Any biomedical research being based on human population groups or specific population groups shall not use any materials obtained from a Biobank the establishment of which is not authorized.
Where an Operator uses or provides to any third party the biological specimens, and related data and information, such use and the provision shall be conducted pursuant to the scope, duration, and method as agreed to by the Participant.

In the event that a Biobank that is established for the purpose of public interests or subsidized by the government should provide its biological specimens and relevant data and information to a third party, the principle of fairness and equality shall apply.

Any storage, use, or disclosure of the concerned operator’s entire biological specimens and related data and information shall be encoded, encrypted, delinked, or transformed so that the participant’s identity is unable to be determined.
An Operator shall encrypt and independently administer information that can determine the identity of an individual participant, such as his/her name, identification number, and date of birth. An Operator shall establish a review and control procedure for cross referencing the aforesaid personal information with the biological specimens and relevant data and information. Such information shall be restored immediately after each necessary use.
When an Operator cross references data or information of different sources, the Operator shall comply with Paragraph 1 hereof and restore the information immediately after the cross-reference is complete.
Documents that are unable to be separated from the information which can determine the identity of a participant, such as the agreement of consent and declarations of participation termination, are not subject to the rules set forth in the preceding three paragraphs. Nevertheless, the Operator shall adopt other necessary measures to maintain the confidentiality.
Article 5, Paragraph 3 hereof shall apply to the cross reference and application procedures referred to in Paragraphs 2 and 3.

An Operator’s staff and interested parties shall recuse themselves in the event of conflict of interests.

Any use of biological specimens, derivatives and relevant data and information in the Biobank shall not be used for purposes other than biomedical research. Medical research approved in accordance with Particle 5, Paragraph 3 hereof shall not be subject to this rule.

Any profits derived from the commercial use and received by an Operator and Biobank shall be given back to the human population groups or specific population groups to which the respective participants belong.
The Competent Authority shall stipulate regulations governing the distribution of profits mentioned in the preceding Paragraph.

An Operator shall regularly publish studies and research results of using the Biobank.