校園美景
週三, 27 八月 2025 09:08

Supplementary Explanation from the Ministry of Education to the Ministry of Health and Welfare Regarding Queries on "Human Blood Collection in Human Subjects Research Projects"


The Ministry of Education hereby forwards the supplementary explanation to the Ministry of Health and Welfare concerning the queries on "human blood collection in human subjects research projects" as follows:


1. This matter is handled in accordance with the Ministry of Health and Welfare’s letter No. 1141666600 dated August 19th, 2025.


2. The Ministry of Health and Welfare’s interpretation letter No. 1010203180 dated April 11th, 2012, addressed the legality of school nursing personnel assisting in blood collection for research projects within schools. Further clarification is deemed necessary. To uphold the rights of research subjects as stipulated in Article 2 of the Human Subjects Research Act, and to safeguard their life and physical health, this supplementary explanation is hereby provided.


3. Pursuant to Article 2 of the Human Subjects Research Act: "Human subjects research shall respect the autonomy of research subjects, ensure a balance between risks and benefits, minimize harm to subjects, and fairly distribute research burdens and outcomes to protect the rights of research subjects." Furthermore, Article 4, Paragraph 1 defines "human subjects research" as research involving the use of human specimens, while Paragraph 2 defines the scope of "human specimens" to include organs, tissues, cells, bodily fluids, and the like. In light of the above, since blood is a type of tissue, it may be utilized as a subject of human research.


4. One method of obtaining blood required for human subjects research is through venous or arterial extraction. The collection of venous or arterial blood (hereinafter referred to as blood drawing) is a medical professional skill that must be performed by medical personnel who have received relevant blood drawing training and hold a valid professional license. This requirement remains unchanged regardless of whether the blood drawing is for diagnosis, treatment, or human subjects research. According to the scopes of practice defined in the Medical Technologists Act, Nursing Personnel Act, and Physicians Act, medical technologists, medical technologist trainees, registered nurses, nurses, and physicians—all of whom have received training in blood drawing—are authorized to perform this procedure. Therefore, blood drawing should be conducted by the aforementioned medical personnel to ensure the protection of the life and physical health of the individuals undergoing blood collection and to comply with legal regulations.

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