主旨：
教育部函轉衛生福利部有關「人體研究計畫涉人體血液採集」疑義之補充說明。

說明：
一、依衛生福利部114年8月19日衛部醫字第1141666600號函辦理。
二、衛生福利部101年4月11日衛署醫字第1010203180號函釋，係教育部轉詢「學校護理人員受託協助校內研究計畫進行人體抽血採樣之適法性」，尚有補充必要。為落實人體研究法第2條保障研究對象之權益，並維護其生命及身體健康，特此補充說明。
三、依人體研究法第2條規定：「人體研究應尊重研究對象之自主權，確保研究進行之風險與利益相平衡，對研究對象侵害最小，並兼顧研究負擔與成果之公平分配，以保障研究對象之權益。」復依同法第4條第1款有關「人體研究」之定義，包括從事運用人體檢體所為之研究，而同條第2款定義「人體檢體」之範圍，包括器官、組織、細胞、體液。四、人體研究所需之血液，其取得方式之一，為自人體靜脈或動脈抽取；而採集靜脈或動脈血液（以下簡稱抽血），係醫事專業技術，應由接受相關抽血訓練，且具有效期間執業執照之醫事專業人員為之，尚不因抽血係為診斷、治療或人體研究而有不同。觀諸醫事檢驗師法、護理人員法、醫師法所定各該醫事人員執行業務之範圍，與醫事檢驗師、醫事檢驗生、護理師、護士或醫師均受過抽血之相關訓練，從而得從事抽血者，即應由上開醫事人員為之，始能保障接受抽血者之生命及身體健康，並符法制。

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.