Circular No. 45/2017/TT-BYT on the establishment, functions, tasks, and powers of the Ethics Committee in Biomedical Research

CIRCULAR

PROVISIONS ON THE ESTABLISHMENT, FUNCTIONS, TASKS, AND LIMITATIONS OF THE ETHICS COMMITTEE IN BIOMEDICAL RESEARCH

Pursuant to the Medicine Law number 105/2016/QH13 dated April 6, 2016;

Pursuant to the Law on Medical Examination and Treatment No. ARTICLE 2. This Circular applies to agencies, organizations, and individuals related to the prescription of traditional medicine and herbal drugs and the combined prescription of traditional medicine and herbal drugs with chemical drugs.2 dated November 23, 2009;

Pursuant to 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 stipulating the establishment, functions, tasks, and limitations of the Ethics Committee in Biomedical Research.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the establishment, functions, tasks, and limitations of the National Ethics Committee in Biomedical Research and the Institutional Ethics Committee in Biomedical Research (hereinafter referred to as the Ethics Committee).

Article 2. Applicability

This Circular applies to agencies, organizations, and individuals both within and outside Vietnam that engage in biomedical research related to human health in Vietnam, and other agencies, organizations, and individuals related thereto.

Article 3. Explanation of Terms

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

1. Biomedicalresearch involving human participants (Research involving human participants) is scientific research in the fields of biomedicine, sociology, behavior, epidemiology, and other related sciences concerning health, where the subjects of study are humans affected, intervened upon, observed, or otherwise interacted with due to their participation in the research, or may be identified through the collection, analysis, and use of personal data and biological materials for the research.

2. Bioethics y Bioethics refers to ethical principles and standards that must be considered and ensured in biomedical research involving human participants.

3. Ethics Committee in Biomedical Research (Research Ethics Committee, Ethical Review Board, Ethical Review Committee, Human Research Ethics Committee, Institutional Review Board, Independent Ethics Committee)research is an organization comprising advisory experts who review, assess, and evaluate (hereinafter referred to as reviewing and assessing) the scientific and ethical aspects of biomedical research involving human participants to ensure that such research is conducted in accordance with Vietnamese laws' bioethical regulations. Ethical Guidelines

4. are documents applied to review and assess the ethical assurance in biomedical research involving human participants. Research Protocol

5. (Research protocol)research is a document or set of documents detailing the research including basic knowledge, reasons, objectives, design, methods, organization, and conduct of the research, ethical and statistical explanations in the research, and other relevant contents and information about the research. Researcher

6. Principal Investigator (Principal investigator - PI) Principal Investigator (PI)

7. is the researcher in charge, directly responsible for completing the research and reporting the process and results of the research directly to the sponsor."b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Sponsor Data and Safety Monitoring Board (The Data and Safety Monitoring Board - DSMB)

8. is an independent group established by the sponsor tasked with reviewing and evaluating accumulated research data regarding the safety of participants; the implementation, progress of the research; the effectiveness of the research to advise and recommend to the sponsor whether to continue, modify, or terminate the research. Research

9. Multisite Research is biomedical research conducted according to a single protocol at two or more independent sites collecting research subjects, each site having at least one principal investigator.

10. Research Monitoring and Supervision is the process of checking and overseeing the progress of the research, the compliance of researchers with the approved protocol and legal regulations on research.

11. Informed Consent Form (Informed Consent form - ICF) is a document proving the participant's consent to participate in the research, which describes the rights of the research participant; clearly communicates and respects the participant, including: the title of the research, timeframe, principal investigators, purpose of the research, description of the research process, potential harms and benefits, alternative treatment methods, confidentiality commitment, collected information and data, data storage time, data storage method and persons who can access the data, conflict of interest, the right of the participant to withdraw from the research at any time, publicizing that the participant has understood the research and agreed before signing, written in language understandable to the research participant. For research participants with limited educational qualifications, the informed consent form must be provided and explained orally.

12. Assent Form (Assent Form - AF) is a document proving the consent to participate in the research of research participants who do not have the capacity to give legally binding consent, such as children, individuals with limited civil capacity, or patients in a state of impaired consciousness, including similar information to the informed consent form but written in a simpler, shorter, and easier-to-understand manner.

13. Voluntary intention Privacy is the state or condition of being alone or separated, unaffected, not noticed by others, chosen by oneself within their scope of authority; not interfered with or violated; not disclosed or exposed, protected from public recognition.

14. Conflict of Interest (Privacy)

15. is a situation where the researcher or member of the Ethics Committee has a personal interest that poses a risk of conflicting with the researcher's or Ethics Committee member's obligations or responsibilities, potentially affecting the objectivity of the research. Personal Data

16. is data related to living individuals and personally identifiable information related to the research. Benefit

17. is a beneficial outcome arising from the research. Risk

18. Benefit is the advantageous result arising from research.

19. Risk is the probability that a favorable or unfavorable event or outcome occurs within a defined period of study under an epidemiological approach.

20. Minimal Risk is the 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 ordinarily encountered in daily life or during routine physical or psychological examinations.

21. Potential Harm is the probability that an adverse event (potential harm) causes discomfort, damage, injury (physical, mental, social), or economic loss due to participation in the research.

22. Compensation is the monetary or material, spiritual reparation made by individuals or organizations responsible for the research according to the research contract, research proposal, or legal provisions for those affected by the research.

23. Reimburse is the act of returning fully and intact the amount of money or materials related to the research to the owner or beneficiary according to the research contract or legal provisions.

24. THErime Minister cFull Review is the review process conducted with at least the minimum number of members present and voting at the meeting of the Ethics Committee.

25. Expedited Review is the review process conducted solely by the Chairperson of the Ethics Committee or a member with voting rights or a group of members with voting rights.

26. Standard Operating Procedure (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.

27. Clinical Trial is a biomedical research in which participants are assigned to one or more interventions according to a pre-defined plan by the researcher to evaluate the impact of these interventions on human health.

28. Good Clinical Practice (GCP) is a set of principles and standards for designing, organizing, implementing, monitoring, inspecting, recording, analyzing, and reporting clinical research to ensure the reliability and accuracy of data and research results reports, protect the rights, safety, and confidentiality of research subjects.

Article 4. General Principles Ensuring Biomedical Ethics

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

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.

Independence of the Ethics Committee

Article 5. Independence of the Ethics Committee

1. Members of the Ethics Committee shall not review research in which the member or their spouse, biological or adopted parents, biological or adopted children, full siblings, full in-laws, and half-siblings have a conflict of interest.

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

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

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

5. The National Ethics Committee shall not include civil servants of the Ministry of Health.

Chapter II

Establishment

Article 6. Authority to establish the Ethics Committee

1. The Minister of Health shall establish the National Ethics Committee for Biomedical Research and approve its operational regulations, appoint, dismiss, relieve from duty, or supplement and replace members of the National Ethics Committee.

2. Organizations with authority to approve research shall establish the Institutional Ethics Committee for Biomedical Research. The head of the organization shall approve the organizational and operational regulations of the Institutional Ethics Committee and appoint, dismiss, relieve from duty, or supplement and replace members of the Institutional Ethics Committee.

3. For organizations that do not meet the conditions to establish an Ethics Committee, the review and evaluation of biomedical research involving humans shall be conducted by the Ethics Committee established by the Department of Health or a specialized Ethics Committee.

Article 7. Organization of the Ethics Committee

1. The National Ethics Committee includes: Chairperson, Vice-Chairperson, Standing Sub-committee, specialized sub-committees, data monitoring sub-committee, and permanent office.

2. Legal status: The National Ethics Committee is an independent advisory body with its own seal used in activities related to its functions and responsibilities.

3. The Institutional Ethics Committee has a standing section, and may have specialized sub-committees if necessary.

4. The Institutional Ethics Committee may use the seal of the establishing organization in activities related to its functions and responsibilities according to the regulations of the organization's head.

Article 8. Number and Composition of Members of the Ethics Committee

1. Number of Ethics Committee Members

a) The National Ethics Committee shall have at least nine regular members, including one Chairperson, two to three Vice-Chairpersons, heads of sub-committees, and other regular members. The Institutional Ethics Committee shall have at least five regular members, including one Chairperson, one to two Vice-Chairpersons, heads of sub-committees (if any), and other regular members.

b) The term of the Ethics Committee is five years and must be re-established or reorganized upon completion of the term.

c) The composition of the subsequent term of the Ethics Committee must include at least 25% new regular members compared to the previous term's composition.

2. Composition of Ethics Committee Members

a) Members with professional qualifications in health-related fields relevant to common research areas assessed by the Ethics Committee.

b) Clinical physician members.

c) Members with expertise in legal and/or ethical issues.

d) Members without professional qualifications in health-related fields.

e) Members under 40 years old, members aged 40 to under 50, and members aged 50 and above.

f) Male and female members, with each gender comprising at least 20% of the total number of Ethics Committee members.

Article 9. Qualifications of Ethics Committee Members

1. Possess the necessary experience, knowledge, skills, and relevant capabilities to perform member duties to protect the rights of research subjects and researchers.

2. Members with professional qualifications in health-related fields and members with expertise in legal and/or ethical issues must hold a bachelor's degree or higher.

3. Have time to participate in the duties of the Ethics Committee.

4. Fully disclose their name, profession, and connections to research sponsors.

5. Commit to maintaining confidentiality regarding research information, discussion opinions during meetings, commercial secrets of individuals or organizations participating in research, and personal information about research participants.

6. Hold training certificates on Good Clinical Practice and standard operating procedures of the Ethics Committee issued by the Ministry of Health or recognized organizations, and continuously trained to access and update new issues related to biomedical ethics.

Article 10. Standards for the Chairperson and Deputy Chairperson of the Ethics Committee

1. Meeting the membership standards prescribed in Article 9 of this Circular.

2. Being a reputable scientist with sufficient management and leadership capabilities to independently, impartially, and disinterestedly oversee the Ethics Committee, free from pressure from the research organizing entity, researchers, and other agencies, organizations, or individuals.

3. Possessing the ability to encourage and facilitate consensus among Ethics Committee members and having sufficient time to adequately prepare for Ethics Committee meetings.

4. The deputy of the head of the organization establishing the Ethics Committee shall not participate as Chairperson or Deputy Chairperson of the Ethics Committee.

5. A person shall not be appointed as Chairperson of the Ethics Committee for more than two terms.

Article 11. Appointment, Resignation, Removal, Supplement, and Replacement of Ethics Committee Members

1. Appointment

a) For organizations without an Ethics Committee, the head of the unit or department overseeing and managing the Committee's activities shall base on actual needs to propose to the authorized head of the organization to establish the Ethics Committee.

b) For organizations already having an Ethics Committee, three months before the end of the current term of the Ethics Committee, the head of the unit overseeing and managing the Committee's activities (the Science, Technology and Training Department of the Ministry of Health for the National Ethics Committee) shall propose to the authorized head of the organization to establish the Ethics Committee for the next term.

c) After receiving written approval from the head of the organization establishing the Ethics Committee regarding the establishment of the Ethics Committee, the head of the unit overseeing and managing the Committee's activities shall base on needs, appointment criteria, and conditions to propose personnel plans to the head of the organization establishing the Ethics Committee for decision-making on appointments.

d) For personnel under the management of another organization, the organization establishing the Ethics Committee must seek written opinions from the managing organization regarding the proposed appointment of Ethics Committee members.

đ) Within one month from receiving the proposal from the head of the unit overseeing and managing the Committee's activities, the head of the organization establishing the Ethics Committee shall issue a decision appointing Ethics Committee members for each specific case.

The term of office for each regular member and replacement member is five years and is recorded in the appointment decision but does not exceed the term of the Ethics Committee calculated from the date of establishment, reorganization, or reinforcement of the Ethics Committee.

2. Resignation

a) During the period of being appointed as a member of the Ethics Committee, if a member feels they do not meet the conditions to fulfill their duties or have a desire to resign for other reasons, they shall submit a resignation letter detailing the reasons to the head of the organization establishing the Ethics Committee and the Chairperson of the Ethics Committee for consideration.

b) During the period that the resignation has not been accepted by the competent authority, the Ethics Committee member must continue to perform their assigned tasks and responsibilities.

Within one month from the date of receipt of the resignation letter, the head of the organization establishing the Ethics Committee must review the resignation letter and issue a decision to accept or reject the resignation of the Ethics Committee member. The decision not to accept the resignation will be sent to the Chairperson of the Ethics Committee and the member who submitted the resignation. The decision to accept the resignation will be sent to the member who submitted the resignation and recorded in the minutes of the nearest Ethics Committee meeting.

3. Removal

a) A member may be removed when they fall into one of the following situations: poor health; failure to complete tasks; violation of the Ethics Committee regulations; lack of independence; absence from more than three consecutive Ethics Committee meetings.

b) In cases where there is a basis for removing a specific Ethics Committee member, the Chairperson of the Ethics Committee shall propose to the head of the organization establishing the Ethics Committee to issue a removal decision for that member.

c) Within one month from the date of receipt of the proposal, the head of the organization establishing the Ethics Committee must review the proposal and issue a decision to remove or not accept the removal of the Ethics Committee member. The decision not to accept the removal or the removal will be sent to the Chairperson of the Ethics Committee and the member proposed for removal and recorded in the minutes of the nearest Ethics Committee meeting.

4. Supplement and Replacement

a) Based on the supplementation and replacement criteria for Ethics Committee members, the head of the unit overseeing and managing the Committee's activities shall propose to the head of the organization establishing the Ethics Committee a plan for supplementary and replacement appointments to become Ethics Committee members.

b) For personnel under the management of another organization, the organization establishing the Ethics Committee must seek written opinions from the managing organization regarding the proposed supplementary and replacement appointments as Ethics Committee members.

c) Within one month from the date of receipt of the proposal from the head of the unit overseeing and managing the Committee's activities, the head of the organization establishing the Ethics Committee shall review and issue a decision to supplement and replace Ethics Committee members.

d) The term of office for supplemented and replaced Ethics Committee members is the remaining time of the supplemented and replaced member.

đ) For Ethics Committees with specialized sub-committees, members of these sub-committees can become replacement members when participating in meetings of other sub-committees.

Article 12. Secretary of the Ethics Council

1. Professional secretary of the Ethics Council

a) The number of professional secretaries shall be proposed by the Chairperson of the Ethics Council and decided by the head of the organization establishing the Ethics Council to ensure sufficient support for the Council in reviewing and keeping records of its tasks. For the national-level Ethics Council, the maximum number shall not exceed three persons, and for the grassroots-level Ethics Council, the maximum number shall not exceed two persons.

b) Professional secretaries must be honest, impartial individuals with a university degree in health-related fields, possessing knowledge on management of science and technology, scientific research, ethics in biomedical research, and adequately trained to understand their responsibilities related to the confidentiality of the Ethics Council's records. Members of the Ethics Council may concurrently serve as professional secretaries of the Ethics Council.

2. Administrative secretary of the Ethics Council

a) The number of administrative secretaries shall be proposed by the Chairperson of the Ethics Council and decided by the head of the organization establishing the Ethics Council to ensure sufficient support for the Council in reviewing and keeping records according to its tasks. For the national-level Ethics Council, the maximum number shall not exceed three persons, and for the grassroots-level Ethics Council, the maximum number shall not exceed two persons.

b) Administrative secretaries must be honest, impartial individuals with a university degree, having expertise in administration, clerical work, archiving, and adequately trained to understand their responsibilities related to recordkeeping, retrieval, and confidentiality of the Ethics Council's records.

Article 13. Independent Consultants for the Ethics Council

1. Consultants may include experts in ethics, law, specialized fields, science, specific medical procedures, representatives of communities, patients, and other relevant groups necessary for discussions.

2. Consultants must have no conflict of interest with the research they are invited to review.

3. Independent consultants may attend meetings to exchange and discuss research but do not have voting rights or decision-making powers and are not counted among the minimum number of members in the Ethics Council meeting. In cases where independent consultants cannot attend the meeting, their written opinions will be considered by the Ethics Council during the review process of corresponding research proposals and will be recorded in the minutes.

4. Independent consultants are responsible for maintaining confidentiality of information and documents related to the research they have accessed. Prior to review meetings, independent consultants must complete and submit comment forms to the Ethics Council secretary.

Article 14. Resources of the Ethics Council

The organization establishing the Ethics Council is responsible for providing adequate resources to enable the Ethics Council to effectively perform its duties, including ensuring the following resources:

1. Professional secretaries and administrative secretaries must be sufficient in number and adequately trained to carry out the professional and administrative duties of the Ethics Council.

2. Providing office space, meeting rooms, and equipment and supplies to conduct administrative work and securely store the Ethics Council's records.

3. Ensuring sufficient facilities and equipment for the Ethics Council to convene meetings and for members to work.

4. Financial resources for the activities of the Ethics Council from the state budget shall be implemented in accordance with current financial regulations applicable to scientific councils issued by the Ministry of Finance and the Ministry of Science and Technology. For projects not using state funds, researchers and sponsors must prepare self-funded budgets for all review and evaluation activities of the Ethics Council in accordance with internal expenditure rules of the organization establishing the Ethics Council, consistent with legal provisions.

Article 15. Training for Members of the Ethics Committee

1. Members of the Ethics Committee must be trained after being appointed and must undergo continuous training and updates on the ethical and scientific aspects of biomedical research.

2. Continuous training activities must be conducted at least once every two years.

3. When training activities are supported by research sponsors, mechanisms must be in place to ensure that sponsors do not directly or indirectly influence through training content.

4. In addition to general training for all members, training courses must be tailored to meet the needs of each member and specific requirements of the Ethics Committee. The training content must include:

a) The role and responsibilities of the Ethics Committee, the role of the Ethics Committee with respect to other related units, according to relevant international guidelines (International Ethical Guidelines for Biomedical Research, International Ethical Guidelines for Epidemiological Research of the International Council of Medical Science Organizations, Good Clinical Practice of the International Conference on Harmonization of Clinical Trials).

b) Rights and obligations of Ethics Committee members, actions that Ethics Committee members must not undertake, the independence of the Ethics Committee, and other relevant regulations concerning Ethics Committee members;

c) Content of standard operating procedures of the Ethics Committee, laws related to biomedical research;

d) Ethical considerations in biomedical research involving humans;

e) Basic aspects of research methods and design;

f) The impact of different scientific designs and objectives on the ethical issues of a study;

g) Ways to identify and resolve differences that may arise between different ethical perspectives and approaches when evaluating studies;

h) Conducting research in practice and the feasibility of research.

Article 16. Documentation and Procedures for Issuing Operational Codes for National Ethics Committees

Within five working days from the date of receipt of the Minister of Health's decision on the establishment of the National Ethics Committee, the Department of Science, Technology, and Training under the Ministry of Health shall be responsible for issuing operational codes for the National Ethics Committee and publicly announcing information about the name, address, operational code of the Ethics Committee, and the name of the Chairperson of the Ethics Committee on the Department's electronic information website.

Article 17. Documentation and Procedures for Issuing Operational Codes for Institutional Ethics Committees

1. The application dossier for issuing operational codes for institutional Ethics Committees includes:

a) An application form for issuing operational codes for the Ethics Committee as prescribed in Appendix No. 01 issued together with this Circular.

b) A certified copy or a copy with the original for comparison of the Decision establishing the Ethics Committee.

c) A certified copy or a copy with the original for comparison of the Regulation on the organization and operation of the Ethics Committee.

d) Scientific curriculum vitae and certified copies of training certificates on Good Clinical Practice of the Ethics Committee members, secretary of the Ethics Committee, and standard operating procedures of the Ethics Committee.

e) A list of research projects reviewed by the Ethics Committee in the twelve months prior to the date of compilation (if applicable), as prescribed in Appendix No. 02 issued together with this Circular.

f) A list of research projects monitored and inspected by the Ethics Committee in the twelve months prior to the date of compilation (if applicable), as prescribed in Appendix No. 03 issued together with this Circular.

g) A list of standard operating procedures of the Ethics Committee as prescribed in Appendix No. 04 issued together with this Circular.

h) A list of activity forms of the Ethics Committee as prescribed in Appendix No. 05 issued together with this Circular.

i) Information on human resources, infrastructure, and equipment of the Ethics Committee as prescribed in Appendix No. 06 issued together with this Circular.

2. Procedures for Issuing Operational Codes for Institutional Ethics Committees

a) The competent authority establishing the institutional Ethics Committee shall submit one (01) set of the notification dossier on the operation of the Ethics Committee directly or via postal service to the Department of Science, Technology, and Training under the Ministry of Health within ten working days from the date of the decision establishing the Ethics Committee.

b) The Department of Science, Technology, and Training under the Ministry of Health shall be responsible for verifying the validity of the dossier and issuing a receipt for the dossier as prescribed in Appendix No. 07 issued together with this Circular.

c) Within seven working days from the date of receipt of a valid dossier, the Department of Science, Technology, and Training under the Ministry of Health shall be responsible for reviewing the dossier and issuing a document granting the operational code to the Ethics Committee if the dossier meets the requirements as prescribed in Appendix No. 08 issued together with this Circular. In cases where the dossier does not meet the requirements or requires corrections, the Department of Science, Technology, and Training shall issue a notice to the submitting organization detailing the reasons.

d) If corrections are required, the submitting organization shall be responsible for completing the dossier within a maximum period of sixty days from the date of receipt of the notice. Beyond this period, the procedure for issuing the operational code for the Ethics Committee must be restarted from the beginning.

e) Within five working days from the date of receipt of a complete dossier in accordance with the notice, the Department of Science, Technology, and Training under the Ministry of Health shall issue a document granting the operational code to the Ethics Committee.

f) The Department of Science, Technology, and Training under the Ministry of Health shall be responsible for publicly announcing information about the name, address of the Ethics Committee, the name of the Chairperson of the Ethics Committee, and the operational code of the Ethics Committee on the Department's electronic information website within five working days from the date of issuance of the document granting the operational code.

Article 18. Updating information on changes to the Ethics Council

1. Cases for updating information on changes to the Ethics Council:

a) Changing the contact address or information of the Chairperson of the Ethics Council or the secretary responsible for liaison with the Ethics Council.

b) Changing members of the Ethics Council.

c) The Ethics Council decides to dissolve or terminate its research review activities.

d) The Ethics Council is established for a new term or reorganized according to the decision of the competent authority.

2. Documents for updating information on changes to the Ethics Council include:

a) A request form for updating or changing information about the Ethics Council attached as Appendix No. 09 issued together with this Circular.

b) Documentation proving the changes stated in the request form for updating information on changes to the Ethics Council.

3. Procedures for updating and changing information of the Ethics Council

a) The National Ethics Council or the competent organization that establishes the grassroots Ethics Council shall submit one (01) set of application documents for updating information on changes to the Ethics Council directly or through postal service to the Science, Technology and Training Department, Ministry of Health within fifteen working days from the date of the change requiring update.

b) Within seven working days from the date of receipt of valid documents, the Science, Technology and Training Department, Ministry of Health shall be responsible for reviewing the documents and updating the information on changes to the Ethics Council on the Department's electronic information website if the documents meet the requirements. In cases where the documents do not meet the requirements or need corrections, the Science, Technology and Training Department shall issue a notification letter to the submitting organization detailing the reasons.

Chapter III

FUNCTIONS, DUTIES, POWERS AND RESPONSIBILITIES OF THE ETHICS COUNCIL

Article 19. Functions of the Ethics Council

The Ethics Council in biomedical research has the function of advising the head of the organization establishing the Ethics Council to consider and review the ethical and scientific aspects of related human biomedical research as a basis for approving, implementing, and accepting such research.

Article 20. Duties of the Ethics Council

1. National Ethics Council:

a) Reviewing the ethical and scientific aspects of biomedical research proposals involving humans before implementation for clinical trials serving registration purposes for products; clinical trials of products not yet approved for circulation in Vietnam; multicenter clinical trials; research applying new techniques and methods for the first time on humans in Vietnam; international collaborative research involving the transfer of biological samples of research subjects abroad or research results representing Vietnamese people, and other biomedical research as required by the Ministry of Health and the main organizations or individuals 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) Monitoring compliance with research protocols and ethical regulations during research; evaluating the recording, reporting, and handling of adverse events occurring during research that have been approved by authorized agencies.

d) Reviewing research outcomes according to approved research protocols for research previously accepted and reviewed by the Ethics Council, and reviewing clinical trial outcomes for drug, medical device, new technique, and method registration purposes in diagnosis and treatment.

đ) Implementing the storage and management of the Ethics Council's activity records.

e) Advising management authorities on policy and legal development related to human biomedical research and the professional activities of grassroots Ethics Councils.

2. Grassroots Ethics Council:

a) Reviewing the ethical and scientific aspects of research proposals involving humans that do not fall under the provisions of Clause 1 of this Article for submission to the competent authority for research approval.

b) Reviewing the ethical and scientific aspects of research involving humans as stipulated in Point a, Clause 1 of this Article, which is primarily conducted by the organization establishing the Ethics Council, before submitting the research proposal for national-level Ethics Council review.

c) Performing the duties specified in Points b, c, d, and e of Clause 1 of this Article for research primarily conducted by the organization establishing the Ethics Council.

Article 21. Rights of the Ethics Committee regarding research

1. Approve, request modifications to the research outline before approval, or not approve the biological research dossier as the basis for the competent authority to issue a decision allowing the implementation of the research.

2. Decide on the expedited review process for research with minimal risk levels.

3. Approve or not approve changes to the research content during its implementation.

4. Require the principal researcher, the implementing organization, and the research sponsor to report data, results, and related research documents.

5. Inspect and monitor compliance with the research outline and good clinical practice principles at the research site.

6. Propose the competent authority to halt the research when there are signs, evidence of non-compliance with good clinical practices, violations of the research outline, or potential risks that may endanger the safety of research subjects during the research.

7. Temporarily suspend recruitment of new participants, temporarily stop using research products on current participants if necessary to avoid harm to participants and clearly state the reasons for suspension.

8. Request adjustments and supplements to the research outline, information provision forms, and consent forms, and other materials provided to participants to ensure their safety when necessary.

Article 22. Rights of the Ethics Committee regarding researchers

The Ethics Committee has the right to require researchers to fulfill the following responsibilities:

1. Submit applications and all necessary information for comprehensive and thorough consideration of both ethical and scientific aspects of the research.

2. Conduct research according to the outline approved by the Ethics Committee and the competent authority.

3. Not alter or deviate from the approved outline without prior approval from the Ethics Committee and the competent authority approving the outline, except in cases where immediate changes are clearly necessary to prevent harm to participants and must be reported immediately to the Ethics Committee.

4. Any additions must be approved by the Ethics Committee when modifying selection documents, information for potential participants, or information provision and consent forms.

5. Report to the Ethics Committee any changes at the research site that reduce protection, diminish benefits provided, or increase risks to participants.

6. Promptly report to the Ethics Committee and/or relevant authorities as required by the Ethics Committee about all serious adverse events related to the conduct of the research, research products, or unforeseen issues related to potential harm to participants or others.

7. Immediately implement any recommendations of the Ethics Committee concerning safety reports to protect the rights, safety, and health of participants.

8. Provide written summaries of the research status to the Ethics Committee annually or as requested by the Ethics Committee for periodic reviews and provide information as required by the Ethics Committee for such reviews.

9. Notify the Ethics Committee when the research is completed or prematurely terminated.

10. Inform the Ethics Committee of the reasons for early termination of the research; submit a summary of the results obtained before stopping or terminating the research early; describe how participants will be informed of the termination and plans for follow-up care for participants.

11. Notify the research conducting organization, research sponsors, and other related organizations if the Ethics Committee terminates or suspends approval of a research project.

12. Provide participants and their families or communities with updates and research results through appropriate means when:

a) Research is terminated or suspended;

b) There are changes in the research altering potential benefits or risks;

c) Research is completed;

d) There are research results.

Article 23. Responsibilities of the Ethics Committee

The Ethics Committee shall be responsible for advising and being accountable to the head of the organization that established the Ethics Committee regarding its advisory opinions on the following matters:

1. Protecting the rights, safety, and health of research participants and related communities, particularly paying attention to trials that may include vulnerable subjects; protecting the rights of researchers.

2. Ensuring fairness in the distribution of benefits and risks among different social strata, age groups, genders, economic, cultural, ethnic, and religious backgrounds of research participants.

3. Reviewing the research proposal, relevant documents, and providing an objective, unbiased opinion within a reasonable time frame. Timely responding to their views in writing to the researcher.

4. Ensuring the legality and scientific nature of the research proposal and file, and safeguarding the confidentiality of the research.

5. Assessing the competence of researchers based on current resumes and/or any other relevant documents requested by the Ethics Committee.

6. Conducting periodic reviews of ongoing research during appropriate intervals corresponding to the level of risk to research participants, but at least once a year for clinical trial research.

7. Considering the quantity and method of payment to research participants to ensure there is no coercion or undue influence on them; payments are made per visit and are not contingent upon completion of the research by the participant.

8. Ensuring that information related to payments to research participants, including methods, amounts, and progress of payments, is specified in the informed consent form and approval to participate in research and in other documents provided to participants.

9. Creating conditions for researchers to discuss with Ethics Committee members on common issues and decisions of the Ethics Committee concerning specific research.

10. Publicly announcing the decisions of the Ethics Committee, except confidential information, through clinical trial registration mechanisms, websites, newsletters, and other forms of notification from the Ethics Committee.

11. Including the activity code of the Ethics Committee on certificates of approval issued by the Ethics Committee.

12. Establishing sufficient measures to maintain the confidentiality of records. The standard operating procedure clearly specifies who has access to Ethics Committee records and documents.

13. Ensuring the confidentiality of information and protecting Ethics Committee members from retaliation due to their involvement in Ethics Committee-related issues or reviewing research proposals.

14. Storing and managing the Ethics Committee's operational records according to legal regulations, with research review files needing to be stored for at least five years after acceptance.

Article 24. Responsibilities of Ethics Committee Members

1. Responsibilities of the Chair of the Ethics Committee

a) Deciding whether to conduct a streamlined or full review process for research files.

b) Assigning Ethics Committee members to provide primary reviews and inviting independent consultants for each research file.

c) Calling and chairing regular or extraordinary meetings of the Ethics Committee and being responsible for the conclusions of the meeting.

d) Representing the Ethics Committee before management authorities and the public.

đ) Directing the development and approval of the Ethics Committee's meeting plans and other activities.

e) Ensuring timely processing of Ethics Committee documents, especially the Ethics Committee's opinions on ethical approvals for research proposals.

g) Directing and supervising the administrative secretary of the Ethics Committee in preparing the budget for the Ethics Committee's operations.

h) Supervising and recommending training and development activities for Ethics Committee members and consultants for the Ethics Committee.

i) Acting on behalf of the Ethics Committee to make decisions in emergency situations to ensure the safety of research participants.

k) Checking and signing off on the standard operating procedures of the Ethics Committee before submitting them to the head of the organization that established the Ethics Committee for issuance or issuing them under the authorization of the head of the organization that established the Ethics Committee.

l) Issuing forms and documents for the operation of the Ethics Committee.

m) Promptly reporting to the head of the organization that established the Ethics Committee about the decisions of the Ethics Committee regarding research.

n) Fulfilling the responsibilities of Ethics Committee members as stipulated in Clause 4 of this Article.

2. Responsibilities of the Vice-Chair of the Ethics Committee

a) Fulfilling the responsibilities of the Chair of the Ethics Committee when authorized by the Chair of the Ethics Committee or when the Chair has a conflict of interest with the reviewed research.

b) Fulfilling the responsibilities of Ethics Committee members as stipulated in Clause 4 of this Article.

3. Responsibilities of Ethics Committee members assigned to provide primary reviews

a) Reviewing the research proposal, informed consent and participation agreement forms, and other relevant documents related to the research. Submitting the research review form to the Ethics Committee secretary before the meeting for consolidation.

b) Presenting their views on research issues to the entire Ethics Committee at the review meeting.

c) Fulfilling the responsibilities of Ethics Committee members as stipulated in Clause 4 of this Article.

4. Responsibilities of Ethics Committee members

a) Participating in at least 70% of Ethics Committee meetings, not missing more than three consecutive meetings without a valid reason.

b) Submitting the research file review form within the requested timeframe, attending Ethics Committee meetings, and participating in voting to evaluate research.

c) Review, discuss, evaluate the research outline, information provision form, and consent to participate in research, and other documents in the research file. For members without expertise in the health sector, it is necessary to review and provide specific opinions on the information provision form and consent to participate in research to protect the rights of research participants.

d) Review progress reports and monitor ongoing research studies.

đ) Monitor serious adverse events and propose appropriate solutions.

e) Evaluate the final research report and research results.

g) Ensure the confidentiality of documents and discussion contents at meetings of the Ethics Committee.

h) Provide their scientific curriculum vitae to the administrative secretary of the Ethics Committee.

i) Notify the Chairperson of the Ethics Committee about their conflict of interest regarding the reviewed research (if any).

k) Perform tasks assigned by the Chairperson of the Ethics Committee.

l) Participate in continuous training programs on bioethics and biomedical research.

m) Adhere to the standard operating procedures of the Ethics Committee.

5. Responsibilities of substitute members

Fulfill the responsibilities of the regular member they replace and have the right to vote when substituting for a regular member.

Article 25. Responsibilities of the Secretary of the Ethics Committee

1. Responsibilities of the professional secretary

a) Identify and recommend to the Chairperson of the Ethics Committee research cases that require expedited review or full review.

b) Recommend to the Chairperson of the Ethics Committee the primary reviewers for each research study.

c) Truthfully record minutes of Ethics Committee meetings, prepare annual activity reports of the Ethics Committee.

d) Follow up on tasks assigned by the Ethics Committee to principal investigators such as progress reports, result reports, corrective actions, modifications to approved research outlines or information provision forms and consent to participate in research.

đ) Coordinate with the administrative secretary to perform tasks as specified in Clause 2 of this Article.

2. Responsibilities of the administrative secretary

a) Inform and advise principal investigators, sponsors, and new members of the Ethics Committee on current regulations, guidelines, procedures, and processes. In some cases, the secretary maintains an electronic webpage to ensure public access to this information.

b) Receive applications, identify and request missing documents in applications, and compile complete files for Ethics Committee review.

c) Prepare and organize Ethics Committee meetings, including sending relevant documents to members, independent consultants, scheduling meetings, and ensuring the minimum number of participants required for meetings.

d) Maintain, organize, and keep research outlines, related documents, and files for research reviews and Ethics Committee monitoring of research studies in an orderly manner for easy retrieval and reference. The secretary ensures the confidentiality of Ethics Committee files.

đ) Maintain communication with Ethics Committee members and applicants for review.

e) Facilitate access to useful documents and educational programs for Ethics Committee members and staff.

g) Update information on Ethics Committee members, including conflict of interest declarations.

h) Closely coordinate with the Chairperson of the Ethics Committee to prepare and submit budgets for Ethics Committee operations for approval by competent authorities.

i) Be responsible for preparing, reviewing, and issuing standard operating procedures of the Ethics Committee.

k) Update the Ethics Committee on emerging issues related to its activities.

l) Provide administrative support and perform other tasks as assigned by the Chairperson of the Ethics Committee in accordance with the qualifications and duties of the secretary.

m) Adhere to the standard operating procedures of the Ethics Committee.

Chapter IV

ACTIVITIES OF THE ETHICS COMMITTEE

Article 26. Principles of Operation of the Ethics Committee

1. The operation of the Ethics Committee must be non-profit.

2. The Ethics Committee makes decisions on research based on the consistent, clear, and comprehensive application of ethical principles in international guidelines, national guidelines, and legal provisions. The ethical guidelines used for decision-making must be clearly stated and disseminated to researchers.

3. When the national Ethics Committee delegates the review of research to the institutional Ethics Committee, it must ensure that the delegated Ethics Committee uses similar ethical principles to make decisions.

4. The Ethics Committee operates under the principles of collective democracy, independence when reviewing and making decisions.

5. When considering research involving vulnerable groups, there must be participation of individuals with knowledge and experience working with these subjects in the Ethics Committee meetings or during evaluations.

6. The Ethics Committee needs to establish procedures for coordination and/or seeking opinions, review results from other Ethics Committees within or outside the country.

7. In necessary cases, the Ethics Committee may invite independent experts to provide specialized opinions for the Ethics Committee on specific research proposals, populations, or topics according to Article 15 of this Circular.

Article 27. Principles of Work for Members of the Ethics Committee

1. Members work independently, objectively, honestly, respect different viewpoints, and are personally responsible for their decisions when reviewing and evaluating research content before implementation, during implementation, and upon completion of research.

2. During the review process, members of the Ethics Committee may consult by directly contacting colleagues for relevant information about the research and must ensure that colleagues have no conflict of interest with the research.

3. Members of the Ethics Committee have the right to report to the head of the direct supervising agency of the Ethics Committee to address violations of the principles of work by the Chairperson of the Ethics Committee or by members of the Ethics Committee.

Article 28. Guidelines for Submitting Research Applications to the Ethics Committee

The Ethics Committee must issue written guidelines regarding the requirements for submitting research applications for review, providing information requests, and prescribed forms for researchers. The content of the guidelines must include the following issues:

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

2. List of all textual documents in the application package.

3. Format of the proposed documents.

4. Language of the documents in the application package.

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. Estimated time for notification of the decision after review.

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

10. Fee structure (if applicable) for reviewing a proposed research.

11. Procedures for requesting approval to modify the proposal or related documents.

12. Requirements for formatting selection documents, providing information to participants in the research, and consent form templates.

Article 29. Documents the Ethics Committee needs to review1. For reviewing the research proposal outline

b) The research outline with a clear code number and date, along with supporting documents and appendices (if any).

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

d) A description (which may be included in the outline) of ethical considerations related to the proposed research; measures to be taken to protect participants' privacy and data confidentiality; money or other goods and services provided to research participants; insurance coverage for research participants (if applicable).

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

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

e) All data collection forms used in the research with a clear code number and date.

g) All forms, documents, advertisements used in recruiting potential participants.

h) An information provision and consent form for participating in the research (dated and version numbered) in language that is understandable and appropriate for potential research participants. For research participants under 7 years old, their legal parents/guardians will sign the information provision and consent form on their behalf. For research participants aged between 7 and 12 years old, the consent process must include verbal agreement from the child and the legal representative or guardian signing the information provision and consent form. For research participants aged between 12 and 16 years old, the consent process must include the participant signing a simplified consent form and the legal representative or guardian signing the information provision and consent form. For research participants aged between 16 and under 18 years old, both the participant and their legal representative or guardian will sign the information provision and consent form.

i) A detailed description of the selection process for subjects and the collection of information provision and consent forms.

k) Procedures for monitoring, evaluating, handling adverse events and serious adverse events (for research involving interventions on research subjects).

l) Previous decisions of other Ethics Committees or regulatory authorities regarding the proposed research (including those opposing or suggesting modifications to previous outlines).

m) Documentation from the managing organization at the site where the research is implemented agreeing to allow the research to proceed after approval by the competent authority (if the research is conducted outside the organization establishing the Ethics Committee).

n) Commitment statements from researchers agreeing to adhere to ethical principles in relevant guidelines.

o) Current curriculum vitae and relevant diplomas, certificates of the principal researcher.

p) Other related documents.

2. For reviewing the research results report

b) The research results report with a clear code number and date, along with supporting documents and appendices (if any).

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

b) A report on the research results, clearly marked with a code number and date, along with supporting documents and appendices (if any).

c) Research products (if any).

d) Other related documents.

Article 30. Contents that the Ethics Committee needs to review

1. When evaluating research proposals, throughout the research process, and after the research has been completed, the Ethics Committee must pay attention to the following contents:

a) Research design and implementation

The Ethics Committee either self-determines or relies on previous scientific evaluations to ensure that research methods have a scientific basis and to examine the ethical impacts of selected research designs or strategies. The Ethics Committee also evaluates how the research will be conducted and the appropriateness of regulations implemented for monitoring and inspecting the research.

b) Potential risks and benefits

The Ethics Committee considers the social and scientific value of the research and ensures that the research does not place participants or their communities at risk without any potential benefits. The Ethics Committee examines different aspects of possible risks (physical, social, financial, or psychological) at various levels of risk (individual, family, or community level). The Ethics Committee only accepts research when risks are minimized (both by preventing potential harm and reducing negative impacts if they occur) and are reasonable compared to expected benefits.

c) Selection of research population and protection of research participants

The Ethics Committee ensures fair sharing of burdens and benefits of participating in research, which include direct benefits of participation (if any) and new knowledge gained from research. The Ethics Committee ensures that the research proposal clearly outlines plans for appropriate care, counseling, supervision, and follow-up for research participants, especially for vulnerable subjects.

d) Financial interests and financial costs

The Ethics Committee must consider to ensure that compensation for participants (including research-related payments such as travel expenses, childcare costs, or lost wages, and compensation for participants' time) is reasonable, not overly generous, or free healthcare or other forms of compensation that may affect the voluntariness of potential participants.

đ) Protection of privacy and confidentiality of research participation

The Ethics Committee must carefully check the protection of privacy and confidentiality of participants to show respect for participants and avoid adverse effects due to breaches of privacy and confidentiality.

e) Process of providing information and obtaining consent to participate in research

The Ethics Committee must review the process, environment for providing information and obtaining consent to participate in research, as well as the information to be provided to ensure that individuals have sufficient capacity to freely choose whether to participate in research and make decisions based on full understanding of what the research requires. Decisions for children or persons with limited civil capacity to participate in research must be made by their legal representatives after being fully informed about the research. In cases where participants or their representatives cannot voluntarily agree to participate in research, the Ethics Committee may waive the requirement for consent after providing appropriate information in accordance with international standards and Vietnamese law.

g) Impact of research on the community selecting participants

The Ethics Committee must review the obligation to respect and protect the community where the research takes place and/or may be related to findings from the research, with the aim of minimizing any negative impact on the community, such as discrimination or depletion of local resources, and promoting positive effects related to the community, including health or capacity development impacts.

h) Competence of researchers and research sites

The Ethics Committee must consider the competence of researchers and research sites. Evaluation of researchers' competence is based on assessing suitability in terms of qualifications, experience, time dedicated to research, and conflicts of interest of researchers regarding the research. Evaluation of research sites is based on assessing patient/source selection to meet sample size requirements of the protocol, facilities to conduct the research, and ability to handle adverse events.

2. The Ethics Committee may use checklists to ensure that all relevant criteria are considered during the evaluation process and to ensure that similar protocols are treated equally.

Article 31. Review of research according to the abbreviated procedure

1. Research files permitted to be reviewed according to the abbreviated procedure include:

a) The research application poses minimal risk.

b) Research files that have been reviewed and approved by the Institutional Ethics Committee in accordance with the provisions and guidance set forth in this Circular;

c) Periodic research reports that have been approved;

d) Files requesting amendments and supplements to the research outline that have been approved;

đ) Reports on adverse events occurring during research that have been approved;

e) Reports on violations of the research outline that have been approved.

2. Written procedures must identify the person responsible for making decisions, the number of reviewers required for review according to the abbreviated procedure, the method of selecting reviewers, as well as the method of compiling written comments.

3. The review file according to the abbreviated procedure must be sent to the reviewer member within five working days from the date the Ethics Committee receives the valid file.

4. Except in cases of urgent meetings, all documents for consideration must be sent to the assigned Ethics Committee member at least five working days before the date requested for returning the review and evaluation form.

5. Based on reviewing the research file, the assigned Ethics Committee member may approve, conditionally approve, not approve, or request a full review of the research file. The decision of the Ethics Committee member regarding the research must be recorded on the review and evaluation form of the research file, signed by the Ethics Committee member, and returned to the Ethics Committee within seven working days from the date of receipt of the file.

6. The minutes summarizing opinions and decisions of the Ethics Committee regarding the research must be completed within five working days from the date of receiving the review and evaluation forms of the research file from the assigned Ethics Committee members.

7. The conclusion on the research must be recorded in the minutes summarizing the opinions of the Ethics Committee. The research proposal is approved when no member does not approve or requests a full review of the research file.

8. If the Ethics Committee conditionally approves the research file, the Ethics Committee must clearly state the contents that need to be amended and supplemented. If the Ethics Committee does not approve the research file, the Ethics Committee must clearly state the reasons for non-approval.

9. The decision of the Ethics Committee must be notified to the applicant no later than five working days from the date of the decision.

10. At the next Ethics Committee meeting, the Chairperson informs the Ethics Committee members about the research that has been reviewed according to the abbreviated procedure between two consecutive Ethics Committee meetings.

Article 32. Review of research according to the full procedure

1. The Ethics Committee must review according to the full procedure for research files that do not meet the conditions for review according to the abbreviated procedure or for files that have been reviewed according to the abbreviated procedure but the reviewer requests a full review.

2. When reviewing research according to the full procedure, the Ethics Committee may organize a meeting at a single location or multiple locations through online meetings. The meeting of the Ethics Committee only has legal validity if convened by the Chairperson of the Ethics Committee or the Vice-Chairperson of the Ethics Committee (authorized by the Chairperson of the Ethics Committee) and attended by at least five Ethics Committee members, including at least one medical specialist, one non-specialist, one independent member, and members of both genders, who vote to make a decision on the proposed research and have minutes of the meeting.

3. The review meeting must be organized within thirty days from the date the Ethics Committee receives the complete file.

4. Except in cases of urgent meetings, Ethics Committee members and independent consulting experts must receive related documents at least seven working days before the meeting.

5. Managers, researchers, sponsors, and funding supporters may attend the Ethics Committee meeting to answer questions about their research outlines and related documents, but they must not be present when the Ethics Committee discusses and makes decisions on their research proposals.

6. The Ethics Committee needs to invite external independent consultants when necessary, especially in relation to research involving individuals with significantly different living conditions and experiences compared to Ethics Committee members.

7. Decisions on research outlines at the Ethics Committee meeting must be based on a thorough and comprehensive discussion process.

8. The Ethics Committee ensures sufficient time for discussions and respects all opinions, allowing different perspectives to be presented. The Chairperson of the Ethics Committee is responsible for the decision-making process.

9. The decision of the Ethics Committee regarding the research must be made through a recorded and signed ballot by voting Ethics Committee members.

10. Only members without conflicts of interest with the research, participating in the meeting and discussion on the research, have the right to evaluate and vote.

11. Based on the review of the research file, the results of the discussion at the meeting of the participating Ethics Committee members can approve, conditionally approve, or not approve the research file.

12. If the Ethics Committee conditionally approves the research file, the Ethics Committee must clearly state the contents that need to be amended and supplemented and specify whether the resubmitted file will be reviewed according to the full review procedure or the abbreviated review procedure.

13. If the Ethics Committee does not approve the research file, the Ethics Committee must clearly state the reasons for non-approval.

14. The conclusion of the Ethics Committee on research must be based on the consensus of the Ethics Committee members and must be recorded in the minutes of the Ethics Committee meeting. In cases where consensus cannot be reached within the Ethics Committee, the Chairperson of the Ethics Committee has the right to decide to conduct a vote immediately or to request the researcher to complete the research application for the Ethics Committee to review and vote at the next Ethics Committee meeting. Research will only be approved if there are fewer than two disapproving votes among the valid votes.

15. The minutes of the Ethics Committee meeting must be completed within seven working days from the date of the Ethics Committee meeting.

16. The decision of the Ethics Committee must be notified to the applicant no later than five working days from the date of the decision.

Article 33. Notification of the Ethics Committee's Decision on Research

The content of the notification of the Ethics Committee's decision on research includes:

1. Information about the research:

a) The name of the reviewed research;

b) The name, date, and version number of related documents reviewed;

c) The name and position of the applicant and/or sponsor;

d) The names of the research points;

đ) The date and location of the decisions;

e) The name of the Ethics Committee making the decision.

2. The Ethics Committee's decision on research:

a) In case of approval

- For the research proposal:

+ Any ethical issues discussed during the Ethics Committee meeting and their solutions;

+ Clearly stating that the approval is given with the expectation that the proposed research framework and related documents comply;

+ The maximum validity period of each approval is one year and procedures for extending the approval (if applicable);

+ The responsibilities of the researcher as stipulated in Article 21 of this Circular.

- For the research result report:

+ Summary information about the subjects, methods of research;

+ The Ethics Committee's conclusion on the research results.

b) In case of conditional approval, the notification must clearly state all requirements of the Ethics Committee, including requests for modifications and procedures for re-evaluation.

c) In case of disapproval, the notification must clearly state the reasons for disapproval related to specific ethical aspects.

d) Non-binding recommendations or suggestions may accompany the Ethics Committee's decision.

3. Signature, date, and year of signature of the Chairperson of the Ethics Committee or a person authorized by the Chairperson of the Ethics Committee.

4. Clearly specify the method for handling the researcher's request to reconsider the Ethics Committee's decision by the same Ethics Committee that reviewed the research or by another organization. If handled by an external organization, the process, file components, address for submitting the file, and the final decision-maker must be specified.

5. The Ethics Committee's decision must be published on the bulletin board or on the website of the organization establishing the Ethics Committee or the main research organization or the Ethics Committee.

Article 34. Periodic Review of Approved Research

1. The Ethics Committee must have standard operating procedures describing how to monitor the progress of all research, reviewing contents to assess compliance with the research framework by researchers and sponsors from the time of notification, subject selection to implementation according to approved standard operating procedures; emerging issues, incident handling, reporting information, drug management, techniques, research methods, and records, research results.

2. The periodic review timeframe is determined by the nature of the proposed research but must occur at least once a year on or before the approval date.

3. Additional reviews outside the planned periodic reviews include:

a) Modifications to the research framework that could affect the rights, safety, and/or benefits of research participants or the conduct of the research.

b) Serious adverse events related to the conduct of the research or research products.

c) Events or information that may impact potential benefits or risks associated with the research.

d) Requests for full or partial suspension of the research by the Safety Monitoring Board or other monitoring units or regulatory authorities.

4. Documents reviewed by the Ethics Committee include:

a) Summary of the research outline.

b) A complete research framework including previously approved amendments (for at least one primary reviewer of the Ethics Committee).

c) Progress reports on the implementation of the research, final reports.

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

đ) Reports on adverse event cases and any emerging issues posing risks to research participants, any withdrawal cases from the research.

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) Notifications from the applicant regarding the suspension/early termination or completion of the research.

5. Conclusions on the results of periodic reviews must be issued and notified to the applicant, clearly stating whether initial decisions remain in effect or have been changed, suspended, or revoked by the Ethics Committee.

Article 35. Documents and Records

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 regulations on record keeping.

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

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

a) All formal documents establishing the Ethics Committee;

c) Documents published by the Ethics Committee;

d) Annual activity summary report of the Ethics Committee;

d) Annual reports summarizing the activities of the Ethics Committee;

e) Financial records of the Ethics Committee;

e) Financial records 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;

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

m) Other documents (if any).

4. The standard operating procedures of the Ethics Committee must specify the period during which documents must be retained in accordance with the law, but the minimum period is five years after the completion of the research. All documents related to the review of specific researches must include:

a) Copies of all documents;

b) Correspondence between the Ethics Committee and the applicant or relevant parties regarding the research;

c) Copies of initial, continuing decisions, and any recommendations or requests sent to the applicant;

d) All written documents received during the monitoring of the research, including recommendations or requests sent to the applicant;

đ) Notifications of completion, early termination, or early suspension of the research;

e) Final summary or final report of the research.

Article 36. Standard Operating Procedures of the Ethics Committee

1. The Ethics Committee is responsible for developing and adhering to standard operating procedures to fulfill its functions and responsibilities.

2. The Secretary of the Ethics Committee shall send the standard operating procedures to all members of the Ethics Committee and make them publicly available.

3. The standard operating procedures of the Ethics Committee must be reviewed at least once a year to determine whether adjustments are necessary based on regular assessments of the Ethics Committee's performance.

4. The standard operating procedures of the Ethics Committee must address the following issues:

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.

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

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

d) Administrative processes: requirements for submitting applications for review, including forms that need to be completed, documents to be submitted, and related procedural issues; receipt of applications; preparation for meetings; meeting management; recording and approving minutes; preparation and issuance of review result notifications; handling complaints from applicants regarding the opinions of the Ethics Committee; management of files during the research process; storage and retrieval of research documents; preservation, retention, and filing of administrative records, notebooks, and forms of the Ethics Committee; maintaining the confidentiality of research files and documents of the Ethics Committee.

đ) Technical processes: initial review of research application files; re-review of files; periodic review of research; review of changes and additions; review of final reports; handling serious adverse event reports; handling violations of research protocols; handling complaints and requests from research subjects; review of prematurely terminated research; site inspections; use of protocol evaluation forms.

5. The Ethics Committee needs to develop and publicize review and assessment forms, refer to guidelines on the website of the Science and Technology Department and Training, Ministry of Health, to build forms used in the operation of the Ethics Committee.

Chapter V

IMPLEMENTING PROVISIONS

Article 37. Implementation

1. The Science and Technology Department and Training, Ministry of Health, in charge and coordinating with relevant units under the Ministry of Health to perform the following responsibilities:

a) Promulgating, guiding, and inspecting the implementation of this Circular.

b) Recommending the Minister of Health to suspend the activities of the Ethics Committee if it is found that the Ethics Committee violates the provisions of this Circular, affecting the protection of the rights, safety, and health of research participants.

c) Issuing operational codes for the Ethics Committee and making them publicly available on the website of the Science and Technology Department and Training, Ministry of Health, in accordance with this Circular.

2. Provincial Departments of Health have the responsibility to disseminate, organize, and inspect the implementation of this Circular at agencies and units under their jurisdiction.

3. Responsibilities of organizations establishing the Ethics Committee:

a) Disseminating and implementing this Circular at the institution.

b) Issuing regulations on the organization and operation of the Ethics Committee for biomedical research based on the specific provisions of this Circular.

c) Evaluating compliance with regulations, rules, and standard operating procedures of the Ethics Committee and the consistent application of ethical principles outlined in international guidelines and national standards by Ethics Committee members.

d) When conducting evaluations of the Ethics Committee's activities, they must notify the Ethics Committee about the scope, method, and timing of the evaluation at least one month before the start of the evaluation and inform the Ethics Committee of the evaluation results to facilitate quality improvement activities.

đ) Ensuring that the evaluation is conducted by knowledgeable, independent, and impartial individuals.

e) Reviewing and monitoring corrective and preventive actions taken by the Ethics Committee based on internal and external audit findings and recommendations.

g) Receiving, processing, and monitoring complaints about the Ethics Committee from researchers, research participants, and other relevant parties (if any).

h) Allocating resources for the Ethics Committee in accordance with Article 14 of this Circular.

i) Reporting annually in December the results of the Ethics Committee's activities to the Science and Technology Department and Training, Ministry of Health, in accordance with Appendix 10 issued together with this Circular.

Article 38. Effective Date

This Circular takes effect from January 1, 2018.

Article 39. Responsibility for Implementation

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

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