VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

There is no remuneration for individuals serving as IRB members. No IRB member may participate in the review of any study on which he or she is an investigator or co-investigator, or where a potential for conflict of interest arises. 4.3. Terms IRB members will be appointed by the Provost. Each member’s participation and performance is reviewed annually by the IRB Administration. IRB members are appointed for a three-year term, but there is no limit to the number of successive terms a member can serve. Committee members may be appointed to multiple terms by mutual consent. The Chair may recommend that the Provost terminate a member’s participation if it is determined that the individual is not exercising his or her responsibilities in an ethical manner (consistent with IRB policies and Federal Regulations), is excessively absent from meetings or is unable to complete duties in a timely manner. If a member wishes to discontinue membership, he or she must notify the Chair and the Provost in writing. Upon appointment to the IRB, new members will receive an appointment letter from the IRB Chair. Prior to attendance at a convened meeting, each newly appointment member will be required to submit to IRB administration the following: • Signed IRB member appointment agreement • Completed information form • CV/resume/biographical sketch • Confidentiality agreement Each member must also complete IRB member CITI training. Training must be renewed every three years. 4.4. Schedule The IRB will meet on the second Tuesday of each month throughout the calendar year. IRB applications must be uploaded to IRBNet at least 14 working days prior to the second Tuesday of the month if they are to be included in the agenda for the next IRB meeting. AUTHORITY OF THE IRB The VCOM IRB was established under the mandate of the National Research Act of 1974 and is organized and authorized to act under authority of 45 CFR 46, 21 CFR 50, and 21 CFR 56. The IRB will review all human subject research conducted at VCOM or cooperative research conducted at VCOM in conjunction with other institutions., as well as those affiliate institutions for which an institutional authorization agreement (IAA) is in place. The IRB policies apply to all VCOM faculty, staff, and students using VCOM facilities, the facilities of any other off-campus site, and the facilities of another institution. The policies also apply to visitors and users of the campus or off-campus VCOM facilities. VCOM faculty members planning to conduct research at another institution must also obtain the approval of that institute’s IRB or there must be a cooperative agreement in place between institutions. The protocol, informed consent, and approval letter must all be submitted to the VCOM IRB for review (see Section 20. Responsibilities of the Principal Investigator ). 5.

VCOM Institutional Review Board Policies and Procedures

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