Standard Operating Procedures of the Ethics Council from March 15, 2020

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To be specific, the Ethical Review Board in biomedical research must have Organizational and Operational Regulations, which are approved by the head of the organization forming the board based on the proposal of the Board's Chairman and the head of the unit managing the scientific research activities of the organization forming the Ethical Review Board. The Organizational and Operational Regulations of the Ethical Review Board must comply with the provisions of Circular 4/TT-BYT and be consistent with the practical conditions of the institution.

The Ethical Review Board is responsible for developing, approving, publicly announcing, complying with, and annually reviewing the standard operating procedures to carry out the functions and duties of the Ethical Review Board.

The standard operating procedures of the Ethical Review Board include the following contents:

- System Management: guiding the writing and presentation of standard operating procedures; controlling documents and records; internal assessment; cooperating with other Ethical Review Boards.- Establishing and Training Members of the Ethical Review Board: composition, duties, responsibilities, and organization of the Ethical Review Board; appointment, dismissal, resignation, and replacement of the Chairman, members of the Ethical Review Board, and the secretary of the Ethical Review Board; information confidentiality, conflict of interest management; training members of the Ethical Review Board; selecting independent advisory experts.- Research Evaluation Methods: full process evaluation; expedited process evaluation; emergency meetings.- Administrative Procedures: instructions for submitting dossiers for evaluation, including required forms to be completed, documents to be submitted, and related procedures; dossier receipt; meeting preparation; meeting management; recording and approving meeting minutes; preparing and issuing evaluation result notices; resolving the petitioner's complaints regarding the opinions of the Ethical Review Board; managing records during the research process; archiving and extracting research documents; preserving, storing, and organizing the administrative records, logbooks, and forms of the Ethical Review Board; maintaining the confidentiality of research records and Ethical Review Board documents.- Technical Procedures: initial research dossier evaluation; re-evaluation of dossiers; mid-term research evaluation; evaluation of changes and additions; evaluation of final reports; handling serious adverse event reports; managing violations of the research proposal; handling complaints and requests from research subjects; early termination of research evaluation; checking research sites; using research proposal review forms.

Additionally, the Ethical Review Board should refer to the guidelines on the website of the Department of Science, Technology, and Training to develop and publicly announce the forms used in the operating process of the Ethical Review Board.

See the entire regulation at Circular 4/TT-BYT, effective from March 15, 2020.

Thu Ba

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