Guidance on Training for Members of the Ethics Council

Training for members of the Ethics Council is guided by Circular 45 as follows:

- Members of the Ethics Council must receive training after being appointed and continuously updated on ethical and scientific aspects of biomedical research.

- Continuous training activities must be conducted at least once every 02 years.

- When training activities are supported by research sponsors, there must be mechanisms to ensure that sponsors do not directly or indirectly influence the training contents.

- Besides general training for all members, training courses should be tailored to the needs of each member and specific requirements of the Ethics Council. Training content should include:

- The role and duties of the Ethics Council, the role of the Ethics Council in relation to other involved entities, according to relevant international guidelines (International Ethical Guidelines for Biomedical Research and International Ethical Guidelines for Epidemiological Studies of the Council for International Organizations of Medical Sciences, Good Clinical Practice of the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use);- Rights and obligations of Ethics Council members, prohibited actions for Ethics Council members, the independence of the Ethics Council, and other regulations related to Ethics Council members;- Contents of the Ethics Council's standard operating procedures, laws related to biomedical research;- Ethical considerations in biomedical research involving humans;- Basic aspects of research methods and design;- Impact of scientific designs and different objectives on the ethical issues of research;- How to identify and resolve potential differences in perspectives, ethical approaches that may arise when evaluating research;- Conducting research in practice and the feasibility of the research.

For more details, see Circular 45/2017/TT-BYT, effective from January 01, 2018.

-Thao Uyen-

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