Administrative Regulations on the Establishment of Human Biobank Article 2
Institutions meet one of the following qualifications and have set up a bio-medical director and an information director shall apply for a human biobank (hereafter referred to as the Biobank) establishment to the central competent authority after being approved by the Ethics Committee specified in Paragraph 1 of Article 5 (hereafter referred to as the Ethics Committee):1. Government agencies of justice, health, bio-technology industries or scientific development-related;2. Hospitals who have passed the accreditation of teaching hospitals;3. Public/Private technological academies or above; or4. Central government-associated institutions or national incorporated foundations and judicial associations that have been set up for life science research.
中文原文 人體生物資料庫設置許可管理辦法第2條
機構具有下列資格之一,並置有生物醫學主管及資訊主管者,得於經本條例第五條第一項所定倫理委員會(以下稱倫理委員會)審查同意後,向主管機關申請設置人體生物資料庫(以下稱生物資料庫):
一、職掌司法、衛生或生物技術之產業、科學發展有關之政府機關。
二、通過教學醫院評鑑之醫院。
三、公私立專科以上學校。
四、以研究生命科學為目的設立之中央政府所屬機構或全國性財團法人、社團法人。
一、職掌司法、衛生或生物技術之產業、科學發展有關之政府機關。
二、通過教學醫院評鑑之醫院。
三、公私立專科以上學校。
四、以研究生命科學為目的設立之中央政府所屬機構或全國性財團法人、社團法人。