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人體研究倫理審查委員會Institutional Review Board
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:::Institutional Review Board > Introduction > Structure

Structure

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Updated 2023/11/21 17:10:56
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IRB組織圖


1. Purpose
Complied with the latest version of Helsinki Declaration of the World Health Organization, relevant regulations on human subject research or clinical trials issued by the Ministry of Health and Welfare, and the latest ethical standards for medical research, the purpose of the Institutional Review Board (IRB) of Taichung Veterans General Hospital (TCVGH) is to strengthen research ethics education for medical or research personnel in order to protect the rights and responsibilities of patients, subjects and all research participants and improve the overall quality of medical research.

2. Organization
  • 2.1 Our hospital has an "Administrative Center for Human Research Ethics Review", which has the First, Second and  Third IRB Committees. Each committee has 11 to 21 members, designated or selected according to Article 7 of the Human Subjects Research Act: "The IRB shall consist of five or more members, including a legal expert and other impartial citizens; more than two-fifths of all members shall not be affiliated with the research entity; and the number of the representatives of each gender shall not be less than 1/3 of the total members.”
  • 2.2 The IRB Chair is appointed by the Superintendent of TCVGH from among senior medical specialists of TCVGH. The IRB Vice Chair is appointed by the IRB Chair from among IRB members.  The Chair and Vice Chair are ex-officio members of the IRB. The remaining members are selected either by recommendations made by the Chair or other members, or by open elections. After the selection is approved in the IRB board meeting, the members shall be appointed by the Chair.  The list of all IRB members shall then be submitted to the central competent health authority for recordation.  IRB members are appointed to a term of two years.  The above appointment procedure complies with the "Regulations for Organization and Operation of IRB Committees." When a member is changed or a new member is added during a term of office, the new member’s term starts when the appointment is offered, and ends the same as all members. 
  • 2.3 The Administrative Center for Human Research Ethics Review has set a center director, one or two executive secretaries, and several staff members. The Director of the Center shall be appointed by the Superintendent of TCVGH. The remaining executive secretary and staff members shall be publicly selected by the director of the center in accordance with the personnel recruitment procedures. The director of the center and the executive secretary can be the IRB committee members. The first, second, and third IRB committees can be mutually supported by personnel from the Administrative Center for Human Research Ethics Review.
  • 2.4 An independent review mechanism is set up by the IRB Review Committees in order to protect the rights and welfare of clinical trial subjects and to improve review efficiency.
  • 2.5 The head of business development (such as fundraising for research) cannot be a member of the IRB and performs the day-to-day operations of the IRB.

3. Mission
  • 3.1 Compose human research policies and regulations in TCVGH.
  • 3.2 Promote research ethics education for medical personnel in TCVGH.
  • 3.3 Review and protect the rights of clinical trial participants.
  • 3.4 Review human research protocols and research findings.
  • 3.5 Monitor ongoing trials and suspend or terminate trials if necessary.
  • 3.6 Monitor reports of serious adverse events and recommend appropriate measures.
  • 3.7 Keep records of documents and meeting minutes in accordance with relevant laws and regulations.

4. Session
  • 4.1 Regular meetings are held according to actual needs, and the meeting should have a quorum.
  • 4.2 When there is a problem or an emergency that threatens the life safety of a clinical trial subject, the Chair or Vice Chair may hold an ad hoc meeting according to the actual situation.

5. Evaluation
  • 5.1 The Chair conducts evaluation of the Vice Chair/IRB Members on meeting attendance rate, quality of review, etc.  The Secretariat will tally all evaluation data in the end of the year and send for evaluation by the Chair, who will use the data as basis for re-appointment.  The Chair is assessed in a similar way by the Superintendent.  The assessment results will be returned in writing, with feedback and suggestions, to the Chair and used as the basis for extending the appointment.
  • 5.2 The Director of the Center evaluates once a year, the performance of the executive secretary and staff members, in terms of abilities to cooperate and coordinate, their learning attitude, and reception of education and training.  The executive secretary is assessed by the Director.  The staff members are assessed by the executive secretary and the Director.  

6. Award
The Administrative Center for Human Research Ethics Review will record the excellent performance of the in-house review committee members and the staff members of the IRB Committee (e.g. passing the review of Ministry of Health /Legal Foundation of Hospital Evaluation & Medical Quality Policy Promotion Committee, receiving AAHRPP International Certification, FERCAP International Certification, etc.), and submit applications of awards for the above-mentioned personnel based on their performances.  The applications of awards should be approved by higher ranked directors and the Superintendent of TCVGH and referred to the Performance Appraisal Committee for review and processing.

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