This is a guide that will take you through all of the steps an Institutional Animal
Care and Use Committee (IACUC) protocol takes from submission to approval to termination.
NOTE: ALL communications regarding IACUC protocols are directly with the responsible
Primary Investigator (PI). The PI may set up an Outlook inbox rule to automatically
forward communications to the proper people in their lab; however, all return communications
must come directly from the PI in order to be considered valid by the committee.
- Submit protocol by the second Wednesday of the month PRIOR to meeting (for example,
if you would like your protocol reviewed at the 12/10/14 meeting, the deadline for
submitting would be 11/12/14).
- The IACUC encourages all PI’s to consult with the Department of Laboratory Animal
Research (DLAR) during the planning phases of all animal use protocols. DLAR consultation
is REQUIRED before protocols involving USDA-regulated animals will be accepted for
- Protocol PI’s must be UT Faculty members (not students, post docs, volunteers, adjunct
- Forms can be downloaded at www.utoledo.edu/research/forms.html. Protocol form requires Adobe Acrobat Reader Version 9 or later, or Adobe Acrobat
Professional Version 8 or later.
- Email one saved Adobe form to the IACUC Administrator, Monika DeGregorio (Monika.DeGregorio@utoledo.edu). Please note:
The IACUC meets to review protocols on the second Wednesday of the month.
- Protocols must be mailed from PI’s UT-issued email address.
- It is advised that you use Outlook’s “Read Receipt requested” feature to serve as
proof that the protocol was received on time.
- Protocol review - One of the following outcomes is applied to the protocol at the
NOTE: To avoid unnecessary approval delays, if the PI is uncertain about acceptable
procedures, or does not fully comprehend the context of a question on the form, they
should contact the IACUC office, an IACUC committee member, or the Attending Veterinarian’s
office for clarifications or assistance.
- Protocol is signed by Committee chair and work can begin immediately.
- Modifications are required to secure approval
- Memo is emailed to the PI indicating that the protocol requires modifications before
it can be approved.
- Depending on the extent and subject matter of the requested modifications, the revised
protocol will be re-reviewed via:
- Full Committee Review
- After submission the revised protocol will be reviewed by the committee at the next
regular IACUC meeting
- Minimum time before protocol approval – 1 month
- Designated Member Review
- AV, Committee Chair, and/or Chair-appointed reviewers work with the PI to address
the requested modifications.
- Protocol will be approved after all reviewers are satisfied with the modifications.
- IACUC administrator will send a final electronic copy to the PI to be printed TWICE,
signed, and returned to the IACUC office via campus mail or personal drop off.
- The Committee chair signs the approved protocol, the original is returned to the PI,
and work can begin.
- Deferred or tabled review
- In effect no review has taken place as the committee feels that substantial information
is lacking or unclear making a complete review impossible.
- Common examples include:
- Missing procedural description, such as surgery
- Search for alternative methods incomplete
- Lack of a statistical basis/rationale behind animals numbers
- Memo is emailed to the PI describing the issues that need to be changed or clarified.
Be advised that following review of the re-submitted protocol, the committee is likely
to require modifications that were not part of the initial review attempt.
- PI can request to attend the follow-up IACUC meeting on the second Wednesday of the
following month to directly address the committee and answer and questions the committee
may have, however they will not be able to remain in the room when the committee is
- Approval Withheld
- Protocol is rejected outright and will not be considered by the committee. This would
be due to gross violation of animal welfare regulations or failure to demonstrate
that proposed work can be done at UT while maintaining animal welfare.
NOTE: Animal Welfare regulations expressly forbid higher institutional authority
from overruling an IACUC decision to withhold approval.
- Approved protocols
- Protocol is approved for 1 year from the date of the Committee Chairman's signature.
- Annual renewal paperwork is required for protocol to be re-approved. These forms
will be sent via campus mail 2 months prior to the protocol expiration date.
- If for some reason, the PI has not received the annual renewal paperwork 2 months
prior to expiration of the protocol, it is the PI’s responsibility to contact the
IACUC office to request the forms.
- To avoid problems, it is recommended that upon receipt of an approved protocol the
PI sets up these dates using the calendar reminder feature in Outlook to remind them
these dates are approaching.
- Every 3 years, resubmission and de novo re-review of the complete protocol is required.
Resubmissions must be done on the latest version of the IACUC forms available on the
- Expiring protocols
- As a courtesy, the IACUC office will send out a notice via campus mail prior to expiration
date advising you of the expiration date, and the deadline for resubmission of new
- Ending protocols
- It is the PI’s responsibility to ensure that there are no animals on the protocol
when it expires.
- Renewing protocols
- All protocols must be submitted for a complete de novo review of the whole protocol
every 3 years.
- Renewal protocol must be received by the IACUC office for review 8 weeks prior to
the protocol expiration date. Protocols received after the submission deadline (8
weeks prior to protocol expiration) may not be reviewed by the IACUC in time to avoid
a gap in approval. If a protocol is not renewed in time, it is the PI’s responsibility
to ensure that there are no animals on the protocol when it expires. Department chairs
will be alerted at the deadline as after the protocol expires, all animal-related
charges incurred will be applied to departmental accounts.
- If a protocol expires with animals remaining on the protocol, none of the following
can be avoided:
- As this is considered a major protocol violation, per UT Assurance with the Office
of Laboratory Animal Welfare (OLAW) an IACUC subcommittee will be formed to investigate
the matter. Furthermore, NIH policy requires the Institution to report the matter
to OLAW when the work is NIH-Funded.
- Granting Agency that funds the animal work will be alerted.
- Department Chair will be alerted that the protocol expired.
- As most funding agencies specifically forbid animal-related charges without an approved
IACUC protocol, all animal related charges will be applied to departmental accounts.
- DLAR will take possession of all remaining animals; all scientific manipulations will
be suspended. The ultimate dispensation of the animals will be at the discretion
of the AV.