Administrative Regulations on the Establishment of Human Biobank Article 5

The review criteria for application specified in Article 3 are as follows:1. Completeness and feasibility of the proposal;2. Considerateness of guarantee of participants’ rights and interests;3. Appropriateness of the review process carried out by the Ethics Committee.To examine the application for the establishment of the Biobank, the competent authority may dispatch personnel for inspection if necessary.
中文原文 人體生物資料庫設置許可管理辦法第5條
第三條申請之審查基準如下:
一、計畫之完整性及可行性。
二、參與者權益保障之周延性。
三、倫理委員會審查過程之適當性。
主管機關為審查生物資料庫設置申請案件,得視需要派員勘驗。

English translation for reference only; the Chinese text prevails. Not legal advice.