Animal Use Protocol

Date adopted: June 26, 2007

Last updated: April 13, 2016

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.

Policy Procedure

A.  Basic Principles 
  • The principal investigator (PI) is the responsible party for all activities included in and related to the animal use protocol (AUP).
  • 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).
  • 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
  • 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.
  • AUP forms are available on the IACUC website
  • There are 3 different Animal Use Protocols to choose from depending upon the type of animal research to be conducted
    • Laboratory Animal Use Protocol: use for any laboratory-related species such as mice, rats, rabbits, guinea pigs, etc.
    • Wildlife Laboratory Animal Use Protocol: use for wildlife field studies.
    • Wildlife Observational Animal Use Protocol: use for wildlife field studies that are observational only and do not require any handling of animals
C.  Review of New Protocols and Triennial Resubmissions
  • Designated member review (DMR) process 
    • Submission to IACUC Coordinator
      • Preliminary number assigned
      • AUP reviewed for completeness
      • AUP formatted for conciseness
      • Animal users listed on AUP added to animal user list and notified of training and occupational health and safety requirements for animal use
    • Veterinary review
      • Principal investigator (PI) asked for clarifications or revisions
      • Drug dosages reviewed
      • 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
    • AUP availability to IACUC
      • 5 business days for review; IACUC Coordinator emails the AUP to the IACUC members.
      • Any committee member may request a full IACUC review
      • A quorum of the IACUC must recommend the protocol for Designated Member review (DMR) before the IACUC Coordinator can forward to DMR
      • IACUC Coordinator maintains a list of committee members responding to each protocol
    • Designated member review
      • 5 business days for designated member review (DMR).
      • The Chair or Vice-Chair assigns a member of the IACUC as the reviewer.
      • IACUC Coordinator maintains a list of designated reviewers used for all AUPs
      • Designated reviewers may approve, recommend revisions, or request a full committee review of the protocol
      • Approved protocols receive final approval number from IACUC Coordinator
      • Approval letter from IACUC Coordinator and approved AUP sent to PI and posted in their folder on the password-protected website.
  •  Full committee review 
    • Submission to the IACUC Coordinator and veterinary review as described above.
    • The AV, any IACUC member, or the Designated reviewer may request a full committee meeting at any step during the DMR process above.
    • All E category protocols will receive full committee review.
    • All protocols involving major survival surgery in UDSA-regulated animals will receive full committee review.
      • Major survival surgery is defined in the Guide as a surgery which "penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions." 
    • 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.
    • AUP PIs may be requested to attend the meeting or to be available by phone to address questions from the IACUC related to animal care and use. The IACUC may offer suggestions to revise the AUP prior to approval.
    • A quorum of the committee must be present, and a majority vote is required for protocol approval.
    • Approved protocols receive final approval number from IACUC Coordinator
    • Approval letter from IACUC Coordinator and the approved AUP are sent to PI and posted in their folder on the password-protected website.
  • DMR to review an AUP subsequent to FCR when modifications are needed to secure approval
    • If all members are not present at the FCR, the committee has the option to vote to return the AUP for FCR at a convened meeting or to employ DMR.  If electing to use DMR, all members, including the members not present at the meeting, must have the revised research protocol available to them and must have the opportunity to call for FCR.  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.  Review of Annual Renewals and Amendments
  • Notification
    • The IACUC Coordinator sends electronic reminders of protocol expirations to PIs 90 days in advance.  If necessary, additional reminders are sent at 60 and 30 days.
    • PIs are informed in reminders that submission of renewal requests must be submitted 60 days before the AUP expiration date to allow sufficient time for AUP review if amendments are included.
  • Review process
    • Significant changes
      • Proceed through protocol review process as for new protocols and triennial resubmissions
      • Administratively approved in consultation with the AV
      • An approval letter is sent to the PI by the IACUC Coordinator
    • Minor changes
      • Administratively approved by the IACUC Coordinator, AV or IACUC Chair
      • An approval letter is sent to the PI by the IACUC Coordinator.
    • IACUC Coordinator provides a brief report of the number of renewed protocols at each IACUC meeting.
  • Significant changes handled by the IACUC (DMR or FCR)
    • Change from nonsurvival to survival surgery
    • Changes resulting in greater pain, distress, or degree of invasiveness
    • Changes in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC
    • Changes in species
    • Changes in study objectives
    • Changes in Principal Investigator
    • Changes that impact personnel safety
  • Significant changes handled administratively by Attending Veterinarian
    • Change in anesthesia,k analgesia, sedation, or experimental substances
    • Changes in euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals
    • Changes in duration, frequency, type of number of procedures performed on an animal
  • Minor changes
    • Change in strain of mice or rats used in the same experiment(s)
    • Change in support personnel other than PI (such personnel must be adequately trained and qualified)
    • Addition/substitution of new non-invasive procedure for same experiment(s)
    • Increase in animal numbers of less than or equal to 10% of like species listed in protocol
    • Correction of grammar
    • Contact information updates
E.  Suspension of AUP Activity
  • The IACUC may suspend the activity of an approved AUP when necessary to ensure animal welfare.
  • 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.
  • Recommended corrective action should be outlined by the IACUC for recommendation to the IO
  • 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.
  • The IO must then notify (see Policy on Reporting) appropriate regulatory, accrediting and funding agencies of the suspension and corrective actions taken.
  • The IO does not have the authority to overturn an IACUC suspension of AUP activity.
F.  Recordkeeping
  • Responsibility
    • It is the responsibility of the IACUC Coordinator to maintain records and official communications concerning protocol renewals with PIs
    • Copies of all communications should be saved electronically and in hard copy form
  • Electronic AUP records
    • 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
    • Permits for field work and AUP approvals from other institutions will be embedded into current AUPs or maintained in the PI folder
    • 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.