Pilot Study Modification Request Application
University of California, Irvine
Institutional Animal Care and Use Committee
IACUC #:
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.
The following criteria must be met in order for the pilot study request to undergo Designated Review:
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 fullyupdated 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 IACUC@uci.edu. This must be submitted
within 6 months from the approval date of the pilot study.
Changes must not be implemented until IACUC approval is granted.
UCI Institutional Animal Care and Use Committee
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IACUC Pilot Study Application
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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
List relevant
sections in
protocol narrative:
Procedures
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
LR Signature
Date
Faculty Sponsor Signature
Date
List relevant
sections in
protocol narrative:
NOTE: IACUC has granted approval for this pilot study to be performed ONLY on the number of animals indicated above.
IACUC Chair
UCI Institutional Animal Care and Use Committee
Version 3.2
Date
IACUC Pilot Study Application
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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
Version 3.2
IACUC Pilot Study Application
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