An investigator submits one copy of the following information in sufficient detail for the IRB to evaluate and make a determination that the protocol satisfies the approval criteria (see 45 CFR 46.111 and, if applicable, 21 CFR 56.111 and any other funding agency regulations, as applicable).
Investigators will provide additional information and materials as requested by the IRB and OIRB staff in order for the IRB to complete its review. The investigator may be requested to:
Each IRB member receives and is expected to review all of the following materials in enough depth to discuss the information at the convened meeting:
Primary Review Team members receive and review the above materials as well as the following additional materials in depth to present the protocol to the convened IRB meeting:
The IRB determines that the materials are acceptable to undergo review and perform substantive review in accordance with the criteria in 45 CFR 46.111, 21 CFR 56.111, and any other funding agency regulations, as applicable.
Chair or designee:
The Clerical Staff:
The Administrative Staff:
The Review Staff:
Approved on March 5, 2015 by:
Richard B. Marchase, PhDVice President for Research and Economic Development
Ferdinand Urthaler, MDIRB Chair
Jonathan Miller, MPPA, CIPOIRB Director