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Annual Review and Three-Year Renewal

Annual Review

Three Year Renewal


Background

USDA Animal Welfare Regulations require that the IACUC conduct continuing reviews of activities involving live animals not less often than once per year. The Public Health Service Policy requires that the IACUC conduct a complete review of all previously-approved ongoing activities at least once every three years.
 
UCI’s IACUC complies with these requirements by:
  • Allowing two annual reviews that are performed by the IACUC (either administratively or by full committee depending on species) on the first and second anniversary of the original approval, and
  • Complete resubmission of the protocol for full committee review every three years.

Reporting Animal Numbers

A common element of both the Annual Review and Three-Year Renewal is the reporting of animal numbers.  While all animals purchased through routine ULAR purchasing procedures are automatically deducted from a protocol's approved allocation, researchers are required to self-report all other animals, such as:
  • Animals produced in UCI breeding colonies
  • Offspring of animals purchased as pregnant dams or dams-with-litter
  • Exotic animals (e.g., reptiles caught in the wild or procured from non-traditional sources)

Ideally, researchers should be maintaining internal lab records that keep track of the above types of animal numbers that require self-reporting.
 
Animal usage numbers are required by both annual review and three-year renewal.  If the number of animals reported at either of these submissions does not agree with the number of animals shown as "used" in the animal use database, the numbers in the database will be adjusted accordingly. 

*COMING SOON:  A new way to report animals online via RMS will be available in the future. In the meantime, the IACUC recommends that labs keep track of your animal numbers internally.


Annual Review

Annual reviews must be submitted by the IACUC before the first and second anniversary of the original IACUC-approved protocol. The Annual Review serves as an progress report, and provides the researcher with an opportunity to update animal usage and report adverse events and refinements to the original experimental design. The Principal Investigator and lab staff listed in the "Co-investigator/Senior Researcher" and "Research Personnel" categories of the Personnel Tab in RMS will receive an auto-generated reminder memo via email approximately 60 days  and then 30 days prior to the anniversary date.
The review must be received by the IACUC Administrative Office at least two weeks prior to the anniversary date to allow sufficient time for administrative review or discussion by the IACUC.
  • Annual reviews of protocols that use USDA-covered species are discussed at the IACUC full committee meetings. All other annual reviews that do not use USDA-covered species are processed administratively.

    USDA-covered species include:
    • Peromyscus Mouse
    • Hamster
    • Guinea Pig
    • Rabbit
    • Cat
    • Sheep
    • Pig
    • ...and other warm-blooded vertebrate animals! (EXCLUDES mice and rats purposely bred for research)

      Unsure if you use USDA-covered species? Email IACUC@uci.edu for assistance.
        
       
  • Annual reviews must be completed online via the Research Management System (RMS) - See online guidance for Annual Review Submissions and completing the Annual Review Tab in RMS
     
  • Failure to submit Annual Review may result in closure of your protocol.  Any remaining animals under a closed protocol will be placed on the ULAR Holding Protocol and are off limits to investigators and research personnel.  No experimental use or observation of animals may take place during a protocol lapse period – failure to act in accordance with this restriction will be handled as regulatory noncompliance.

Three-Year Renewal

All animal use protocols must be submitted for full committee review at a convened meeting of the IACUC every three years.
 
This review is sometimes called a de novo review because the protocol receives the same scrutiny by the committee as if it were a brand-new submission. Principal Investigators should not assume that their three-year renewal protocol will automatically receive approval, even if the submission is exactly the same as that of the previously approved cycle; many factors may have changed since the last full committee review, including federal animal welfare regulations, societal expectations, and the composition of the committee.  

Alll Three-Year Renewal submissions require full committee review at a convened meeting of the IACUC, and must be submitted by published deadlines - see our online Committee Calendar for submission deadlines and meeting dates. Researchers are responsible for determining the best meeting date for review of their protocol to avoid delays that could lead to a lapse in approval.

  • The Principal Investigator and lab staff listed in the "Co-investigator/Senior Researcher" and "Research Personnel" categories of the Personnel Tab in RMS will receive an auto-generated three-year reminder memo via email approximately 90 days prior to the anniversary date, with a follow up reminder 60 days before the protocol is due to expire.  

  • Researchers should keep in mind that the IACUC meets only once per month; three-year renewal submissions should be submitted for review at the meeting that occurs in the month prior to the original protocol expiration (e.g., protocols expiring in June should be submitted for review at the May IACUC meeting).

A protocol will expire on its expiration date if a three-year renewal application has not been reviewed and approved by the IACUC. During the lapse in approval, animals are placed on the ULAR holding protocol and are off limits to investigators and research personnel. No experimental use or observation of animals may take place during a protocol lapse period – failure to act in accordance with this restriction will be handled as regulatory noncompliance. Per federal regulations and UCI’s Animal Welfare Assurance, there are no exceptions and no extensions of approval granted by the IACUC.

Important Reminders about 3-year renewals:

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