Circular No. 43/2024/TT-BYT stipulates the establishment, organization, and operation of the Ethics Council in Biomedical Research issued by the Minister of Health.

CIRCULAR

Regulations on the establishment, organization, and operation of the Ethics Committee for Biomedical Research

Council for Medical Research Ethics

Pursuant to the Drug Law dated April 6, 2016;

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

Pursuant to Decree No. 96/2023/NĐ-CP dated December 30, 2023 of the Government detailing certain provisions of the Law on Medical Examination and Treatment;

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

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

The Minister of Health issues this Circular regulating the establishment, organization, and operation of the Ethics Committee for Biomedical Research.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates the establishment, organization, and operation of the National Ethics Committee for Biomedical Research and the Institutional Ethics Committee for Biomedical Research (hereinafter referred to as the Ethics Committee).

Article 2. Interpretation of Terms

1. Conflict of Interest (Conflict of interest) is a situation where the personal interests of the researcher or member of the Ethics Committee or independent consultant may conflict with their duties and responsibilities, potentially affecting the objectivity of the research or the review of the research.

2. Study Site (Study site) is the actual location where the research is conducted, under the control of the clinical trial testing institution.

3. Minimal Risk (Minimal risk) is a risk where the probability and degree of harm, discomfort, or other adverse effects on physical, mental, or social well-being expected in the research are not greater than those commonly encountered in daily life or during routine examinations or tests.

Chapter II
ESTABLISHMENT OF THE ETHICS COMMITTEE

Article 3. Establishment of the National Ethics Committee

1. The National Ethics Committee shall be established by decision of the Minister of Health.

2. The Minister of Health shall decide on the appointment, supplementation, replacement, resignation, and removal of members of the National Ethics Committee.

3. The term of office of the National Ethics Committee is five years; members of the subsequent term of the National Ethics Committee shall inherit from the previous term and include at least 20% new members.

4. The National Ethics Committee shall have its own seal and separate account to perform its functions, tasks, and powers.

Article 4. Establishment of the Institutional Ethics Committee

1. The Institutional Ethics Committee shall be established by the head of the organization.

2. The head of the organization establishing the Institutional Ethics Committee shall decide on the appointment, supplementation, replacement, resignation, and removal of members of the Institutional Ethics Committee.

3. The term of office of the Institutional Ethics Committee is five years; members of the subsequent term of the Institutional Ethics Committee shall inherit from the previous term and include at least 20% new members.

4. For organizations that do not establish an Institutional Ethics Committee, the review and assessment of biomedical research involving human subjects shall be carried out by the Institutional Ethics Committee appropriate to the field of research.

Chapter III
FUNCTIONS, TASKS, AND POWERS OF THE ETHICS COMMITTEE

Article 5. Functions of the Ethics Committee

The Ethics Committee has the function of reviewing the ethical and scientific aspects of biomedical research involving human subjects to provide advisory bases for competent authorities in approving, inspecting, evaluating, and accepting research.

Article 6. Tasks of the Ethics Committee

1. The Institutional Ethics Committee has the following tasks:

a) Review the following documents for clinical trials of drugs, medical devices, and new diagnostic and therapeutic techniques before submitting them to the National Ethics Committee:

- Research files, research outlines, qualifications of researchers, and research sites.

- Files requesting changes to research outlines, periodic reviews of research, and unscheduled reviews of research.

- Reports on research results.

b) Review the following documents for bioequivalence studies of drugs for approval by the responsible professional of the bioequivalence study institution: research files, research outlines, qualifications of researchers, and research sites; files requesting changes to research outlines, periodic reviews of research, and unscheduled reviews of research; reports on research results.

c) Monitor compliance with research outlines and ethical regulations during the research process; evaluate the recording, reporting, and handling of adverse events occurring during the research.

d) Store and manage, secure records of the Ethics Committee's activities in accordance with the law.

2. The National Ethics Committee has the following tasks:

a) Review research files, research outlines, qualifications of researchers, and research sites before implementing the research.

b) Review research during implementation at testing institutions, including: changes to research outlines, periodic reviews of research, and unscheduled reviews of research.

c) Review reports on research results from testing institutions.

d) Monitor compliance with research outlines and ethical regulations during the research process at testing institutions; evaluate the recording, reporting, and handling of adverse events occurring during the research at testing institutions.

đ) Store and manage, secure records of the Ethics Committee's activities in accordance with the law.

Article 7. Powers of the Ethics Committee

1. Approve or disapprove:

a) Research proposals, research outlines, amendments to research outlines, research result reports;

b) Exemption from obtaining informed consent forms for research participants or voluntary participation forms in cases where absolute confidentiality of participant information is required, or it is impossible to obtain consent from the research participants or their legal representatives, after fully considering the benefits and risks of the research to the participants and measures to protect the rights and safety of the participants;

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

2. Invite independent consultants to provide professional opinions for the Ethics Committee.

3. Require principal researchers, research organizing entities, and research sponsors to report data, results, related research files, and to amend and supplement research outlines to ensure the safety of research participants.

4. Propose competent authorities to halt research when non-compliance with good clinical practice principles or violations of research outlines are discovered.

Article 8. Responsibilities of the Ethics Committee

1. Ensure the maximum reduction of adverse effects on the health of research participants.

2. Conduct periodic reviews at least once a year for clinical trial research.

3. Monitor, supervise, conduct ad hoc reviews, and examine adverse events occurring during research, violations of research outlines to ensure the rights, health, safety of research participants, the accuracy, reliability, integrity, objectivity, and scientific nature of data and research results.

4. The Chair of the Committee promulgates the operational regulations of the Ethics Committee, which stipulate procedures and processes for reviewing research, both full and expedited; approve and publicly announce standard operating procedures of the Ethics Committee to achieve consistency in establishing members, training committee members, and performing specific tasks and responsibilities.

5. Publicize ethical guidelines used by the Ethics Committee in biomedical research.

6. Maintain confidentiality of information related to research.

Chapter IV
ORGANIZATION OF THE ETHICS COMMITTEE

Article 9. Organization of the National Ethics Committee

1. The National Ethics Committee consists of the Chairman of the Committee, at least three Deputy Chairmen of the Committee, Committee members, alternate members (if any), specialized sub-committees, and the Committee Office.

2. The number of Deputy Chairmen, Committee members, alternate members, professional secretaries, administrative secretaries, the number of specialized sub-committees of the National Ethics Committee, and the number of Deputy Heads of the Committee Office and staff of the National Ethics Committee Office are specified in the operational regulations of the Committee.

3. The Science, Technology and Training Department serves as the permanent office of the National Ethics Committee.

4. The National Ethics Committee has an assisting agency, the National Ethics Committee Office located within the Science, Technology and Training Department under the Ministry of Health.

5. The National Ethics Committee Office includes the Director of the Office, Deputy Directors of the Office, Chief Accountant working on a part-time basis, and other staff of the Committee Office.

Article 10. Structure of the Institutional Ethics Committee

1. The Institutional Ethics Committee consists of the Chairperson of the Committee, at least one Vice-Chairperson of the Committee, members of the Committee, substitute members (if any), the standing body of the Committee, and specialized subcommittees when necessary.

2. The number of Vice-Chairpersons, members, substitute members (if any), professional secretaries, administrative secretaries, and the number of specialized subcommittees of the Institutional Ethics Committee shall be stipulated in the operational regulations of the Committee.

3. The head of the organization establishing the Institutional Ethics Committee assigns a unit to serve as the standing body of the Institutional Ethics Committee.

Article 11. Composition of Members of the Ethics Committee

1. The Ethics Committee must have at least five members, ensuring gender balance, including:

a) A member with expertise in the health sector and independent from the organization establishing the Ethics Committee;

b) A clinical doctor;

c) A member with experience reviewing legal files;

d) A member not belonging to the health sector;

đ) A member under fifty years old and a member fifty years old or older.

2. Substitute members of the Ethics Committee:

a) The composition of the Ethics Committee may include substitute members;

b) Substitute members must meet the criteria and have responsibilities like regular members of the Ethics Committee;

c) In cases where the meeting to review research file of the Ethics Committee does not ensure the required number and composition of members, the Committee Leader may invite substitute members to participate in reviewing research files and vote as regular members.

3. The Ethics Committee shall not include the head of the organization establishing the Ethics Committee.

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

Article 12. Criteria for the Chairperson, Vice-Chairperson, and Members of the Ethics Committee

1. Criteria for the Chairperson and Vice-Chairperson of the National Ethics Committee:

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

b) Have at least fifteen years of work experience related to the research areas evaluated by the Ethics Committee;

c) Possess credibility, leadership skills, ability to synthesize and unify opinions to achieve consensus among committee members;

d) Understand good clinical practice principles and standard operating procedures of the Ethics Committee;

đ) No person shall be appointed as Chairperson of the Ethics Committee for more than two consecutive terms.

2. Criteria for the Chairperson and Vice-Chairperson of the Institutional Ethics Committee:

a) Hold a bachelor's degree or higher in the health sector;

b) Have at least ten years of work experience related to the research areas evaluated by the Ethics Committee;

c) Meet the criteria specified in points c, d, and đ of Clause 1 of this Article.

3. Criteria for members of the Ethics Committee:

a) Members with expertise in the health sector and those with experience reviewing legal files must hold a bachelor's degree or higher;

b) Members without expertise in the health sector must hold an associate degree or higher;

c) Understand good clinical practice principles and standard operating procedures of the Ethics Committee.

Article 13. Standards for professional secretaries and administrative secretaries of the Ethics Committee

1. Standards for professional secretaries:

a) Being honest and impartial;

b) Having a bachelor's degree or higher in health-related fields;

c) Understanding good clinical practice principles and standard operating procedures of the Ethics Committee;

d) Members of the Ethics Committee may concurrently serve as the professional secretary of the Ethics Committee.

2. Standards for administrative secretaries:

a) Being honest and impartial;

b) Having an associate degree or higher;

c) Understanding standard operating procedures of the Ethics Committee.

Article 14. Appointment, supplementation, replacement, resignation, removal of Chairperson, Vice-Chairperson, and members of the Ethics Committee

1. Initial appointment:

a) Based on the standards and structure of the Ethics Committee members, the head of the unit assigned to be the permanent representative of the Committee shall coordinate with the current Chairperson of the Committee (if any) to unify the plan for appointing committee member personnel;

b) The appointment dossier for Ethics Committee members must include sufficient evidence meeting the standards stipulated in Article 12 of this Circular and be kept at the Committee;

c) For personnel under the management of another organization, the organization establishing the Ethics Committee needs to seek written opinions from the managing organization regarding the proposed appointment as a Committee member. For independent experts, written consent from them is required;

d) On the basis of the proposal document from the head of the unit assigned to be the permanent representative of the Committee, the head of the organization establishing the Ethics Committee decides on the appointment of Committee members;

đ) The term of office of members and alternate members follows the term of the Ethics Committee.

2. Supplemental appointment, replacement:

When there is a need to supplement or replace Ethics Committee members, the head of the unit assigned to be the permanent representative of the Committee shall coordinate with the Chairperson to unify the human resources plan for supplementation or replacement as Committee members according to the standards, dossier, and time as stipulated in Clause 1 of this Article.

3. Resignation:

a) An Ethics Committee member can resign when they feel they do not meet the conditions to fulfill their duties as a member or have a personal wish to resign;

b) A member wishing to resign must notify their resignation intention to the Chairperson and the head of the unit assigned to be the permanent representative of the Committee;

c) The head of the unit assigned to be the permanent representative of the Committee has the responsibility to report to the head of the organization establishing the Ethics Committee for consideration and decision on accepting or not accepting the resignation of the Committee member.

4. Removal:

a) In cases where an Ethics Committee member does not meet the membership standards, the head of the unit assigned to be the permanent representative of the Committee shall coordinate with the Chairperson to unify the removal of that member;

b) Based on the proposal document from the head of the unit assigned to be the permanent representative of the Committee, the head of the organization establishing the Ethics Committee decides on removing or not removing the Committee member.

Article 15. Independent Consultants for the Ethics Committee

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

1. Independent consultants must be individuals without conflicts of interest with the reviewed research.

2. Independent consultants may attend Ethics Committee meetings to exchange and discuss research but do not have voting rights. In cases where independent consultants cannot attend meetings, their written opinions must be considered by the Ethics Committee and recorded in the minutes.

3. Independent consultants are responsible for maintaining confidentiality of information and materials related to accessed research.

Chapter V
ACTIVITIES OF THE ETHICS COMMITTEE

Article 16. Principles of Operation of the Ethics Committee

1. The operation of the Ethics Committee is non-profit.

2. When reviewing, commenting, guiding, and approving human-related biomedical research, members of the Ethics Committee must fully apply ethical principles as stipulated in this Circular, the operational regulations of the Committee, standard practice procedures of the Committee, and relevant laws.

3. The Ethics Committee operates on the principle of collective democracy and independence when appraising and making decisions.

4. Meetings to review research involving vulnerable groups must include representatives from these groups or experts with experience working with them.

5. A full appraisal process must have at least five members of the Ethics Committee attend and vote, including at least one member with appropriate expertise in the health sector, one member without expertise in the health sector, one independent member, and members of both genders; for specialized sub-committees, meetings must have at least two members of the relevant sub-committee attend and vote; research can only be approved if there are fewer than two disapproving votes among valid ballots. In cases where consensus cannot be reached during the appraisal meeting, the Chair of the Ethics Committee has the authority to decide on immediate voting or requesting the principal researcher to complete the research application for further review and voting at the next Committee meeting.

6. A simplified appraisal process may only be applied to research with minimal risk, completed applications based on previous appraisals, research applications previously reviewed and approved by another Ethics Committee, applications for changes to research proposals, periodic reports, unexpected reports on research, updates during the research process, adverse event reports, and protocol deviation reports; research can only be approved if all assigned reviewers approve it. If a reviewer does not approve, the Chair of the Ethics Committee has the authority to decide on a full appraisal process.

7. Members of the Ethics Committee shall not appraise research in which themselves, their spouse, biological or adoptive parents, biological or adoptive children, full siblings, or in-laws have a conflict of interest; they shall not participate in implementing research that they have appraised and approved through the Ethics Committee.

Article 17. Guidelines for Submitting Research Applications to the Ethics Committee

The Ethics Committee issues guidelines regarding the requirements for submitting research applications for appraisal. These guidelines include the following contents:

1. Name and address of the secretary, staff, or committee member receiving the application or online submission address (if applicable);

2. List of all written documents in the application;

3. Format of the documents;

4. Language of the documents in the application;

5. Number of copies required to be submitted;

6. Deadline for submission relative to the date of appraisal;

7. Method of notification for incomplete applications;

8. Timeframe for resubmitting the application (if necessary);

9. Expected time for notifying the appraisal results;

10. Format of forms required to be submitted according to the Committee's regulations (if applicable);

11. Appraisal fee for research applications (if applicable).

Article 18. Contents to be reviewed by the Ethics Committee

1. Contents to be reviewed for research before implementation:

a) Research design and data collection process;

b) Preclinical and clinical research results (if applicable);

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

d) Selection of the research population, information used in recruiting potential participants; the process of providing information and obtaining informed consent from research participants; financial benefits and costs related to research participants;

đ) Protection of privacy and confidentiality of research participants; procedures for monitoring, evaluating, and handling adverse events (for research involving interventions on participants);

e) Competence of researchers and research sites.

2. Contents to be reviewed for ongoing research:

a) Compliance with the approved research protocol;

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

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

d) Protocol violations and measures to correct and prevent such violations (if any);

đ) Contents of protocol amendments and related documents (if any).

3. Contents to be reviewed for research result reports:

a) Compliance with the research protocol during implementation;

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

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

Article 19. Notification of Ethics Committee's Review Results

Within five working days from the date of the review results of the research proposal, the Ethics Committee shall send a notification letter regarding the review results to the testing facility, principal researcher, specifically as follows:

1. In case the research protocol is approved by the Ethics Committee: notify according to the Model Approval Certificate for Research Protocol attached as Appendix I to this Circular.

2. In case amendments and supplements to the research protocol are approved by the Ethics Committee: notify according to the Model Approval Certificate for Amendments and Supplements to the Research Protocol attached as Appendix II to this Circular.

3. In case the research result report is approved by the Ethics Committee: notify according to the Model Approval Certificate for Research Result Report attached as Appendix III to this Circular.

4. In case the research protocol or amendments and supplements to the research protocol or research result report are conditionally approved by the Ethics Committee: notify according to the Model Conditional Approval Notice attached as Appendix IV to this Circular.

5. In case the research protocol or amendments and supplements to the research protocol or research result report are not approved by the Ethics Committee: notify according to the Model Non-Approval Notice attached as Appendix V to this Circular.

6. The head of the organization establishing the Ethics Committee at the facility level shall be responsible for specifying the confirmation method of the organization on the notification letter of the Ethics Committee's review results.

Article 20. Monitoring and Supervising Research

1. The Ethics Committee shall monitor and supervise research through direct supervision at the research implementation site or by reviewing progress reports, research results, regular and ad hoc assessments of research.

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

Article 21. Archiving Documents of the Ethics Committee

1. All documents and notifications of the Ethics Committee must be dated with the month, day, and year, filed, and stored according to the standard operating procedures of the Ethics Committee and legal regulations on archiving.

2. Records may be stored in paper or electronic form.

3. Documents that need to be archived include:

a) Documents regarding the establishment of the Committee;

b) Standard operating procedures of the Committee;

c) Documents issued by the Ethics Committee;

d) Annual activity summary reports of the Committee;

đ) Scientific resumes of Committee members;

e) Meeting invitations and agendas of the Committee;

g) Review forms, research evaluation forms, meeting minutes of the Committee;

h) Notifications of assessment results by the Committee;

i) Legal documents used by the Committee;

k) Guidance materials on research ethics used by the Committee;

l) Research files reviewed by the Committee;

m) Other related documents as prescribed by law.

Chapter VI
IMPLEMENTING PROVISIONS

Article 22. Effectiveness

1. This Circular shall take effect from February 1, 2025.

2. Circular No. 04/2020/TT-BYT dated March 5, 2020 of the Minister of Health on the establishment, functions, tasks, and powers of the Ethics Committee in biomedical research is repealed from the date this Circular takes effect.

Article 23. Implementation Organization

1. The Science, Technology and Training Department, Ministry of Health

a) Shall take the lead and coordinate with relevant units to disseminate and guide the implementation of this Circular;

b) Update the list of established Ethics Committees on the Science, Technology and Training Department's website within fifteen days from the date of receiving the notification of establishment of the Ethics Committee;

c) Shall take the lead and coordinate with relevant units to periodically or ad hoc check whether the Ethics Committee meets the requirements stipulated in this Circular;

d) In case of discovering that the Ethics Committee does not meet the requirements stipulated in this Circular during inspection, the Science, Technology and Training Department shall remove the Ethics Committee from the updated list on the Science, Technology and Training Department's website;

đ) Suspend or recommend the competent authority to suspend the activities of the Ethics Committee if it is found that the Committee violates the provisions of this Circular, affecting the protection of the rights, safety, and health of research participants.

2. Provincial Departments of Health, Central Departments of Health

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

b) Periodically or ad hoc check whether the Ethics Committee under their management meets the requirements stipulated in this Circular;

c) Recommend the Ministry of Health (Science, Technology and Training Department) to remove the Ethics Committee from the updated list on the Science, Technology and Training Department's website if it is found that the Ethics Committee under their management violates the provisions of this Circular, affecting the protection of the rights, safety, and health of research participants.

3. Organizations establishing the Ethics Committee

a) Ensure human resources, infrastructure, and equipment conditions for the operation of the Committee and its Office or permanent department;

b) Allocate and ensure sufficient funding for the operation of the Committee and its Office or permanent department from state budget and other lawful sources as prescribed by law;

c) Conduct annual evaluations of compliance with legal regulations, organizational rules and operations, and standard operating procedures of the Ethics Committee;

d) Notify the Science, Technology and Training Department, Ministry of Health about the establishment and improvement of the Ethics Committee according to the model attached to this Circular and update information on the organization's website within fifteen days from the date of the decision to establish or improve the Committee.

4. The Ethics Committee at the grassroots level may refer to this Circular for application in accordance with practical circumstances when assessing biomedical research involving humans.

During the implementation process, if any issues arise or difficulties occur, agencies, organizations, and individuals should promptly report to the Ministry of Health (through the Science, Technology and Training Department) for guidance and resolution./.

 

ANNEX I

(Issued together with Circular No. 43/2024/TT-BYT)

 

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

Approval of Research Outline

Based on Decision No... dated... of... concerning the establishment of the Ethics Committee in biomedical research...¹;

Based on Decision No... dated... of... concerning the issuance of the Rules on Organization and Operation of the Ethics Committee in biomedical research...¹;

Based on Minutes No... dated... of the Ethics Committee in biomedical research...¹ regarding the review of the research outline,

The Ethics Committee in biomedical research...¹:

1. Approves the scientific and ethical aspects of the research:

1.1. Research code:

1.2. Research name:

1.3. Research phase:

1.4. Principal researcher:

1.5. Lead organization:

1.6. Main collaborating agency:

1.7. Sponsor:

1.8. Research implementation location:

1.9. Research participants:

1.10. Estimated number of research participants:

1.11. Research duration:

2. Permits the use of the following documents in the above research:

3. Date of approval:

4. Next reporting date:

5. Recommendations of the Ethics Committee for the research (if any):

6. The principal researcher has the following responsibilities:

1. Comply with the approved research outline and related documents, Good Clinical Practice principles, and current laws on research ethics.

2. Report to the Bioethics Committee for Medical Research...¹ serious adverse events (Serious Adverse Event - SAE) and suspected unexpected serious adverse reactions (Suspected Unexpected Serious Adverse Reaction - SUSARs) related to the research product according to the current guidelines and regulations.

3. Report to the Bioethics Committee for Medical Research...¹ review and approve changes, deviations, or amendments to the research outline and informed consent forms, and information materials provided to participants before implementing them in the study, except in cases where clear changes are necessary to eliminate direct risks to participants.

4. Annually report the progress of the research implementation to the Bioethics Committee for Medical Research...¹ on the same day or before the date of the previous year's assessment.

5. Promptly report the progress of the research implementation to the Bioethics Committee for Medical Research...¹

when requested by the Bioethics Committee for Medical Research...

6. Timely notify about the termination of the research, early completion of the research before the expected completion date, and the reasons for early termination.

ANNEX II

(Issued together with Circular No. 43/2024/TT-BYT)

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

Approval of Research Outline Changes

Based on Decision No... dated... of... concerning the establishment of the Ethics Committee in biomedical research...¹;

Based on Decision No... dated... of... concerning the issuance of the Rules on Organization and Operation of the Ethics Committee in biomedical research...¹;

Based on Decision number... dated... of... approving the research outline "...".

Based on Minutes number... dated... of the Bioethics Committee for Medical Research...¹ regarding the assessment of changes to the research outline,

The Bioethics Committee for Medical Research...¹:

1. Approve changes to the research outline for the following research:

1.1. Research code:

1.2. Research name:

1.3. Principal Investigator:

1.4. Lead Organization:

1.5. Sponsor:

2. Approve the following main changes to the research outline:...

3. Permit the use of the following modified and supplementary documents in the above-mentioned research:

4. Effective approval date:

5. Date of the next periodic report:

6. The principal investigator is responsible for complying with the research outline and the modified and supplemented documents from the effective date of this approval.

ANNEX III

(Issued together with Circular No. 43/2024/TT-BYT)

 

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

report research results

Based on Decision number... dated... of... establishing the Bioethics Committee for Medical Research...¹;

Based on Decision number... dated... of... promulgating the Regulation on the Organization and Operation of the Bioethics Committee for Medical Research ...¹;

Based on Decision number... dated... of... approving the research outline...

Based on Minutes No... dated... of the Ethics Committee in biomedical research...¹ regarding the assessment of the research result report and final documentation (if applicable),

The Bioethics Committee for Medical Research...¹
certifies the research result report as follows:

1. Research code (if applicable):

2. Research name:

3. Research phase (if applicable):

4. Principal Investigator:

5. Lead Organization:

6. Main coordinating agency:

7. Sponsor:

8. Research location:

9. Research period:

10. Name of product/technique/method researched (if applicable):

11. Dosage regimen of the product/technique/method used in the research (if applicable):

12. Bioethics Committee's conclusion on the research:

13. Approval date:

 ANNEX IV

(Issued together with Circular No. 43/2024/TT-BYT)

NOTICE OF CONDITIONAL APPROVAL

On..., the Bioethics Committee for Medical Research...³ (the Bioethics Committee) conducted a meeting to review the research application before implementation/reporting ongoing research/reporting research results.

1. General information about the research

1.1. Research name:

1.2. Lead Organization:

1.3. Principal Investigator:

1.4. Sponsor:

1.5. Research location:

2. The Bioethics Committee's opinion on the research

2.1. Requirements of the Bioethics Committee:

2.2. Recommendations of the Bioethics Committee (if any):

We request the lead research organization and the principal investigator to complete the application and submit... completed copies of the application to the Standing Office of the Bioethics Committee within... days from the receipt of this letter (electronic files of the application sent to the email address...) for the Bioethics Committee to re-examine/re-assess.

The application submitted to the Standing Office of the Bioethics Committee includes:

- Explanation of the adoption of the Bioethics Committee's opinions;

- Completed documents;

- Other related documents.

Please be informed for the lead research organization and the principal investigator to take note and comply./.

ANNEX V

(Issued together with Circular No. 43/2024/TT-BYT)

NOTICE OF NON-APPROVAL

On..., the Bioethics Committee for Medical Research...³ (the Bioethics Committee) conducted a meeting to review the research application before implementation/reporting ongoing research/reporting research results.

1. General information about the research

1.1. Research name:

1.2. Lead Organization:

1.3. Principal Investigator:

1.4. Sponsor:

1.5. Research location:

2. The Bioethics Committee's opinion on the research

2.1. The Bioethics Committee does not approve the research application before implementation/reporting ongoing research/reporting research results.

2.2. Reasons for non-approval:...

Please be informed for the lead research organization and the principal investigator to take note./.

ANNEX VI

(Issued together with Circular No. 43/2024/TT-BYT)

Respected: Department of Science, Technology and Training, Ministry of Health

[Name of the organization establishing the Bioethics Committee] hereby informs the Department of Science, Technology and Training, Ministry of Health about the establishment of the institutional Bioethics Committee for Medical Research of [Name of the organization establishing the Bioethics Committee], specifically as follows:

1. Decision on the establishment of the committee number..., dated...

2. Committee name:

3. Chairperson of the Committee:

Name:

Telephone:                                 Email:

4. Professional/administrative secretary of the Committee:

Name:

Telephone:                                 Email:

5. Committee office:

Fax:

Telephone:                                 Email:

Documents attached to the letter

1. Decision on the establishment of the Committee.

2. Regulation on the operation of the Committee.

3. List and scientific curriculum vitae of Committee members.

4. List and copies of standard operating procedures of the Committee.

Respectfully request the Science, Technology and Training Department to update on the Department's electronic information website in accordance with regulations.

Respectfully,

NAME OF THE ESTABLISHED ETHICS COMMITTEE

LIST OF MEMBERS OF THE ETHICS COMMITTEE IN BIOMEDICAL RESEARCH

(Pursuant to the Decision establishing the Committee number …, dated …)

Total number of Ethics Committee members is ….

NAME OF THE ESTABLISHED ETHICS COMMITTEE

LIST OF STANDARD PROCEDURES OF THE ETHICS COMMITTEE IN BIOMEDICAL RESEARCH 

Total number of standard procedures is ….