The Minister of Health of Vietnam issued Circular 43/2024/TT-BYT on December 12, 2024, stipulating the establishment, organization, and operation of the Ethics Council in biomedical research.
Standards for the Chairperson, Vice Chairperson, and members of the Ethics Council in Biomedical Research at both the national and grasshoots levels in Vietnam are as follows:
- Standards for the Chairperson, Vice Chairperson of the National Ethics Council:
+ Hold a doctoral degree or higher in the health sector;
+ Have at least 15 years of work experience related to the prevalent research fields evaluated by the Ethics Council;
+ Have prestige, ability to lead, aggregate, unify opinions to achieve consensus among Council members;
+ Have knowledge of good clinical research practice principles and standard operational procedures of the Ethics Council;
+ A person shall not be appointed as the Chairperson of the Ethics Council for more than 2 consecutive terms.
- Standards for the Chairperson, Vice Chairperson of the grasshoots Ethics Council:
+ Hold a bachelor's degree or higher in the health sector;
+ Have at least 10 years of work experience related to the prevalent research fields evaluated by the Ethics Council;
+ Meet the standards specified in points c, d, and dd of clause 1, Article 12 of Circular 43/2024/TT-BYT.
- Standards for members of the Ethics Council:
+ Members with health sector expertise and members with experience reviewing legal documents must have at least a bachelor's degree;
+ Members without health sector expertise must have at least an associate degree;
+ Have knowledge of good clinical research practice principles and standard operational procedures of the Ethics Council.
More details can be found in Circular 43/2024/TT-BYT, effective from February 1, 2025.
Circular 04/TT-BYT dated March 5, 2020, of the Minister of Health, which regulates the establishment, functions, duties, and powers of the Ethics Council in biomedical research, shall cease to be effective from the date Circular 43/2024/TT-BYT takes effect.
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