Date Adopted: June 26, 2007Last Review Date: September 11, 2020
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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 2. Approved AUPs are subject to Institutional Animal Care and Use Committee 3. The PI will be notified of any request for full committee review and allowed and B. Animal Use Protocol Application 1. The AUP application is an official document sanctioned by the IACUC. ensure compliance with regulatory requirements. 3. There are 3 different Animal Use Protocols to choose from depending upon the a. Laboratory Animal Use Protocol: use for any laboratory-related species b. Wildlife Laboratory Animal Use Protocol: use for wildlife field studies. c. Wildlife Observational Animal Use Protocol: use for wildlife field studies 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 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 welfare issues for consideration c. AUP availability to IACUC 1) 5 business days for review; IACUC Coordinator emails the AUP to the 2) Any committee member may request a full IACUC review at any step 3) All E category protocols automatically receive full committee review 4) All protocols involving major survival surgery in
USDA-regulated a) Major survival surgery is defined in the Guide as a surgery that 5) A quorum of the IACUC must recommend the protocol for 6) IACUC Coordinator maintains a list of committee members 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 3) IACUC Coordinator maintains a list of designated reviewers used for 4)
Designated reviewers may approve, approve with modifications, or 5) Approved protocols receive final approval number from IACUC 6) Approval letter from IACUC Coordinator and approved AUP are sent a . Submission to the
IACUC Coordinator and veterinary review as described b. Any submitted AUP may be reviewed at a committee meeting as a 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 fromthe date of submission d. All E category protocols will receive full committee review e. All protocols involving major survival surgery in UDSA-regulated animals f. At the request of a full committee review, the AUP is added to the provided the meeting isscheduled 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 h. A quorum of the committee must be present, and a majority vote is i. Approved protocols receive final approval number from IACUC j. Approval letter from IACUC Coordinator and the approved AUP are sent 3. DMR to review an
AUP subsequent to FCR when modifications are needed to a. If substantial modifications to an AUP are recommended during FCR, the to request FCR and none have D. Amendments 1. Amendments are submitted to the IACUC Coordinator on an IACUC AUP 2. Significant amendments are reviewed and approved by the IACUC (DMR or a. Such significant amendments include: 1) Change from nonsurvival to
survival surgery b. Upon approval by the IACUC, the IACUC Coordinator
incorporates the date , and sends the amended AUP plus a cover letter to the PIc . Approved major amendments are reported at the next IACUC meeting 3. Some significant amendments are reviewed and approved
by Veterinary a. Amendments that can be approved by VVC include: 1) Changes to anesthesia, analgesia, or sedation to referenced drugs 2) Changes in the dosage, timing or route of an experimental substance 3) Changes to experimental substances, including a change in test pharmaceutical grade drug or a change from pharmaceutical
4) Changes in euthanasia to any method approved in the current 5) Changes in duration, frequency, type, or number of approved b. Upon approval by VVC, the IACUC Coordinator incorporates the , and sends the amended AUP plus a cover letter to the PIc . Approved VVC amendments are reported at the next IACUC meeting
a. Such minor changes include: 1) Change in strainof mice or rats used in the same experiment(s) 2) Change in support personnel other than PI (such personnel must be 3) Increase in animal numbers of less than or equal to 10% of like species 4) Correction of grammar 5) Contact information updates b. Upon approval, the IACUC Coordinator incorporates the amendment the amended AUP plus a cover letter to the PIc . 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 necessary , additional reminders are sent at 60 and 30 days b. PIs are informed that a renewal request should be submitted to the sufficient time for approval of any requested amendments c. Additionally, for annual renewal of an AUP involving USDA-regulated before the AUP renewal date. Members have 3 days to review the AUP 2. Process a. Significant changes to AUP 1) The PI requests renewal of the AUP and submits an amendment for 2) Upon approval of the amendment by the IACUC (as described b. Minor changes to AUP 1) The PI requests renewal of the AUP and submits an amendment for 2) Upon approval of the minor amendment, the
IACUC Coordinator 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 d. The IACUC Coordinator provides a report of the
number of renewed F. Suspension of AUP Activity 1. The IACUC may suspend the activity of an approved AUP when necessary to 2. Suspension of AUP activity should be discussed and voted on at a full committee emergency IACUC meeting can be called to discuss a proposed suspension in a 3. Immediately following a suspension, the IACUC Chair or his/her designee will 4. Immediately after IACUC suspension of AUP activity, the IACUC Chair or his/her designeewill inform the IO of the suspension and recommended correctiveactions . 5. The IO must then notify (see Policy on Reporting) appropriate regulatory, 6. The IO does not have the authority to overturn an IACUC suspension
of an AUP G. Recordkeeping 1. Responsibility a. It is the responsibility of the IACUC Coordinator to maintain records and b. Copies of all communications should be saved electronically and in hard 2. Electronic AUP records a. All current and expired AUPs will be
maintained in PI folders on the expiration of the AUPs b. Permits for field work and AUP approvals from other institutions will be c. Basic identifying information and expiration dates on all approved
and Who is authorized to overturn a decision by an IACUC to suspend an activity?Who is authorized to overturn a decision by an IACUC to suspend an activity involving animals? NOBODY; If an IACUC votes to suspend a protocol or animal activity, its decision cannot be overturned by any administrator at the organization (including the Institutional Official).
Which agency approves the use of animals in research?Research institutions are required to establish an Institutional Animal Care and Use Committee (IACUC), which evaluates any proposed experiments. Approval by the IACUC is a prerequisite to receiving federal funding for animal research.
Why are infectious agents and toxins listed as Selectments given additional regulatory oversight CDC quizlet?Because they have potential to be used in biological warfare, select agents are given additional regulatory oversight by the CDC.
What are two principal animal regulatory documents?The PHS Policy and the U.S. Department of Agriculture's (USDA) Animal Welfare Regulations 2, are the two principal federal documents that set forth requirements for animal care and use by institutions using animals in research, testing, and education.
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