Regulations on the establishment of internal RECs in Vietnam

Regulations on the establishment of internal RECs in Vietnam
Nguyễn Thị Diễm My

What are the regulations on the establishment of internal RECs in Vietnam? – Thanh Phong (Binh Dinh, Vietnam)

Quy định về thành lập hội đồng đạo đức trong nghiên cứu sinh học
Regulations on the establishment of internal RECs in Vietnam (Internet image) 

1. The power to establish RECs in Vietnam

- The Minister of Health of Vietnam shall establish the National REC.

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

- 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.

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

- 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.

- 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 of Circular 4/TT-BYT.

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

- 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 of Circular 4/TT-BYT.

The entity establishing the REC shall ensure that the quantity of specialized secretaries and administrative secretaries is adequate to perform REC’s tasks.

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

(Article 5 of Circular 4/TT-BYT)

2. Establishment of internal RECs in Vietnam

- 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.

- The term of office of the internal REC shall comply with Clause 3 Article 5 of Circular 4/TT-BYT.

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

- 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.

- 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 of Circular 4/TT-BYT.

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

- 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 of Circular 4/TT-BYT.

The entity establishing the REC shall ensure that the quantity of specialized secretaries and administrative secretaries is adequate to perform REC’s tasks.

(Article 6 of Circular 4/TT-BYT)

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