University of California, Irvine
Institutional Animal Care and Use Committee / Pilot Study #:
Level of Review: / Designated Review
For Office Use Only
Protocol #:
Lead Researcher:
This form is to be used ONLY for small trials, pilot or feasibility studies that will not be added as a permanent part of your approved protocol if unsuccessful. The IACUC may allow Designated Member Review for such preliminary studies which would otherwise require full committee review, including fundamental changes in the original protocol’s scope of work. See pilot study guidelines for more information and examples.
1. Researcher must have an active IACUC protocol with similar focus or aims that has undergone full committee review and approval.
2. Research team must have demonstrated proficiency in procedures similar to those requested for the pilot study.
3. Procedures associated with this pilot study may only be performed on the animals specifically approved for the pilot study. (Please see below for additional requirements needed upon completion of the pilot study)
4. Pilot studies may request only a minimal number of animals (e.g., 10 rodents, 1-2 of the larger species), that is consistent with the approved group size in the active protocol.
NOTE: It is not necessary to submit an updated protocol narrative with this request. Instead, reference the applicable sections of your existing protocol below.
Requirements for Completion of Pilot Study:
· If you wish to continue the new procedures, you must submit either a new, stand-alone protocol or a formal modification request for full committee review and approval. (Formal modification request must include a fully-updated protocol narrative - see modification submission instructions). Data collected during the pilot study must be reported as a part of this formal submission.
Additional trials associated with the pilot study may not be performed until the IACUC has reviewed and approved the formal modification or new protocol.
· Complete and submit the Pilot Study Follow-Up Report and send to . This must be submitted within 6 months from the approval date of the pilot study.
Place an X in the checkboxes to indicate the changes being proposed and briefly describe the change.
Animals / List / List relevant sections in protocol narrative:Add new species or strain:
# of animals from currently approved allocation to be used for pilot project:
# of animals being added to be used for pilot project
Procedures / List relevant sections in protocol narrative:
New procedure / Briefly describe below:
New experimental/therapeutic agent: / Briefly describe below:
Change in currently approved procedures: / Briefly describe below:
Other Changes (list below) / Briefly describe / List relevant sections in protocol narrative:
LR Signature / Date
Faculty Sponsor Signature / Date
NOTE: IACUC has granted approval for this pilot study to be performed ONLY on the number of animals indicated above.
IACUC Chair / Date
Pilot Study Modification Descriptive Summary
For each modification:
· Provide a summary explaining the details of the pilot study.
· Include the rationale for why this is appropriate for the protocol
· List the relevant sections in the protocol narrative that would apply to this particular pilot study.
MODIFICATION SUMMARY BELOW
UCI Institutional Animal Care and Use Committee IACUC Pilot Study Application
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