VCOM Institutional Policy and Procedure Manual

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A7 Effective Date:

February 13, 2012

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

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ ADDENDUM TO VCOM IRB POLICY NO. R004 VCOM Procedure on Conducting and Documenting Continuing Review ____________________________________________________________________________________ P URPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the process of continuing review of research to be followed by the VCOM IRB, in order to aid in the compliance with federal regulations and OHRP recommendations. S COPE This SOP applies to all VCOM IRB submissions which involve continuing review, to include those reviews conducted and approved under expedited review procedure and those approved at a convened meeting. R ESPONSIBILITY The IRB Chair Person, and in the absence of Chair Person, the Co-Chair Person, will designate the type of review required, and if expedited will conduct the review or designate one or more experienced reviewers to conduct the review process. 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 review in accordance with and under the authority of HHS regulations, 45 CFR 46 and FDA regulations, 21CFR 56, and specifically: 45 CFR 46.109(e) Continuing review of research 45 CFR 46.110(b) Criteria for expedited review 46 CFR 46.107(e) IRB member conflict of interest 45 CFR 46.110 (c) Advising IRB members of expedited approval 45 CFR 46. 103(b)(4) Written procedure for IRB review 1. 2. 3. 4.