Thông tư 4/TT-BYT 2020 thành lập chức năng nhiệm vụ hội đồng đạo đức trong nghiên cứu y sinh học

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 medical equipment management; Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 on amendments to some Articles of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on medical equipment management and Government’s Decree No. 03/2020/ND-CP dated January 01, 2020 on amendments to Article 68 of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on medical equipment management amended by the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018 on amendments to some Articles of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on medical equipment management;

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.

Chapter I

GENERAL

Article 1. Scope and regulated entities

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

2. This Circular applies to RECs, organizations and individuals engaged in biomedical research involving human subjects in healthcare field in Vietnam and other relevant organizations and individuals.

Article 2. Definitions

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

1. “research involving human participants” refers to a medical-scientific research 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” refers to a field of ethical enquiry that examines ethical issues and dilemmas arising from research involving human participants.

3. “researcher” refers to a person responsible for the conduct of the research at a research site.

4. “principal investigator - PI” refers to a researcher who oversees or conducts the research process and reports the research process and results directly to the sponsor.

5. “sponsor” refers to an individual or organization that takes responsibility for the initiation, management, and/or financing of a research project.

6. “research monitoring and supervision” refers to a process of monitoring and supervising research progress and adherence of a researcher to the approved protocol and relevant regulations of law on research.

7. “Informed Consent form - ICF” refers to 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.

8. “Assent Form - AF” means a document that documents agreement by a participant, e.g. a child aged from 12 to under 16, person having insufficient legal capacity or cognitively impaired person, not competent to give legally valid informed consent, includes information similar to the informed consent form to be involved in research but written in a more easily understandable and simple language. For participants aged from 07 to under 12, the verbal communication of the AF details should be provided.

9. “voluntary” refers to 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.

10. “privacy” refers to 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.

11. “conflict of interest” refers to 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, thereby potentially influencing the objectivity in research or research review.

12. “personal data” refers to any information that relates to an identified individual.

13. benefit” refers to a favorable consequence arising from a research study.

14. “risk” refers to the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.

15. “minimal risk” refers to the case where the probability and magnitude of physical or psychological harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily lives or during the performance of routine physical or psychological examinations or tests.

16. “compensation” refers to 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.

17. “reimburse” refers to the case where a researcher fully returns the amount of money, documents or items related to a research to a research subject under a research contract or regulations of law.

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

19. “clinical trial” refers to a research study in which one or more human subjects are prospectively assigned to one or more interventions according to an approved plan to evaluate the effect of those interventions on human health.

20. “Good Clinical Practice - GCP” refers to 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 3. General principles of bioethics

1. A research shall be only conducted after the research protocol is approved.

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

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

4. For an organization that is ineligible to establish an internal REC, the review and assessment of research involving human participants shall be carried out by a REC established by the provincial Department of Health or another unit’s REC having appropriate expertise.

Article 4. Independence of REC

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 they 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, members of the research funding organization or the organization conducting research reviewed by the REC.

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

Chapter II

ESTABLISHMENT OF RECS

Article 5. The power to establish RECs

1. The Minister of Health shall establish the National REC.

2. The Minister of Health shall approve the National REC charter and decide on designation, dismissal, addition or replacement or allow resignation of its members.

3. A term of office of the National REC lasts 05 years and it is required to re-establish or re-organize the REC upon the expiry of the term of office. The REC for the next consecutive term of office must be joined by at least 25% of new official members.

4. The National REC has its own seal and account to perform its functions and tasks and exercise its rights.

5. The National REC shall include a Chair, 03 Deputy Chairs, standing sub-committee, expert sub-committees, data monitoring sub-committee and Committee office, and if necessary, other sub-committees when necessary.

6. The National REC shall have at least 09 official members that comply with the regulations on REC composition and standards mentioned in Article 7 and Article 8 hereof.

In addition to its official members, the National REC may have replacements that are clearly specified in the designation decision.

7. The National REC shall have up to 03 specialized secretaries and up to 02 administrative secretaries that satisfy the standards set forth in Article 9 hereof. The entity establishing the REC shall ensure that the quantity of specialized secretaries and administrative secretaries is adequate to perform REC’s tasks.

8. The Administration of Science Technology and Training or Ministry of Health shall act as a standing member of the Nation REC Office.

Article 6. Establishment of internal RECs

1. The head of the organization that has the power to approve research shall decide to establish an internal REC and approve its regulation on organizational structure and operation and decide on designation, dismissal, addition or replacement or allow resignation of internal REC members.

2. The term of office of the internal REC shall comply with Clause 3 Article 5 hereof.

3. The internal REC shall include a Chair, 01 – 02 Deputy Chairs, standing unit, and if necessary, expert sub-committees.

3. The internal REC may use the seal of the entity establishing the REC to carry out activities pertaining to REC’s functions and tasks in accordance with regulations laid down by the head of the entity establishing the REC.

4. The National REC shall have at least 5 official members that comply with the regulations on REC composition and standards mentioned in Article 7 and Article 8 hereof. In addition to its official members, the National REC may have replacements that are clearly specified in the designation decision.

5. The National REC shall have up to 02 specialized secretaries and up to 02 administrative secretaries that satisfy the standards set forth in Article 9 hereof. The entity establishing the REC shall ensure that the quantity of specialized secretaries and administrative secretaries is adequate to perform REC’s tasks.

Article 7. Composition of REC members

1. A REC must have:

a) members that have a degree in the health sector related to common research assessed by the REC, including 01 person with no connection to the entity establishing the REC;

b) members that are clinical doctors;

c) members that have expertise in legal matters and/or ethics;

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

2. Regarding the age structure, the REC shall include members are under the age of 40, members aged from 40 to under 50 and members aged 50 or older.

3. The REC shall include male and female members that take up at least 20% of total number of REC members.

Article 8. Standards to be satisfied by REC members

1. General standards

a) Every member must have experience, knowledge, necessary skills and competence to perform their tasks, ensure objectivity in research and protect rights of research subjects.

b) The member that has expertise in the health sector and the member that has expertise in legal matters and/or ethics must obtain at least a bachelor’s degree.

c) The member that has expertise in the health sector must have at least 05 years’ work experience related to common research assessed by the REC.

d) Members have performed tasks of the REC.

dd) Every member must undertake to maintain confidentiality of information relating to research, comments made at meetings, commercial secrets of research participants or personal information about research participants.

e) Every member must obtain the certificate of training in Good Clinical Practice and REC's SOPs issued by the Ministry of Health or organizations recognized by the Ministry of Health, and be recurrently trained as prescribed in Article 13 hereof.

2. Standards to be satisfied by the Chair or Deputy Chairs of a REC

a) They must meet the standards specified in Clause 1 of this Article.

b) They must have at least 15 years’ work experience related to years’ work experience, be reputable and sufficiently competent to manage the REC in an independent, fair and unbiased manner without any pressure from the research presiding organization, researchers and other organizations and individuals.

c) They must have the ability to manage and consolidate comments of REC members and assist in achieving consensus of REC members and making necessary preparations for REC meetings.

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

Article 9. Standards to be satisfied by REC secretaries

1. A REC specialized secretary must:

a) be honest and objective;

b) obtain at least a bachelor’s degree in the health sector; have knowledge about science and technology management, scientific research and ethics;

c) obtain the certificate of training in Good Clinical Practice and REC's SOPs issued by the Ministry of Health or organizations recognized by the Ministry of Health and be recurrently trained as prescribed in Article 13 hereof.

2. A REC administrative secretary must:

a) be affiliated to an entity licensed to manage scientific research activities conducted by the entity establishing the REC;

b) be honest and objective;

c) obtain at least a bachelor’s degree; have expertise in archives and office management and obtain the certificate of training in REC's SOPs issued by the Ministry of Health or organizations recognized by the Ministry of Health.

Article 10. Independent consultants to RECs

1. Consultants could include experts in ethics; law; science; specific medical specialties 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 authority. If independent consultants fail to attend a meeting, their written comments shall be considered by the REC and specified in the minutes of meeting.

4. Independent consultants have the responsibility to maintain confidentiality of information and documents relating to the research to which they have had an access.

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

1. Designation

a) At the beginning of the REC’s term of office, the head of the entity licensed to manage scientific research activities conducted by the entity establishing the REC shall, according to the demand of and standards applied to REC members, propose a human resource plan to the head of the entity establishing the REC for decision on designation.

b) For personnel under the management of another organization, the entity establishing the REC shall send an enquiry to the organization managing personnel expected to be designated as a REC member. In case of designation of an independent consultant as a REC member, it is required to obtain his/her written consent.

c) Within 30 days from the receipt of the human resource plan, the head of the entity establishing the REC shall make a decision on designation.

d) The term of office of the official members and replacing members is the same as that of the REC.

2. Resignation

a) If a REC member is allowed to resign if he/she finds that he/she is ineligible to complete tasks of the REC or wishes to resign.

b) The member that applies for resignation shall submit his/her resignation to the head of the entity establishing the REC.

c) Within 30 days from the date on which the resignation is received, the head of the entity establishing the REC shall consider it and decide whether to accept the resignation.

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 the independence or has not attended more than 03 REC meetings in a row.

b) The head of the entity licensed to manage scientific research activities conducted by the entity establishing the REC shall, according to Point a of this Clause, request the head of the entity establishing the REC in writing to decide to dismiss REC members.

c) Within 30 days from the date on which the written request is received, the head of the entity establishing the REC shall consider it and decide whether to accept the dismissal.

4. Addition or replacement

a) The head of the entity licensed to manage scientific research activities shall, according to standards or demand for addition or replacement of REC members, submit a member addition or replacement plan to the head of the entity establishing the REC.

b) For personnel under the management of another organization, the entity establishing the REC shall send an enquiry to the organization managing personnel expected to be designated as a REC member. In case of designation of an independent consultant as a REC member, it is required to obtain his/her written consent.

c) Within 30 days from the date on which the member addition or replacement plan is received, the head of the entity establishing the REC shall consider it and decide to add or replace REC members.

d) The ending date of the term of office of an added or replacing member is the same as that of the REC.

Article 12. Funding, infrastructures, equipment and supplies for supporting REC's operations

1. The head of the entity establishing the REC shall provide resources to support REC’s operations. To be specific:

a) Annual operating funding;

b) Office space, meeting rooms, equipment and supplies intended for organizing REC meetings, conducting administrative business, storing committee files, and keeping documents secure and confidential.

2. Funding for operation of the REC shall be covered by the state budget in accordance with 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 to provide funding for covering costs of consideration, review and evaluation by the REC according to regulation on internal spending of the entity establishing the REC or regulations of sponsors in accordance with laws.

Article 13. Training REC members

1. REC members must be trained before designation and recurrently trained to update biomedical research ethics during their committee service.

2. The head of the head of the entity establishing the REC shall assign the entity licensed to manage scientific research activities to prepare a training plan and implement it. The recurrent training shall 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. The training provided to REC members before designation focuses on:

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 the REC and other regulations relating to REC members;

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

d) Ethical considerations relevant to research with human participants;

6. The recurrent training provided to REC members focuses on:

a) The contents in Clause 5 of this Article and any revisions thereto;

b) Basic aspects of research methodology;

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

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

dd) Practice and feasibility of a research study.

Chapter III

FUNCTIONS, TASKS AND RIGHTS OF RECS

Article 14. Functions of RECs

RECs exercise the functions of advising the head of the entity establishing the REC about considering and reviewing ethical and scientific aspects of research involving human participants to form a basis for approving, conducting and completing the research.

Article 15. Tasks of RECs

1. The Nation REC has the following tasks:

a) Review research documentation before undertaking ethical and scientific review and considering capacity of researchers and research sites with regard to clinical trials of medicinal products, equipment and other products that have not yet been licensed for sale in Vietnam; multicenter trials; research on clinical trial of new techniques and methods in humans in Vietnam; ministerial and national scientific research involving human subjects in healthcare field in Vietnam; international cooperation 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) Carry out follow-up reviews of ongoing research studies.

dd) Review research results according to approved research protocols of research approved by the REC.

e) Archive, manage and keep confidentiality of documents of the REC in accordance with regulations of law on archives. Research review documentation shall be archived for a minimum period of 05 years following completion of the research.

g) Advise regulatory authorities about developing policies and regulations related to biomedical research involving human subjects and specialized operations of internal RECs.

2. Every internal REC has the following tasks:

a) Undertake ethical and scientific review of documents about research studies involving human participants other than those specified in Clause 1 of this Article to request a competent authority to approve such research studies.

b) Undertake ethical and scientific review of research studies 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 review by the national REC.

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

Article 16. Rights of RECs

Every REC has the right to:

1. approve and request modifications to research protocols or refuse to approve biomedical research documentation to form a basis for the competent authority to issue a decision to conduct research.

2. decide to carry out full or expedited review as prescribed in Article 20 hereof.

3. allow the exemption from obtaining the assent form from a research subject if it is necessary to keep confidentiality of information about the research subject or if it is impossible to obtain assent from an emergency patient or his/her legal representative in full consideration of benefits and risks of the research and measures to protect rights and safety of the research subject.

4. approve or refuse to approve changes of contents of a research study during its conduct.

5. request PIs, organizations conducting research and sponsors to report research data and results and documents relating to the research.

6. inspect information to be provided to research subjects, process of providing information and obtaining assent forms from research subjects. Inspect and supervise the adherence to research protocols and GCP rules at research sites.

7. request the competent authority to suspend the research if it is found that a researcher fails to comply with GCP requirements or violates the research protocol or the safety of research subjects is not ensured during the course of the research.

8. suspend the recruitment of research participants, suspend the application of research products to research subjects if it is deemed necessary to avoid causing harm to research participants. The reasons for suspension shall be stated.

9. request modifications to research protocols, ICFs and other documents that are provided to research participants during the course of the research to ensure their safety.

Article 17. Responsibilities of RECs

Every REC has the responsibility to:

1. safeguard the rights, safety and well-being of all research subjects, especially vulnerable subjects and concerned communities; safeguard the rights of researchers.

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

3. ensure risks that may occur in different dimensions (e.g. physical, social, financial, or psychological), at an individual level or at the family or population level are minimized and reasonable in relation to the potential benefits.

4. ensure the research protocol clearly specifies the plans for care, consulting, monitoring and follow-up suitable for research subjects, especially vulnerable subjects.

5. determine that research protocols and documentation are scientifically sound and examine the ethical implications of the chosen research design or strategy.

6. review both the amount and method of payment to research subjects to ensure that neither presents problems of coercion or influence on voluntariness of the subjects. Payment to a subject should be prorated based on the number of visits.

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

8. ensure the protection of research subjects’ privacy and the confidentiality of data.

9. ensure confidentiality of information and protect REC members from retaliation based on positions taken with respect to REC-related matters or review of research proposals.

10. ensure research subjects have adequate understanding of the research and voluntarily consent to participate in the research. Decisions for children or adults who lack the mental capacity to provide informed consent should be made by their legal guardians or other appropriate representatives.

11. minimize any negative effects and promoting, as relevant, positive effects on communities from which research participants will be drawn.

12. enable researchers to discuss concerns with REC members, both on general matters and in response to REC decisions on particular research studies.

13. make publicly available REC decisions, excluding confidential information, through website of the entity establishing the REC, bulletin boards and other appropriate manner.

Chapter IV

OPERATIONS OF RECS

Article 18. Operating principles of RECs

1. RECs shall operate for non-profit purpose.

2.  RECs shall fully apply the ethical principles articulated in this Circular, relevant legislative documents and international ethics guidelines. The RECs shall make clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers.

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

4. When considering research involving vulnerable persons, representatives of research subjects or experts with experience of working with these persons shall attend the REC meeting.

5. RECs shall establish the procedures for coordinating with and/or relying on the comments and reviews of other domestic RECs or RECs in other countries.

6. Where necessary, RECs may call upon independent consultants to provide special expertise to the RECs.

7. A REC’s conclusion on the research shall be given by consensus of REC members and specified in the minutes of REC meeting.  If it is difficult to achieve consensus, the REC Chair is entitled to decide to immediately have a vote or request a PI to complete the research documentation in order for the REC to consider and vote at the next REC meeting.

The research shall be only approved when there are less than 02 disapproval votes out of valid votes.

Article 19. Contents that RECs need to review

When assessing research documentation, supervising the research process and assessing research results, the following shall be reviewed by the REC:

1. Research design and conduct of the research;

2. Risks and potential benefits;

3. Selection of research population, and recruitment and protection of research participants;

4. Financial benefits and financial costs;

5. Protection of research participants’ privacy and confidentiality;

6. Informed consent process;

7. Effects of research on communities from which participants will be drawn;

8. Capacity of researchers and research sites.

Article 20. Full and expedited review of research

1. Research documentation will be reviewed through a full procedure by the REC if:

a) it is ineligible to be reviewed through an expedited procedure prescribed in Clause 2 of this Article.

b) it has been reviewed through an expedited review but the reviewer requests a full review.

2. Research documentation will be reviewed through an expedited procedure by the REC if:

a) it contains minimal risks;

b) it has been reviewed by the REC before;

c) it has been reviewed and approved by another REC at the same level;

d) The periodic research report has been approved;

dd) The application for amendments to the approved research protocol has been approved;

e) The report on adverse events occurring in the context of the approved research has been approved;

g) The report on violations against the approved research protocol has been approved.

3. Within 30 days from the receipt of the satisfactory documentation, the REC shall review it and issue a REC’s decision to the applicant.

4. The documentation subject to a full review will be legally valid when a meeting 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 research, and a minutes of meeting is required.

5. The documentation subject to an expedited review shall be legally valid only when at least 02 REC members assess it.

Article 21. Follow-up and irregular reviews of research

1. The REC shall carry out a follow-up review of ongoing research at intervals appropriate to the level of risks to research subjects, but the intervals should generally be at least once a year on or before the day the research protocol is approved by the REC. A decision resulting from a follow up review should indicate either that the original decision is still valid or that there has been a modification, suspension, or withdrawal of the REC’s original decision.

2. An irregular review shall include 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 study.

b) serious unexpected adverse events related to the conduct of the study or study product.

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

d) decisions made by a sponsor or regulatory authority to suspend a study in whole or in part.

Article 22. 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 researchers. 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;

5. The number of copies to be submitted;

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 23. Documents required for review

1. In the case of review of the research protocol for the first time:

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

b) The protocol for the research project (with date and version number), 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 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, with date and version number.

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

h) Informed consent form(s) (with date and version number) for the research subjects (if research subjects are aged 18 or older and have full legal capacity to provide informed consent).

i) Informed consent form(s) (with date and version number) for the research subjects and their parents or legal guardians (if research subjects are aged from 16 to under 18).

k) Informed consent form(s) (with date and version number) for the research subjects and their parents or legal guardians (if research subjects are aged under 16).

l) Assent form(s) (with date and version number) for the research subjects who are not competent to give legally valid informed consent, including children aged from 12 to under 16, person having insufficient legal capacity or cognitively impaired persons.

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

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

o) All previous decisions (including the reasons for previous negative decisions and modification(s) to the proposal made on that account) by other RECs or regulatory authorities for the proposed research.

p) Written permission for conduct of the research after obtaining the approval of the competent authority, which is granted by the organization managing research sites (if the research is conducted outside the entity establishing the REC).

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

r) Current curricula vitae and relevant certificates of the PI(s).

s) Other relevant documents.

2. In the case of re-review of the research protocol:

a) A description of opinions of the REC.

b) Modified research protocol and documents.

3. In the case of follow-up review of ongoing research report

a) Summary of the research protocol.

b) A complete research protocol, including the modifications previously approved.

c) Research progress reports.

d) Report on number of subjects that are selected, complete or withdraw from participation in the research or whose track is lost.

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) Independent audit reports of the researcher and the sponsor.

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

4. In the case of review of documents about modifications to the research protocol

a) A report on modifications.

b) Modified documents.

c) Other relevant documents.

5. In the case of review of report on adverse events occurring in the context of the research

a) A report on adverse events occurring in the context of the research

b) Other relevant documents (if any).

6. In the case of review of report on violations against the research protocol

a) A report on violations against the research protocol.

b) Other relevant documents (if any).

7. In the case of review of the research result report

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

b) A research result report (with date and version number), together with supporting documents and annexes (if any).

c) Study products (if any).

d) Other relevant documents.

Article 24. Notification of results of research reviews by RECs

1. Within 05 working days from the date on which the result of research documentation review is available, the REC shall send a written notification of review result to the entity presiding over the research and PI and publish the result on the bulletin board or website of the REC or the entity establishing the REC.

2. If the research protocol has been approved by the REC, the REC shall give a written approval as prescribed in the Appendix 02 hereof.

3. If the research protocol has been approved by the REC, the REC shall give a written approval as prescribed in the Appendix 03 hereof.

4. If the research result has been approved by the REC, the REC shall send a written notification as prescribed in the Appendix 04 hereof.

5. If the REC grants conditional approval for the research protocol or modification to the research protocol or research result, it shall send a written notification as prescribed in the Appendix 05 hereof.

6. If the REC does not grant approval for the research protocol or modification to the research protocol or research result, it shall send a written notification as prescribed in the Appendix 06 hereof.

Article 25. Archiving documentation of RECs

1. All documentation and communication of an EC should be dated, filed, and archived according to its written procedures and regulations of law on archives.

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

3. REC documents to be archived by the REC include:

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 records of the REC;

g) Agendas of the REC meetings;

h) Minutes of the REC meetings;

i) Document certifying approval of the REC;

k) Regulatory texts used by the REC;

l) Ethical guidelines used by the REC;

m) All documents and materials related to the review of specific projects, including one copy of all materials submitted to the REC; any correspondence by the REC with PIs or concerned parties regarding applications, decisions, and follow-up; the notification of the completion, premature suspension, or premature termination of a study (if any); the final summary or final report of the study.

n) Other relevant documents.

4. The REC’s SOPs should specify length of time documents must be archived in accordance with regulations of law on archives. The documents should be archived for a minimum period of 05 years from the date on which the research is completed or the written consent to termination of the research is obtained.

Article 26. RECs’ Regulation on organizational structure and operation and SOPs

1. A REC must have a Regulation on organizational structure and operation that is approved by the head of the entity establishing the REC at the request of the REC Chair and the head of the entity licensed to manage scientific research activities conducted by the entity establishing the REC. The Regulation on organizational structure and operation shall be conformable with regulations of this Circular and conditions of the REC.

2. The REC shall develop, approve, make publicly available, comply with and annually review SOPs to perform its functions and tasks.

3. 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 of documents during the research; archiving and making of copies 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 for the first time; re-review of research documentation; mid-term review of research; review of changes and additions; review of research completion 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.

4. RECs should make reference to guidelines on the website of the Administration of Science Technology and Training to design and publish forms used in operating procedures of the RECs.

Chapter V

IMPLEMENTATION CLAUSE

Article 27. Responsibilities of Departments affiliated to the Ministry of Health

1. The Administration of Science Technology and Training affiliated to the Ministry of Health has the responsibility to:

a) disseminate and provide guidance on the implementation of this Circular;

b) update the list of RECs that have notified their establishment on the website of the Administration of Science Technology and Training within 15 days from the receipt of the REC establishment notification;

c) carry out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs;

d) if it is found that a REC fails to comply with regulations laid down in this Circular, remove it from the list published on the website of the Administration of Science Technology and Training.

dd) suspend or request a competent authority suspend operation of a REC if it is found that such REC violates the regulations set forth in this Circular, thereby affecting the protection of rights, safety and well-being of research subjects.

2. Departments affiliated to the Ministry of Health have the responsibility to:

a) cooperate with the Administration of Science Technology and Training in disseminating and providing guidance on the implementation of this Circular.

b) cooperate with the Administration of Science Technology and Training in carrying out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs.

Article 28. Responsibilities of Departments of Health of provinces and central-affiliated cities and health authorities of ministries

Departments of Health of provinces and central-affiliated cities and health authorities of ministries have the responsibility to:

1. disseminate and provide guidance on the implementation of this Circular to units under their management.

2. carry out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs established by the entities under their management.

3. request the Administration of Science Technology and Training affiliated to the Ministry of Health to suspend operation of RECs if it is found that such RECs violate the regulations set forth in this Circular, thereby affecting the protection of rights, safety and well-being of research subjects.

Article 29. Responsibilities of entities establishing RECs

An entity establishing the REC has the responsibility to:

1. disseminate and organize the implementation of this Circular at the entity.

2. promulgate its Regulation on organizational structure and operation of the REC by realizing regulations specified in this Circular.

3. assess the compliance with regulations of law, Regulations on organizational structure and operation and SOPs of the REC.

4. maintain the compliance with regulations of this Circular by its REC.

5. receive and respond to complaints about the REC from researchers, research subjects and concerned parties.

6. notify and update REC activities on its website within 10 working days from the date on which the REC establishment decision is obtained.

7. send a notification of establishment within 15 days from the date on which the REC establishment decision is obtained according to the Appendix 01 hereof to the Administration of Science Technology and Training affiliated to the Ministry of Health.

Article 30. Effect

1. This Circular comes into force from March 15, 2020.

2. The Circular No. 45/2017/TT-BYT dated November 16, 2017 of the Minister of Health is null and void from the effective date of this Circular.

Article 31. 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./.

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