Subject:
Ministry of Education Forwarding of the Ministry of Health and Welfare’s Supplementary Explanation on Issues Regarding “Human Research Projects Involving the Collection of Human Blood Samples.”
Explanation:
1.This matter is handled in accordance with the Ministry of Health and Welfare’s official letter Wei-Bu-Yi-Zi No. 1141666600, dated August 19, 2025.
2.The Ministry of Health and Welfare’s interpretation in its official letter Wei-Shu-Yi-Zi No. 1010203180, dated April 11, 2012, concerning the Ministry of Education’s inquiry on “the legality of school nurses being commissioned to assist with blood sampling in human research projects conducted on campus,” requires further supplementation. To implement Article 2 of the Human Subjects Research Act, thereby safeguarding the rights of research participants and protecting their life and health, this supplementary explanation is hereby provided.
3. According to Article 2 of the Human Subjects Research Act:
“Human research shall respect the autonomy of research participants, ensure a balance between risks and benefits, minimize harm to participants, and consider fairness in both the burdens and the distribution of research outcomes, in order to safeguard the rights and interests of research participants.”
Furthermore, pursuant to Article 4, Subparagraph 1 of the same Act, the definition of “human research” includes research conducted using human specimens. Subparagraph 2 of the same Article defines the scope of “human specimens” to include organs, tissues, cells, and bodily fluids.
4. One method of obtaining blood required for human research is through venous or arterial blood collection. Such procedures (hereinafter referred to as “blood sampling”) constitute a medical professional technique and must be performed by healthcare professionals who have received relevant training in blood sampling and who hold a valid professional license during its effective period. The nature of the procedure does not differ whether the blood sampling is conducted for diagnosis, treatment, or human research.
In accordance with the scope of practice defined respectively under the Medical Laboratory Technologist Act, the Nursing Personnel Act, and the Physicians Act, only medical laboratory technologists, medical laboratory technicians, registered nurses, nurses, or physicians who have received training in blood sampling are qualified to perform such procedures. This requirement ensures the protection of the life and health of the individuals undergoing blood sampling, and upholds compliance with legal and regulatory frameworks.