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.
2.1 The IRB of TCVGH has two committees: The First and the Second 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 A secretariat is set up within each of the First and Second IRB Committees. The secretariat of each committee has an executive secretary and several staff members, selected publicly by the IRB Chair in accordance with personnel employment procedures. The executive secretary can be an IRB committee member. The staff in each committee secretariat of the First and Second IRB Committees may share duties and responsibilities across the two committees.
2.4 An independent review mechanism is set up by the First/Second 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 developement (such as fundraising for research) cannot be a member of the IRB and performs the day-to-day operations of the IRB.
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.
4.1 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.
The secretariat of the committee will record the excellent performance of the in-house review committee members and the staff members of the First/Second IRB Committee (e.g. passing the review of Ministry of Health /Legal Foundation of Hospital Evaluation & Medical Quality Policy Promotion Committee, receiving 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.