Protocol Application Approval
All protocol applications must be approved before any animal work begins. We recommend that researchers submit protocol applications up to 3 months in advance of the expected project start date to allow enough time for the completion the multi-phase review process.
Be sure to include with your submission a copy of the funding proposal/final grant pages sent to the funding agency detailing the animal research described in the protocol. Federal regulations require the IACUC to compare the protocol to the funding proposal statement of work or project description. Any substantive differences must be satisfactorily addressed prior to IACUC approval.
The application should be approved by the department head. ORIA will route the application to the department head for you in the TOPAZ system. When the department chair is the Principal Investigator (PI) named in the protocol, no other approval is required.
ORIA will provide a preliminary review and then route the application to the GT Attending Veterinarian for veterinary consultation and to the Offices of Environmental Health and Safety (EHS) for their respective reviews. If modifications are required, the PI should revise the protocol in accordance with the combined veterinary and EH&S and Chemical Safety preliminary consultations and submit the revised protocol to the IACUC team for distribution to the full IACUC.
All protocols are distributed to the IACUC in the order received. IACUC member(s) are assigned to perform the formal review using the designated member review (DMR) process. If a Committee member calls for Full Committee Review (FCR), the protocol will be placed on the agenda for that month’s meeting, unless it was received without sufficient lead time. The majority of protocols do not require FCR.
If no member calls for FCR, the DMR may approve the protocol outright, require modifications to secure approval, or call for FCR. If the reviewer recommends approval of an application likely to produce no pain or distress, or only minor and transient pain or distress, the approval process is completed without convened Committee review. If a reviewer requires modification, the PI is given an opportunity to respond and may confer with the reviewer, Attending Veterinarian, or ORIA Associate. When a satisfactory response is received, the designated reviewing member may approve the application.
If the project involves the use of any infectious agent or hazardous chemical (including chemical carcinogen), a review by the Biological Materials Safeguards Committee (BSMC) is required. Protocols involving rDNA or synthetic nucleic acids also require review by the Institutional Biosafety Committee. These reviews should be sought in parallel with the IACUC evaluation.
Each project funded by the Department of Defense (including subcontracts under DoD/military prime contracts) requires a separate protocol. DoD/military funding cannot be added to a protocol that has already been funded by another source. Instead, the PI should submit a new protocol specifically for the work described in the DoD/military funded project.