A Biobank Operator must be a governmental agency, medical or academic institution, research institution, or legal person (hereinafter collectively referred to as “Organization”) and shall apply to the Competent Authority for a permit.
The Competent Authority shall stipulate rules and regulations to govern matters related to the permit applications mentioned in the preceding paragraph, such as applicant qualifications, application procedures, conditions for the establishment approval, review standards, regular inspections, relevant managerial matters, and other matters of compliance.

A Biobank Operator shall establish an ethics committee to review and supervise matters relating to the management of the Biobank.
There shall be between nine (9) to fifteen (15) commissioners in an ethics committee mentioned in the preceding paragraph, of which more than one half (1/2) shall be legal experts, social workers, and other disinterested community members; and at least two thirds (2/3) of the commissioners shall not be the personnel of the Organization.
Any matters related to the applications of data and information contained in the Biobank shall be drafted as a plan to be submitted to the ethics committee for approval, after which the plan shall be submitted to the Competent Authority who will further invite legal experts, social workers, and other disinterested community members to conduct a review on the plan. Only upon the final approval should the plan be enforced.
The number of each type of professionals mentioned in the preceding paragraph shall be no less than one fourth (1/4) of the total seats; and the professionals of the same gender shall not amount to less than one third (1/3) of the total seats.
The Competent Authority may commission private professional agencies (organizations) or groups to process the reviews set forth in Paragraph 3.
The reviewers referred to in Paragraphs 2 and 3 shall be recused to avoid conflicts of interest if necessary.