Human Biobank Management Act Article 6

Collections of biological specimens shall be conducted in compliance with medical and research ethics. Participants shall be informed of related matters in a clearly comprehensible manner. Such matters shall be specified in an agreement of consent. Any collection may only be undertaken after the participant’s written consent is obtained.The Participant referred to in the preceding Paragraph must be an adult who demonstrates legal capacity. However, a participant of the biobank on specific population groups is not subjected to this rule.In the event that a participant of the biobank on specific population groups set forth in the proviso in the preceding Paragraph is under seven (7) years of age or is subject to a declaration of guardianship, the Operator shall obtain the consent of the participant’s legal representative. In the event that a minor participant is seven (7) years of age or older or subject to a declaration of assistance, consent shall be obtained from the participant and his/her legal representative.The content of the agreement of consent mentioned in Paragraph 1 shall be submitted to the Competent Authority for records after being approved by the ethics committee of the concerned operator.