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 IRB Review of Applications for HHS Support ____________________________________________________________________________________

1. P URPOSE The purpose of the VCOM Procedure on IRB Review of Applications for HHS Support is to describe the process to be followed by the VCOM IRB to ensure that all research described in the HHS grant application or proposal is entirely consistent with any corresponding protocol(s) submitted to the IRB. S COPE This Standard Operating Procedure (SOP) applies to all VCOM IRB submissions which constitute HHS supported human subject research. R ESPONSIBILITY The IRB Chair Person, and in the absence of Chair Person, the Co-Chair Person, will designate an IRB member to conduct the comparison of the grant application to the IRB proposal(s) on a case-by-case basis. This SOP must be reviewed annually by the Associate Vice President for Research. R EGULATIONS To ensure the compliance with human subject protections requirements, congruency checks will be in accordance with and under the authority of 45 CFR 46.103(f) of the HHS regulations which requires that each application or proposal for HHS-supported human subject research be reviewed and approved by the IRB, as designated by the Office of Human Research Protections (OHRP) Federalwide Assurance. P ROCEDURE 1. The designated IRB member will perform a side-by-side comparison of the application for IRB approval to the federal grant application, comparing the following sections for consistency. (The IRB reviewer should have access to the entire application or proposal, excluding appendices). 2. 3. 4. 5.