Circular No. 45/2017/TT-BYT dated November 16, 2017 establishment, functions, tasks and rights of Research Ethics Committees

• Official number: 45/2017/TT-BYT
• Legislation Type: Circular
• Organization: The Ministry of Health
• Signer: Le Quang Cuong
• Issued Date: 16/11/2017

THE MINISTRY OF HEALTH -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 45/2017/TT-BYT	Hanoi, November 16, 2017

CIRCULAR

ESTABLISHMENT, FUNCTIONS, TASKS AND RIGHTS OF RESEARCH ETHICS COMMITTEES

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

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

Pursuant to the Government's Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, rights and organizational structure of the Ministry of Health;

At the request of the Director of the Administration of Science Technology and Training;

The Minister of Health hereby promulgates a Circular on establishment, functions, tasks and rights of Research Ethics Committees.

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GENERAL PROVISIONS

Article 1. Scope

This Circular provides for establishment, functions, tasks and rights of National Research Ethics Committee and Internal Research Ethics Committees (hereinafter referred to as “the Research Ethics Committee”).

Article 2. Regulated entities

This Circular applies to Vietnamese and foreign organizations and individuals engaged in biomedical research involving human subjects in Vietnam and other relevant organizations and individuals.

Article 3. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “research involving human participants” means any social science, biomedical, behavioral or epidemiological activity  in which human beings are exposed to manipulation, intervention, observation or other interaction with investigators or become individually identifiable through investigators’ collection, preparation or use of biological material or medical or other records.

2. “bioethics” means a field of ethical enquiry that examines ethical issues and dilemmas arising from research involving human participants.

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4. “ethical guidelines” mean documents applied to consider and assess the responsibility to adhere to moral principles and standards when conducting research involving human participants.

5. “research protocol” means a document that describes the background, rationale, objectives, design, methodology, statistical considerations, ethical considerations, organization of a research and other information relating to the research.

6. “researcher” means a person responsible for the conduct of the research at a research site.

7. “principal investigator - PI” means a researcher who directs and takes direct responsibility for completing a research and reporting the research process and results directly to the sponsor.

8. “sponsor” means an individual or organization that takes on responsibility for initiation, management and/or financing of the research.

9. “data and Safety Monitoring Board - DSMB” means an independent group of experts that is established by an sponsor and has the responsibility to review and evaluate the accumulated research data for participant safety; research conduct and progress, and research efficacy to make recommendations to the sponsor concerning the continuation, modification, or termination of the research.

10. “multi-site research” means a biomedical research conducted according to a single protocol but at more than one site, and therefore, carried out by at least one principal investigator.

11. “research monitoring and supervision” means a process of monitoring and supervising research progress and adherence of a researcher to the approved protocol and regulations on research.

12. “Informed Consent form - ICF” means a document that documents a potential participant’s consent to be involved in research and describes the rights of an enrolled research participant. This form should communicate the following in a clear and respectful manner: research timeframe, title of research, researchers involved, purpose of research, description of research,  potential harms and benefits, treatment alternatives, statement of confidentiality, information and data to be collected, how long the data will be kept,  how it will be stored and who can access it, any conflicts of interest, a statement of the participant’s right to withdraw from participation at any point, declarative statement of understanding that the potential participant agrees to and signs. The consent form should be in a language the potential participant understands. For potential participants with limited literacy, the verbal communication of the consent document details should be provided along with proper documentation of consent, if it is given.

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14. “voluntary” means the performed or done of one’s own free will freedom, impulse, or choice; not constrained, prompted, or suggested by another, and free of coercion, duress, or undue inducement.

15. “privacy” means a state or condition of being alone, undisturbed, or free from public attention, as a matter of choice or right; seclusion; freedom from interference or intrusion, absence or avoidance of publicity or display; protection from public knowledge or availability.

16. “conflict of interest” means a situation where a researcher or REC member has a conflict of interest if he/she stands to achieve personal gain by failing to discharge professional obligations, either to protect the welfare of participants or to uphold the integrity of the scientific process. .

17. “personal data” means data that relate to a living person and contain personally identifying information relating to a research.

18. “benefit” means a favorable consequence arising from a research study.

19. “risk” means the probability that a favorable or adverse event or outcome occurs within a defined period of the research according to the epidemiological approach.

20. “minimal risk” means that the probability and magnitude of physical or psychological harm anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

21. “potential harm” means the probability that an adverse event (potential harm) causes discomfort or harm or injury (physical, psychological, social) or economic loss occurring as a result of participation in a research.

22. “compensation” means the compensation that is paid in the form of money or material and spiritual values by an individual or organization responsible for research under a contract or research protocol or according to the law to research subjects suffering damage caused by the research.

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24. “full review” means a review conducted to check minimum number of members required to be present and vote at a REC meeting.

25. “expedited review” means a review of proposed research by the REC Chair or a designated voting member or group of voting members.

26. “Standard Operating Procedure - SOP” means detailed and written instructions to achieve uniformity of the performance of a specific function during research or operation of the REC.

27. “clinical trial” means a research in which participants are prospectively assigned to one or more interventions according to a researcher’s plan to evaluate the effect of the intervention(s) on human health.

28. “Good Clinical Practice - GCP” means a standard for the design, conduct performance, monitoring, auditing, analyses and reporting of clinical trials to provide assurance that the data and reported  results are credible and accurate, and the rights and confidentiality  of trial participants are protected.

Article 4. General principles of bioethics

1. A research shall be only conducted after the competent authority approves the research protocol.

2. Before obtaining approval from the competent authority and being conducted, all research involving human participants  in Vietnam must be considered, assessed, directed and approved by REC in terms of ethics and science according to regulations of this Circular.

3. All research involving human participants must be under the supervision of the REC during its conduct.

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1. REC members are not allowed to review the research in which the members themselves or spouses, natural/foster parents, natural/adopted children, younger/elder siblings or siblings-in-law of those members and their spouses have a conflict of interest.

2. REC members are not allowed to participate in supporting and conducting research that such members have reviewed.

3. REC members shall include at least one person with expertise in the health sector independent of the entity establishing the REC.

4. A REC shall not include the head of the entity establishing the REC, head and deputy head of research funding organization or the organization conducting research reviewed by the REC.

5. The national REC shall not include officials of the Ministry of Health.

Chapter II

ESTABLISHMENT OF RECs

Article 6. The power to establish RECs

1. The Minister of Health shall establish national REC, approve its charter and decide on designation, dismissal, addition or replacement of its members.

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3. For organizations ineligible to establish a REC, the REC established by the Department of Health or REC with appropriate qualifications shall consider and assess research involving human participants.

Article 7. Organizational structure of REC

1. A national REC includes: Chair, Deputy Chairs, standing sub-committee, expert sub-committees, data monitoring sub-committee and standing office.

2. Legal status: National REC is an independent consultancy and has a separate seal that is used for activities pertaining to functions and tasks of the Committee.

3. An internal REC includes a standing sub-committee and may include expert sub-committees where necessary.

4. The internal REC may use the seal of the entity establishing the REC for activities pertaining to functions and tasks of the REC in accordance with regulations imposed by the head of the entity establishing the REC.

Article 8. Quantity and structure of REC members

1. Quantity of REC members

a) The national REC has at least 09 official members, including 01 Chair, from 02 to 03 Deputy Chairs, heads of sub-committees and other official members.  The national REC has at least 5 official members, including 01 Chair, from 01 to 02 Deputy Chairs, heads of sub-committees and other official members.

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c) The REC for the next consecutive term of office must be joined by at least 25% of new official members.

2. Structure of REC members

a) Members that have a degree in the health sector related to common research assessed by REC.

b) Members that are clinical doctors.

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

d) Lay members that do not have expertise in the health sector.

dd) Members under the age of 40, members aged from 40 to under 50 and members aged 50 or older.

e) Male and female members that take up at least 20% of total number of REC members.

Article 9. Standards to be satisfied by a REC member

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2. The member that has expertise in the health sector and the member that has expertise in legal and/or ethical issues must obtain at least a bachelor’s degree.

3. The member has taken on tasks of the REC.

4. The member must sufficiently declare his/her name, job and affiliation with sponsors.

5. The member must make a commitment to maintaining confidentiality of information relating to research, comments made at meetings, commercial secrets of research participants or personal information of research participants.

6. The member must have a certificate of training in Good Clinical Practice and REC's SOPs issued by the Ministry of Health or organizations recognized by the Ministry, and be recurrently trained to access and update new issues concerning bioethics.

Article 10. Standards to be satisfied by the Chair or Deputy Chairs of REC

1. They must meet the standards specified in Article 9 of this Circular.

2. They must be prestige scientists who are sufficiently competent to manage REC in an independent, fair and unbiased manner without any pressure from the research presiding organization, researchers and other organizations and individuals.

3. They must be capable of expediting and assisting in obtaining consent from REC members and make necessary preparations for REC meetings.

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5. A person shall be only designated as the REC Chair to a term of office with a term limit of 02 terms.

Article 11. Designation, resignation, dismissal, addition and replacement of REC members

1. Designation

a) For the organization that has not had a REC, the head of the unit or department in charge of monitoring and managing operation of the REC shall, according to actual demand, submit a policy for establishment of REC to the head of the organization that has the power to establish REC.

b) For the organization that has had a REC, 03 months before the end of the current term of office of the REC, the head of the unit in charge of monitoring and managing operation of REC (the Administration of Science Technology and Training affiliated to the Ministry of Health in the case of national REC) shall submit a policy for establishment of REC for the next term of office to the head of the organization that has the power to establish REC.

c) After obtaining a written consent to REC establishment from the head of the entity establishing the REC, the head of the unit in charge of monitoring and managing operation of REC shall, according to actual demand, standards and conditions for designation of REC members, propose a human resource plan to the head of the entity establishing the REC for decision on designation.

d) For personnel under the management of another organization, the entity establishing the REC shall send an enquiry to the organization managing personnel expected to designated as the REC member.

dd) Within 01 month from the receipt of the proposed plan, the head of the entity establishing the REC shall issue a decision on designation of REC members.

Term of office of each official member and replacement lasts 05 years and is specified in the designation decision but must not exceed the term of office of the REC from the date on which the REC is re-established or re-organized or consolidated.

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a) During the period a person acts as a REC member, if the member finds that he/she is ineligible to complete his/her tasks or wishes to resign for other reasons, he/she shall submit a resignation letter specifying reasons to the head of the entity establishing the REC and REC Chair for consideration.

b) While the resignation letter has not yet been accepted by the competent authority, the REC member shall still perform his/her assigned tasks.

Within 01 month from the receipt of the resignation letter, the head of the entity establishing the REC shall consider it and issue a decision on whether or not the resignation letter is accepted. The decision on rejection of the resignation letter shall be issued to the REC Chair and the member submitting the resignation letter. The decision on acceptance of the resignation letter shall be issued to the member submitting the resignation letter and specified in the minutes of the latest REC meeting.

3. Dismissal

a) A member may be dismissed if he/she is not physically fit or fails to fulfill his/her tasks or violates REC regulation or violates independence or has not attended more than 03 REC meetings in a row.

b) If there are reasonable grounds to dismiss a REC member, the REC Chair shall recommend the head of the entity establishing the REC to issue a decision to dismiss such member.

c) Within 01 month from the receipt of the recommendation, the head of the entity establishing the REC shall consider it and issue a decision on whether or not the recommendation is accepted. The decision on rejection of the recommendation for dismissal shall be issued to the REC Chair and member to be dismissed and specified in the minutes of the latest REC meeting.

4. Addition or replacement

a) The head of the unit in charge of monitoring and managing operation of the REC shall, according to standards, demand for addition or replacement of REC members, submit a plan for addition or replacement of REC members to the head of the entity establishing the REC.

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c) Within 01 month from the receipt of the plan, the head of the entity establishing the REC shall consider it and issue a decision on addition or replacement of REC members.

d) The ending date of the term of office of the replacing member is the same as that of the replaced member.

dd) For the REC that has expert subcomissions, members of one expert sub-committee may be replacements to attend meetings of another expert sub-committee.

Article 12. Secretary of REC

1. Specialized secretaries of REC

a) Specialized secretaries shall be proposed by the REC Chair and decided by the head of the entity establishing the REC. Specialized secretaries shall be shall be adequate in number to support the REC in performing its review and record keeping function. The number of specialized secretaries of national REC and internal REC shall not be more than 03 and 02 persons respectively.

b) Specialized secretaries are those who are honest and objective, obtain a bachelor’s degree in the health sector, are knowledgeable about science and technology management, scientific research and bioethics and are fully trained to understand their responsibilities related to REC record confidentiality. REC members may act as specialized secretaries of the REC.

2. Administrative secretaries of the REC

a) Administrative secretaries shall be proposed by the REC Chair and decided by the head of the entity establishing the REC. Administrative secretaries shall be adequate in number to support the REC in performing its review and record keeping function. The number of administrative secretaries of the national REC and internal REC shall not be more than 03 and 02 persons respectively.

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Article 13. Independent consultants for REC

1. Consultants could include experts in ethics, law, or specific medical specialities or procedures. They might be representatives of communities, patients or other groups relevant to the deliberations required.

2. Consultants must not have any conflict of interest in the research which they are invited to review.

3. Independent consultants are entitled to attend meetings to exchange and discuss research but do not have any voting or decision-making authority and are not included in the quorum. If independent consultants fail to attend a meeting, their written comments shall be considered by REC during the review of corresponding research protocols and specified in the minutes of meeting.

4. Independent consultants shall maintain confidentiality of information and documents relating to the research to which they have had an access. Before document review meetings, independent consultants shall complete and send an assessment form to the REC secretary.

Article 14. REC resources

The entity establishing the REC shall sufficiently provide resources to allow the REC to effectively carry out its responsibilities. To be specific:

1. Specialized secretaries and administrative secretaries must be adequate in number and trained to perform specialized and administrative tasks of REC.

2. Office space, meeting rooms, equipment and supplies must be provided to conduct administrative business, to store committee files, and to keep documents secure and confidential;

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4. Financial resources for operation of the REC provided by state budget shall comply with financial regulations of Ministry of Finance and Ministry of Science and Technology applied to Scientific Committees. For projects not funded by state budget, researchers and sponsors shall prepare a plan for funding for covering costs of consideration and evaluation by the REC according to regulation on internal spending of the entity establishing the REC.

Article 15. Training REC members

1. REC members must be trained after designation and recurrently trained to update ethical and scientific aspects in biomedical research.

2. Recurrent training must be provided at least every 02 years.

3. When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no control, direct or indirect, over the content of the training.

4. In addition to training courses offered to all members, training courses must be appropriately adjusted to satisfy each member's demand and specific requirements laid down by REC. Training contents include:

a) Role and responsibilities of the REC, and its role vis-à-vis other relevant entities, according to relevant international guidelines (International Ethical Guidelines for Health-related Research Involving Human Subjects and International Ethical Guidelines for Epidemiological Studies of the Council for International Organizations of Medical Sciences, Good Clinical Practice of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use);

b) Rights and obligations of REC members, prohibited acts, independence of REC and other regulations relating to REC members;

c) Contents of SOPs of REC, law relating to biomedical research;

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dd) Basic aspects of research methodology and design;

e) The impact of different scientific designs and objectives on the ethics of a research study;

g) The various approaches for recognizing and resolving the tensions that can arise among different ethical considerations and modes of ethical reasoning;

h) Conduct of research in practice and its feasibility.

Article 16. Procedures for issuance of operation code to national REC

Within 05 working days from the receipt of the decision on establishment of national REC, the Administration of Science Technology and Training affiliated to the Ministry of Health shall issue an operation code to national REC and publish information about name, address and operation code of REC and full name of the REC Chair on its website.

Article 17. Applications and procedures for issuance of operation code to internal REC

1. An application for issuance of operation code to internal REC includes:

a) An application form, which is made according to the Appendix 01 hereof.

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c) A certified true copy of the Regulation on organizational structure and operation of REC or a copy thereof presented together with its original for verification purpose;

d) Academic records and copies of certificate of training in Good Clinical Practice of REC members and secretaries and SOP of REC;

dd) A list of research reviewed within the last 12 months prior to the date of compiling the list (if any), which is compiled according to the Appendix 02 hereof;

e) A list of research supervised and inspected by REC within the last 12 months prior to the date of compiling the list (if any), which is compiled according to the Appendix 03 hereof;

g) A list of SOPs of REC, which is compiled according to the Appendix 04 hereof;

h) A list of forms, which is compiled according to the Appendix 05 hereof;

i) A form providing information about human resources, infrastructure and equipment of REC, which is made according to Appendix 06 hereof;

2. Procedures for issuance of operation code to internal REC

a) Within 10 working days from the receipt of the decision on establishment of REC, the entity establishing the internal REC shall submit an application to the Administration of Science Technology and Training, whether in person or by post.

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c) Within 07 working days from the receipt of the valid application, the Administration of Science Technology and Training affiliated to the Ministry of Health shall appraise it and send a notice of issuance of operation code to REC according to the Appendix 08 hereof if the application is satisfactory. If the application is not satisfactory or needs revising, the Administration of Science Technology and Training shall send a notification specifying reasons to the applicant.

d) If the application needs revising, the applicant shall complete the application within 60 days from the receipt of the notification. After the aforementioned deadline, it is required to re-apply for issuance of operation code.

dd) Within 05 working days from the receipt of the complete application, the Administration of Science Technology and Training affiliated to the Ministry of Health shall send a notice of issuance of operation code to REC.

e) Within 05 working days from the receipt of the notice, the Administration of Science Technology and Training affiliated to the Ministry of Health shall publish information about name and address of the REC, full name of the REC Chair and operation code of the REC on its website.

Article 18. Update of changes of information about REC

1. Information about REC shall be updated in the following cases:

a) Contact address or information about the REC Chair or secretary acting as a contact point of REC is changed.

b) A REC member is changed.

c) REC decides to dissolve or terminate research review.

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2. An application for update of changes of information about REC:

a) An application form, which is made according to the Appendix 09 hereof.

b) Documents proving changes specified in the application form.

3. Procedures for update of changes of information about REC

a) Within 15 working days from the date on which there are changes that need updating, the national REC or the entity establishing the internal REC shall submit an application to the Administration of Science Technology and Training affiliated to the Ministry of Health, whether in person or by post.

b) Within 07 working days from the receipt of the valid application, the Administration of Science Technology and Training affiliated to the Ministry of Health shall inspect it and update changes of information about REC on its website if the application is satisfactory. If the application is not satisfactory or needs revising, the Administration of Science Technology and Training shall send a notification specifying reasons to the applicant.

Chapter III

FUNCTIONS, TASKS, RIGHTS AND RESPONSIBILITIES OF RECs

Article 19. Functions of RECs

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Article 20. Tasks of RECs

1. The national REC shall:

a) undertake ethical and scientific review of research involving human participants before conducting clinical trials that serve the purpose of product registration; clinical trials of products have not yet been licensed for sale in Vietnam; multicenter trials; research on application of new techniques and methods in humans in Vietnam; international research where biological samples of research subjects are sent abroad or research results that are representative of Vietnamese people and other biomedical research at the request of the Ministry of Health, organizations and individuals that preside over research.

b) review changes or additions to research protocols and relevant documents during the conduct of the research approved by the competent authority.

c) supervise and monitor adherence to research protocols and regulations on ethics in research; assess the recording, reporting and handling of adverse events that occur during the course of the research approved by the competent authority.

d) review research results according to approved research protocols of research approved by the REC and review results of other clinical trials that serve registration of pharmaceutical products, medical equipment, new techniques and new methods for medical examination and treatment.

dd) retain and manage documents of the REC.

e) advise regulatory authorities about developing policies and law relating to biomedical research involving human subjects and specialized operations of internal RECs.

2. Internal RECs shall:

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b) undertake ethical and scientific review of protocols of research involving human participants in Point a Clause 1 of this Article that is presided over by the entity establishing the REC before submitting research documentation for approval by national REC.

c) performs the tasks specified in Points b, c, d and e Clause 1 of this Article with respect to research presided over by REC.

Article 21. Rights of RECs towards research

1. Approve and request amendments to the research protocol before granting approval, disapprove biomedical research documentation to form a basis for the competent authority to issue a decision to conduct research.

2. Decide to carry out expedited review of minimal risk research.

3. Approve or disapprove changes of research contents during conduct process.

4. Request PIs to conduct research and sponsor to report research data and results and documents relating to research.

5. Inspect and supervise the adherence to research protocols and GCP rules at research sites.

6. Request the competent authority to suspend the research if it is suspected or there is evidence that GCP requirements are not complied with or research protocol is violated or it is found that safety of research subjects is not ensured during the course of the research.

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8. Request amendments to research protocols, ICFs and other documents to be provided to research participants where necessary to ensure safety of research participants.

Article 22. Rights of RECs towards researchers

A REC that reviews research has the right to request researchers to take on the following responsibilities:

1. Submit all information required for a thorough and complete review of the ethics of proposed research.

2. Conduct the research in compliance with the protocol approved by the REC and competent authority.

3. Do not make any deviation or changes to the approved protocol or in following it without prior approval of the REC and competent authority, except where immediate action is necessary to avoid harm to research participants. In such a case, the REC is informed promptly of the changes/deviations made.

4. Obtain REC’s prior approval for amendments to selected documents, information provided to potential research participants or ICFs.

6. Promptly notify REC and/or other relevant authorities as required by REC policies and applicable laws of all serious, unexpected adverse events related to the conduct of the research/research product or unanticipated problems involving risks of harm to the participants or others.

7. Immediately implement any recommendations provided by the REC in response to safety reporting to safeguard the rights, safety and well-being of research participants.

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9. Notify the REC when the research is completed or prematurely suspended/terminated.

10. Notify the REC of the reasons for suspension/termination; provide a summary of results prior to prematurely suspending or terminating the research; describe the manner by which research participants will be notified of the suspension or termination and the plans for care and follow-up for the participants.

11. Notify organization conducting research studies, sponsors and other relevant organizations if the REC terminates or suspend the approval of research.

12. Keep the research participants and their family or communities of the progress of research by appropriate means when:

a) the research is terminated or suspended;

b) any changes occur in the context of the research that alter the potential benefits or risks;

c) the research is completed;

d) results of the research are available.

Article 23. Responsibilities of RECs

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1. safeguarding the rights, safety and well-being of all research participants and relevant community. Special attention should be paid to trials that may include vulnerable subjects; safeguarding the rights of researchers.

2. ensuring fairness in sharing benefits and risks between groups by social class, age, gender, economic status, culture, ethnic group and religion of research participants.

3. reviewing research and relevant documents and giving its objective and unbiased opinions within a reasonable time. Promptly documents its opinions in writing.

4. ensuring legality and scientism of research protocols and dossier, and confidentiality of research.

5. considering the qualifications of the researcher as documented by a current curriculum vitae and/or by any other relevant documentation the REC requests.

6. conducting continuing review of each ongoing research at intervals appropriate to the degree of risk to research participants, but at least once a year in the case of clinical trials.

7. reviewing both the amount and method of payment to research participants to assure that neither presents problems of coercion or undue influence on the participants. Payments to a participant should be prorated and not wholly contingent on completion of the research by the participant.

8. ensuring that information regarding payment to subjects, including the methods, amounts, and schedule of payment to participants, is set forth in the ICF and other documents to be provided to participants.

10. making REC decisions, excluding confidential information publicly available, through mechanisms such as clinical trial registries, websites, newsletters, bulletin boards and other appropriate manner of REC.

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12. adopting all protection measures to maintain confidentiality of documents. SOP shall specify persons granted privileges to documents of the REC.

13. ensuring confidentiality of information and protecting REC members from retaliation based on positions taken with respect to REC-related matters or review of research proposals.

14. retaining and managing documents of the REC in accordance with regulations of law on archives. Retain research review documents for a period of at least 05 years after commissioning.

Article 24. Responsibilities of REC members

1. The REC Chair has the responsibility to:

a) decide to carry out expedited or full review of research documentation.

b) assign REC main assessors and invite independent consultants to provide counsel on research documentation.

c) summon and conduct recurrent or unscheduled meetings of REC and take responsibility for his/her conclusion.

d) represent REC on behalf of regulatory authorities and the public.

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e) promptly process REC's documents, especially REC's comments on ethical approval for research proposals.

g) direct and supervise administrative secretaries of the REC preparing operating budget of REC.

h) supervise and propose training provided to the REC members and consultants.

i) decide on emergency cases to ensure safety of  research participants on behalf of the REC.

k) inspect and sign the REC’s SOPs before submitting them to the head of the entity establishing the REC for promulgation or promulgate them as authorized by the head of the entity establishing the REC.

l) promulgate forms and documents of the REC.

m) promptly notify the head of the entity establishing the REC of the REC decisions on research studies.

n) take on responsibilities of REC members as prescribed in Clause 4 of this Article.

2. A REC Deputy Chair has the responsibility to:

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b) take on responsibilities of a REC member as prescribed in Clause 4 of this Article.

3. A REC main assessor has the responsibility to:

a) perform professional tasks, review ICFs and other documents relating to the research. Send assessment forms to the REC secretary for consolidation.

b) express his/her views on research-related matters at REC review meetings.

c) take on responsibilities of a REC member as prescribed in Clause 4 of this Article.

4. A REC member has the following responsibilities:

a) Attend at least 70% of REC meetings and do not miss no more than 03 consecutive REC meetings without reasonable reasons.

b) Send research documentation assessment forms on schedule, attend REC meetings and vote.

c) Review, discuss and assess research protocols, ICFs and other documents included in the research documentation. For lay members not having expert in the health sector, it is required to review and comment on ICFs to safeguard the rights of research subjects.

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dd) Supervise serious adverse events and propose appropriate solutions.

e) Assess final report and research results.

g) Maintain confidentiality of documents and discussions at REC meetings.

h) Provide their academic records to administrative secretaries of the REC.

i) Notify the REC Chair of their conflicts of interests in the reviewed research (if any).

k) Perform the tasks as assigned by the REC.

l) Join recurrent training courses on bioethics and biomedical research.

m) Comply with the REC’s SOPs.

5. Replacements shall take on responsibilities of the replaced official members and have the voting authority when replacing the official members.

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1. A specialized secretary has the responsibility to:

a) identify and recommend research studies subject to expedited or full review to the REC Chair.

b) recommend main assessors for each research study to the REC Chair.

c) truthfully write minutes of the REC meetings and prepare annual reports of REC activities.

d) follow up with tasks that the REC requests the PIs to perform such as progress reports, final reports, corrective actions and amendment of approved protocols or ICFs.

dd) cooperate with administrative secretaries in performing the tasks specified in Clause 2 of this Article.

2. An administrative secretary has the responsibility to:

a) inform and advise the PIs, sponsors and new REC members of applicable regulations, guidelines, processes and procedures. In some cases, the secretary shall maintain a website ensuring public access to this information.

b) identify and request missing documentation in applications and prepare the completed file for committee review.

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d) keep and maintain records, research protocols and all correspondence in relation to their review, as well as records of any continuing oversight that may be required after approval. The secretary ensures that the confidentiality of REC records is maintained.

dd) keep contact with REC members and applicants for review.

e) facilitate access to literature and educational programmes useful to the members of REC.

g) update information about REC membership, including declarations of potential conflicts of interests.

h) Closely cooperate with the REC Chair and submit operating budget of REC to the competent authority.

i) prepare, review and promulgate the REC’s SOPs.

k) update the REC on new issues concerning REC activities.

l) provide administrative assistance and perform other tasks as assigned by the REC Chair relevant to professional qualifications and tasks of the secretary.

m) comply with the REC’s SOPs.

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OPERATIONS OF RECs

Article 26. Principles for the operation of the REC

1. RECs shall operate for non-profit purpose.

2. A REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international and national guidelines, and regulations of law. The REC makes clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers.

3. When the national REC develops reliance agreements for review of research under its jurisdiction by the internal REC, it is the responsibility of the delegating REC to assure that the same ethical principles serve as the basis of the other REC’s decision-making.

4. RECs shall operate in a collective, democratic and independent manner when undertaking review and making decisions.

5. When considering research involving vulnerable persons, individuals and experts with knowledge and experience of working with these persons shall attend the REC meeting or engage in assessing the research.

6. RECs shall impose regulations on coordinating with and/or relying on the comments and reviews of other domestic RECs or RECs in other countries.

7. Where necessary, RECs may call upon independent consultants to provide special expertise to the RECs on specific research projects, populations, or topics as prescribed in Article 15 of this Circular.

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1. Members work in an independent, objective and honest manner, respect divergent views, takes personal responsibility for their decisions when reviewing and assessing research contents before and during the conduct, and commissioning research results.

2. During the review, REC members may consult by directly contacting their colleagues to update information relating to the research and shall ensure that the colleagues do not have any conflicts of interests in the research.

3. REC members are entitled to notify the head of their supervisory authority to take actions against violations of working principles committed by the REC Chair or REC members.

Article 28. Guidelines for submission of documents to REC

RECs shall adopt written procedures that describe the requirements for submitting a research project for review. Submission requirements and required forms should be readily available to prospective applicants. Application instructions generally include at least the following:

1. The name(s) and address(es) of the REC secretaries, officers or member(s) to whom the application material should be submitted or website where the online documents are submitted to (if any).

2. All written documentation to be submitted as part of the application;

3. The format for submission;

4. The language(s) in which documents are to be submitted;

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6. The deadlines for submission of the application in relation to review dates;

7. The means by which notices about the incompleteness of an application package will be communicated;

8. The expected time for notification of the decision following review;

9. The time-frame to be followed in cases where the REC requests supplementary information or changes to documents from the applicant;

10. A fair and transparent fee structure if any, for reviewing a research project;

11. The procedure for seeking amendments to the protocol, or its related documents;

12. The required format for recruitment material, information to be given to prospective research participants, and the informed consent form.

Article 29. Documents required for review

1. In the case of review of the proposed research protocol:

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b) The protocol for the proposed research project, clearly identified and dated, together with supporting documents and annexes (if any).

c) A project summary or synopsis in non-technical language.

d) A description (which may be included in the protocol) of the ethical considerations involved in the proposed research; a description of measures that will be taken to ensure the protection of participants’ privacy and the confidentiality of data; a statement describing any remuneration or other goods or services to be provided to research participants; a description of arrangements for insurance coverage for research participants (if applicable).

dd) An adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the research product (applicable to research involving an experimental product).

e) All data collection forms to be used in the research project, clearly identified and dated.

g) All forms, documents, advertisements to be used in recruitment of potential participants.

h) Informed consent form(s) (with date and version number) in languages understood and at a reading level appropriate for the potential research participants. For research subjects aged under 7, their parents/legal guardians shall sign the ICF. For research subjects aged from 7 to 12, the procedure for obtaining consent shall require verbal consent of these subjects and their legal representatives or guardians shall sign the ICF. For research subjects aged from 12 to 16, the procedure for obtaining consent shall require such research subjects to sign the simplified assent form and their legal representatives or guardians to sign the ICF. For research subjects aged from 16 to under 18, such research subjects and their legal representatives or guardians shall sign the ICF.

i) A detailed description of the recruitment and ICF collection process.

k) The procedure for monitoring, assessing and handling adverse events and serious adverse events (applicable to research intervening in research subjects).

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m) Written permission for conduct of the research after obtaining the approval of the competent authority, which is granted by the organization managing research sites.

n) A statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines.

o) Current curricula vitae and relevant certificates of the principle investigators.

p) Other relevant documents.

2. In the case of review of the proposed research result report

a) Signed and dated application form, including signatures of listed co-applicants and institutional officials where relevant.

b) The research result report, clearly identified and dated, together with supporting documents and annexes (if any).

c) Research products (if any).

d) Other relevant documents.

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1. When assessing research documentation, during the research and after it is complete, RECs need to pay attention to:

a) Research design and conduct of the research

RECs should have documentation from a prior scientific review, or should themselves determine that the research methods are scientifically sound and should examine the ethical implications of the chosen research design or strategy. RECs should also assess how the research will be conducted and the adequacy of provisions made for monitoring and auditing.

b) Risks and potential benefits

RECs shall consider social and scientific values of the research and ensure the research does not expose research participants or their communities to risks of harm without any possibility of benefit. RECs should be aware that risks may occur in different dimensions (e.g. physical, social, financial, or psychological), at an individual level or at the family or population level. RECs shall accept the research only when risks have been minimized (both by preventing potential harms and minimizing their negative impacts should they occur) and are reasonable in relation to the potential benefits of the research.

c) Selection of research population, and recruitment and protection of research participants

RECs shall ensure fair share of the burdens and benefits of participation in research, these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is designed to yield. RECs shall ensure the research protocol clearly specifies the plans for care, consulting, monitoring and follow-up suitable for research participants, especially vulnerable subjects.

d) Financial benefits and financial costs

It is considered ethically acceptable and appropriate to reimburse participants (including costs associated with transportation, child care, lost wages or compensation for their time). Payments should not be so large, or free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to participate in the research.

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RECs should examine the precautions taken to safeguard participants’ privacy and confidentiality to show their respect for participants and avoid invasions of privacy and breaches of confidentiality.

e) Informed consent process

RECs should examine the process through which informed consent will occur, as well as the information that will be provided to ensure that competent individuals are entitled to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what the research entails. Decisions for children or adults who lack the mental capacity to provide informed consent should be made by an authorized surrogate decision-maker.  If participants or representatives fail to voluntarily consent to participate in the research, RECs may waive the requirement of informed consent only when doing so is consistent with international standards and regulations of Vietnamese law.

g) Effects of research on communities from which participants will be chosen

Duties to respect and protect communities where the research occurs and/or to whom findings can be linked require examining by the REC are aimed at minimizing any negative effects on communities such as stigma or draining of local capacity, and promoting, as relevant, positive effects on communities, including those related to health effects or capacity development.

h) Capacity of researchers and research sites

RECs shall consider capacity of researchers and research sites. Assess capacity of researchers in terms of their qualifications, experience, time devoted to the research and conflicts of interests in the research. Assess the research site by considering sources of patients/subjects to select sufficient sample size as requested by the protocol and infrastructure for conducting research, and capacity for handling adverse events.

2. RECs may utilize a checklist to ensure that all relevant criteria are considered during review and that, as a general rule, similar protocols are treated similarly.

Article 31. Expedited review of research

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a) Minimal risk research documentation;

b) Research documentation reviewed and approved by the internal REC in accordance with regulations and guidelines specified in this Circular;

c) Approved periodic research reports;

d) Applications for amendments to approved research protocols;

dd) Reports on adverse events occurring in the context of the approved research;

e) Reports on violations against approved research protocols.

2. Written procedures shall identify persons responsible for making decisions, number of assessors necessary to undertake expedited review, and define how assessors are selected as well as how written comments are consolidated.

3. An application for expedited review shall be submitted to the assessor within 05 working days from the date on which the REC receives the satisfactory application.

4. Except in the cases where an emergency meeting has to be organized, all documents to be reviewed shall be submitted to the main assessor at least 05 working days prior to the date on which the assessment form is requested to be re-submitted.

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6. A consolidated record of REC comments and decisions on the research shall be completed within 05 working days from the receipt of research documentation assessment forms from REC members.

7. Conclusions on the research shall be specified in the consolidated record of REC comments. The research proposal will be approved if no member shows disapproval or applies for full review of research documentation.

8. If the REC grants conditional approval for the research documentation, contents that need revising shall be clearly stated. If the REC disapproves the research documentation, explanation shall be provided.

9. A communication of REC decisions shall be sent to the applicant within 05 working days from the date on which the decision is made.

10. At the next REC meeting, the Chair shall notify REC members of expedited reviews that have been conducted between convened REC meetings.

Article 32. Full review of research

1. The REC shall undertake full review of research documentation that is ineligible to be reviewed through an expedited procedure or have been reviewed through an expedited procedure but the reviewer requests a full review.

2. When undertaking a full review, the REC may organize a meeting at an only location or an online meeting at different locations. A REC meeting shall be valid only when it is summoned by the REC Chair or Deputy Chair (authorized by the REC Chair) and attended by at least 05 REC members, including at least one member with medical expertise, one lay member, one independent member and male and female members who are all present to make decisions about the proposed research, and a minutes of meeting is made.

3. A review meeting shall be organized within 30 days from the receipt of complete documentation.

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5. Managers, sponsors and funders may attend the REC meeting to respond to questions about their research protocols and relevant documents but shall not be present during committee deliberations.

6. The REC should invite external independent consultants when necessary, particularly in relation to research that involves people whose life experiences may differ significantly from those of the REC members.

7. Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process of discussion and deliberation.

8. The REC shall ensure that the discussions are respectful of all opinions and allow for varied beliefs to be aired. The Chair is responsible for the decision-making process.

9. REC decisions on research shall be arrived at through an open ballot.

10. Only members that do not have any conflict of interests in the research, attend the meeting and discuss the research are entitled to assess and vote.

11. According to the research documentation review and discussion result, REC members participating in assessment may approve, conditionally approve or disapprove the research documentation.

12. If the REC grants conditional approval for the research documentation, the REC shall clearly state contents that need revising and determine whether the re-submitted documentation is reviewed according to an expedited or full procedure.

13. If the REC disapproves the research documentation, explanation shall be provided.

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15. The minutes of REC meeting shall be completed within 07 working days from the date on which the REC meeting is organized.

16. A communication of REC decisions shall be sent to the applicant within 05 working days from the date on which the decision is made.

Article 33. Communicating REC decisions on research

The communication of the REC decision on research includes:

1. Information about the research:

a) Title of the research reviewed;

b) The names, dates and version numbers of the documents reviewed;

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

d) The name of the site(s);

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e) The name of the REC making the decision.

2. The REC decision on the research:

a) In the case of an approval:

- Regarding the research protocol:

+ any significant ethical issues that were discussed during the meeting, and the resolution of those issues;

+ the fact that approval is given only for the protocol and its associated documents as accepted by the REC, with compliance expected;

+ the duration for which the approval is valid (up to 01 year) and the procedures to be followed to renew the approval, if applicable;

+ researchers’ responsibilities that are mentioned in Article 21 of this Circular.

- In the case of research result report:

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+ The REC conclusion on research result.

b) In the case of conditional approval, any requirements by the REC, including suggestions for revision and the procedure for having the application re-reviewed.

c) In the case of a negative decision, clearly stated reasons related specifically to ethical considerations.

d) Advice or suggestions that are non-binding may be appended to the REC decision.

3.  Signature (dated) of the Chair (or other authorized person) of the REC.

4. Written procedures provide mechanisms for researchers to request reconsideration of REC decisions, either by the REC itself or by other entities. If appeals to entities outside the REC are authorized, written procedures address the process for appeals, what materials must be submitted and to whom, and who will be the ultimate decision-maker.

5. Written procedures specify mechanisms for informing the public about REC decisions (e.g., bulletin board or websites of the entity establishing the REC or the entity presiding over the research or the REC).

Article 34. Follow-up reviews of approved research studies

1. Written procedures should be in place to describe the process by which RECs will maintain ethical oversight of research by following up the progress of all approved studies in order to assess the adherence to research protocols by researchers and sponsors from the time communication of decisions is sent and subjects are selected until SOPs are followed; issues that arise, handling of events, communication, management of reagents, research techniques and methods, research documentation and results.

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3. Circumstances that will trigger follow-up reviews, in addition to those that are regularly scheduled, including the following:

a) Any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or the conduct of the research.

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

c) Any event or new information that might affect the potential benefits or risks of harm involved in the research.

d) Decisions made by a data safety monitoring board (DSMB) or other monitoring or regulatory authorities to suspend a research study in whole or in part.

4. Documents to be reviewed by the REC include:

a) Summary of the research protocol.

b) A complete research protocol, including the amendments previously approved (for at least one REC main assessor).

c) Progress reports, final report.

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dd) Reports on adverse events and issues involving risks of harm to the participants, and cases of withdrawal from participation.

e) Summary of relevant information, especially information about safety.

g) Current ICF.

h) Audit reports, independent of the researcher and the sponsor.

i) Notification from the applicant with regard to suspension / premature termination or completion of the research.

5. A decision resulting from a follow up review should be issued and communicated to the applicant, indicating either that the original decision is still valid or that there has been a modification, suspension, or withdrawal of the REC’s original decision.

Article 35. Documentation and archiving

1. All of the REC’s documentation and communication is dated, filed, and archived according to the REC’s SOPs and regulations of law on archives.

2. REC records may be kept in hard copy, electronically, or both.

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a) Any documents formally establishing the REC;

b) The REC’s SOPs.

c) Documents published by the REC;

d) Annual reports summarizing REC activities;

dd) Academic records of all REC members;

e) Financial record of the REC;

g) Agendas of the REC meetings;

h) Minutes of the REC meetings;

i) Document certifying approval of the REC;

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l) Ethical guidelines used by the REC;

m) Other documents (if any).

4. The REC’s SOPs should specify length of time documents must be archived as prescribed by law. The documents should be archived for a minimum period of 05 years following completion of the research. These include:

a) One copy of all materials;

b) Any correspondence by the REC with applicants or concerned parties regarding the study;

c) A copy of initial and follow up decisions and any advice or requirements sent to an applicant;

d) All written documentation received during the follow-up, including any advice or requirements sent to the applicant;

dd) The notification of the completion, premature suspension, or premature termination of a research study;

e) The final summary or final report of the study.

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1. The REC shall develop and comply with SOPs to perform its functions and tasks.

2. REC secretaries shall send SOPs to all REC members and make them publicly available.

3. REC's SOPs shall be reviewed at least once a year to determine whether they are adjusted through regular assessment of REC's activities.

4. REC’s SOPs shall address the following issues:

a) System management: guidelines for writing and presenting SOPs; control of documentation; internal assessment; cooperation with other RECs.

b) Establishment of REC and training of members: composition, tasks, responsibilities and organizational structure of the REC; designation, dismissal, resignation and replacement of REC Chair, members and secretaries; protection of confidentiality of information, management of conflicts of interests; training of REC members; selection of independent consultants.

c) Methods for research review: expedited review; full review; emergency meeting.

d) Administrative procedures: requirements for submitting an application for review, including the forms to be completed, the documents to be submitted and any related process issues; receipt of applications; meeting preparation; meeting management; preparation and approval of minutes of meeting; preparation and notification of review results; measures for handling the applicant’s response to REC comments; management and making of copies of documents during the research; archiving and of research documentation; storage and arrangement of administrative records, logbooks and forms of the REC; maintenance of confidentiality of research documentation and REC records.

dd) Technical procedures: review of research documentation; re-review of research documentation; review of changes and additions; review of commissioning reports; processing of serious adverse event reports; actions against violations of research protocols; handling of complaints and requests of research subjects; review of prematurely terminated research; inspection of research sites; use of protocol assessment forms.

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Chapter V

IMPLEMENTATION CLAUSE

Article 37. Implementation

1. The Administration of Science Technology and Training affiliated to the Ministry of Health shall take charge and cooperate with relevant units affiliated to the Ministry of Health in:

a) disseminating, providing guidelines and inspecting the implementation of this Circular.

b) requesting the Minister of Health to suspend operation of any REC which is found violating regulations of this Circular, thereby affecting the protection of rights, safety and well-being of research participants.

c) issuing operation code to RECs and publishing it on the website of the Administration of Science Technology and Training affiliated to the Ministry of Health as prescribed in this Circular.

2. Departments of Health of provinces and central-affiliated cities shall disseminate, organize and inspect the implementation of this Circular at the authorities and unit under their management.

3. Entities establishing RECs shall:

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b) promulgate Regulation on organizational structure and operation of the REC within the entities by realizing regulations specified in this Circular.

c) assess the compliance with regulations and SOPs of RECs and application of ethical principles set out in international guidelines and national standards by REC members.

d) when assessing operation of a REC, notify the scope, assessment method and interval to the REC at least 01 month prior to the date of starting to carry out assessment and notify assessment results to the REC to conduct activities pertaining to quality improvement.

dd) ensure the assessment is conducted by persons with appropriate qualifications and in an independent and objective manner.

e) consider and supervise corrective actions and precautions by RECs according to findings and recommendations from internal assessment and external assessment.

g) receive, handle and monitor complaints about the REC made by researchers, research subjects and other relevant parties (if any).

h) provide resources to RECs as prescribed in Article 14 of this Circular.

i) in December, submit a report on REC activities to the Administration of Science Technology and Training affiliated to the Ministry of Health according to the Appendix 10 hereof.

Article 38. Effect

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Article 39. Responsibility for implementation

The Director of the Administration of Science Technology and Training, Chief of the Ministry Office, Chief Inspector of the Ministry, General Directors and Directors of Departments affiliated to the Ministry of Health, heads of affiliates of the Ministry of Health and relevant organizations and individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Administration of Science Technology and Training affiliated to the Ministry of Health for consideration.

PP. THE MINISTER
THE DEPUTY MINISTER




Le Quang Cuong