Protocol Application Approval
All protocol applications must be approved before any animal work begins. 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 and the Office of Sponsored Programs (OSP) routing sheet. 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 signed by the department head or, in lieu of a written signature, the department head may send an email to the IACUC team stating he/she is aware of the proposed work and concurs with its submittal. When the department chair is the Principal Investigator (PI) named in the protocol, no other sign-off is required.
ORIA will provide a preliminary review then forward the application to the GT Attending Veterinarian/Director of Animal Resources for veterinary consultation and to the Offices of Environmental Health and Safety (EHS) and Chemical Safety 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; however, protocols requiring FCR are due the first of the month for review at that month’s meeting.
If no member calls for FCR, the DMR may approve the protocol outright, require modifications to secure approval or recommend deferring for clarification 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 clarification, the PI is given an opportunity to respond and may confer with the reviewer, Attending Veterinarian, or Research 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.