical research with high-risk control, the “Measures”  stipulates that a medical and health institution shall entrust the ethics review committee or the regional ethics review committee of a medical and health institution not lower than its level to conduct the ethical review.

1.明确了简易审查的适用情形

i. Clarify the Applicable Situations for Expedited Review

《办法》在11号令和《药物临床试验伦理审查工作指导原则》的基础上，明确了简易审查方式的4种情形，即（1）研究风险不大于最小风险的研究；（2）已批准的研究方案作较小修改且不影响研究风险受益比的研究；（3）已批准研究的跟踪审查；（4）多机构开展的研究中，参与机构的伦理审查委员会对牵头机构出具伦理审查意见的确认等。

On the basis of Decree 11 and the Guidelines for Ethical Review of Clinical Drug Trials, the “Measures” clarify the four situations applicable for expedited review: (1) the research whose risk is not greater than the minimum risk; (2) the research in which a minor modification is made to an approved research protocol and such modification does not affect the risk-benefit ratio; (3) follow-up review of approved research; and (4) in the case of research carried out by multiple organizations, the ethical review committee of participating organizations' confirmation of the ethical review opinions issued by the lead organization.

2.增加免除伦理审查制度

ii. Add Exemption from Ethics Review

考虑到基础研究活动大多不直接涉及人体试验，部分研究也并不直接涉及研究参与者的临床诊疗信息，借鉴国际通行的做法，为提高审查效率，减少科研人员不必要负担[iii]，《办法》新增免除伦理审查的标准，在满足三个前提的条件下，四项研究范围可以免除伦理审查，三个前提分别是（1）不对人体造成伤害；（2）不涉及敏感个人信息；（3）不涉及商业利益的；四种情形分别为，（1）利用合法获得的公开数据，或者通过观察且不干扰公共行为产生的数据进行研究的；（2）使用匿名化的信息数据开展研究的；（3）使用已有的人的生物样本开展研究，所使用的生物样本来源符合相关法规和伦理原则，研究相关内容和目的在规范的知情同意范围内，且不涉及使用人的生殖细胞、胚胎和生殖性克隆、嵌合、可遗传的基因操作等活动的；（4）使用生物样本库来源的人源细胞株或者细胞系等开展研究，研究相关内容和目的在提供方授权范围内，且不涉及人胚胎和生殖性克隆、嵌合、可遗传的基因操作等活动的。

Considering that most basic research activities do not directly involve human experiments, and some research does not directly involve clinical diagnosis and treatment information of research participants, the “Measures” draw on international practices to increase review efficiency and reduce unnecessary burdens on researchers. The “Measures” add standards for exemption from ethical review. Under three prerequisites, four research categories can be exempted from ethical review. The three prerequisites are as follows: (1) no harm to human beings; (2) no involvement of sensitive personal information; and (3) no involvement of commercial interests. The four categories are as follows: (1) conducting research using legally obtained public data or data generated through observation that does not interfere with public behaviors; (2) conducting research using anonymized information and data; (3) conducting research using existing human biological samples, the sources of the biological samples used are in compliance with the relevant laws and regulations and ethical principles, the relevant content and purpose of the research are within the regulated scope of informed consent, and such research does not involve the use of human reproductive cells, embryos and reproductive cloning, chimerism, heritable genetic manipulation or other activities; and (4) conducting research using the human derived cell strains or cell lines from the biological sample library, the relevant content and purpose of the research are within the scope of authorization of the provider, and such research does not involve human embryos and reproductive cloning, chimerism, heritable genetic manipulation or other activities.

1.规定了伦理审查委员会的审查时限

i. Prescribe Time Limit for Ethics Review Committee Review

为提高审查的效率确保审查工作的合规稳步推进，《办法》规定伦理审查委员会开展伦理审查并出具审查意见的期限一般应在受理后30天内。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，且不得降低伦理审查的要求和质量。

In order to improve the efficiency of the review and ensure the compliant and steady progress of the review work, the “Measures” stipulate that the ethics review committee should conduct an ethical review and issue review opinions within 30 days after accepting the application. In case of an emergency, the ethical review shall be conducted in a timely manner. In the case of an epidemic outbreak and other emergencies, the ethical review shall generally be conducted with review opinions issued within 72 hours, provided that the requirements and quality of ethical review shall not be lowered.

2.细化伦理审查材料

ii. Detail Ethical Review Materials

《办法》对所提交伦理审查的材料进一步细化，其中新增（一）研究材料诚信承诺书；（六）生物样本、信息数据的来源证明；（七）科学性论证意见；（八）利益冲突申明；（九）招募广告及其发布形式；（十）研究成果的发布形式说明。

The “Measures” further specify the materials required for ethical review, including the addition of (1) a letter of commitment to the integrity of research materials; (6) the proof of origin of biological samples and information data; (7) opinions of the scientific demonstration; (8) a declaration of conflict of interest; (9) recruitment advertisements and the way of release thereof; (10) an explanation of the way to release the research results.

3.新增重点审查内容

iii. Add Key Review Content

《办法》新增了伦理委员会初始审查的重点审查内容：（一）研究是否符合法律法规、规章和相关规定的要求；（七）研究参与者招募方式、途径是否恰当；（八）是否明确告知研究参与者应当享有的权益，包括不会因为退出研究而受到不公正对待的权利，告知退出研究后的影响、其他治疗方法等；（十三）是否涉及社会敏感的伦理问题；（十四）研究结果是否发布，其发布方式和时间是否恰当。

The “Measures” add key review contents to the initial review of the ethics committee, which include: (1) whether the research is in violation of laws, regulations, rules and relevant provisions; (7) whether the method and channel of recruitment of research participants are appropriate and fair; (8) whether the research participants are clearly informed of the rights and interests that they are entitled to, including the right to not be unfairly treated due to such withdrawal, the impact of withdrawal from the research, other treatment methods, etc.; (13) whether the research involves any socially sensitive ethical issue; (14) whether the research results are released in a proper way at an appropriate time.

就无行为能力、限制行为能力的研究参与者，不仅需要获得其监护人的书面知情同意，还需要在获得监护人同意的同时，研究者还应该在研究参与者可理解的范围内告知相关信息，并征得其同意。前述规定是对知情同意原则中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的具体落实。

For research participants without or with limited capacity for civil conduct, not only is written informed consent required from their legal guardians, but researchers should also inform them of relevant information within their comprehensible range and obtain their consent at the same time as obtaining consent from their legal guardians. The aforementioned provisions are the specific implementation of the principle of informed consent, which respects and safeguards the right to information and the right to make independent decisions of research participants or their legal guardians.

《办法》对知情同意书的内容进行了增补与调整，主要新增内容包括要求：（8）研究者、伦理委员会以及发生问题时的联系人和联系方式；（9）研究的时间和研究参与者数量；（10）研究结果是否会反馈研究参与者；（11）告知研究参与者可能的替代治疗及其主要的受益和风险；（12）涉及人的生物样本采集的，还应当包括生物样本的种类、数量、用途、保藏、利用（包括是否直接用于产品开发、共享和二次利用）、隐私保护、对外提供、销毁处理等相关内容。

The “Measures” made supplementary and adjusted changes to the content of the informed consent form, mainly adding requirements that include:(8) the contact person and contact information of the investigator, contact person and contact information of the ethical review committee, and contact person and contact information when problems occur; (9) the time of the research and the number of research participants; (10) whether the research results will be fed back to the research participants; (11) research participants shall be informed of possible replacement therapy as well as its main benefits and risks; (12) if biological samples involving humans are collected, such information shall also be included as the types, quantity, purpose, preservation and utilization of biological samples (including whether they are directly used for product development, sharing and secondary utilization), privacy protection, provision to external parties, destruction and other related contents.

研究过程中发生下列情形时，研究者应当再次获取研究参与者的知情同意：（1）与研究参与者相关的研究内容发生实质性变化的；（2）与研究相关的风险实质性提高或者增加的；（3）研究参与者民事行为能力等级提高的。

If any of the following circumstances occur during the research, an investigator shall obtain the informed consent of research participants again: (1)where the research contents relating to the research participants have undergone a substantial change; (2) where the risks related to the research have been substantially enhanced or increased; or (3) where the grade of the civil capacity of the research participants has been enhanced.

《办法》草案中仅强调保护“隐私”系涉及人的生命科学和医学研究的原则,未明确提及保护“个人信息”。考虑《个人信息保护法》中将医疗健康信息、生物识别信息列为个人敏感信息，为与个人信息保护相关规定接轨，《办法》正式稿中将保护“个人信息”也列为涉及人的生命科学和医学研究的原则。并要求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。

The draft version of the “Measures” only emphasized the principle of protecting “privacy” in life science and medical research involving human subjects without explicitly mentioning the protection of “personal information”. Considering that the Personal Information Protection Law classifies medical and health information and biometric information as personal sensitive information, in order to align with the relevant provisions of personal information protection, the formal version of the “Measures” include the protection of “personal information” as a principle for life science and medical research involving human subjects. It also requires that the collection, storage, use and confidentiality measures for their personal information and obtain their permission shall be truthfully disclosed and approved by the research participants. No personal information of research participants may be disclosed to any third party without their authorization.

《办法》不仅要求伦理审查委员会委员签署保密协议，独立顾问及其工作人员也应当签署保密协议，承诺对伦理审查工作中获知的敏感信息履行保密义务。

The “Measures” not only require members of ethics review committees to sign confidentiality agreements, but also require independent consultants and their staff to sign confidentiality agreements, undertaking to keep confidential the sensitive information accessed in the ethical review work.

涉及国家秘密的，在提交伦理审查和获取研究参与者知情同意时应当进行脱密处理。无法进行脱密处理的，应当签署保密协议并加强管理。未经脱密处理的研究不得在国家医学研究登记备案信息系统上传。

Where any state secret is involved, it shall be declassified when the research is submitted for ethical review, and the informed consent of research participants is obtained. If it is impossible to declassify the research, a confidentiality agreement shall be signed, and management shall be strengthened. The research without declassification shall not be uploaded to the National Medical Research Registration and Record-filing Information System.

《办法》的出台使伦理审查工作不再局限于医疗机构和医学研究，实现了高等学校、科研院所的全面覆盖。在委托伦理审查、免除伦理审查等制度上实现了创新，对审查资料、审查时限、审查内容、知情同意、个人信息保护等内容都做了优化，回应了各方的诉求，开启了伦理审查工作的新阶段。

The release of the “Measures” has expanded the scope of ethical review beyond medical institutions and medical research, achieving comprehensive coverage of universities and research institutes. The “Measures” have also introduced innovations in the systems for entrusted ethical review and exemption from ethical review, and have optimized the review materials, time limits, review content, informed consent, and personal information protection, among other aspects, in response to the demands of all parties. The “Measures” mark a new stage in the work of ethical review.

[ii]陈仲林，杨梦婕，侯旭敏，李雪宁，董丹妮，冯钰．《涉及人的生命科学和医学研究伦理审查办法》的思考——从医疗机构视角．中国医学伦理学。

[iii]《<涉及人的生命科学和医学研究伦理审查办法>文件解读》, 卫生健康委网站http://www.gov.cn/zhengce/2023-02/28/content_5743660.htm