Circular 43/2024/TT-BYT organization of Councils of Ethics in biomedical research

CIRCULAR

Prescribing the establishment, organization and operation of the Councils of Ethics in biomedical research

Pursuant to the Law on Pharmacy dated April 6, 2016;

Pursuant to the Law on Medical Examination and Treatment dated January 9, 2023;

Pursuant to the Government’s Decree No. 96/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Administration of Science, Technology and Training;

The Minister of Health hereby promulgates the Circular prescribing the establishment, organization and operation of the Councils of Ethics in biomedical research.

Chapter I
GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular prescribes the establishment, organization and operation of the national Council of Ethics in biomedical research and the grassroots-level Councils of Ethics in biomedical research (hereinafter collectively referred to as the Councils of Ethics).

Article 2. Interpretation of terms

1. Conflict of interest refers to a situation in which the personal interests of a researcher, a member of the Council of Ethics, or an independent consultant are likely to be in opposition to his/her duties and responsibilities, potentially affecting the objectivity of the research or the research review process.

2. Study site means the location where the research is actually conducted, which is under the control of the clinical trial hosting institution.

3. Minimal risk refers to the level of probability and magnitude of harm, discomfort, or other adverse physical, mental, or social effects anticipated in the research that is not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.

Chapter II

ESTABLISHMENT OF THE COUNCIL OF ETHICS

Article 3. Establishment of the National Council of Ethics

1. The National Council of Ethics shall be established under the Minister of Health's decision.

2. The Minister of Health shall decide on the appointment, supplementation, replacement, resignation acceptance, and dismissal of members of the National Council of Ethics.

3. The term of office of the National Council of Ethics shall be 5 years; its members of the subsequent term shall be inherited from the previous term and shall include the participation of at least 20% new members.

4. The National Council of Ethics shall have its own seal and account for the performance of its functions, duties, and powers.

Article 4. Establishment of the grassroots-level Council of Ethics

1. The grassroots-level Council of Ethics shall be established under the decision of the head of the organization.

2. The head of the organization establishing the grassroots-level Council of Ethics shall decide on the appointment, supplementation, replacement, resignation acceptance, and dismissal of members of the grassroots-level Council of Ethics.

3. The term of office of the grassroots-level Council of Ethics shall be 5 years; its members of the subsequent term shall be inherited from the previous term and shall include the participation of at least 20% new members.

4. For organizations that do not establish a grassroots-level Council of Ethics, the review and assessment of biomedical research involving human subjects shall be conducted by a grassroots-level-level Council of Ethics that is appropriate to the field of research.

Chapter III

FUNCTIONS, TASKS AND POWERS OF COUNCILS OF ETHICS

Article 5. Functions of the Council of Ethics

The Council of Ethics shall have the function of reviewing the ethical and scientific aspects of biomedical research involving human subjects as a basis for advising competent agencies on the approval, inspection, evaluation, and acceptance of the research.

Article 6. Tasks of the Council of Ethics

1. The grassroots-level Council of Ethics shall perform the following tasks:

a) Appraising the following documents related to clinical drug trials, clinical trials of medical devices, and clinical trials of new techniques and methods in medical examination and treatment before submission to the National Council of Ethics:

- Dossier, research protocol, capability of the investigator and the study site.

- Dossier of request for change to the research protocol, periodic research appraisal, ad hoc research appraisal;

- Research result report.

b) Appraising the following documents related to In vivo bioequivalence studies of drugs for approval by the person responsible for professional matters of the institution hosting the bioequivalence trial: Dossier, research protocol, capability of the investigator and the study site; dossier of request for change to the research protocol, periodic research appraisal, ad hoc research appraisal; research result report.

c) Monitoring and supervising the research regarding compliance with the protocol and regulations on research ethics; assessing the recording, reporting, and handling of adverse events occurring during the research.

d) Archiving and managing the Council of Ethics’ dossiers and ensuring confidentiality in accordance with the law.

2. The grassroots-level Council of Ethics shall perform the following tasks:

a) Appraising the dossier, research protocol, capability of the investigator and of the study sites prior to research implementation.

b) Appraising research during the implementation at the trial hosting institutions, including appraisal of the change to the research protocol, periodic research appraisal, ad hoc research appraisal.

c) Appraising research result reports of the trial hosting institutions.

d) Monitoring and supervising the research regarding compliance with the protocol and regulations on research ethics at trial hosting institutions; assessing the recording, reporting, and handling of adverse events occurring during the research at trial hosting institutions.

dd) Archiving and managing the Council of Ethics’ dossiers and ensuring confidentiality in accordance with the law.

Article 7. Powers of the Council of Ethics

1. Approving or disapproving:

a) The dossier, research protocol, amendments and supplements to the research protocol, and research result reports;

b) The waiver of the requirement to obtain the research information sheet and the informed consent form in cases where absolute confidentiality of participant information is necessary or where it is impossible to obtain consent from the research participant or their legal representative, based on thorough consideration of the benefits and risks of the research to the participant and measures to protect the rights and safety of the research participant;

c) The use of documents in the form of electronic records in accordance with relevant laws.

2. Inviting independent consultants to provide expert opinions to the Council of Ethics.

3. Requesting the principal investigator, the organization in charge of the research, and the research sponsor to: report data, information, research results, and other dossiers related to the research, and to amend or supplement the research protocol in order to ensure the safety of research participants.

4. Proposing that competent agencies suspend the research upon detecting non-compliance with the principles of good clinical practice or violations of the research protocol.

Article 8. Responsibility of the Council of Ethics

1. Ensuring the maximum possible limitation of adverse impacts on the health of research participants.

2. Conducting periodic appraisal at least once a year for clinical trials.

3. Monitoring, supervising, conducting ad hoc appraisals, and reviewing adverse events occurring during the research, as well as violations of the research protocol, in order to ensure the rights, health, and safety of research participants, and the accuracy, reliability, integrity, objectivity, and scientific validity of the data and research results.

4. The Chairperson of the Council shall promulgate the operating regulations of the Council of Ethics, including standard and simplified procedures for research appraisal; approve and publicly disclose the Council of Ethics’ standard operating procedures to ensure consistency in the establishment and training of Council members and the performance of specific duties and tasks of the Council.

5. Disclosing the ethical guidelines for biomedical research adopted by the Council of Ethics.

6. Ensuring the confidentiality of information related to the research.

Chapter IV

ORGANIZATION OF THE COUNCIL OF ETHICS

Article 9. Organization of the National Council of Ethics

1. The National Council of Ethics comprises the Chairperson of the Council, at least 3 Vice Chairpersons, Council members, alternate members (if any), specialized subcommittees, and the Office of the Council.

2. The number of Vice Chairpersons, Council members, alternate members, professional secretaries, administrative secretaries, the number of specialized subcommittees of the National Council of Ethics, and the number of Deputy Chiefs and staff members of the Office of the National Council of Ethics shall be specified in the operating regulations of the Council.

3. The Administration of Science, Technology and Training shall serve as the standing body of the National Council of Ethics.

4. The Office of the National Council of Ethics, located at the Administration of Science, Technology and Training under the Ministry of Health shall act as the body assisting the Council.

5. The Office of the National Council of Ethics consists of the Chief of Office, Deputy Chiefs of Office, Chief Accountant working on a concurrent basis, and other staff members of the Office.

Article 10. Organization of the grassroots-level Council of Ethics

1. The grassroots-level Council of Ethics comprises the Chairperson of the Council, at least 01 Vice Chairperson, Council members, alternate members (if any), the Council’s standing body, and specialized subcommittees, if necessary.

2. The number of Vice Chairpersons, Council members, alternate members (if any), professional secretaries, administrative secretaries, and the number of specialized subcommittees of the grassroots-level Council of Ethics shall be specified in the Council’s operating regulations.

3. The head of the organization establishing the grassroots-level Council of Ethics shall assign a unit to act as the standing body of the grassroots-level Council of Ethics.

Article 11. Composition of members of the Council of Ethics

1. The Council of Ethics must have at least 05 members and must ensure gender balance, including the following:

a) A member with expertise in the health sector who is independent of the organization that establishes the Council of Ethics;

b) A member who is a clinical doctor;

c) A member with experience in reviewing legal dossiers;

d) A member not belonging to the health sector;

dd) A member under 50 years of age and a member aged 50 or older.

2. Alternate members of the Council of Ethics:

a) The composition of the Council of Ethics may include alternate members;

b) Alternate members must meet the same qualifications and bear the same responsibilities as official members of the Council of Ethics;

c) In cases where the appraisal meeting of the Council of Ethics does not meet the required number or composition of members as prescribed, the Council leadership may invite alternate members to participate in the dossier appraisal and to vote as official members.

3. The Council of Ethics shall not include the head of the organization that establishes the Council.

4. Members of the National Council of Ethics shall not include civil servants of the Ministry of Health.

Article 12. Criteria for Chairpersons, Vice Chairpersons, and Members of the Council of Ethics

1. Criteria for the Chairperson and Vice Chairpersons of the National Council of Ethics:

a) Possessing a doctoral degree or higher in the health sector;

b) Having at least 15 years of working experience related to the research areas commonly reviewed by the Council of Ethics;

c) Having credibility, the ability to lead, synthesize, and harmonize opinions to achieve consensus among Council members;

d) Possessing knowledge of the principles of good clinical practice and the standard operating procedures of the Council of Ethics;

dd) A person shall not be appointed as Chairperson of the Council of Ethics for more than 02 consecutive terms.

2. Criteria for the Chairperson and Vice Chairpersons of the grassroots-level Council of Ethics:

a) Possessing a university degree or higher in the health sector;

b) Having at least 10 years of working experience related to the research areas commonly reviewed by the Council of Ethics;

c) Satisfying the criteria specified at Points c, d, and dd of Clause 1 of this Article.

3. Criteria for members of the Council of Ethics:

a) Members with expertise in the health sector and members with experience in reviewing legal dossiers must possess a university degree or higher;

b) Members without expertise in the health sector must possess at least a college degree;

c) Possessing knowledge of the principles of good clinical practice and the standard operating procedures of the Council of Ethics.

Article 13. Criteria for professional secretaries and administrative secretaries of the Council of Ethics

1. Criteria for a professional secretary:

a) Being an honest and objective person;

b) Possessing a university degree or higher in the health sector;

c) Possessing knowledge of the principles of good clinical practice and the standard operating procedures of the Council of Ethics;

d) A member of the Council of Ethics may concurrently serve as a professional secretary of the Council of Ethics.

2. Criteria for an administrative secretary:

a) Being an honest and objective person;

b) Possessing a college degree or higher;

c) Possessing knowledge of the standard operating procedures of the Council of Ethics.

Article 14. Appointment, supplementation, replacement, resignation acceptance, and dismissal of Chairpersons, Vice Chairpersons, and members of the Council of Ethics

1. Appointment at the beginning of the term:

a) Based on the criteria and composition of members of the Council of Ethics, the head of the unit assigned to act as the standing body of the Council shall coordinate with the current Chairperson of the Council (if any) to agree on the personnel plan for the appointment of Council members;

b) The appointment dossier for members of the Council of Ethics must include sufficient documentation demonstrating compliance with the criteria specified in Article 12 of this Circular and shall be retained at the Council;

c) For personnel under the management of another organization, the organization establishing the Council of Ethics must obtain written consent from the organization managing the individual proposed for appointment as a Council member.  In case of independent experts, their written consent is required;

d) Based on the written proposal of the head of the unit assigned to act as the standing body of the Council, the head of the organization establishing the Council of Ethics shall decide on the appointment of Council members;

dd) The term of office of official and alternate members shall coincide with the term of the Council of Ethics.

2. Supplementation and replacement:

When there is a need to supplement or replace members of the Council of Ethics, the head of the unit assigned to act as the standing body of the Council shall coordinate with the Chairperson of the Council to agree on the personnel plan for supplementation or replacement of members in accordance with the criteria, dossier, and term conditions as stipulated for the initial appointment in Clause 1 of this Article.

3. Resignation acceptance:

a) A Council member may resign when they consider themselves unable to fulfill their responsibilities as a Council member or upon personal request;

b) A member wishing to resign must notify their resignation request to the Chairperson of the Council and the head of the unit assigned to act as the standing body of the Council;

c) The head of the unit assigned to act as the standing body of the Council shall be responsible for reporting to the head of the organization establishing the Council of Ethics for consideration and decision on whether to accept the resignation.

4. Dismissal:

a) In case a Council member no longer meets the criteria for Council membership, the head of the unit assigned to act as the standing body of the Council shall coordinate with the Chairperson of the Council to agree on the dismissal of that member;

b) Based on the written proposal of the head of the unit assigned to act as the standing body of the Council, the head of the organization establishing the Council of Ethics shall decide on the dismissal or non-dismissal of the Council member.

Article 15. Independent consultants to the Council of Ethics

In necessary cases, the leadership of the Council of Ethics may invite independent consultants to appraise dossiers and attend Council meetings.

1. Independent consultants must not have any conflict of interest with respect to the research being appraised.

2. Independent consultants may attend meetings of the Council of Ethics to provide input and participate in discussions regarding the research, but shall not have voting rights. In cases where an independent consultant is unable to attend the meeting, their written opinions must be reviewed by the Council of Ethics and recorded in the meeting minutes.

3. Independent consultants shall be responsible for maintaining the confidentiality of information and documents related to the research to which they have access.

Chapter V

OPERATION OF THE COUNCIL OF ETHICS

Article 16. Principles of operation of the Council of Ethics

1. The operation of the Council of Ethics shall be non-profit in nature.

2. When reviewing, commenting on, guiding, or approving biomedical research involving human subjects, members of the Council of Ethics must fully apply the ethical principles prescribed in this Circular, the Council’s operating regulations, the Council’s standard operating procedures, and relevant laws.

3. The Council of Ethics shall operate on the principles of collectivity, democracy, and independence in the appraisal and decision-making process.

4. Meetings reviewing research involving vulnerable groups must include the participation of a representative of such group or an expert experienced in working with such group.

5. Appraisal under the standard procedure must involve at least 05 Council members attending and casting votes, including at least one member with relevant expertise in the health sector, one member without health sector expertise, one independent member, and members of both genders. In case where the Council of Ethics has a specialized subcommittee, the meeting must include at least two members from the relevant specialized subcommittee attending and casting votes. A research shall only be approved if there are fewer than 02 disapproving votes among the total valid votes. In case it is difficult to reach consensus during the appraisal meeting, the Chairperson of the Council of Ethics shall decide whether to proceed with a vote or to request the principal investigator to complete the research dossier for consideration and voting at the next Council meeting.

6. Appraisal under the simplified procedure may only be applied to research with minimal risk, completed dossiers as per previous appraisal outcomes, research dossiers already appraised and approved by another grassroots-level Council of Ethics, dossiers on changes to research protocols, periodic reports, ad hoc reports on research, documents updated during the research process, reports of adverse events occurring during the research, and reports on research protocol violations. Research shall only be approved under the simplified procedure if all assigned appraising members assess it as acceptable. In case where an appraising member assesses it as not acceptable, the Chairperson of the Council of Ethics shall decide on conducting a standard procedure appraisal.

7. Members of the Council of Ethics shall not appraise any research in which they, or their spouses, biological or adoptive fathers, biological or adoptive mothers, biological or adoptive children, biological siblings, brothers-in-law, sisters-in-law, or such persons of their spouses have a conflict of interest; nor participate in the implementation of any research that they have appraised and approved through the Council of Ethics.

Article 17. Guidance on submission of research dossiers to the Council of Ethics

The Council of Ethics shall issue a written guidance document on the requirements for submission of research dossiers for appraisal. Such a guidance must comprise:

1. Name and address of the secretary, staff member, or member of the Council of Ethics responsible for receiving the dossier, or the address of the website for online submission (if any);

2. A list of all written documents included in the dossier;

3. Specifications of the documents;

4. Language of the documents in the dossier;

5. Number of copies required to be submitted;

6. Deadline for dossier submission in relation to the appraisal date;

7. Method of notification for dossiers deemed invalid;

8. Timeframe for supplementing the dossier (if necessary);

9. Estimated time for notification of the appraisal result;

10. Specifications of the forms required to be submitted as prescribed by the Council (if any);

11. Appraisal fee for the research dossier (if any).

Article 18. Contents subject to appraisal by the Council of Ethics

1. Contents to be appraised for research prior to implementation:

a) Research design and data collection;

b) Available pre-clinical and clinical research results (if applicable);

c) Potential risks and benefits of the research or the research product (if applicable); impact of the research on the community involving research participants;

d) Selection of the research population, advertising materials used for recruitment of potential research participants; process of information provision and obtaining the research information sheet and informed consent form; financial benefits and costs related to the research participants;

dd) Protection of privacy and confidentiality of research participants’ information; procedures for monitoring, assessing, and managing adverse events (for research involving interventions on human participants);

e) Competence of the investigator and the study site.

2. Contents to be appraised for ongoing research:

a) Compliance with the approved research protocol;

b) Protection of the rights, health, and safety of research participants;

c) Recording, management, and reporting of adverse events and serious adverse events occurring during the research (if any);

d) Violations of the research protocol and corrective and preventive measures (if any);

dd) Amendments and supplements to the research protocol and related documents (if any).

3. Contents to be appraised for research result reports:

a) Compliance with the research protocol during implementation;

b) Integrity, accuracy, and reliability of research data;

c) Scientific and factual accuracy of the research result report.

Article 19. Notification of appraisal results by the Council of Ethics

Within 05 working days from the date of conclusion of the appraisal of the research dossier, the Council of Ethics shall be responsible for sending a written notification of the appraisal result to the trial hosting institution and the principal investigator, specifically as follows:

1. In case the research protocol is approved by the Council of Ethics: notification shall be made using the Certificate of Approval of the Research Protocol, as provided in Appendix I to this Circular.

2. In case the amendments and supplements to the research protocol are approved by the Council of Ethics: notification shall be made using the Certificate of Approval of Amendments and Supplements to the Research Protocol, as provided in Appendix II to this Circular.

3. In case the research result report is approved by the Council of Ethics: notification shall be made using the Certificate of Approval of the Research Result Report, as provided in Appendix III to this Circular.

4. In case the research protocol or the amendments and supplements to the research protocol or the research result report is approved with conditions by the Council of Ethics: notification shall be made using the Conditional Approval Notification Form, as provided in Appendix IV to this Circular.

5. In case the research protocol or the amendments and supplements to the research protocol or the research result report is not approved by the Council of Ethics: notification shall be made using the Non-Approval Notification Form, as provided in Appendix V to this Circular.

6. The head of the organization establishing the grassroots level Council of Ethics shall be responsible for prescribing the method of authentication of the organization on the written notification of the appraisal result issued by the Council.

Article 20. Monitoring and supervision of research

1. The Council of Ethics shall monitor and supervise research either through direct supervision at the research implementation site or by reviewing progress reports, research results, periodic appraisals, or ad hoc appraisals.

2. Contents of monitoring and supervision: compliance with procedures, standards for recruitment of research participants, protection of the rights, safety, and health of research participants, and the collection of biological samples, information, and research data from research participants.

Article 21. Archiving of documents of the Council of Ethics

1. All documents and notifications of the Council of Ethics must specify the date of issuance, be documented and archived in accordance with the Council’s standard operating procedures and the provisions of law on archives.

2. Dossiers may be archived in either paper or electronic form.

3. Documents to be archived by the Council of Ethics include:

a) Documents on the establishment of the Council;

b) The Council’s standard operating procedures;

c) Documents issued by the Council of Ethics;

d) Annual summary reports on the activities of the Council;

dd) Scientific curricula vitae of Council members;

e) Invitations and agendas of the Council’s meetings;

g) Comment sheets, research evaluation forms, and meeting minutes of the Council;

h) Written notifications of appraisal results issued by the Council;

i) Legal documents used by the Council;

k) Guidelines on research ethics used by the Council;

l) Research dossiers appraised by the Council;

m) Other related documents in accordance with the law.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 22. Effect

1. This Circular takes effect from February 1, 2025.

2. The Minister of Health’s Circular No. 04/TT-BYT dated March 5, 2020, on the establishment, functions, tasks and powers of the Councils of Ethics in biomedical research, ceases to be effective from the effective date of this Circular.

Article 23. Implementation organization

1. The Administration of Science, Technology and Training under the Ministry of Health shall

a) Assume the prime responsibility for, and coordinate with relevant units in, disseminating, guiding and implementing this Circular;

b) Update the list of Councils of Ethics whose establishment has been notified on the website of the Administration of Science, Technology and Training within 15 days from the date of receipt of the notification on the establishment of the Council of Ethics;

c) Assume the prime responsibility for, and coordinate with relevant units in, conducting periodic or ad hoc inspections regarding compliance with the provisions of this Circular by the Councils of Ethics;

d) In case of detecting that a Council of Ethics fails to meet the requirements prescribed in this Circular during inspection, the Administration of Science, Technology and Training shall remove the name of the Council from the updated list on the its website;

dd) Suspend or propose the competent agency to suspend the operation of a Council of Ethics upon discovering violations of this Circular that affect the protection of the rights, safety, and health of research participants.

2. Departments of Health of provinces and centrally-run cities, and health units of Ministries and sectors shall

a) Organize dissemination and guidance on the implementation of this Circular;

b) Conduct periodic or ad hoc inspections on the compliance with the provisions of this Circular by the Councils of Ethics under their management;

c) Propose the Ministry of Health (the Administration of Science, Technology and Training) to remove the name of a Council of Ethics from the updated list on the Administration of Science, Technology and Training’s website in case of detecting that a Council of Ethics under their management has violated the provisions of this Circular, affecting the protection of the rights, safety, and health of research participants.

3. Organizations establishing the Councils of Ethics shall

a) Ensure sufficient human resources, infrastructure, and equipment for the operation of the Council and the Office of the Council or the Council’s standing body;

b) Allocate and ensure sufficient funding for the operation of the Council and the Office of the Council or the Council’s standing body from the state budget and other lawful financial sources in accordance with law;

c) Conduct annual assessments on compliance with legal regulations, organizational and operational regulations, and the standard operating procedures of the Council of Ethics;

d) Notify the Administration of Science, Technology and Training under the Ministry of Health of the establishment or consolidation of the Council of Ethics using the form provided in Appendix VI to this Circular and update such information on the organization’s website within 15 days from the date of the decision on establishment or consolidation of the Council.

4. Grassroots-level Councils of Ethics appraising biomedical research involving human subjects may refer to the guidance provided in this Circular for appropriate application in practice.

Any difficulties arising in the course of implementation should be promptly reported to the Ministry of Health (via Administration of Science, Technology and Training) for consideration and settlement./.