IACUC Protocol Review and Requirements
Number: IACUC-POL-003
Responsible Office: Office of Research and Creative Scholarship (ORCS)
Applies to: All research, teaching, and testing activities involving vertebrate animals conducted under the auspices of The 91次元, regardless of funding source or location.
1. Purpose
This policy establishes the procedures and regulatory framework for the review, approval, and oversight of animal use protocols by the Institutional Animal Care and Use Committee (IACUC) in accordance with federal regulations and institutional standards.
2. 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 91次元-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.
All activities involving the use of live vertebrate animals must be reviewed and approved by the IACUC prior to initiation. The IACUC is responsible for ensuring that all animal use protocols comply with applicable regulations, ethical standards, and institutional policies.
All protocols must undergo preliminary review by the IACUC Manager and the Attending Veterinarian (AV). Protocols will be returned to the Principal Investigator (PI) with comments for revision as necessary until deemed complete and ready for committee consideration. To be placed on a meeting agenda, protocols must complete preliminary review no later than ten business days prior to the scheduled meeting. The IACUC Chair may authorize shorter submission timelines at their discretion.
3. Types of Reviews
- Full Committee Review (FCR): New protocols, De Novo submissions (3-year renewals), and Category E protocols, as well as any submissions for which an IACUC member has requested Full Committee Review (FCR) during a Designated Member Review (DMR), are reviewed at the convened monthly IACUC meeting. Common activities that typically require review in this setting include: Procedures involving unrelieved pain or distress, multiple survival surgeries, the use of non-pharmaceutical-grade substances, new and de novo submissions. Approval requires a majority vote.
- Designated Member Review (DMR): The Designated Member Review (DMR) process may be used for protocol reviews and amendments when Full Committee Review (FCR) is not required. DMR can only proceed after all IACUC members have received sufficient information about the proposed activity and have been given the opportunity to request FCR. Committee members are given five (5) business days to review the submission and request changes or call for FCR. If no member requests FCR within this period, the IACUC Chair may assign one or more qualified members to serve as designated reviewers. The assigned reviewer will evaluate the protocol and may request modifications from the Principal Investigator (PI) as needed. The protocol may go through multiple rounds of revision until the reviewer determines it meets all requirements for approval. To maintain the integrity of the review process, the identity of designated reviewers remains confidential. All reviewer comments and communications with the PI will be coordinated through the IACUC office.
- Veterinary Verification and Consultation (VVC): Specific significant changes that do not unduly impact animal welfare or alter study objectives may be handled administratively in consultation with UMs AV. The veterinarian is not conducting Designated Member Review, but is serving as a subject matter expert to verify that the proposed change is consistent with all applicable IACUC approved policies and is appropriate for the species. Examples of eligible changes include anesthesia agents, analgesics, euthanasia methods or housing. Please refer to the VVC policy for more information.
- Observational Studies: Studies that are purely observational—i.e., those involving no manipulation, interaction, or interference with animals—are typically exempt from review under the Public Health Service (PHS) Policy and the Animal Welfare Act (AWA). However, they require IACUC review and are still subject to institutional oversight. Following submission, the IACUC Manager and Attending Veterinarian will perform a Pre-Review. Afterward, the IACUC Committee is given 5 business days during which all committee members are invited to review the protocol and/or any requested changes. The protocol will be returned to the Principal Investigator (PI) for modifications as many times as necessary until the IACUC Committee is satisfied. Once this review process is complete, the IACUC Manager will administratively approve the protocol and notify the PI of the approval.
IACUC Protocol Review Process
PI submits protocol or amendment -> Stage 1: Review completed by IACUC office -> Stage 2: IACUC Committee Review
| Committee Comments | No Comments |
|---|---|
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4. Protocol Submission Requirements
Each protocol must include:
- Scientific justification for the use of animals
- Justification for the species and number of animals requested
- Detailed description of procedures (including anesthesia, analgesia, euthanasia)
- Description of alternatives to potentially painful procedures
- Description and implementation of the 3Rs
- Assurance of personnel qualifications and training
- Description of endpoints and criteria for humane intervention
5. Review Frequency
- A new protocol must be submitted, reviewed and approved by the IACUC at least once every three years (De Novo review).
- Annual continuing reviews and progress reports are required for each approved protocol.
6. Modification to Approved Protocols
All changes to approved protocols must be submitted for review before implementation. Modifications are categorized as:
- Significant Changes – Require FCR or DMR (e.g., changes in species, objectives, or procedures causing more than momentary pain, change in PI, change in protocol title).
- Specific significant changes that do not unduly impact animal welfare or alter study objectives - May be eligible for VVC.
- Minor Changes – May be eligible for administrative review (e.g., adding or removing personnel, increase in animal numbers if less than 10% of the approved total, modifications to funding.
7. Suspension of Protocols
- 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. An emergency IACUC meeting can be called to discuss a proposed suspension in a timely manner.
- Immediately following a suspension, the IACUC Chair or his/her designee will contact OLAW to describe the circumstances of the suspension.
- Immediately after IACUC suspension of an 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) the 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 an AUP activity.
8. Record Keeping
All protocol-related documents (initial submissions, modifications, correspondence, minutes, etc.) will be maintained for at least three years after protocol expiration or termination, in accordance with regulatory requirements.
9. Appeals and Disputes
Investigators may appeal IACUC decisions by submitting a written justification to the IACUC Chair. The IACUC will reconsider the decision at a subsequent meeting. The final decision rests with the IACUC and cannot be overturned by Institutional Official (per PHS Policy IV.C.8).
10. Training and Guidance
Investigators and research personnel must complete mandatory training on animal care, use, and regulatory requirements before working with animals. The IACUC office provides consultation and resources to assist investigators with protocol development and compliance.
11. References
- Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare (OLAW)
- Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR), United States Department of Agriculture (USDA)
- Guide for the Care and Use of Laboratory Animals, 8th Edition, National Research Council
- 9 CFR Parts 1–3, USDA Animal and Plant Health Inspection Service (APHIS)
- Health Research Extension Act of 1985
12. Review, Approval and Version History
|
Version |
Date |
Description of Changes |
Approved By |
|---|---|---|---|
|
1.0 |
June 26, 2007 |
Initial policy creation |
IACUC Committee |
|
2.0 |
September 13, 2017 |
Review |
Heivilin |
|
3.0 |
July 10, 2025 |
Review and rewrite |
Hicks |