Date Adopted: June 26, 2007

Last Review Date: September 11, 2020

I.  Policy

The Institutional Animal Care and Use Committee (IACUC) is responsible for the review and approval of all animal care and use associated with The University of Montana-Missoula or conducted by its faculty, staff, students, visitors, or affiliates. The IACUC has the authority to suspend activities involving animals if the activities are not in compliance with federal regulations, such as the Animal Welfare Act, deviate from the approved protocol, or occur in the absence of an approved protocol. Suspensions of activity will be promptly reported to the funding agency and appropriate regulatory agencies.

II.  Policy Procedure

A.  Basic Principles 

1.  The principal investigator (PI) is the responsible party for all activities included in
     and related to the animal use protocol (AUP).

2.  Approved AUPs are subject to Institutional Animal Care and Use Committee
     (IACUC) full committee review at any time at the request of an IACUC member,
     the Attending Veterinarian (AV) or the Institutional Official (IO).

3.  The PI will be notified of any request for full committee review and allowed and
     encouraged to attend the meeting or to send a representative.

B.  Animal Use Protocol Application

1.  The AUP application is an official document sanctioned by the IACUC.
     Modifications of the form must be reviewed and approved by the IACUC to
     ensure compliance with regulatory requirements.

2.  AUP forms are available at umt.edu/research/compliance/IACUC/default.php

3.  There are 3 different Animal Use Protocols to choose from depending upon the
     type of animal research to be conducted

a.  Laboratory Animal Use Protocol: use for any laboratory-related species
      such as mice, rats, rabbits, guinea pigs, etc.

b.  Wildlife Laboratory Animal Use Protocol: use for wildlife field studies.

c.  Wildlife Observational Animal Use Protocol: use for wildlife field studies
     that are observational only and do not require any handling of animals

C.  New Protocols and Triennial Resubmissions

1.  Designated member review (DMR) process 

a.  Submission to IACUC Coordinator

1)  Preliminary number assigned

2)  AUP reviewed for completeness

3)  AUP formatted for conciseness

4)  Animal users listed on AUP added to the animal user list and notified of
     training and occupational health and safety requirements for animal
     use

b.  Veterinary review

1)  The Principal Investigator (PI) asked for clarifications or revisions

2)  Drug dosages reviewed

3)  Appropriate animal handling procedures are reviewed

4)  AUP sent to IACUC Coordinator for distribution to the IACUC with a
     brief explanation of the proposed work and any potential animal
     welfare issues for consideration

c.  AUP availability to IACUC

1)  5 business days for review; IACUC Coordinator emails the AUP to the
      IACUC members.

2)  Any committee member may request a full IACUC review at any step
     during the approval process

3)  All E category protocols automatically receive full committee review
     (FCR)

4)  All protocols involving major survival surgery in USDA-regulated
     species will receive FCR

a)  Major survival surgery is defined in the Guide as a surgery that
      “penetrates and exposes a body cavity or produces substantial
      impairment of physical or physiologic functions."

5)  A quorum of the IACUC must recommend the protocol for
     Designated Member Review (DMR) before the IACUC Coordinator
     can forward to DMR

6)  IACUC Coordinator maintains a list of committee members
     responding to each protocol

d.  Designated member review

1)  5 business days for designated member review (DMR).

2)  The Chair or Vice-Chair assigns a member of the IACUC as the
     reviewer.

3)  IACUC Coordinator maintains a list of designated reviewers used for
     all AUPs

4)  Designated reviewers may approve, approve with modifications, or
     request a full committee review of the protocol

5)  Approved protocols receive final approval number from IACUC
     Coordinator

6)  Approval letter from IACUC Coordinator and approved AUP are sent
     to PI and posted in their folder on the password-protected website.

 2.  Full committee review 

a.  Submission to the IACUC Coordinator and veterinary review as described
     above.

b.  Any submitted AUP may be reviewed at a committee meeting as a
     “timely review”.

c.  For FCR, the AUP is added to the agenda for the next full committee
      meeting, provided the meeting is scheduled for not less than 1 week from
      the date of submission

d.   All E category protocols will receive full committee review

e.   All protocols involving major survival surgery in UDSA-regulated animals
      will receive full committee review

f.   At the request of a full committee review, the AUP is added to the 
     agenda for the next full committee meeting, provided the meeting is
     scheduled for not less than 1 week from the date of request.

g.  PIs with AUPs being reviewed are invited to attend the meeting if possible
     to address questions from the IACUC related to animal care and use. The
     IACUC may offer suggestions to revise the AUP prior to approval

h.  A quorum of the committee must be present, and a majority vote is
     required for protocol approval

 i.  Approved protocols receive final approval number from IACUC
     Coordinator

 j.  Approval letter from IACUC Coordinator and the approved AUP are sent
    to PI and posted in their folder on the password-protected website

3.  DMR to review an AUP subsequent to FCR when modifications are needed to
     secure approval

a.  If substantial modifications to an AUP are recommended during FCR, the 
     committee has the option to return the modified AUP for FCR at a convened 
     meeting or to employ DMR.  A DMR may be conducted only if all members of
     the committee have had the opportunity to request FCR and none have
     done so.

D.  Amendments 

1.  Amendments are submitted to the IACUC Coordinator on an IACUC AUP
     Amendment Form

2.  Significant amendments are reviewed and approved by the IACUC (DMR or
     FCR as described above)

a.  Such significant amendments include:

1)  Change from nonsurvival to survival surgery
2)  Changes resulting in greater pain, distress, or degree of invasiveness
3)  Changes in housing and or use of animals in a location that is not part
      of the animal program overseen by the IACUC
4)  Changes in species
5)  Changes in study objectives
6)  Changes in Principal Investigator
7)  Changes that impact personnel safety

b.  Upon approval by the IACUC, the IACUC Coordinator incorporates the
      amendment into the AUP with a notation of the amendment approval
      date, and sends the amended AUP plus a cover letter to the PI

c.  Approved major amendments are reported at the next IACUC meeting

3.  Some significant amendments are reviewed and approved by Veterinary
     Verification and Consultation (VVC).  (See VVC policy)

a.  Amendments that can be approved by VVC include:

1)  Changes to anesthesia, analgesia, or sedation to referenced drugs
      and dosages for a given species listed

2)  Changes in the dosage, timing or route of an experimental substance
      if the change will not increase the potential for animal pain or distress

3)  Changes to experimental substances, including a change in test
      compound, dose, or route of administration, as long as the changes
      does not result in a change in study objectives or greater pain,
      distress, or degrees of invasiveness (note that the addition of a non  
      pharmaceutical grade drug or a change from pharmaceutical
      grade to a non-pharmaceutical grade drug requires additional
      justification and will not be authorized under this mechanism)

4)  Changes in euthanasia to any method approved in the current
      AVMA Guidelines

5)  Changes in duration, frequency, type, or number of approved
      procedures performed on an animal, as long as the change does not
      result in greater pain, distress, or degree of invasiveness.  The AV may
      use his/her discretion to authorize minor procedural changes to
      previously IACUC-approved AUP’s providing, in the judgment of the
      Attending Veterinarian, the change will not unduly impact animal
      welfare (i.e., lessens or involves equivalent pain, acute or chronic 
      stress, distress or effects upon animal welfare) and is consistent with
      current standards of veterinary practice or specifically addressed in
      IACUC policy

b.  Upon approval by VVC, the IACUC Coordinator incorporates the 
      amendment into the AUP with a notation of the amendment approval 
      date, and sends the amended AUP plus a cover letter to the PI

c.  Approved VVC amendments are reported at the next IACUC meeting

4.  Minor amendments are reviewed and approved by the IACUC Coordinator

a.  Such minor changes include:

1)  Change in strain of mice or rats used in the same experiment(s)

2)  Change in support personnel other than PI (such personnel must be
     adequately trained and qualified)

3)  Increase in animal numbers of less than or equal to 10% of like species
     listed in the protocol

4)  Correction of grammar

5)  Contact information updates

b.  Upon approval, the IACUC Coordinator incorporates the amendment
      into the AUP with a notation of the amendment approval date and sends
      the amended AUP plus a cover letter to the PI

c.  Approved minor amendments are reported at the next IACUC meeting

E.  Annual Reviews and Renewals

1.  Notifications

a.  The IACUC Coordinator ends electronic reminders for a protocol
      review/renewal to PIs 90 days in advance of the renewal date.  If
      necessary, additional reminders are sent at 60 and 30 days

b.  PIs are informed that a renewal request should be submitted to the
      IACUC Coordinator 30 days before the AUP renewal date to allow
      sufficient time for approval of any requested amendments

c.  Additionally, for annual renewal of an AUP involving USDA-regulated
     species, all IACUC members are emailed a review/renewal notice 90 days
     before the AUP renewal date.  Members have 3 days to review the AUP
     and make any suggestions for amendments. Any such suggestions are
     emailed to the PI by the IACUC Coordinator

2.  Process

a.  Significant changes to AUP

1)  The PI requests renewal of the AUP and submits an amendment for
     significant changes to the AUP to the IACUC Coordinator as
     described above

2)  Upon approval of the amendment by the IACUC (as described
     above), the IACUC Coordinator renews the AUP and sends a letter to
     the PI stating that the amendment has been approved and the AUP
     has been renewed

b.  Minor changes to AUP

1) The PI requests renewal of the AUP and submits an amendment for
     minor changes to the AUP to the IACUC Coordinator as described
     above

2)  Upon approval of the minor amendment, the IACUC Coordinator
     renews the AUP and sends a letter to the PI stating that the
     amendment has been approved and the AUP has been renewed

c.  No changes to AUP

1)  The PI requests renewal of the AUP without changes

2)  The IACUC Coordinator renews the AUP and sends a letter to the PI
      stating that the AUP has been renewed

d.  The IACUC Coordinator provides a report of the number of renewed
      protocols at the next IACUC meeting

F.  Suspension of AUP Activity

1.  The IACUC may suspend the activity of an approved AUP when necessary to
     ensure animal welfare.

2.  Suspension of AUP activity should be discussed and voted on at a full committee
     meeting and requires a majority vote of a quorum of the committee. An
     emergency IACUC meeting can be called to discuss a proposed suspension in a
     timely manner.

3.  Immediately following a suspension, the IACUC Chair or his/her designee will
     contact OLAW to describe the circumstances of the suspension

4.  Immediately after IACUC suspension of AUP activity, the IACUC Chair or his/her
     designee will inform the IO of the suspension and recommended corrective
     actions.

5.  The IO must then notify (see Policy on Reporting) appropriate regulatory,
     accrediting and funding agencies of the suspension and corrective actions
     taken

6.  The IO does not have the authority to overturn an IACUC suspension of an AUP
     activity.

G.  Recordkeeping

1.  Responsibility

a.  It is the responsibility of the IACUC Coordinator to maintain records and
     official communications concerning protocol renewals with PIs

b.  Copies of all communications should be saved electronically and in hard
     copy form

2.  Electronic AUP records

a.  All current and expired AUPs will be maintained in PI folders on the
     password-protected IACUC website for a minimum of 3 years after
     expiration of the AUPs

b.  Permits for field work and AUP approvals from other institutions will be
     embedded into current AUPs or maintained in the PI folder

c.  Basic identifying information and expiration dates on all approved and
     renewed AUPs will be inserted into a spreadsheet that will be maintained
     on the IACUC website.