Biomedical research may only be conducted after the protocol has been approved

16:29, 10/07/2024

This is one of the important principles that ensure bioethics as stipulated in Circular 4/TT-BYT issued by the Ministry of Health regarding the establishment, functions, tasks, and authority of the Ethics Council in biomedical research.

Circular 4/TT-BYT stipulates that Bioethics refers to the implementation and assurance of ethical principles and standards in biomedical research involving humans.

biomedical research, 4/TT-BYT

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General principles ensuring bioethics include:

- Research shall only be carried out after the research proposal is approved by the competent authority.

- Prior to being approved and implemented by the competent authority, all biomedical research involving humans in Vietnam must be reviewed, commented on, guided, and approved for ethics and science by the Ethics Council according to the regulations set forth in this Circular.

- All biomedical research involving humans is subject to oversight by the Ethics Council during the implementation process.

- For organizations that do not meet the conditions to establish a local Ethics Council, the review and evaluation of biomedical research involving humans will be conducted by the Ethics Council established by the Department of Health or the Ethics Council of another unit with appropriate expertise.

For more related regulations, see: Circular 4/TT-BYT effective from March 15, 2020.

Thu Ba

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