---
title_en: "Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans"
title_zh: "涉及人的生命科学和医学研究伦理审查办法"
abbreviation: "Life Sciences Ethics Review Measures"
hierarchy: "rule"
issuing_body: "National Health Commission; Ministry of Education; Ministry of Science and Technology; National Administration of Traditional Chinese Medicine"
adopted_date: 2023-02-18
effective_date: 2023-02-18
status: "effective"
related_laws: ["sci-tech-ethics-review-measures", "biomedical-research-ethics-review-measures-2016", "hgr-regulation", "hgr-implementing-rules", "drug-clinical-trial-qms-2026", "medical-device-clinical-trial-qms", "healthcare-institutions-data-security-pi-measures", "national-health-medical-big-data-measures", "basic-medical-health-care-promotion-law", "civil-code-personal-info", "pipl"]
domains: ["health", "personal-information"]
url: https://datacompliancechina.com/laws/life-sciences-medical-research-ethics-review-measures/
summary: "Issued on February 18, 2023 as 国卫科教发〔2023〕4号 by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the National Administration of Traditional Chinese Medicine, after review by the National Science and Technology Ethics Committee and with State Council consent, and effective on issue, these 54-article Measures replace the 2016 rules on biomedical research and are the operative ethics-review regime for any research that uses human subjects or human biological samples and information data — health records and behavioral data included. Level-2-and-above hospitals, prefecture-level-and-above health institutions, universities and research institutes must set up ethics review committees of at least seven members (with outside and different-gender members), file them within three months, and upload every approved study to the national medical research registration system before it starts. The Measures fix a 30-day review clock (72 hours in an epidemic), majority voting, follow-up review at least every 12 months, a simplified track for minimal-risk work, and — the provision data lawyers cite most — Article 32's four exemptions from ethics review: research on lawfully obtained public data or unobtrusive observation, on anonymized information data, on existing samples within their original consent, and on biobank cell lines within the provider's authorization, provided no sensitive personal information or commercial interest is involved. Chapter IV specifies the twelve mandatory elements of informed consent, including how data will be shared or reused, and requires re-consent when research content or risk changes materially. Article 28 makes institutions that supply samples or data to enterprises responsible for contractually fixing scope and use and supervising disposal after the study."
---

> **Source: Data Compliance China** — https://datacompliancechina.com/laws/life-sciences-medical-research-ethics-review-measures/ · English rendering and annotations by DCC; the Chinese original governs. Cite as: Data Compliance China, "Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans", https://datacompliancechina.com/laws/life-sciences-medical-research-ethics-review-measures/
**Promulgated by:** National Health Commission (国家卫生健康委), Ministry of Education, Ministry of Science and Technology, National Administration of Traditional Chinese Medicine.  
**Document No.:** 国卫科教发〔2023〕4号 (Guo Wei Ke Jiao Fa [2023] No. 4).  
**Issued and effective February 18, 2023.**

> *Translation note — DCC. Translated in full from the official Chinese text
> of the issuing notice and the Measures. Terminology follows DCC's bilingual
> glossary. 研究参与者 is rendered "research participant" — the Measures
> deliberately broaden the older term 受试者 ("subject") to cover anyone whose
> samples, data, health records or behavior are used (see Article 50). These
> Measures replace the 2016
> [Measures for the Ethical Review of Biomedical Research Involving Humans](/laws/biomedical-research-ethics-review-measures-2016/)
> and operate under the cross-sector
> [Measures for the Ethical Review of Science and Technology (Trial)](/laws/sci-tech-ethics-review-measures/).*

---

## Notice on Issuing the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans

To the people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions and directly affiliated institutions of the State Council, and the China Association for Science and Technology:

The *Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans* have been deliberated and adopted by the National Science and Technology Ethics Committee. With the consent of the State Council, they are hereby issued to you. Please organize their implementation conscientiously in light of actual work.

National Health Commission  
Ministry of Education  
Ministry of Science and Technology  
National Administration of Traditional Chinese Medicine

February 18, 2023

---

# Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans

## Chapter I General Provisions

**Article 1.** These Measures are formulated in accordance with the Civil Code of the People's Republic of China, the Law of the People's Republic of China on Basic Medical and Health Care and the Promotion of Health, the Law of the People's Republic of China on Progress of Science and Technology, the Biosecurity Law of the People's Republic of China, the Regulations of the People's Republic of China on the Administration of Human Genetic Resources and other instruments, in order to protect human life and health, safeguard human dignity, respect and protect the lawful rights and interests of research participants, promote the healthy development of life sciences and medical research, and regulate the ethical review of life sciences and medical research involving humans.

**Article 2.** These Measures apply to the ethical review of life sciences and medical research involving humans carried out by healthcare institutions, institutions of higher education, research institutes and the like within the territory of the People's Republic of China.

**Article 3.** "Life sciences and medical research involving humans" as used in these Measures means the following research activities carried out with humans as subjects or using the biological samples or information data (including health records, behavior and the like) of humans (collectively "research participants"):

(1) research using physical, chemical, biological, traditional Chinese medicine or other methods on human reproduction, growth, development, aging and the like;

(2) research using physical, chemical, biological, traditional Chinese medicine, psychological or other methods on human physiology, psychological behavior, pathological phenomena, the causes and mechanisms of disease, and the prevention, diagnosis, treatment and rehabilitation of disease;

(3) experimental research on the human body using new technologies or new products;

(4) research using epidemiological, sociological, psychological or other methods to collect, record, use, report or store biological samples, information data (including health records, behavior and the like) and other scientific research materials relating to humans that involve life sciences and medical issues.

**Article 4.** Ethical review and the persons involved in it shall comply with the Constitution, laws and relevant regulations of the People's Republic of China. Life sciences and medical research involving humans shall respect research participants, follow the principles of beneficence, non-maleficence and justice, and protect the right to privacy and personal information.

## Chapter II Ethics Review Committees

**Article 5.** Medical institutions at level 2 or above, health institutions at the level of cities divided into districts or above (including disease prevention and control, maternal and child health, and blood collection and supply institutions), institutions of higher education, research institutes and other institutions that carry out life sciences and medical research involving humans are the entities responsible for the management of ethical review; they shall establish ethics review committees to conduct the ethical review of such research, and shall regularly provide bioethics education and training to researchers, students, research administrators and other personnel engaged in such research.

**Article 6.** Institutions shall take effective measures and provide resources to ensure the independence of the work of the ethics review committee.

**Article 7.** The ethics review committee shall conduct ethical review of life sciences and medical research involving humans, including initial review and follow-up review; accept and coordinate the handling of complaints from research participants, ensuring that research does not expose participants to unreasonable risk; and organize ethics review training and provide ethics consultation.

**Article 8.** Members of the ethics review committee shall be selected from experts in life sciences, medicine, bioethics, law and other fields and from members of the public not belonging to the institution; there shall be no fewer than seven members, including members of different genders, and in ethnic regions consideration shall be given to members from ethnic minorities.

Members shall possess the corresponding capability for ethical review and shall regularly receive training in the ethics of life sciences and medical research and in the relevant laws and regulations.

Where necessary, the ethics review committee may engage independent consultants to provide professional advisory opinions on specific issues in the research under review. Independent consultants shall not take part in voting and shall have no conflict of interest.

**Article 9.** The term of a member shall not exceed five years and may be renewed. The ethics review committee shall have one chair and several vice-chairs, recommended by consultation or elected by the members and appointed by the institution.

**Article 10.** Members of the ethics review committee, independent consultants and its staff shall sign confidentiality agreements undertaking to keep confidential the sensitive information learned in the course of ethical review.

**Article 11.** The ethics review committee shall accept the management of the institution to which it belongs and the supervision of research participants.

**Article 12.** The ethics review committee shall establish ethical review working systems and standard operating procedures, and improve its conflict-of-interest management mechanism and ethical review quality-control mechanism, to ensure that the review process is independent, objective and impartial.

The ethics review committee shall formulate in advance an ethical review system for emergencies such as epidemic outbreaks, specifying review time limits.

**Article 13.** An institution shall file its ethics review committee for the record within three months of its establishment and upload the information to the national medical research registration and filing information system. Healthcare institutions shall file with their practice-registration authority. Other institutions shall file with their superior competent department according to their line of administrative affiliation. The ethics review committee shall submit the previous year's work report to the filing authority by March 31 each year.

The filing materials for an ethics review committee include:

(1) the list of members and members' curricula vitae;

(2) the committee's charter;

(3) its working systems or relevant working procedures;

(4) other relevant materials required by the filing authority.

When the above information changes, the institution shall promptly update it with the filing authority.

**Article 14.** Where an institution carrying out life sciences and medical research involving humans has not established an ethics review committee, or its committee is unable to meet the needs of review, the institution may entrust in writing a capable institutional ethics review committee or a regional ethics review committee to conduct the review. The entrusted committee shall conduct follow-up review of the research it reviews. A healthcare institution shall entrust the ethics review committee of a healthcare institution of no lower grade than its own, or a regional ethics review committee.

Provincial health authorities shall, together with the relevant departments, formulate measures for the establishment and management of regional ethics review committees. Regional ethics review committees shall file with the provincial health authority and upload information to the national medical research registration and filing information system.

## Chapter III Ethical Review

**Article 15.** Ethical review shall generally be conducted by meeting of the ethics review committee.

**Article 16.** The ethics review committee shall require the researcher to provide the materials needed for review and shall conduct the review and issue its review opinion within 30 days of acceptance.

In urgent circumstances, ethical review shall be conducted promptly. In emergencies such as epidemic outbreaks, ethical review shall generally be conducted and a review opinion issued within 72 hours, and the requirements and quality of ethical review shall not be lowered.

**Article 17.** Life sciences and medical research involving humans shall have scientific and social value, shall not violate the relevant national laws and regulations, shall follow internationally recognized ethical guidelines, shall not harm the public interest, and shall meet the following basic requirements:

(1) Risk control. The scientific and social interests of the research shall not override consideration of the personal safety and health rights and interests of research participants. The risk–benefit ratio of the research shall be reasonable, minimizing the risks to which research participants may be exposed.

(2) Informed consent. The right to know and the right to decide autonomously whether to participate in research of research participants or their guardians shall be respected and safeguarded; the informed-consent procedure shall be strictly performed; deception, inducement, coercion or other means shall not be used to obtain the consent of research participants or their guardians; and research participants or their guardians shall be allowed to withdraw from the research unconditionally at any stage.

(3) Fairness and justice. Research participants shall be selected fairly and reasonably, inclusion and exclusion criteria shall have a clear scientific basis, and the benefits, risks and burdens of research shall be allocated fairly and reasonably.

(4) No charge, and compensation and damages. No research-related fees shall be charged to research participants for participating in research; reasonable expenses incurred by research participants because of their participation shall be appropriately compensated. Where a research participant suffers research-related harm, they shall receive timely, free treatment and compensation or damages in accordance with laws, regulations and the agreement of the parties.

(5) Protection of privacy and personal information. The right to privacy of research participants shall be effectively protected; the collection, storage and use of research participants' personal information and the confidentiality measures shall be truthfully disclosed to research participants and their permission obtained; and research participants' personal information shall not be disclosed to third parties without the participants' authorization.

(6) Special protection. Research participants belonging to specific groups such as children, pregnant and postpartum women, the elderly, persons with intellectual disabilities and persons with mental disorders shall be given special protection; research involving fertilized eggs, embryos, fetuses or persons who may be affected by assisted reproductive technology shall be given special attention.

**Article 18.** When applying for initial ethical review, the researcher of life sciences and medical research involving humans shall submit the following materials to the ethics review committee:

(1) an undertaking as to the integrity of the research materials;

(2) the ethical review application form;

(3) information on the researchers, proof of the lawful qualifications of the institutions involved in the research, and an explanation of the sources of research funding;

(4) the research protocol and related materials, including the literature review, preclinical research and animal-experiment data;

(5) the informed-consent form;

(6) proof of the sources of biological samples and information data;

(7) the opinion on scientific validity;

(8) the conflict-of-interest declaration;

(9) recruitment advertisements and the form of their publication;

(10) an explanation of the form in which research results will be published;

(11) other relevant materials the ethics review committee considers necessary.

**Article 19.** Upon receiving the application materials, the ethics review committee shall promptly accept them and organize the initial review, focusing on the following:

(1) whether the research violates the requirements of laws, regulations, rules and relevant provisions;

(2) whether the researchers' qualifications, experience and technical capability meet the requirements of the research;

(3) whether the research protocol is scientific, has social value and meets the requirements of ethical principles; in reviewing traditional Chinese medicine research protocols, traditional practical experience shall also be considered;

(4) whether the risks to which research participants may be exposed are within a reasonable range compared with the expected benefits of the research;

(5) whether the information provided in the informed-consent form is sufficient, complete and understandable, and whether the process of obtaining informed consent is compliant and appropriate;

(6) whether the confidentiality measures for research participants' personal information and related materials are adequate;

(7) whether the methods, channels, inclusion and exclusion criteria for recruiting research participants are appropriate and fair;

(8) whether research participants have been clearly informed of the rights and interests they enjoy, including the right to withdraw at any time during the research without giving reasons and without unfair treatment, and informed of the consequences of withdrawal and of alternative treatments;

(9) whether reasonable expenses incurred by research participants have been appropriately compensated, and whether the treatment, compensation or damages provided when research participants suffer harm are reasonable and lawful;

(10) whether a qualified or trained researcher is responsible for obtaining informed consent and available at all times to answer research-related questions;

(11) whether there are preventive and response measures for the risks research participants may bear in the research;

(12) whether the research involves conflicts of interest;

(13) whether the research involves socially sensitive ethical issues;

(14) whether the research results will be published and whether the manner and timing are appropriate;

(15) other key contents requiring review.

**Article 20.** Members of the ethics review committee who have a conflict of interest with the research shall recuse themselves from the review. The committee shall require members with a conflict of interest to recuse themselves.

**Article 21.** The basic standards for approval of research by the ethics review committee are:

(1) the research has scientific and social value, does not violate laws and regulations and does not harm the public interest;

(2) the rights of research participants are respected, and their privacy and personal information are protected;

(3) the research protocol is scientific;

(4) the inclusion and exclusion criteria for research participants are scientific and fair;

(5) the risk–benefit ratio is reasonable and risks are minimized;

(6) informed consent is standardized and effective;

(7) the research institution and researchers are competent;

(8) the manner, content and timing of publication of research results are reasonable;

(9) the researchers comply with research norms and integrity.

**Article 22.** The ethics review committee may decide to approve, not approve, approve subject to modification, re-review after modification, continue, suspend or terminate the research under review, and shall state its reasons.

A decision of the ethics review committee shall be agreed by more than one-half of all its members. Members shall vote after full discussion of the ethical issues involved in the research, and opinions differing from the review decision shall be recorded in detail.

**Article 23.** Where research approved by the ethics review committee requires modification of the research protocol, informed-consent form, recruitment materials or other materials provided to research participants, the researcher shall submit the modified documents to the committee for review.

**Article 24.** Before research approved by the ethics review committee is implemented, the researcher, the ethics review committee and the institution shall each truthfully, completely and accurately upload the research, the ethics review opinion, the institutional review opinion and other information in accordance with the requirements of the national medical research registration and filing information system, and shall update the information promptly as the research progresses. Researchers, ethics review committees and institutions are encouraged to upload information in real time in the course of research management.

The National Health Commission shall continuously optimize the national medical research registration and filing information system.

**Article 25.** For research that has been approved and implemented, the researcher shall promptly submit as required reports of various kinds on research progress, serious adverse events, protocol deviations, suspension, termination and completion.

The ethics review committee shall conduct follow-up review on the basis of the reports submitted by the researcher. Follow-up review shall cover:

(1) whether the research is being conducted in accordance with the approved protocol and reported promptly;

(2) whether the research content has been changed without authorization in the course of the research;

(3) whether there are changes or new information that increase the risk to research participants or significantly affect the conduct of the research;

(4) whether the research needs to be suspended or terminated early;

(5) other contents requiring review.

The interval between follow-up reviews shall not exceed 12 months.

**Article 26.** Unless otherwise provided, the researcher shall immediately report serious adverse events occurring in the course of the research to the ethics review committee; the committee shall review them promptly to determine whether the measures taken by the researcher to protect the personal safety and health rights and interests of research participants are adequate, re-assess the risk–benefit ratio of the research, and issue a review opinion.

**Article 27.** Research carried out at multiple institutions may establish a collaborative ethics review mechanism to ensure that all institutions follow the principles of consistency and timeliness.

Both the lead institution and the participating institutions shall organize ethical review.

The ethics review committee of a participating institution shall conduct follow-up review of the research in which its institution participates.

**Article 28.** Where an institution cooperates with an enterprise or other institution in life sciences and medical research involving humans, or provides human biological samples or information data to an enterprise or other institution for such research, the institution shall fully understand the overall situation of the research, conduct ethical review and follow-up review, specify by agreement the scope of use and manner of handling of the biological samples and information data, and supervise their proper disposal after the research ends.

**Article 29.** When publishing the results of life sciences and medical research involving humans, academic journals shall confirm that the research has been approved by an ethics review committee. Researchers shall provide the relevant proof.

**Article 30.** Ethical review shall be independent; no institution or individual shall interfere with the ethical review process or review decisions of the ethics review committee.

**Article 31.** Simplified-procedure review may apply in the following circumstances:

(1) research whose risk is no greater than minimal risk;

(2) research involving a minor modification to an approved protocol that does not affect the risk–benefit ratio;

(3) follow-up review of approved research;

(4) in multi-institution research, confirmation by the ethics review committee of a participating institution of the ethics review opinion issued by the lead institution, and the like.

Simplified-procedure review shall be conducted by two or more members designated by the chair of the ethics review committee, who shall issue the review opinion. The review opinion shall be reported at a meeting of the ethics review committee.

Where, in the course of simplified-procedure review, the risk–benefit ratio of the research changes, the reviewing members disagree, or a reviewing member requests meeting review, the review shall be converted to meeting review.

**Article 32.** Life sciences and medical research involving humans that uses human information data or biological samples in the following circumstances, that causes no harm to the human body and involves no sensitive personal information or commercial interest, may be exempted from ethical review, so as to reduce unnecessary burdens on researchers and promote the conduct of life sciences and medical research involving humans:

(1) research using lawfully obtained public data, or data generated by observation without interference with public behavior;

(2) research using anonymized information data;

(3) research using existing human biological samples, where the sources of the samples comply with the relevant regulations and ethical principles, the content and purpose of the research fall within the scope of standardized informed consent, and the research does not involve the use of human germ cells, embryos, or reproductive cloning, chimerism, heritable genetic manipulation or similar activities;

(4) research using human-derived cell strains or cell lines from biobanks, where the content and purpose of the research fall within the scope of the provider's authorization and the research does not involve human embryos, reproductive cloning, chimerism, heritable genetic manipulation or similar activities.

## Chapter IV Informed Consent

**Article 33.** Before conducting research, the researcher shall obtain an informed-consent form voluntarily signed by the research participant. Where the research participant lacks the capacity to express consent in writing, the researcher shall obtain their oral informed consent and keep audio or video recordings and other process records and supporting materials.

**Article 34.** Where the research participant is a person without civil capacity or with limited civil capacity, the written informed consent of their guardian shall be obtained. While obtaining the guardian's consent, the researcher shall also inform the research participant of the relevant information to the extent they can understand and obtain their assent.

**Article 35.** The informed-consent form shall contain sufficient, complete and accurate information and shall be expressed in language, text, video images or the like that the research participant can understand.

**Article 36.** The informed-consent form shall include the following:

(1) the purpose, basic content, process, methods and time limit of the research;

(2) basic information on the researchers and the qualifications of the research institution;

(3) the benefits the research may bring to research participants, related persons and society, and the discomfort and risks it may bring to research participants;

(4) the protective measures for research participants;

(5) the scope and manner of use of research data and research participants' personal materials, whether they will be shared and reused, and the scope of and measures for confidentiality;

(6) the rights of research participants, including voluntary participation and withdrawal at any time, the right to be informed, to consent or refuse, confidentiality, compensation, free treatment and compensation or damages in the event of harm, access to new information, re-signing of new versions of the informed-consent form, and receipt of the informed-consent form;

(7) matters for research participants' attention before, after and during the research;

(8) the contact person and contact details of the researchers, of the ethics review committee, and in the event of problems;

(9) the duration of the research and the number of research participants;

(10) whether research results will be fed back to research participants;

(11) information on possible alternative treatments and their main benefits and risks;

(12) where human biological samples are collected, the type, quantity, use, preservation, utilization (including whether they will be used directly for product development, shared or reused), privacy protection, external provision, destruction and disposal of the samples, and related matters.

**Article 37.** In obtaining informed consent, the researcher shall explain the contents of the informed-consent form to the research participant item by item.

The researcher shall give the research participant sufficient time to understand the contents of the informed-consent form; the research participant shall decide whether to consent to participate and sign the form.

In psychological research where informed consent may affect research participants' answers and thus the accuracy of the results, the researcher may, on the premise that research participants are not harmed and with the review and approval of the ethics review committee, fully inform research participants and obtain their consent after the research is completed; otherwise the data shall not be included in the research data.

**Article 38.** The researcher shall obtain the research participant's informed consent again where any of the following occurs in the course of the research:

(1) the research content relating to the research participant changes substantively;

(2) the risks associated with the research increase substantively;

(3) the research participant's level of civil capacity increases.

## Chapter V Supervision and Administration

**Article 39.** The National Health Commission, together with the relevant departments, is jointly responsible for the supervision and administration of the ethical review of life sciences and medical research involving humans nationwide.

The National Health Commission is responsible for supervising the ethical review of such research carried out by healthcare institutions nationwide; the National Administration of Traditional Chinese Medicine is responsible for supervising the ethical review of research in traditional Chinese medicine involving humans. The Ministry of Education is responsible for supervising the ethical review of such research carried out by institutions of higher education nationwide and manages the relevant work of institutions directly under it. The supervision and administration of the ethical review of such research carried out by other institutions of higher education and research institutes shall be the responsibility of the relevant departments according to lines of administrative affiliation.

The health, education and other departments of local people's governments at or above the county level shall, according to their division of duties, be responsible for the supervision and administration of the ethical review of such research within their jurisdictions.

Supervision and inspection shall mainly cover:

(1) whether the institution has established an ethics review committee as required and filed it for the record;

(2) whether the institution provides sufficient funding for the committee, and whether the full-time and part-time staff, equipment and premises provided and the measures taken ensure that the committee can work independently;

(3) whether the committee has established and improved a conflict-of-interest management mechanism;

(4) whether the committee has established an ethical review system;

(5) whether the content and procedures of ethical review meet the requirements;

(6) whether the research reviewed has been truthfully and promptly uploaded and updated on the national medical research registration and filing information system;

(7) the implementation of ethical review results;

(8) the management of ethical review documentation;

(9) the ethics training and study of committee members;

(10) other relevant contents requiring supervision and inspection.

Health authorities at all levels shall establish effective mechanisms with the relevant departments of the government at the same level to strengthen consultation and information exchange.

**Article 40.** The national and provincial health authorities shall take the lead in establishing medical ethics expert committees at the same level, or entrust relevant institutions to undertake the work of such committees, to provide technical support to the health, education and other departments in conducting ethical review and its supervision and administration, regularly train the members of ethics review committees within their jurisdictions, and assist the health, education and other competent departments at the same level in supervision and inspection.

**Article 41.** Institutions shall strengthen the day-to-day management of the ethical review of life sciences and medical research involving humans conducted by their ethics review committees, regularly evaluate the quality and efficiency of the committees' work, promptly put forward opinions or proposals for improvement of problems found, and adjust the committee or its members as necessary.

**Article 42.** Institutions shall urge their ethics review committees to implement the rectification opinions put forward by the relevant departments of governments at or above the county level; where a committee fails to complete rectification within the prescribed period or refuses to rectify, and the violation is serious or causes serious consequences, the institution shall adjust the committee, revoke the qualification of its chair, and hold the relevant persons accountable.

**Article 43.** Any unit or individual has the right to report violations of medical research ethics, violations of laws and regulations, or misconduct in life sciences and medical research involving humans.

**Article 44.** Where a healthcare institution fails to establish an ethics review committee as prescribed or to entrust an ethics review committee to conduct review, and carries out life sciences and medical research involving humans without authorization, the local health authority at or above the county level shall impose administrative penalties and sanctions on the institution and persons concerned in accordance with law.

Other institutions shall be dealt with by their superior competent departments according to lines of administrative affiliation.

**Article 45.** Where a healthcare institution or its ethics review committee violates these Measures in any of the following ways, the local health authority at or above the county level shall impose administrative penalties and sanctions on the institution and persons concerned in accordance with law:

(1) the composition of the ethics review committee or the qualifications of its members do not meet the requirements;

(2) the committee has not established a conflict-of-interest management mechanism;

(3) no ethical review working system or operating procedures have been established;

(4) review has not been conducted in accordance with the principles of ethical review and the relevant rules and systems;

(5) research information or research participants' personal information has been disclosed;

(6) filing has not been made or information uploaded to the national medical research registration and filing information system as prescribed;

(7) an ethics review opinion has been issued for another institution without formal entrustment;

(8) researchers have not been urged to submit the relevant reports and follow-up review has not been conducted;

(9) other circumstances in violation of these Measures.

Other institutions shall be dealt with by their superior competent departments according to lines of administrative affiliation.

**Article 46.** Where a researcher of a healthcare institution violates these Measures in any of the following ways, the local health authority at or above the county level shall impose administrative penalties and sanctions on the institution and persons concerned in accordance with law:

(1) carrying out research without the research or research protocol having been reviewed and approved by the ethics review committee;

(2) failing to report promptly to the ethics review committee serious adverse reactions or serious adverse events occurring in the course of the research;

(3) carrying out research in violation of the provisions on informed consent;

(4) failing to submit the relevant research reports promptly;

(5) failing to upload information promptly to the national medical research registration and filing information system;

(6) other circumstances in violation of these Measures.

Other institutions shall be dealt with by their superior competent departments according to lines of administrative affiliation.

**Article 47.** Where an institution, ethics review committee or researcher violates the requirements of laws and regulations in carrying out life sciences and medical research involving humans, it shall be dealt with in accordance with the relevant laws and regulations.

**Article 48.** Administrative action taken by the relevant administrative departments of people's governments at or above the county level against institutions and individuals that violate these Measures shall be made public. Institutions and individuals that seriously violate these Measures shall be recorded in the database of seriously dishonest conduct in research integrity, included in the credit information system in accordance with the relevant national provisions, and subjected to joint disciplinary measures in accordance with laws and regulations.

**Article 49.** Where an institution or individual violates these Measures and causes harm to the person or property of others, it shall bear civil liability in accordance with law; where a crime is constituted, criminal liability shall be pursued in accordance with law.

## Chapter VI Supplementary Provisions

**Article 50.** "Research participants" as used in these Measures include the subjects of human research and individuals who provide personal biological samples, information data, health records, behavior and the like for use in life sciences and medical research involving humans.

**Article 51.** "Humans or human biological samples" as used in these Measures include the human body itself, human cells, tissues, organs, body fluids, microbiota and the like, and fertilized eggs, embryos and fetuses.

**Article 52.** Where State secrets are involved, declassification processing shall be carried out when submitting for ethical review and obtaining research participants' informed consent. Where declassification is not possible, confidentiality agreements shall be signed and management strengthened. Research that has not undergone declassification processing shall not be uploaded to the national medical research registration and filing information system.

**Article 53.** The ethical review of life sciences and medical research involving humans that is included in the list of high-risk science and technology activities for science and technology ethics shall also comply with the relevant national requirements for the ethical review of high-risk science and technology activities.

**Article 54.** These Measures shall come into force on the date of publication. Institutions engaged in life sciences and medical research involving humans that had established ethics review committees before the implementation of these Measures shall file them for the record as prescribed and upload information to the national medical research registration and filing information system within six months of the implementation date. Life sciences and medical research involving humans that had been approved by ethics review and commenced shall complete the uploading of information to the national medical research registration and filing information system within nine months of the implementation date. Late submissions will not be accepted.