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.
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