Annual Reviews and Expired Animal Protocols

Purpose

In order to comply with both NIH-PHS government regulations that cover all vertebrate animals and USDA government regulations that cover most warm-blooded vertebrate animals, the UConn Health’s Institutional Animal Care and Use Committee (IACUC) has implemented a policy regarding the expiration of protocols and the requirements for annual review.

Action

1. Protocols expire approximately 33 months from the approval date with the requirement that they are reviewed every year. USDA regulations are clear that a review of the protocol must occur “no less than annually” and PHS Policy requires a triennial de novo review every 3 years and subsequent reviews as determined to be necessary by the IACUC.

2. The PI is required to complete an annual review when notified by the IACUC office; this annual review is submitted through TOPAZ.  Modifications to the document may NOT be made during the annual review; the only exceptions are addition/deletion of personnel, addition/deletion of funding sources, and addition/deletions of room locations.

3. If the annual review is not received by the date of the IACUC meeting for the month of the protocol being reviewed, the protocol will be withdrawn. The PI and Center for Comparative Medicine (CCM) will be notified by email. All work on that protocol must cease and no more animals may be ordered. Breeding pairs covered under the expired protocol must be separated.  Once the annual review is submitted and approved by the IACUC, it may be reactivated.

4. All protocols require a new submission approximately every 33 months if the work continues.

5. Email notifications via Topaz are sent to the PI four (4) months prior to the protocol expiration date stating that the protocol is expiring and a new application will be due two (2) months prior to the expiration date.

6. All protocols will be terminated on the expiration date; extensions are not allowed under federal regulations or our PHS Assurance.  If a new replacement protocol has not been approved, all experimental animal use must cease.  Breeding pairs covered under the expired protocol must be separated.

7. A “stop census” in TOPAZ must be performed on the day the protocol expires and animals must be transferred to another active protocol (e.g., the PI’s renewal protocol or the CCM holding protocol). The transferred animals will be counted against the renewal or holding protocol.

Effective Dates:   December 21, 2017 thru November 30, 2020