Circular No. 04/2020/TT-BYT stipulates the establishment, functions, tasks, and powers of the Ethics Council in Biomedical Research.

CIRCULAR

Regulations on establishment, functions, tasks, and authorities
of the Bioethics Council in Biomedical Research

 

 

 

 

Based on the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Based on the Law on Medical Examination and Treatment No. 40/2009/QH12; November 23, 2009;

Based on Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management; Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing certain articles of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management; and Decree No. 03/2020/NĐ-CP dated December 31, 2020 of the Government amending and supplementing Article 68 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management, which has been amended and supplemented by Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing certain articles of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management;

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 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 to regulate the establishment, functions, tasks, and authorities of the Bioethics Council in Biomedical Research.

 

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation andApplicability

1. This Circular stipulates the establishment, functions, tasks, and authorities of the National Bioethics Council and the Bioethics Council at the institutional level (hereinafter referred to as the Bioethics Council).

2. This Circular applies to the Bioethics Council, agencies, organizations, and individuals conducting biomedical research involving humans in the healthcare sector in Vietnam and other relevant agencies, organizations, and individuals.

 

Article 2Definitions

In this Circular, the following terms are understood as follows:

1. Biomedical research involving human participants (Research involving human participants) is scientific research in the healthcare field where humans are affected by interventions, observations, or other interactions due to participation in the research or may be identified through the collection, analysis, use of healthcare-related data, biological materials.
2. Bioethics y (Bioethics) is the implementation and assurance of ethical principles and standards in biomedical research involving humans. Researcher
3. (Researcher) is the person responsible for conducting research at the research site. Principal Investigator (PI)
4. is the researcher responsible for directly overseeing the completion of the research and reporting the process and results of the research directly to the sponsor. Sponsor
5. (Sponsor) is an individual, agency, or organization responsible for initiating, managing, and/or providing funding for the research. Research
6. Monitoring and Supervision (Research monitoring and supervision) is the process of checking and tracking the progress of the research, the compliance of researchers with the approved protocol and relevant laws governing the research.
7. Informed Consent Form (- ICF is a document proving the participant's consent to participate in the research, describing the rights of the research subject; conveying information clearly and respecting the research subject, including: title of the research, timeframe, principal investigator, purpose of the research, description of the research process, potential risks and benefits, alternative treatments, confidentiality commitment, information and data collected, data storage time, method of storing data and who can access the data, conflict of interest, right of the research subject to withdraw from the research at any time, affirming that the research subject understands the research and agrees before signing the ICF, written in language easily understood by the research subject. For research subjects with limited educational qualifications, the content of the ICF needs to be provided and explained verbally. Assent Form - AF) is a document proving the consent of the research subject who does not have the capacity to give legally binding consent, including children aged 12 to under 16 years old, persons with limited civil capacity, or patients in a state of impaired cognition, containing similar information to the ICF but written more simply, concisely, and easily understood. For research subjects aged 7 to under 12 years old, the content of the AF needs to be provided and explained verbally.
8. Voluntary (Voluntary)
9. is the free choice or action without being bribed, encouraged, coerced, forced, incited, restricted, reminded, suggested, or influenced by others in any way. (Privacy) (Privacy)
10. is the state or condition of being alone or separated, not being affected or noticed by others, chosen by oneself within their scope of authority; not being interfered with or violated; not being disclosed or revealed, protected from being recognized in public. Conflict of Interest (Conflict of interest)
11. is a situation where the personal interests of the researcher or member of the Bioethics Council pose a risk of conflicting with the obligations and responsibilities of the researcher or member of the Bioethics Council, potentially affecting the objectivity of the research or the review of the research. Personal Data (Personal data)
12. is data related to personally identifiable information of research participants. Benefit (Benefit)
13. is the advantageous result obtained from the research. Risk (Risk)
14. is the probability of an adverse event (potential harm) causing discomfort or harm or injury (physical, mental, social) or economic loss occurring due to participation in the research. Minimal Risk (Minimal risk)
15. is risk where the probability and degree of harm or discomfort or other adverse effects expected in the research are not greater than what could be recognized in daily life or in the performance of routine examinations or tests. Compensation) (Compensation)
16. is the monetary or material, spiritual compensation by individuals or organizations responsible for the research according to the research contract or legal provisions for those related to the research who suffer losses due to the research. Reimburs) is the compensation in money or material and spiritual values provided by individuals or organizations responsible for research under research contracts or as prescribed by law to those related parties affected by losses caused by the research.
17. Repayment (ReimbursAverage loan repayment period is 10 years;) is the act of the researcher returning in full the amount of money or materials, objects related to the research to the subject of the research according to the research contract or as prescribed by law.
18. Implementation procedure(Standard Operating Procedure - SOP) SOP) is a detailed guide document to achieve consistency in performing a specific task or mission in research or the activities of the Ethics Committee.
19. THEclinical trial (Clinical Trial) is a biomedical research in which the research subjects are allocated to one or more interventions according to a pre-approved plan to evaluate the impact of those interventions on human health.
20. Good Clinical trial Practice - GCP) (is a set of principles and standards for designing, managing, conducting, monitoring, inspecting, recording, analyzing, and reporting clinical trials to ensure the reliability and accuracy of data and reporting of research results, protect the rights, safety, and confidentiality of information of research subjects. ethical assurance 1. Research may only be implemented after being approved by the competent authority for the research outline.

Article 3. General Principles 2. Prior to approval and implementation by the competent authority, all biomedical research involving humans in Vietnam must be reviewed, commented upon, guided, and approved ethically and scientifically by the Ethics Committee in accordance with the provisions of this Circular.

3. All biomedical research involving humans are subject to supervision by the Ethics Committee during implementation.

4. For organizations that do not have the conditions to establish a local Ethics Committee, the review and evaluation of biomedical research involving humans shall be carried out by the Ethics Committee established by the Department of Health or the Ethics Committee of another unit with relevant expertise.

Independence of the Ethics Committee

1. Members of the Ethics Committee shall not review research in which themselves or their spouse, biological or adopted father, biological or adopted mother, biological or adopted child, brother, sister, brother-in-law, sister-in-law, brother-in-law, sister-in-law, and members of their spouse's family have a conflict of interest.

Article 4. 2. Members of the Ethics Committee shall not participate in supporting or implementing research they have reviewed through the Ethics Committee.

3. The Ethics Committee shall include at least one member with expertise in the health sector independent from the organization establishing the Ethics Committee.

4. The Ethics Committee shall not include the head of the organization establishing the Ethics Committee, members of the funding organization, or the organization conducting the reviewed research.

5. Members of the national-level Ethics Committee shall not include civil servants of the Ministry of Health.

ESTABLISHMENT OF THE ETHICS COMMITTEE

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Chapter II

Establishment

Article 5ofhthe Ethics Committee at the national level 1. The national-level Ethics Committee in biomedical research shall be established by decision of the Minister of Health.

2. The Minister of Health shall approve the organizational regulations and operations of the national-level Ethics Committee; decide on the appointment, removal, dismissal, or supplementation and replacement of members of the national-level Ethics Committee.

3. The term of office of the national-level Ethics Committee is five years, and the committee must be re-established or reorganized when the term ends. The composition of the next consecutive term's Ethics Committee must include at least 25% new members compared to the previous consecutive term's composition.

4. The national-level Ethics Committee has its own seal and account to perform its functions, duties, and powers.

5. The national-level Ethics Committee includes a Chairperson, three Deputy Chairpersons, a permanent subcommittee, specialized subcommittees, a data monitoring subcommittee, and the Ethics Committee Office and other subcommittees as necessary.

6. The national-level Ethics Committee shall have at least nine regular members ensuring the structure and standards stipulated in Article 7 and Article 8 of this Circular. In addition to regular members, the national-level Ethics Committee may have substitute members clearly stated in the appointment decision.

7. The national-level Ethics Committee may have up to three professional secretaries and up to two administrative secretaries meeting the standards stipulated in Article 9 of this Circular. The organization establishing the Ethics Committee is responsible for ensuring sufficient numbers of professional and administrative secretaries to carry out the duties of the Ethics Committee.

8. The Science, Technology, and Training Department of the Ministry of Health serves as the permanent office of the national-level Ethics Committee.

at the local level

Article 6ofhthe Ethics Committee at the national level 1. The head of the organization authorized to approve research decides to establish the local-level Ethics Committee in biomedical research, approves the organizational regulations and operations of the Committee, and decides on the appointment, removal, dismissal, or supplementation and replacement of members of the local-level Ethics Committee.

2. The term of office of the local-level Ethics Committee is implemented in accordance with Clause 3 of Article 5 of this Circular.

3. The local-level Ethics Committee includes a Chairperson, one to two Deputy Chairpersons, a permanent department, and may have specialized subcommittees if necessary.

3. The local-level Ethics Committee may use the seal of the organization establishing the Committee in activities related to the functions and duties of the Ethics Committee as stipulated by the head of the organization establishing the Committee.

4. The local-level Ethics Committee shall have at least five regular members ensuring the structure and standards stipulated in Article 7 and Article 8 of this Circular. In addition to regular members, the local-level Ethics Committee may have substitute members clearly stated in the appointment decision.

5. The local-level Ethics Committee may have up to two professional secretaries and up to two administrative secretaries meeting the standards stipulated in Article 9 of this Circular. The organization establishing the Ethics Committee is responsible for ensuring sufficient numbers of professional and administrative secretaries to carry out the duties of the Ethics Committee.

5. The basic-level Ethics Council has a maximum of two professional secretaries and a maximum of two administrative secretaries meeting the criteria specified in Article 9 of this Circular. The organization establishing the Ethics Council is responsible for ensuring an adequate number of professional and administrative secretaries to carry out the tasks of the Ethics Council.

Article 7. Structure of Members of the Ethics Council

1. The Ethics Council must have members meeting the following requirements:

1. Members holding a degree in a health-related field relevant to the research area evaluated by the Ethics Council, including at least one person independent from the organization establishing the Ethics Council;
2. Members who are clinical doctors;
3. Members with expertise in law or understanding of ethical principles in biomedical research;
4. Members without expertise in the health sector;

2. Members of the Ethics Council shall be structured by age groups: under 40 years old, between 40 and under 50 years old, and 50 years old and above;
3. Members of the Ethics Council shall include both genders, with each gender comprising at least 20% of the total number of Ethics Council members;

Article 8. TCriteria of ENVIRONMENTMember at the national level

1. General Standards

a) Having the necessary experience, knowledge, skills, and related capabilities to perform member duties to ensure scientific integrity and protect the rights of research subjects;

b) Members with expertise in the health sector and those with legal expertise or understanding of ethical principles in biomedical research must hold a bachelor's degree or higher;

c) Members with expertise in the health sector must have at least five years of work experience related to the research area evaluated by the Ethics Council;

d) Availability to participate in fulfilling the duties of the Ethics Council;

e) Commitment to confidentiality regarding information related to research, discussion opinions during meetings, commercial secrets of individuals and organizations participating in research, and personal information about research subjects;

f) Having been trained and certified in Good Clinical Practice and standard operating procedures of the Ethics Council issued by the Ministry of Health or recognized organizations, and updated training according to Article 13 of this Circular;

2. Criteria for Chairperson and Deputy Chairperson of the Ethics Council

a) Meeting the member criteria stipulated in Clause 1 of this Article;

b) Having at least fifteen years of work experience related to the research area evaluated by the Ethics Council, having credibility, sufficient management and leadership capability to independently, impartially, and disinterestedly manage the Ethics Council, free from pressure from the research leading organization, researchers, and other agencies and organizations;

c) Possessing the ability to lead, synthesize, and unify the opinions of Ethics Council members, having the ability to persuade and help achieve consensus among members, and having time to fully prepare for Ethics Council meetings;

d) A person may not be appointed as Chairperson of the Ethics Council for more than two consecutive terms;

Article 9. Criteria for theSecretary of the Ethics Council

1. The professional secretary of the Ethics Council must meet the following criteria:

1. Being honest and objective;
2. Holding a bachelor's degree or higher in the health sector; possessing knowledge on science and technology management, scientific research, and ethical principles in biomedical research;
3. Having been trained and certified in Good Clinical Practice and standard operating procedures of the Ethics Council issued by the Ministry of Health or recognized organizations, and updated training according to Article 13 of this Circular;

2. The administrative secretary of the Ethics Council must meet the following criteria:

1. Being from a unit responsible for managing scientific research activities of the organization establishing the Ethics Council;
2. Being honest and objective;
3. Holding a bachelor's degree or higher; having administrative, clerical, and archival skills, and being trained and certified in standard operating procedures of the Ethics Council issued by the Ministry of Health or recognized organizations;

Article 10. Independent consultant specialized agency under the People's Committee of the province/city.ho at the national level

1. Consultants include experts knowledgeable about ethical principles in biomedical research; legal; scientific; expertise related to reviewed research or specific professional processes; representatives of the community; research subjects, and other relevant groups involved in reviewed research;

2. Consultants must be individuals without conflicts of interest with the reviewed research;

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

4. Independent consultants are responsible for maintaining confidentiality of information and documents related to accessed research;

Article 11. Appointment, Resignation, Removal, Supplement, Replacement of Chairperson, Deputy Chairperson, and Members at the national level

1. Appointment

a) At the beginning of the Ethics Council term, the head of the unit responsible for managing scientific research activities of the organization establishing the Ethics Council proposes personnel plans based on needs and member criteria for the head of the organization establishing the Ethics Council to decide on appointments;

b) For personnel managed by another organization, the organization establishing the Ethics Council must seek written consent from the managing organization regarding the proposed appointment as a member of the Ethics Council. For independent experts, written agreement from them is required;

c) Within thirty days from receiving the proposal document, the head of the organization establishing the Ethics Council decides on appointing Ethics Council members;

d) The term of regular members and replacement members follows the term of the Ethics Council;

2. Resignation

a) Members of the Ethics Council may resign when they feel they do not meet the conditions to fulfill their duties or have personal resignation wishes;

b) Resigning members must submit a resignation letter to the head of the organization establishing the Ethics Council;

c) Within thirty days from receiving the resignation letter, the head of the organization establishing the Ethics Council must review and decide to accept or reject the resignation of Ethics Council members;

3. Removal

a) A member of the Ethics Council shall be relieved of their duties when they fall under any of the following circumstances: inadequate health; failure to complete assigned tasks; violation of the Ethics Council's regulations; breach of independence; absence from more than three consecutive meetings of the Ethics Council.

b) The head of the unit responsible for managing scientific research activities of the organization that establishes the Ethics Council shall propose to the head of the organization establishing the Ethics Council to decide on relieving members of their duties based on the provisions set out in point a of this Clause.

c) Within thirty days from receiving the proposal document, the head of the organization establishing the Ethics Council must review and decide on relieving or not relieving members of their duties.

4. Supplement and replacement

a) Based on the criteria and needs for supplementing and replacing members of the Ethics Council, the head of the unit responsible for managing scientific research activities shall submit to the head of the organization establishing the Ethics Council a plan for appointing additional and replacement personnel as members of the Ethics Council.

b) For personnel under the management of another organization, the organization establishing the Ethics Council must seek the written opinion of the managing organization regarding the proposed appointment of additional or replacement personnel as members of the Ethics Council. For independent experts, written consent from them is required.

c) Within thirty days from receiving the proposal document, the head of the organization establishing the Ethics Council must review and decide on the supplementation and replacement of members of the Ethics Council.

d) The term of office for supplemented and replaced members of the Ethics Council is the remaining period of the Ethics Council's term.

Article 12. Funding, infrastructure, equipment serving internal control activities the Ethics Council

1. The head of the organization establishing the Ethics Council is responsible for allocating resources for the operation of the Ethics Council, specifically as follows:

a) Annual operating funds of the Ethics Council;

b) Office space, meeting rooms, and equipment to organize meetings of the Ethics Council and to carry out administrative work, file storage, and record keeping of the Ethics Council ensuring safety and confidentiality.

2. Financial resources for the operation of the Ethics Council are allocated from the state budget according to the laws issued by the Ministry of Finance and the Ministry of Science and Technology for scientific councils. For projects not using state budget funding, researchers and sponsors must prepare plans to self-fund all activities of the Ethics Council's review, assessment, monitoring, and supervision according to internal expenditure rules of the organization establishing the Ethics Council or sponsor regulations consistent with applicable laws.

Article 13Training for members of the Ethics Council

1. Members of the Ethics Council must undergo training before appointment and receive ongoing and supplementary training on ethical and scientific aspects of biomedical research during their tenure.
2. The head of the organization establishing the Ethics Council is responsible for assigning the unit responsible for managing scientific research activities to develop and implement a training plan for members of the Ethics Council. Ongoing and supplementary training must be conducted at least once every two years.
3. When training is supported by research sponsors, the organizing unit must ensure that sponsors do not directly or indirectly influence through the training content.

4. Pre-appointment training content for members of the Ethics Council includes:

a) Functions, responsibilities of the Ethics Council, relationships between the Ethics Council and other related units according to guidelines of the Ministry of Health and relevant international guidelines: International Ethical Guidelines for Biomedical Research, International Ethical Guidelines for Epidemiological Research of International Organizations on Health Sciences, Good Clinical Practice of the International Conference on Harmonization of Good Clinical Practice;

b) Authorities and responsibilities of members of the Ethics Council, actions members of the Ethics Council are prohibited from taking, the independence of the Ethics Council, and other relevant regulations concerning members of the Ethics Council;

c) Contents of standard procedures of the Ethics Council, regulations related to biomedical research;

d) Ethical considerations in biomedical research involving humans that need attention;

6. Ongoing and supplementary training content for members of the Ethics Council must include:

a) Training content prescribed in Clause 5 of this Article with updates and supplements;

b) Basic aspects of research methods;

c) Impact of research designs on research ethics issues;

d) Ways to identify and resolve issues arising from differences in perspectives and approaches when assessing research ethics aspects;

đ) Practicality and feasibility of research.

 

Chapter III

FUNCTIONS, DUTIES, AND AUTHORITY OF THE ETHICS COUNCIL

Article 14Function the Ethics Council

The Ethics Council in biomedical research has the function of advising the head of the organization establishing the Ethics Council on reviewing and assessing the ethical and scientific aspects of biomedical research involving humans to serve as the basis for approving, implementing, and accepting biomedical research.

Article 15. Task the Ethics Council

1. Duties of the National-level Ethics Council

a) Review research proposals before implementation regarding ethical, scientific, researcher capability, and research site aspects for: clinical trials of drugs, equipment, and other products not yet approved for circulation in Vietnam; multi-center clinical trials; first-time human clinical trials of new techniques and methods in Vietnam; ministry-level and national-level scientific and technological research involving humans in the healthcare sector in Vietnam; international collaborative research transferring biological samples of research subjects abroad or research results representing Vietnamese people, and other biomedical research as required by the Ministry of Health, the lead agency, or organization conducting the research.

b) Review changes and additions to the research outline and related documents during implementation for studies that have been approved by the competent authority.

c) Monitor compliance with the research outline and ethical regulations in research, evaluate the recording, reporting, and handling of adverse events by the principal investigator during the implementation of approved research.

d) Periodically review ongoing research studies.

đ) Review research results according to the approved research outline for studies that have been approved by the Ethics Council.

e) Store and manage, secure the activity records of the Ethics Council in accordance with the law on archiving, for review files that need to be stored for at least five years after acceptance.

g) Advise management agencies in developing policies and regulations related to human biobank research and activities specific to the institutional Ethics Council.

2. Duties of the Institutional Ethics Council

a) Review the ethical and scientific aspects of research proposals involving humans not covered under this Article's provisions for submission to the competent authority for approval.

b) Review the ethical and scientific aspects of research involving humans as specified in point a, Clause 1 of this Article, which are led by the institution establishing the Ethics Council before submitting the research proposal for national-level Ethics Council review.

c) Carry out tasks specified in points b, c, d, e, and g, Clause 1 of this Article for research led by the institution establishing the Ethics Council.

Article 16. Article 24uyền THE the Ethics Council

1. Approve, request modifications to the research outline, or reject the biobank research proposal, serving as the basis for the competent authority to decide whether to allow the research to proceed.
2. Decide on conducting a full or abbreviated review process as stipulated in Article 20 of this Circular.
3. Permit exemption from obtaining voluntary participation consent documentation from research subjects when absolute confidentiality is required for the research subject or in emergency patient research where consent cannot be obtained from the research subject or their legal representative, based on a thorough assessment of the benefits and risks of the research to the research subject and measures to protect the rights and safety of the research subject.
4. Approve or reject changes to the research content during implementation.
5. Require the principal investigator, implementing organization, and research sponsor to report data, results, and related research files.
6. Verify information provided to research subjects, the information provision process, and the voluntary participation consent documentation from research subjects. Monitor compliance with the research outline, Good Clinical Practice principles and standards at the research site.
7. Recommend the competent authority to halt research if non-compliance with Good Clinical Practice principles and standards, violation of the research outline, or potential risks to the safety of research subjects are identified during the study.
8. Temporarily suspend recruitment of new research subjects and the use of research products on existing research subjects if necessary to prevent harm to research subjects and clearly state the reasons for suspension.
9. Request adjustments and supplements to the research outline, information provision forms, voluntary participation consent forms, and other materials provided to research subjects during the research implementation phase to ensure their safety.

Article 17. Responsibilities of the Ethics Committee

1. Protecting the rights, safety, and health of research subjects, with particular attention to vulnerable research subjects and related communities; protecting the rights of researchers.

2. Ensuring fairness in the distribution of benefits and risks among groups based on social strata, age, gender, economic status, culture, ethnicity, and religion for research subjects.

3. Ensuring that potential physical, social, financial, or psychological risks at individual, family, or community levels are minimized and acceptable compared to expected benefits.

4. Ensuring that the research plan clearly outlines appropriate care, counseling, monitoring, and follow-up plans for research subjects, especially for vulnerable ones.

5. Ensuring the legality and scientific nature of the research plan and application, and reviewing the ethical impacts of research designs or strategies.

6. Considering the quantity and method of payment to research subjects to ensure there is no coercion or influence on their voluntary participation; payments are made according to each visit.

7. Ensuring that information related to payments to research subjects, including methods, amounts, and payment schedules, is specified in the information provision and consent form and other documents provided to research subjects.

8. Ensuring the privacy and confidentiality of personal information of research subjects.

9. Ensuring the confidentiality of information and protecting ethics committee members from retaliation for performing ethics committee-related tasks or evaluating research proposals.

10. Ensuring that research subjects have full understanding of the research and participate voluntarily. For children or individuals with limited civil capacity participating in research, their lawful representatives or guardians must give consent after being fully informed about the research.

11. Minimizing negative impacts and promoting positive impacts on the community with research subjects.

12. Creating conditions for researchers to discuss with ethics committee members on common issues and ethics committee decisions regarding specific research.

13. Publicly announcing ethics committee decisions, except confidential information, through the website of the organization establishing the ethics committee, newsletters, and other appropriate forms of notification.

 

Chapter IV

ACTIVITIES OF THE ETHICS COMMITTEE

Article 18. Principles internal control activities the Ethics Council

1. The activities of the Ethics Committee are non-profit.
2. The Ethics Committee must fully apply ethical principles as stipulated in this Circular, relevant legal regulations, and international guidelines on ethical conduct in biomedical research. The ethical guidelines applied by the Ethics Committee must be clearly stated and disseminated to researchers.
3. The Ethics Committee operates based on collective, democratic, and independent principles when reviewing and making decisions.
4. When considering research involving vulnerable groups, the Ethics Committee must have representatives of the research subjects or experts with experience working with such subjects attend the Ethics Committee meetings.
5. The Ethics Committee needs to establish rules for cooperation and/or referencing the assessment results of other domestic or foreign Ethics Committees.
6. In necessary cases, the Ethics Committee may invite independent consultants to provide professional opinions for the Ethics Committee.
7. The Ethics Committee's conclusion on research must be based on the consensus of Ethics Committee members and recorded in the meeting minutes. In cases where consensus cannot be reached, the Ethics Committee Chair has the authority to immediately proceed with voting or request the principal researcher to improve the research application for review and voting at the next Ethics Committee meeting. Research can only be approved if there are fewer than two dissenting votes among valid ballots.

Article 19. Content at the national level need to assess

The content assessed by the Ethics Committee when reviewing research applications, monitoring during the research process, and evaluating research outcomes includes:

1. Research design and implementation;
2. Potential risks and benefits;
3. Selection of research populations and protection of research subjects;
4. Financial interests and costs related to research subjects;
5. Protection of the privacy and confidentiality of research subjects;
6. The process of providing information and obtaining consent for participation in research from research subjects;
7. The impact of research on the community with research subjects;
8. Researchers' capabilities and research points.

Article 20. Assessing research according to the full process or simplified process

1. In cases where the research application is reviewed by the Ethics Committee according to the full process:

a) The research application does not meet the conditions for review according to the simplified process as stipulated in Clause 2 of this Article.

b) The application has been reviewed according to the simplified process but the reviewer requests a full process review.

2. In cases where the application is reviewed by the Ethics Committee according to the simplified process:

a) The research application poses minimal risk.

b) The research application has been previously reviewed by the Ethics Committee.

c) The research application has been reviewed and approved by another Ethics Committee at the same level.

d) Periodic reports on the implementation of the research have been approved.

đ) Applications for amendments and supplements to the research plan have been approved.

e) Reports on adverse events occurring during the research have been approved.

g) Reports on violations of the research plan have been approved.

3. Within thirty days from the date of receiving complete and valid applications, the Ethics Committee is responsible for organizing the review and notifying the decision of the Ethics Committee to the applicant.

4. The review file is legally valid when the meeting is convened by the Chairman of the Ethics Committee or the Vice-Chairman of the Ethics Committee (authorized to do so), with at least five members of the Ethics Committee present, including at least one member with relevant expertise in the health sector, one member without such expertise in the health sector, and one independent member; both genders must be represented, and decisions on the research must be made through voting, with minutes of the meeting being recorded.

5. The shortened review file of the Ethics Committee has legal validity only if it is reviewed and evaluated by at least two members of the Ethics Committee.

Article 21. Periodic review, ad hoc review of research

1. The Ethics Committee periodically reviews ongoing research within a timeframe appropriate to the level of risk for the research subjects, but at a minimum once a year on or before the date the research outline was approved by the Ethics Committee. The conclusion of the periodic review of the research file should clearly state any previous decisions of the Ethics Committee regarding the research that remain in effect, have been changed, suspended, or revoked.

2. In cases of ad hoc review, which include:

a) Amendments to the research outline that may affect the rights, safety, and/or interests of the research subjects or the conduct of the research.

b) Serious adverse events arising from the implementation of the research or research products.

c) New events or information that could impact the potential benefits or risks associated with the research.

d) Requests to suspend all or part of the research by sponsors or regulatory authorities.

Article 22. Guidelines for submittingfiles Clinical to the Ethics Committee

The Ethics Committee issues guidelines on the requirements for submitting research files for review, providing information requests and prescribed forms for researchers. These guidelines include the following contents:

1. Name and address of the secretary, staff member, or Ethics Committee member receiving the file or the online submission website address (if available).

2. List of all textual documents in the file.

3. Specifications of the documents.

4. Language of the documents in the file.

5. Number of copies required to be submitted.

6. Deadline for submission relative to the review date.

7. Procedures for recording and notifying incomplete submissions.

8. Expected time frame for notification of post-review decisions.

9. Timeframe to be adhered to when the Ethics Committee requires the submitter to provide additional information or modify documents.

10. Review fees for research files (if applicable).

11. Procedures for requesting approval of amendments to the research outline or related documents from the Ethics Committee.

12. Specifications of selection materials, information provision, and consent forms for participation in research.

Article 23Documents required by the Ethics Committee need VIETNAMESE VALUATION STANDARDS

1. For initial review of the research outline

a) Signed application form, including signatures of co-applicants and representatives of related organizations.

b) Research outline (with version number and date) and supporting documents, appendices (if any).

c) A simple summary of the research in easily understandable language.

d) Description of ethical considerations related to the research (which may be included in the outline); measures to protect the privacy of participants and data confidentiality; care and protection of research subjects; compensation or other goods/services provided to research subjects; insurance package for research subjects (if applicable).

đ) A comprehensive update summary of all safety, pharmacological, pharmaceutical, toxicological, and clinical trial data of the research product (applicable to research involving test products).

e) All data collection forms used in the research, with version number and date.

g) All recruitment materials, advertisements used to select potential participants.

h) Information and consent form for research participation (with version number and date) for research subjects who are 18 years old or older and have full civil capacity to give consent.

i) Information and consent form for research participation (with version number and date) for research subjects and their legal guardians (for research subjects aged 16 to under 18 years old).

k) Information and consent form for research participation (with version number and date) for the legal guardians of research subjects (for research subjects under 16 years old).

l) Consent form for research participation (with version number and date) for research subjects who lack the legal capacity to give valid consent, including children aged 12 to under 16 years old, individuals with limited civil capacity, or patients in a state of impaired consciousness.

m) Detailed description of the participant selection process and the collection of information and consent forms.

n) Monitoring, evaluation, and handling procedures for adverse events (for research involving interventions on research subjects).

o) All previous decisions of other Ethics Committees or regulatory bodies regarding the research (including reasons for objections or requests for previous amendments).

p) Written agreement from the implementing organization's management to allow the research to proceed after approval by the competent authority (if the research is conducted outside the organization establishing the Ethics Committee).

q) Commitment to adhere to ethical principles according to relevant guidelines by the principal investigator.

r) Current curriculum vitae and certificates of relevant expertise and ethics training of the principal investigator.

s) Other related documents.

2. For re-review of the research outline

a) Explanation of the Ethics Committee's opinion.

b) Revised and supplemented research outline and supporting documents.

3. For review of periodic reports of ongoing research

a) Summary of the research outline.

b) The complete research outline, including the amended portion previously approved.

c) Progress reports on the implementation of the research.

d) Report on the number of subjects selected, completed, withdrawn from the study, and lost to follow-up.

đ) Detailed report on adverse events and issues arising that pose risks to the research subjects, cases requesting withdrawal from the study.

e) Summary of relevant information, particularly safety information.

g) The current informed consent form and approval for participation in the study.

h) Independent review report by the researcher and sponsor.

i) Notification from the principal investigator or sponsor regarding suspension/early termination or completion of the study.

4. For reviewing the amendment and supplement application of the research outline.

a) Explanation report on the amended and supplemented contents.

b) Amended and supplemented documents.

c) Other related documents.

5. For reviewing the report on adverse events occurring during the research.

a) Report on adverse events occurring during the research.

b) Other related documents (if any).

6. For reviewing the report on violations of the research outline.

a) Report on violations of the research outline.

b) Other related documents (if any).

7. For reviewing the research result report.

a) Signed application form, including signatures of co-applicants and representatives of related organizations.

b) Research result report (with version number and date) and related documents, appendices (if any).

c) Research products (if any).

d) Other related documents.

Article 24. Notification results of the review the Ethics Council for the research

1. Within five working days from the date of the research proposal review results, the Ethics Committee must send a written notification of the review results to the main research organization, the principal investigator, and publicly announce the review results on the Notice Board or on the Ethics Committee's website or the website of the organization establishing the Ethics Committee.

2. In case the research outline is approved by the Ethics Committee, the Ethics Committee shall issue an approval document in accordance with Appendix 02 issued together with this Circular.

3. In case the amendment and supplement of the research outline is approved by the Ethics Committee, the Ethics Committee shall issue an approval document in accordance with Appendix 03 issued together with this Circular.

4. In case the research results are approved by the Ethics Committee, the Ethics Committee shall issue a notification document in accordance with the provisions of Appendix 04 issued together with this Circular.

5. In case the research outline or amendment and supplement of the research outline or research results are conditionally approved by the Ethics Committee, the Ethics Committee shall issue a notification document in accordance with the provisions of Appendix 05 issued together with this Circular.

6. In case the research outline or amendment and supplement of the research outline or research results are not approved by the Ethics Committee, the Ethics Committee shall issue a notification document in accordance with the provisions of Appendix 06 issued together with this Circular.

Article 25. Lstorage Ethics Committee's documents 1. All documents and notifications of the Ethics Committee must be dated, filed, and stored according to the standard operating procedures of the Ethics Committee and the legal regulations on archiving.

2. Records may be kept in paper or electronic format.

3. Documents of the Ethics Committee that need to be stored include:

a) All documents relating to the establishment of the Ethics Committee;

b) Standard operating procedures of the Ethics Committee;

c) Documents published by the Ethics Committee;

d) Annual activity summary report of the Ethics Committee;

đ) Scientific curriculum vitae of Ethics Committee members;

e) Financial records of the Ethics Committee;

g) Meeting invitations and agendas of the Ethics Committee;

h) Minutes of Ethics Committee meetings;

i) Certificates of approval issued by the Ethics Committee;

k) Legal documents used by the Ethics Committee;

l) Guidance materials on research ethics used by the Ethics Committee;

m) Documents related to each specific research, including: copies of documents submitted to the Ethics Committee; exchange documents, decisions, recommendations, or requests of the Ethics Committee to the principal investigator or related parties regarding the research; notifications about the completion, early suspension, or early termination of the research (if any); final summaries or final reports of the research.

n) Other related documents.

4. The standard operating procedures of the Ethics Committee must specify the period for which documents must be retained in compliance with legal regulations on archiving, but must ensure a minimum retention period of five years from the date the competent authority accepts the research results or issues a document agreeing to terminate the research.

Organizational Regulations and Activities and Standard Operating Procedures of the Ethics Committee

Article 26. The Ethics Committee must have Organizational Regulations and Activities approved by the head of the organization establishing the committee based on the proposal of the Ethics Committee Chairperson and the head of the unit responsible for managing scientific research activities of the organization establishing the Ethics Committee. The Organizational Regulations and Activities of the Ethics Committee must comply with the provisions of this Circular and be suitable for the practical conditions of the institution.

1. The Ethics Committee is responsible for developing, approving, publicly announcing, complying with, and annually reviewing the standard operating procedures to perform its functions and responsibilities.
2. The standard operating procedures of the Ethics Committee include the following contents:
3. a) System management: guidance on writing and presenting standard operating procedures; document and record control; internal evaluation; coordination with other Ethics Committees.

b) Establishment and training of Ethics Committee members: composition, duties, responsibilities, and organization of the Ethics Committee; appointment, removal, resignation, and replacement of the Ethics Committee Chairperson, members, and secretary; confidentiality of information, conflict of interest management; training of Ethics Committee members; selection of independent consultants.

c) Research review methods: full process review; abbreviated process review; emergency meeting.

c) Research review methods: full process review; abbreviated process review; emergency meeting.

d) Administrative procedures: guidance on submitting applications for review, including forms to be completed, documents to be submitted, and related procedures; receiving applications; preparing meetings; managing meetings; recording and approving meeting minutes; preparing and issuing notifications of review results; handling applicants' complaints about the opinions of the Ethics Committee; managing applications during the research process; storing and retrieving research documents; preserving, keeping, and organizing administrative records, logs, and forms of the Ethics Committee; maintaining the confidentiality of research files and documents of the Ethics Committee.

đ) Technical procedures: initial review of research application files; re-review of application files; mid-term research review; review of changes and supplements; final acceptance report review; handling serious adverse event reports; handling violations of research protocols; handling complaints and requests from research subjects; early termination research review; checking research points; using protocol review comment sheets.

4. The Ethics Committee shall refer to the guidelines available on the website of the Science, Technology and Training Department to develop and publicize the forms used in the operation procedures of the Ethics Committee.

 

Chapter V

IMPLEMENTING PROVISIONS

Article 27. Responsibilities of Departments and Agencies under the Ministry of Health

1. Responsibilities of the Science, Technology and Training Department, Ministry of Health

1. Popularizing and guiding the implementation of this Circular;
2. Updating the list of established Ethics Committees on the website of the Science, Technology and Training Department within fifteen days from the date of receipt of the notification of establishment of the Ethics Committee;
3. Periodically or randomly inspecting the compliance with the requirements stipulated in this Circular by Ethics Committees;
4. In case of inspection revealing that an Ethics Committee does not meet the requirements stipulated in this Circular, the Science, Technology and Training Department shall remove the Ethics Committee from the updated list on its website.

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

2. Responsibilities of Departments and Agencies under the Ministry of Health

1. Cooperating with the Science, Technology and Training Department to popularize and guide the implementation of this Circular.
2. Cooperating with the Science, Technology and Training Department to periodically or randomly inspect the compliance with the requirements stipulated in this Circular by Ethics Committees established by units under their management.

Article 28. Responsibilities of Provincial and Municipal Health Departments and health agencies of ministries and sectors

1. Organizing the popularization and guidance on the implementation of this Circular to units under their management.
2. Periodically or randomly inspecting the compliance with the requirements stipulated in this Circular by Ethics Committees established by units under their management.
3. Recommending the Ministry of Health (Science, Technology and Training Department) to suspend the activities of an Ethics Committee if it is found that the Ethics Committee violates the provisions of this Circular, thereby affecting the protection of the rights, safety, and health of research subjects.

Article 29. Responsibilities of the organization establishing the Ethics Committee

1. Disseminate and implement this Circular at the facility.
2. Issue regulations on the organization and operation of the Ethics Committee for biomedical research based on concretizing the provisions of this Circular.
3. Evaluate compliance with legal regulations, organizational and operational regulations, and standard operating procedures of the Ethics Committee.
4. Ensure continuous compliance with the provisions of this Circular for the Ethics Committee of the organization.
5. Receive, process, and monitor complaints about the Ethics Committee from researchers, subjects of research, and related parties.
6. Announce and update the activities of the Ethics Committee on the facility's website within ten working days from the date of the decision to establish the Ethics Committee.
7. Send notification of establishment within fifteen days from the date of the decision to establish the Ethics Committee according to the form prescribed in Appendix No. 01 issued together with this Circular to the Department of Science, Technology and Training, Ministry of Health.

Article 30. Effective date

1. This Circular takes effect from March 15, 2020.

2. Circular No. 45/2017/TT-BYT dated November 16, 2017 of the Minister of Health on the establishment, functions, tasks, and powers of the Ethics Committee for biomedical research shall cease to be effective from the date this Circular takes effect.

Article 31Responsibility for Implementation

The Director of the Department of Science, Technology and Training, the Head of the Ministry’s Office, the Inspector General, the Heads of Departments, Directors of Bureaus, and General Directors of General Departments under the Ministry of Health, the Heads of units directly under the Ministry of Health, and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, organizations and individuals are requested to promptly report to the Ministry of Health (Department of Science, Technology and Training) for consideration and resolution./.