Regulations on Training for Members of the Ethics Council Prior to Appointment in 2020

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According to the regulations in Circular 4/TT-BYT, members of the Ethics Committee in biomedical research must be trained before appointment and receive updated and supplementary training on the ethical and scientific aspects of biomedical research during their participation in the Committee.

The head of the organization establishing the Ethics Committee is responsible for assigning the unit with functions of managing scientific research activities to develop and implement the training plan for Ethics Committee members. Updated and supplementary training activities must be conducted at least once every 2 years.

Training content for Ethics Committee members before appointment includes:

- Functions and duties of the Ethics Committee, relationship of the Ethics Committee with other related units according to the guidelines of the Ministry of Health and relevant international guidelines: International Ethical Guidelines for Biomedical Research and International Ethical Guidelines for Epidemiological Research by the Ethics Committees of International Organizations on Medical Science, Good Clinical Practice of the International Conference on Harmonization for pharmaceuticals for human use;- Rights and responsibilities of Ethics Committee members, actions that Ethics Committee members must not take, the independence of the Ethics Committee, and other relevant regulations related to Ethics Committee members;- Content of the standard operating procedures of the Ethics Committee, regulations related to biomedical research;- Ethical considerations in biomedical research involving humans that need attention;

Additionally, updated and supplementary training content for Ethics Committee members must include:

- Training content specified in Clause 5 of this Article, with updates and supplements;- Basic aspects of research methodology;- Impact of research designs on ethical issues in research;- How to identify and resolve issues arising from differences in views, approaches in evaluating ethical aspects of research;- Practicality and feasibility of research.

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

Thu Ba

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