National Health Commission issued ethics review measures (draft for comments)

Article 5 Medical institutions above the secondary level and municipal health institutions with districts (including disease prevention and control, maternal and child health care, blood collection and supply institutions, etc.
), institutions of higher learning, scientific research institutes, etc.
that carry out human life science and medical research Institutions are the main body of management responsibility for ethics review work.
Ethics review committees should be established to conduct ethical reviews of life science and medical research involving humans, and regularly review relevant scientific research personnel, students, and scientific research managers engaged in human life sciences and medical research.
Personnel conduct bioethics education and training
.

Other institutions that carry out human-related life science and medical research and do not have an ethical review committee can entrust a regional ethics review committee or a competent institutional ethical review committee in writing to conduct ethical reviews of human life science and medical research
.
The entrusted ethics review committee shall conduct follow-up review of the research projects reviewed
.
Medical and health institutions shall entrust the ethics review committees of medical and health institutions higher than their level to conduct ethical reviews of life science and medical research involving people
.

All ethical review committees should pre-determine review systems in emergency situations such as outbreaks
.

The specific measures for the establishment and management of regional ethics review committees shall be formulated by the provincial health administrative department in conjunction with relevant departments
.

Article 6 Institutions shall take effective measures to ensure that the ethics review committee independently conducts ethics review work
.

Article 7 The responsibility of the ethics review committee is to protect the legal rights and interests of the subjects, safeguard the dignity of the subjects, avoid damage to the public interest, and promote the standardized development of life science and medical research involving people; life sciences and medical ethics review of research projects, including the initial review, follow-up review and reexamination
.

Article 8 The members of the institutional ethics review committee shall be selected from experts in the fields of life sciences, medicine, bioethics, law, etc.
and non-institutional members of the society.
The number of members shall not be less than 7, and there shall be members of different genders.
, Ethnic minority areas should consider minority committee members
.

When necessary, the ethics review committee may hire independent consultants to cover the professional fields of the project under review
.
Independent consultants provide advice on specific issues of the project under review and do not participate in voting
.

Article 9 The term of office of the members of the institutional ethics review committee is 3 years, and they can be re-elected
.
The ethics review committee has 1 chairman and several vice-chairmen, who are elected or elected by the members of the ethics review committee through consultation and appointed by the institution
.

The members of the ethics review committee shall have the corresponding ethics review capabilities and receive regular training on life science and medical research ethics knowledge and related laws and regulations
.

Article 10 The ethics review committee shall conduct ethical review and provide review opinions within 30 days of the accepted application project; if the situation is urgent, it shall conduct ethical review in a timely manner and provide review opinions
.

Carry out regular follow-up review of approved research projects, accept complaints from subjects and coordinate handling, to ensure that project research will not put subjects at unreasonable risks
.

Article 11 When conducting an ethical review, the ethics review committee shall require the applicant to provide the materials required for the review, and put forward ethical review opinions on the research project plan, informed consent and other documents according to its responsibilities
.

Article 12 The members of the ethics review committee shall sign a confidentiality agreement and promise to perform confidentiality obligations for the ethics review work undertaken, and to keep confidential the accepted research project plans and subject information
.

Article 13 The institution shall file for the record within 3 months from the date of establishment of the ethics review committee, and upload the information in the national medical research registration and record information system
.
The medical and health institution shall file with the practice registration authority of the institution
.
Other institutions shall file with the higher-level competent authorities according to their administrative affiliation
.
The institutional ethics review committee shall submit the work report of the previous year's ethics review committee to the filing agency before March 31 each year
.

The ethics review committee's filing materials include:

(1) List of personnel composition and work resumes of committee members
.

(2) The constitution of the ethics review committee
.

(3) Work system or related work rules
.

(4) Other relevant materials required by the filing agency
.

When the above information changes, the institution shall update the information to the filing agency in a timely manner
.

Article 14 The ethics review committee shall accept the management of the institution where it belongs and the supervision of the subjects
.

Article 15 The ethics review committee shall establish an ethics review work system and standard operating procedures, improve the management mechanism for conflicts of interest, and ensure that the ethics review process is independent, objective and fair
.

Chapter III Ethical Review

Article 16 Life science and medical research involving humans shall comply with the following principles:

(1) The principle of legal compliance
.
Research activities must strictly abide by relevant national and local laws, regulations and ethical guidelines
.

(2) The principle of informed consent
.
Respect and protect the subjects’ right to know and the right to make independent decisions to participate in the research, strictly perform the informed consent procedure, do not allow the use of deception, inducement, coercion and other means to make subjects agree to participate in the research, and allow subjects to withdraw unconditionally at any stage Research
.

(3) The principle of risk control
.
The personal safety and health rights of subjects are given priority, followed by scientific and social interests
.
The ratio of research risk to benefit should be reasonable, and every effort should be made to make the subjects accept the research that minimizes the risk, and strive to avoid harm to the subjects
.

(4) The principle of fairness and reasonableness
.
Subjects should be selected fairly and reasonably, and the selection and exclusion criteria have clear life science and medical evidence
.
The benefits, risks, and burdens of research should be distributed fairly and reasonably
.

(5) The principle of free and compensation and compensation
.
Subjects shall not be charged any research-related expenses for participating in the research, and appropriate compensation shall be provided for reasonable expenses incurred by the subjects during the research process
.
When subjects suffer research-related damages, they shall receive timely and free treatment, and be compensated or compensated in accordance with laws, regulations and mutual agreement
.

(6) The principle of privacy protection
.
Protect the subject’s privacy, truthfully inform the subject of the storage, use and confidentiality measures of the subject’s personal information and obtain permission, and shall not disclose the subject’s personal information to a third party without authorization
.

(7) The principle of special protection
.
Special protection should be given to subjects from special populations such as children, pregnant women, the elderly, persons with mental retardation, and patients with mental disorders, as well as potential subjects involved in fertilized eggs, embryos, fetuses or other assisted reproductive technologies
.

(8) The principle of public interest
.
When there is a conflict between personal interests and public interests, strict argumentation should be conducted
.

Article 17: The person in charge of a human life science and medical research project shall submit the following materials to the ethics review committee when applying for ethics review:

(1) Letter of Commitment for Integrity of Project Materials
.

(2) Application form for ethics review
.

(3) Information on researchers, legal qualification certificates of relevant institutions involved in the research project, and an explanation of the source of funding for the research project
.

(4) Research project plan and related materials, including literature review, preclinical research and animal experiment data
.

(E) subject informed consent or sample, proof and other information sources
.

(6) Scientific argumentation opinions
.

(7) Statement of conflict of interest
.

(8) Subject recruitment advertisement and its release form
.

(9) Explanation of the release form of scientific research results
.

(10) Other relevant materials deemed necessary by the ethics review committee
.

Article 18 After receiving the application materials, the ethics review committee shall organize the ethics review of the accepted project in a timely manner, and focus on reviewing the following contents:

(1) Study whether it meets the requirements of laws, regulations, rules and relevant regulations
.

(2) Whether the qualifications, experience, and technical capabilities of the researchers meet the research requirements
.

(3) Whether the research plan is scientific and meets the requirements of ethical principles; the review of the research plan of the Chinese medicine project should also consider its traditional practical experience
.

(4) Whether the degree of risk that the subject may suffer is within a reasonable range compared with the expected benefit of the research, including the weighing and review of social benefits and risks
.

(5) Whether the relevant information provided in the informed consent form is sufficient, complete and easy to understand, and whether the process of obtaining informed consent is compliant and appropriate
.

(6) Whether the confidentiality measures of the subjects’ personal information and related materials are adequate
.

(7) Whether the methods, channels, inclusion and exclusion criteria of subjects are appropriate and fair
.

(Viii) whether it should be clearly informed enjoy rights to the subject, including in the course of the study at any time and no reason to withdraw the right to non-discrimination, to inform other treatments exit after the research
.

(9) Whether the reasonable expenses of the subjects participating in the research have been properly compensated; whether the treatment, compensation or compensation given to the subjects is reasonable and legal when the subjects are damaged in participating in the research
.

(10) Whether a qualified or trained researcher is responsible for obtaining informed consent and accepting consultation on safety issues at any time
.

(11) Whether there are preventive and response measures for the risks that the subjects may bear in the research
.

(12) Study whether there is a conflict of interest
.

(13) Whether the study involves socially sensitive ethical issues
.

(14) Whether the research results are released, and whether the method and time are appropriate
.

(15) Other key content that needs to be reviewed
.

Article 19 Members of the ethics review committee shall avoid conflicts of interest with the research project
.
The ethics review committee should request members who have conflicts of interest with the research project to avoid review
.

Article 20 The basic criteria for the approval of research projects by the ethics review committee are:

(1) The research meets the requirements of laws and regulations
.

(2) Research has scientific and social value
.

(3) Respect the rights of subjects and protect the privacy of subjects
.

(4) The research plan is scientific and reasonable
.

(5) Reasonable and fair recruitment and selection of subjects
.

(6) The risk-benefit ratio is reasonable and risks are minimized
.

(7) Norms of informed consent
.

(8) Do not harm the public interests of society
.

(9) Compatible with the capabilities of research institutions and researchers
.

(10) Reasonable arrangements for the release method and time of research results
.

(11) Comply with scientific research norms and integrity
.

Article 21 The ethics review committee shall approve, disapprove, approve after modification, review after modification, continue the research, suspend or terminate the research, and explain the reasons for the research project under review or follow-up review
.

Ethics reviews are generally held in the form of meetings
.
In urgent situations, the web conference and its review procedures can be used
.

The decision of the ethics review committee shall be approved by more than half of all members of the ethics review committee
.
The committee members shall fully discuss the ethical issues involved in the research and vote, and the negative opinions must be recorded
.

Article 22 When the research project approved by the ethics review committee needs to modify the research plan, informed consent, recruitment materials, other materials provided to the subjects, etc.
, the research project leader shall submit the revised documents to the ethics review Committee review; if a research project has not been reviewed and approved by the ethics review committee, no project research work may be carried out
.

Article 23 Research projects whose research risk is not greater than the minimum risk, and research projects that have been approved for minor revisions to research projects that do not affect the research risk-benefit ratio may apply for simplified procedures for review
.

The summary procedure review can be reviewed by the chairman of the ethics review committee or two or more members designated by it
.
The review results and reasons should be reported to the ethics review committee at the next ethics review meeting
.

Article 24 Before the implementation of a research project approved by the ethics review committee, the person in charge of the research project, the institutional ethics review committee, and the institution shall register the research project, the project’s ethical review opinions, institutional review opinions and other information in accordance with the national medical research registration The filing information system requires truthful, complete and accurate upload, and timely updates of information based on research progress
.
Encourage research project leaders, institutional ethics review committees and institutions to upload information in real time during research project management
.

The National Health Commission should continuously optimize the national medical research registration and filing information system to improve work efficiency
.

Article 25 During the project research process, the project investigator shall report serious adverse events that have occurred to the institutional ethics review committee within 24 hours of being notified; the ethics review committee shall review in a timely manner to determine the researcher’s measures to protect the subjects Whether the measures for personal safety and health rights are adequate, and re-evaluate the research risk and benefit ratio, and issue a review opinion
.

Article 26 For research projects that have been approved for implementation, the researcher shall submit various reports such as research progress, violation of the plan, suspension/suspension, termination, and completion of research in a timely manner as required
.

The institutional ethics review committee shall conduct follow-up review in accordance with the relevant report submitted by the researcher
.
Follow-up review includes the following:

(1) Whether to conduct research in accordance with the approved research plan and report in time
.

(2) Whether the research content of the project has been changed without authorization during the research process
.

(3) Whether the change or new information increases the risk of the subjects or significantly affects the implementation of the research
.

(4) Whether it is necessary to suspend or terminate the research project early
.

(5) Other content that needs to be reviewed
.

There shall be no less than 2 members of the follow-up review.
The follow-up review shall be reported to the ethics review committee at the next ethics review meeting.
If serious problems are found during the follow-up review, they shall be reported to the ethics review committee immediately
.

Article 27 Research conducted in multiple institutions may establish an ethical review coordination mechanism to ensure that each institution follows the principles of consistency and timeliness
.

Both the lead agency and the participating agencies should organize ethical reviews
.
The ethical review committee of the participating institution can approve the ethical review conclusion of the lead institution through a simplified review procedure after fully understanding the overall situation of the project
.

The ethical review committee of the participating institution shall promptly follow up and review the ethical situation of the research project in which the institution participates
.

Article 28: Where an institution cooperates with other institutions such as enterprises to carry out life science and medical research or provides biological samples and data for enterprises and other institutions to carry out life science and medical research, the institution shall fully understand the overall situation of the research and adopt ethical methods.
Review and carry out follow-up review, clarify the scope of use and processing methods of biological samples and data by agreement, and supervise their proper disposal after the study is completed
.

Article 29 When academic journals publish life science and medical research results involving humans, they shall confirm that the research project has been approved by the ethics review committee
.
The researcher should provide relevant certification
.

Article 30 The ethics review committee independently conducts project ethics review work, and no institution or individual may interfere with the ethics review process and review decisions of the ethics review committee
.

Chapter IV Informed Consent

Article 31 For projects with subjects, the investigator shall obtain an informed consent form voluntarily signed by the subject before conducting the research; when the subject cannot express consent in writing, the project investigator shall obtain his orally informed consent , And submit process records and certification materials
.

Article 32 If the subject is a person without or with limited capacity for civil conduct, the written informed consent of his guardian (legal representative) shall be obtained
.
When the guardian (legal representative) consents to the subject on behalf of the subject, he should inform the subject of relevant information within the scope of the subject’s understanding, and try to get the subject to sign the informed consent form in person
.

Article 33 The informed consent form should contain sufficient and complete information and be expressed in a language that the subject can understand
.

Article 34 The informed consent form shall include the following contents:

(1) Research purpose, basic research content, process, method and research time limit
.

(2) Basic information of researchers and qualifications of research institutions
.

(3) The benefits that the research may bring to the subjects, related personnel and society, as well as the discomfort and risks that may be brought to the subjects
.

(4) Protective measures for subjects
.

(5) The scope and method of use of research data and subjects’ personal data, whether to share and secondary use, and the scope and measures of confidentiality
.

(6) The rights of subjects, including voluntary participation and withdrawal at any time, knowledge, consent or disagreement, confidentiality, compensation, free treatment and compensation or compensation in case of damage, acquisition of new information, and renewal of a new version of the informed consent form signed, informed consent was obtained and so on
.

(7) Precautions for subjects before, after and during the research process
.

(8) The contact person and method of the researcher, the contact person and method of the ethics review committee, and the contact person and contact method when a problem occurs
.

(9) The time of the study and the approximate number of subjects
.

(10) Whether the research results will be fed back to the subjects
.

(11) Inform subjects of possible alternative treatments and their main benefits and risks
.

(12) Where the collection of human biological samples is involved, it should also include the type, quantity, purpose, preservation, use (including whether it is directly used for product development, sharing, and secondary use), privacy protection, external provision, and destruction.
And other related content
.

Article 35 During the process of obtaining informed consent, the project researcher shall explain to the subjects item by item according to the content of the informed consent form
.

The project investigator shall give the subjects sufficient time to understand the contents of the informed consent form, and the subjects shall make a decision whether to agree to participate in the research and sign the informed consent form
.

In psychology research, if informed consent may affect the subjects’ answers to questions and affect the accuracy of the research results, the investigator can be reviewed and approved by the ethics committee on the premise of ensuring that the subjects are not harmed.
After completion, the subjects shall be fully informed and written informed consent shall be obtained, otherwise the research data shall not be included
.

Article 36 When the following circumstances occur, the researcher shall seek the informed consent of the subjects again:

(1) The research plan, scope, and content related to the subject have changed
.

(2) Research using identity-marked samples used for diagnosis and treatment in the past
.

(3) Research on human biological samples with identification marks or relevant clinical history data in the biological sample database is beyond the scope of informed consent
.

(4) Informed consent for research has been obtained in the early stage, but it is used for research outside the scope of authorization
.

(5) The subject's capacity for civil conduct has improved
.

Article 37 Unless otherwise specified, the requirements for seeking informed consent may be exempted in the following circumstances after being reviewed and approved by the ethics review committee:

(1) Research using the biological samples or data of a person with identifiable information has been unable to find the subject to seek informed consent again, and the research project takes adequate measures to protect personal information and does not involve personal privacy and commercial interests
.

(2) The biological sample donor has signed an informed consent form, agreeing to use the donated sample and related information in the research field involved
.

Chapter V Supervision and Administration

Article 38 The National Health Commission and relevant departments are jointly responsible for the supervision and management of the ethical review of life science and medical research involving people throughout the country
.

The National Health Commission is responsible for the ethical review and supervision of human life science and medical research carried out by medical and health institutions across the country
.
The Ministry of Education is responsible for the ethical review and supervision of human life science and medical research carried out by higher education institutions across the country, and manages the relevant work of higher education institutions directly under the Ministry of Education
.
Other institutions of higher learning and scientific research institutes are responsible for the supervision and management of the ethical review of life science and medical research involving people in accordance with the administrative affiliation
.

The health, education and other departments of the local people's government at or above the county level are responsible for the supervision and management of the life science and medical research ethics review and management of the people involved in their jurisdictions according to the division of responsibilities
.

The main supervision and inspection are as follows:

(1) Whether the institution has established an ethical review committee in accordance with the requirements and filed it
.

(2) Whether the institution provides sufficient funds for the ethics review committee, and whether the full-time and part-time staff, equipment, places and relevant measures taken can ensure that the ethics review committee can independently carry out its work
.

(3) Whether the ethics review committee has established a sound conflict of interest management mechanism
.

(4) Whether the ethics review committee has established an ethics review system
.

(5) Whether the content and procedures of the ethical review meet the requirements
.

(6) Whether the reviewed research project is truthfully and timely uploaded and updated in the national medical research registration and record information system
.

(7) Implementation status of ethical review results
.

(8) Management of ethics review documents
.

(9) The ethics training and learning of the members of the ethics review committee
.

(10) Other related content that needs to be supervised and inspected
.

Health administrative departments at all levels shall establish effective mechanisms with relevant government departments at the same level to strengthen work consultations and information communication
.

Article 39 The national and provincial health administrative departments shall take the lead in establishing the medical ethics expert committee at the same level or entrust relevant institutions to undertake the work of the medical ethics expert committee at the same level, and provide ethical review and supervision and management for the health, education and other departments.
Technical support, regular training of ethics review committee members in the jurisdiction, and assisting the administrative departments of health and education at the same level to carry out supervision and inspection
.

Article 40 The institution shall strengthen the daily management of the ethical review work of life science and medical research carried out by the ethics review committee established by the institution, regularly evaluate the quality of the work of the ethics review committee, and promptly propose improvements or suggestions for problems found.
Adjust the members of the ethics review committee as necessary
.

Article 41 The institution shall supervise the institution’s ethics review committee to implement the rectification opinions put forward by relevant government departments at or above the county level; if the ethics review committee fails to complete the rectification within the prescribed time limit or refuses to rectify, the violation is serious or causes serious consequences.
The institution where it belongs shall revoke the qualifications of the chairman of the ethics review committee and hold relevant personnel accountable
.

Article 42 Any unit or individual has the right to report violations or misconduct in life science and medical research involving people
.

Article 43: If a medical and health institution does not establish an ethics review committee in accordance with the regulations or entrusts an ethics review committee to review, and conducts life science and medical research involving humans without authorization, the local health administrative department at or above the county level shall conduct legal inspections on relevant institutions and personnel.
Impose administrative penalties and sanctions
.

Other institutions shall be handled by their superior authorities in accordance with their administrative affiliation
.
If there is no higher-level competent department, it shall be handled by the agency registration authority
.
Where social organizations are involved, the social organization registration management agency shall handle the matter in accordance with relevant registration management regulations
.

Article 44: If a medical and health institution and its ethics review committee violate the provisions of these Measures and have one of the following circumstances, the local health and health administrative department at or above the county level shall impose administrative penalties and sanctions on the relevant institutions and personnel according to law:

(1) The composition of the ethics review committee and the qualifications of the members do not meet the requirements
.

(2) The institution does not provide sufficient funds for the ethics review committee, and the full-time and part-time staff, equipment, places and relevant measures taken are not enough to ensure the ethics review committee to independently carry out its work
.

(3) The ethics committee has not established a conflict of interest management mechanism
.

(4) Failure to establish an ethical review work system or operating procedures
.

(5) Failure to conduct review in accordance with the principles of ethical review and relevant rules and regulations
.

(6) Disclosure of research project information and personal information of subjects
.

(7) Failing to file in accordance with the regulations
.

(8) Failure to accept formal entrustment to issue ethical review opinions for other institutions
.

(9) Failure to urge researchers to submit relevant reports and conduct follow-up review
.

(10) Other circumstances that violate the provisions of these Measures
.

Other institutions shall be handled by their superior authorities in accordance with their administrative affiliation
.
If there is no higher-level competent department, it shall be handled by the agency registration authority
.
Where social organizations are involved, the social organization registration management agency shall handle the matter in accordance with relevant registration management regulations
.

Article 45: If the project researchers of medical and health institutions violate the provisions of these Measures and have one of the following circumstances, the local health administrative department at or above the county level shall impose administrative penalties and sanctions on the relevant institutions and personnel according to law:

(1) The research project or research plan has not been reviewed and approved by the ethics review committee to carry out project research work without authorization
.

(2) A serious adverse reaction occurred during the research process or the serious adverse event was not reported to the ethics review committee in time
.

(3) Conducting project research in violation of relevant regulations on informed consent
.

(4) Failure to submit relevant research reports in time
.

(5) Other circumstances that violate the provisions of these Measures
.

Other institutions shall be handled by their superior authorities in accordance with their administrative affiliation
.
If there is no higher-level competent department, it shall be handled by the agency registration authority
.
Where social organizations are involved, the social organization registration management agency shall handle the matter in accordance with relevant registration management regulations
.

Article 46: Institutions, institutional ethics review committees, and project researchers who violate the requirements of laws and regulations in carrying out human life science and medical research work shall be dealt with in accordance with relevant laws and regulations
.

Article 47: The administrative handling of institutions and individuals that violate these Measures by the relevant administrative departments of the people's governments at or above the county level shall be disclosed to the public
.
Institutions and individuals who seriously violate the provisions of these Measures shall be recorded in the database of serious untrustworthy conduct in scientific research, be included in the credit information system in accordance with relevant national regulations, and joint punishments shall be implemented in accordance with laws and regulations
.

Article 48 Institutions and individuals who violate the provisions of these Measures and cause damage to the person or property of others shall bear civil liability according to law; if a crime is constituted, criminal liability shall be investigated according to law
.

Chapter VI Supplementary Provisions

Article 49 The term "human or human biological samples" as used in these Measures includes the human body itself, as well as human cells, tissues, organs, body fluids, flora, etc.
, as well as fertilized eggs, embryos, and fetuses
.

Article 50 Subjects referred to in these Measures include the subjects of human body research, as well as individuals who provide personal biological samples, biological genetic information, diagnosis and treatment information, behavior records, etc.
for life science and medical research involving humans
.

Article 51 Where state secrets are involved, they shall be declassified when submitting ethical review and obtaining informed consent of subjects
.
If it is impossible to declassify, a confidentiality agreement shall be signed and management shall be strengthened
.
Research projects that have not been declassified shall not be uploaded in the National Medical Research Registration and Filing Information System
.

Article 52 These Measures shall come into force on ×××× year ×× month ×× day
.
Before the implementation of these Measures, institutions engaged in human life science and medical research that have established ethical review committees shall file in accordance with regulations within 3 months from the date of implementation of these Measures, and upload the information to the National Medical Research Registration and Filing Information System
.

Before the implementation of these Measures, life science and medical research projects involving humans that have been approved by ethics review shall be uploaded in the National Medical Research Registration and Record Information System within 6 months from the date of implementation of these Measures
.
It will no longer be accepted after the deadline
.