The review is initiated when receipt of complete protocol application or amendment, including all required documents, is accepted by the IRB/IACUC Administrator. Protocol Approval is required at least every three (3) years. Protocols requiring Institutional Biosafety Committee approval must obtain it prior to IACUC approval. Principal Investigators (PIs) are strongly encouraged to consult with the committee veterinarian during the planning stages and prior to protocol submission, particularly for studies that have significant potential for pain or distress. Experts from within or outside the University community or consultants may be asked to assist in review of protocols that are complex in nature.
The IACUC Chair will receive the accepted protocol from the IRB/IACUC Administrator and will recommend one of two review methods: Designated Member Review (DMR) or Full Committee Review (FCR).
Designated Member Review (DMR)
A copy of the written protocol is sent to all IACUC committee members via email. Any member of the committee may request a FCR within 5 business days if they deem it necessary. Following a FCR request, a full committee meeting must convene with a properly constituted quorum. If no requests for FCR are received, the IACUC Chair will appoint one qualified committee member, along with the committee’s veterinarian, to head the review process as the Designated Member Reviewer (DMR).
The DMR has the following options:
- Approve the protocol or amendment if all criteria are met and satisfied
- Request revision(s) to the protocol or amendment if outstanding issues are present in order to secure approval
- Request FCR when further review of the protocol or amendment is warranted
Full Committee Review (FCR)
When FCR is recommended or requested, the IRB/IACUC Administrator will convene an ad hoc meeting with committee members, including the committee veterinarian, and subject matter experts/consultants if needed. Typically, the PI is not asked to attend the IACUC meeting at which his/her protocol is being reviewed. However, the PI may be invited to appear to address specific problems or questions in person.
The following outcomes of a FCR may occur:
- Approval by majority affirmative vote
- Revisions requested to secure approval
- Defer or table review of protocol if more clarification or outside consultation is needed
- Withhold approval of protocol if it has not adequately addressed all requirements necessary
If the IACUC is unable to approve a protocol, the PI is notified with a detailed report of the committees’ concerns. The PI has the opportunity to address the concerns to the committee in the next scheduled review.
Modifications to an Approved Protocol:
Investigators who desire to make modifications to an approved protocol during the approval period, must submit a modification for approval prior to initiating the change. Modifications include administrative changes such as addition or deletion of research personnel, as well significant changes such as modifications to the study design or objectives, the number of animals or species used, increases in pain or distress, changes to therapeutic or experimental agents or changes in euthanasia methods. Approval of a modification does not change the existing protocol expiration date.
Investigators who plan to submit an animal protocol should email the IACUC Administrator for the protocol application. Applications must be submitted electronically via email to firstname.lastname@example.org. The application must be attached in Word format. The last page of the application (PI assurance statement) is to be signed by the PI and his/her department chair or direct supervisor and submitted separately. You may submit this as a scanned PDF or with an electronic signature.
Upon receipt, the application will be logged and assigned a unique IACUC number. An email confirmation will be sent to the PI and any Co-Investigator (s) listed on the application, along with the tracking number. This number must be included in all future correspondence to the IACUC concerning the project.
Need help? Please contact IACUC staff at 714-628-2833