VCOM Institutional Policy and Procedure Manual

Edward Via Virginia College of Osteopathic Medicine

Effective Date: October 15, 2009

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ___________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ VCOM Procedure on Central Institutional Review Board (CIRB) Facilitated Review ____________________________________________________________________________________ 1. P URPOSE The purpose of VCOM Procedure on Central Institutional Review Board (CIRB) Facilitated Review is to describe the process of facilitated review/acceptance to be followed by the VCOM IRB, as a participant in the CIRB Initiative, for CIRB approved protocols. S COPE This Standard Operating Procedure (SOP) applies to all VCOM IRB submissions which involve clinical cancer research, specifically Cooperative Group trials, which list the CIRB as the IRB of record for full IRB review. 2. 3. R ESPONSIBILITY The IRB Chair Person, and in the absence of Chair Person, the Co-Chair Person, will designate an IRB member to conduct a facilitated review of the given CIRB approved protocol. This SOP must be reviewed annually by the Associate Vice President for Research. R EGULATIONS To ensure the compliance with human subject protections requirements, VCOM IRB will conduct a facilitated review in conjunction with a central review of CIRB, in accordance with and under the authority of HHS regulations, 45 CFR 46 and FDA regulations, 21CFR 56, specifically: 45 CFR 46.103 Assuring compliance with policy 45 CFR 46.111 Criteria for IRB approval of research 45 CFR 46.114 Cooperative research 45 CFR 46.116 General requirements for informed consent 45 CFR 46.408 Requirements for permission by parents or guardians and assent by children. 4.