1. Basis
Provisions of Articles 8, 78, 79, and 80 of the Medical Law and the Ministry of Health and Welfare's “Regulations on the Organization and Operation Management of Human Research Ethics Review Committees”
2. Purpose
To support clinical medical (pharmaceutical) research and properly conduct human trials, the “Human Trial Committee” (hereinafter referred to as the Committee) establishes its organizational charter, thereby safeguarding the basic rights of both participants and personnel executing human trial projects, and enhancing the clinical research standards and quality of this hospital.
3. Name
The Committee is named “Kaohsiung Armed Forces General Hospital Human Trial Committee” (hereinafter referred to as the Committee). In English, it is the Institutional Review Board of Kaohsiung Armed Forces General Hospital, abbreviated as KAFGHIRB.
4. Mission
(1) Review all human trial projects of the hospital. The term “human trial project” refers to those that fall within the scope stipulated by the Medical Law or announced by the Ministry of Health and Welfare.
(2) Review other human trial projects not covered by the Medical Law that need to be submitted to the Committee as required.
(3) Deliberate on other matters related to human trials.
(4) Track and supervise human trial projects accepted by this review committee.
(5) Conduct education and training related to human trials
5. Organization
(1) The Committee shall consist of 15 to 21 members, including one Chairperson and one to two Vice‑Chairpersons. Apart from medical professionals, at least one‑third of the members shall be legal experts, persons of social justice, or representatives of civil organizations; external members should constitute at least two‑fifths, and the proportion of any single gender must not be less than one‑third.
(2) The Committee shall have a Secretariat, which must include at least one Executive Secretary and one full‑time Director. Depending on operational needs, the Chairperson may appoint additional staff.
6. Term
The term of Committee members is two years, and they may be reappointed for consecutive terms. As a principle, the number of members replaced in any appointment cycle shall not exceed one‑half of the total membership. If a member seriously violates the principle of conflict‑of‑interest avoidance, the Committee may dismiss the member immediately.
7. Confidentiality Agreement
All Committee staff, members, experts, and related administrative personnel must sign a confidentiality agreement upon appointment and during the performance of duties. The contents of the agreement are stipulated in a separate document.
8. Meeting Schedule and Resolutions
In principle, the Committee convenes a meeting at noon on the last Friday of each month, with the exact time subject to flexible adjustment according to circumstances. A meeting may be held only when more than half of the members are present. Members who cannot attend must request leave from the Secretariat. If the Chairperson is unable to attend, a Vice‑Chairperson or a designated member shall preside over the meeting; an extraordinary meeting may be called if necessary. A meeting cannot proceed if all non‑medical‑professional members and all external members are absent. Resolutions must be approved by a majority of the members present, using an anonymous voting procedure.
9. Data Management
All relevant documents and communication records of the Committee are filed and archived by the Secretariat. Access to or extraction of confidential documents, files, or databases requires the Chairperson’s approval and is handled by the Secretariat. The Committee retains the review committee’s written procedures, member lists, member basic information, submitted documents, meeting minutes, correspondence, and other clinical trial‑related materials for three years after the trial’s completion, and these may be inspected by health authorities at any time.
10. Follow-up Review
The Committee conducts at least one follow‑up review or on‑site audit and supervision of each project annually. If, during the trial, unexpected serious adverse reactions to the product, other improper circumstances, or changes that could affect participants’ rights, safety, welfare, or the trial’s execution arise, the Committee is authorized to implement necessary follow‑up reviews and measures, and may, if required, request suspension or termination of the project.
11.
The Committee operates independently of the trial institution in carrying out its affairs; the hospital shall allocate sufficient full‑time or part‑time personnel to handle the Committee’s matters in accordance with the above regulations.
12.
This charter becomes effective upon approval by the Kaohsiung Armed Forces General Hospital Human Trial Committee. Amendments shall be made in the same manner for any matters not covered.
