Institutional Review Board of Taipei Veterans General Hospital Articles of Association

I.    Basis
Article 8, Article 78, Article 79, Article 79-1 and Article 79-2 of the Medical Care Act (revised on June 27, 2012), Regulations for Good Clinical Practice, Human Subjects Research Act, Regulations on Human Trials, and Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research.

II.    Name
The Board is named Institutional Review Board of the Taipei Veterans General Hospital, a.k.a. IRB-TPEVGH.

III.    Mission
The IRB conducts review on human research, human research ethics and subjects' interest and right independently, including:
1.    Enactment of TPEVGH human research and human trial policy and regulations;
2.    Review on human research and human trial ethics
3.    Review on protection of subjects' interests and rights;
4.    Review on human research and human trial protocol, and final report thereof;
5.    Audit the human research and human trials that have been already approved at least once per year;
6.    Terminate the human research and human trial, if necessary;
7.    Keep the clinical trial-related information, including human research and human trial protocol, meeting minute and audit record, et al.
8.    Review on other related matters.

IV.    Organization
TPEVGH founds three boards for the time being, namely, IRB (1), IRB (2) and IRB (3).

Each board shall have one chairman who is assumed by the candidate appointed by the Superintendent, and one vice chairman, one executive secretary, 1~2 vice executive secretaries who shall be appointed by the chairman. The board shall consist of more than 7 members who are nominated by the executive secretary and retained upon the chairman's approval. The member shall fulfill the term of office for two years and may be re-electable, provided that the number of reelected members shall be no more than one-seconds of the total members upon expiration of each term. The members shall consist of the professionals specialized in at least five fields. The medical expertise shall be responsible for the review from the scientific point of view, and more than one-thirds non-medical expertise (e.g. experts in law, social worker and other social justices or civil groups, and at least one of them shall act on behalf of the subjects). The non-institutional members shall account for more than two-fifths of the total members, and the members of any specific gender shall be no less than one-thirds of the total members.

The IRB sets up:
1.    Standard Operation Procedure, SOP
The chairman shall act as the convener.  The vice chairman, executive secretary and vice executive secretary of each board act as the members ex officio. Meanwhile, one non-medical expertise of each board shall be nominated by the executive secretary from each board and retained upon the chairman's approval. The group shall meet once per year, in principle, and may hold a temporary meeting, if necessary. More than half of the group members shall attend each meeting.
2.    Conflict Of Interest Deliberation

V.    Term of Office
The member shall fulfill the term of office for two years, and may be re-electable.

VI.    Review meeting
1.    The IRB shall meet once per month, and call a temporary meeting, if necessary.
2.    The review meeting called by the IRB shall be attended by a majority of the total members. Any vacancy in the members shall be filled by another member retained by TPEVGH. The successive member shall fulfill the remaining term of office of the precedent one.
3.    The present members shall consist of at least one member related to medical affairs, at least one non-institutional member, and at least one non-medical or scientific member to represent the subjects, and shall be of more than one gender.
4.    Where it is impossible to meet the quorum in the duration of the meeting, and upon request of the present members referred to in the preceding paragraph, or where some present members (if at least one of them is non-medical member) are asked to leave the meeting room, even if the quorum for a majority of the total members is met, no voting may be carried out until the members are asked to be present again.
5.    When the IRB reviews the study on vulnerable subjects who might be coerced or unduly influenced, the IRB may invite one or more professionals specialized in other fields who understand, or have experience in working with, such subjects, or the subjects' representatives of special identity to attend the meeting.

VII.    Dissolution of the IRB
1.    The IRB shall dissolve automatically whenever TPEVGH discontinues the operation of the IRB.
2.    The IRB may be dissolved whenever the IRB chairman gives a written notice to the members.

VIII.    Operating procedure
1.    File applications pursuant to the IRB SOP for filing applications.
2.    Conduct the review pursuant to TPEVGH Human Trial Review Guidelines.

IX.    Revocation and Revision
Any revocation and revision of the Articles herein shall be subject to the IRB's approval, and then promulgated and implemented upon the chairman's approval. The same shall apply to revisions of the Article herein, if any.