Animal Care Committee
Approved ACC Policy
Annual Reviews and Expired
Protocols
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Animal Care Committee
Approved ACC Policy |
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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 University of Connecticut Health Center's Animal Care Committee (ACC) has implemented a policy regarding the expiration of protocols and the requirements for annual review.
FOR USDA COVERED SPECIES (All warm-blooded vertebrate animals except mice of the genus Mus and rats of the genus Rattus bred for research purposes and birds):
1. Protocols expire after three years 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".
2. Annual Review Forms are mailed to the Principal Investigator (PI). These forms must be completed and mailed to the ACC coordinator by the 10th of the month that the annual review is scheduled to occur. Due dates for the annual review forms are clearly marked on the forms.
3. If the review form is not received by the date of the ACC meeting for the month of the protocol being reviewed, the protocol will be considered to be suspended. The PI and CLAC will be notified by letter. All work on that protocol must cease and no more animals may be ordered. If breeding must be maintained, the animals must be transferred to the approved renewal protocol, another approved protocol, or the CLAC holding protocol.
4. Suspension of a protocol requires that the USDA, OLAW (NIH), and the funding agency be informed.
FOR PHS COVERED SPECIES (All vertebrate animals):
1. Protocols expire after three years from the approval date with reviews at appropriate intervals as determined by the ACC. PHS requires a triennial de novo review.
2. Annual review of the protocol is required by institutional policy to comply with our PHS assurance document. Annual review forms are mailed to the PI which must be filled out and returned to the ACC coordinator by the 10th of the month on that the annual review is scheduled to occur. Due dates for the annual review forms are clearly marked on the forms.
3. If the review form is not received by the date of the ACC meeting for the month of the protocol being reviewed, a one month grace period will be given to the PI to submit the completed annual review form. IF the review form is not received by the second month, the protocol will be suspended. The PI and CLAC will be notified by letter. All work on that protocol must cease and no more animals may be ordered. If breeding must be maintained, the animals must be transferred to the approved renewal protocol, another approved protocol, or the CLAC holding protocol.
4. Suspension of a protocol requires that OLAW (NIH) and the funding agency be informed.
FOR ALL ANIMALS:
1. All protocols require a new submission every 3 years.
2. Letters 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. For example, for a protocol that is expiring on 5/20/10, the PI will be mailed an expiration letter on 1/2/10 stating that a new animal care and use protocol application will be due on 3/10/10.
3. All protocols will be terminated on the expiration date and EXTENSIONS ARE NOT ALLOWED UNDER FEDERAL REGULATIONS OR OUR PHS ASSURANCE DOCUMENT. If a new replacement protocol has not been approved, all experimental animal use must cease. If breeding must be maintained, the animals must be transferred to the approved renewal protocol, another approved protocol, or the CLAC holding protocol.
4. A "stop census" in Granite 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, another appropriate approved protocol, or the CLAC holding protocol). The transferred animals will be countered against the protocol the animals were placed on.
Effective Dates: March 29, 2007 thru March 28, 2010
This policy has been approved by a majority vote of the Animal Care Committee
Members
Joseph Lorenzo, M.D., Chair, Animal Care Committee