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.

As set forth in the preceding Article, a participant shall be informed of the following matters:
1.The legal authorities and their contents governing the establishment of the Biobank.
2.The identity of the Biobank Operator.
3.Information regarding the identity and the service unit of the biological specimen collectors.
4.The reasons why a particular participant was selected.
5.The rights and direct benefits to which the participant is entitled pursuant to the Human Biobank Act.
6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types and quantities of specimens to be collected; and regions where specimens are collected.
7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an ethnic group.
9.Any reasonable risks or inconvenience which the participant may anticipate.
10.The rights which are excluded by these Human Biobank Act.
11.The mechanism designed to safeguard personal privacy and other rights and benefits of the participant.
12.The Operator’s organizational structure and operating principles.
13.Specific type of health information of the participant that is expected to be linked in the future.
14.Relevant regulations governing the applications of the Biobank.
15.Anticipated commercial applications.
16.The participant may choose whether upon his/her death or incapacity, his/her biological specimens and related data and information will continue to be stored and used.
17.Other important matters related to the Biobank.

A Participant may make a request to cease providing any biological specimen, withdraw, or change the scope of the use, which the Operator shall not refuse.
Should any participant withdraw from the program, the Operator shall destroy the biological specimens and related data and information provided by the participant. In the event that such materials have been provided to a third party, the third party shall destroy same upon receiving the notification from the Operator. However, this rule shall be inapplicable if one of the following circumstances occurs:
1.The Participant agrees in writing to the continuous use of certain materials.
2.Materials have already been delinked.
3.The preservation of documents such as the agreement of consent is necessary for the purpose of inspections and approved by the ethics committee.

In the event of a participant’s death or incapacity, except as otherwise agreed herein, the Biobank may, in accordance with the original agreement, continue the storage and use of the biological specimens and related data and information.

A Participant shall not request to view, duplicate, add, or correct data or information related to collections or processing of their biological specimens, or data or information with regard to the collection and process of the biological specimens, data, or information pursuant to Human Biobank Act. However, the restriction shall not apply to the personal information that can identify the participant.