Regulations to Know About Establishing the National Ethics Council

On March 5, 2020, the Minister of Health issued Circular 4/TT-BYT regarding the establishment, functions, tasks, and powers of the Ethics Council in biomedical research.

Establishing the National Biomedical Research Ethics Council, 4/TT-BYT

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Regulations on the establishment of the National Ethics Council are clearly stated in Circular 4/TT-BYT as follows:

- The National Biomedical Research Ethics Council is established by decision of the Minister of Health.

- The Minister of Health approves the organization and operational regulations of the National Ethics Council; decides on the appointment, resignation, dismissal, or supplementation and replacement of members of the National Ethics Council.

- The term of the National Ethics Council is 5 years, and the council must be established or reorganized when the term ends. The composition of the council for the next consecutive term must include at least 25% new official members compared to the previous consecutive term.

- The National Ethics Council has its own seal and account to perform its functions, duties, and powers.

- The National Ethics Council consists of a Chairman, 03 Vice Chairmen, a Standing Subcommittee, specialized subcommittees, the data monitoring subcommittee, the council's office, and other necessary subcommittees.

- The National Ethics Council must have at least 09 official members ensuring the member structure and standards as prescribed in Article 7 and Article 8 of this Circular. In addition to official members, the National Ethics Council may have alternate members as specified in the appointment decision.

- The National Ethics Council may have a maximum of 03 professional secretaries and a maximum of 02 administrative secretaries meeting the standards as regulated in Article 9 of this Circular. The organization establishing the Ethics Council is responsible for ensuring the adequate number of professional and administrative secretaries to perform the duties of the Ethics Council.

- The Department of Science, Technology and Training, Ministry of Health acts as the office of the National Ethics Council.

More details can be found in: Circular 4/TT-BYT effective from March 15, 2020.

Thu Ba

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