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 University of Montana, regardless of funding source or location.
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.
Policy
The Institutional Animal Care and Use Committee (IACUC) is responsible for the review, approval, and oversight of all activities (research, teaching, testing and exhibition) involving the use of live vertebrate animals associated with The University of Montana-Missoula, University of Montana-Western, Montana Technological University or conducted by its faculty, staff, students, visitors, or affiliates.
All animal activities must be conducted in accordance with:
- The Animal Welfare Act and Regulations (9 CFR, Chapter I, Subchapter A)
- Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
- The Guide for the Care and Use of Laboratory Animals
- Applicable institutional policies and procedures
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 Office, including 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 (10) business days prior to the scheduled meeting. The IACUC Director or Chair may authorize shorter submission timelines at their discretion.
Definitions
- Full Committee Review (FCR) - Review at a convened meeting with a quorum; outcomes include approve; require modifications to secure approval; or withhold approval.
- Designated Member Review (DMR) - Review by one or more qualified members appointed by the Chair; outcomes include approve, require modifications to secure approval, or refer to FCR; DMR may not withhold approval.
- DMR Subsequent to FCR (DMR/S/FCR) - When the IACUC determines during FCR that modifications are required to secure approval, the revised protocol may be reviewed by designated member review in accordance with OLAW guidance.
- Administrative Review - Minor amendments may include administrative or limited updates that do not significantly impact animal welfare or study objectives. These changes may include typographical corrections, updates to contact information or protocol title, certain personnel or housing location changes, and modest increases in animal numbers (up to 10% of the originally approved total), as well as updates to funding sources.
- Veterinary Verification and Consultation (VVC) (IACUC-POL-014) - Review of certain significant changes handled administratively by the Attending Veterinarian to verify consistency with IACUC-approved policies and procedures.
Types of Reviews
A. Full Committee Review (FCR)
New submissions, De Novo submissions (3-year renewals), as well as any submissions for which an IACUC member has requested FCR during a DMR, are reviewed at a convened IACUC meeting.
Approval requires a majority vote of a quorum of committee members present.
Following FCR, the IACUC may take one of the following actions:
- Approve the protocol
- Require modifications to secure approval
- Withhold approval
If modifications are required to secure approval and not all committee members are present at the meeting, the revised protocol may be reviewed by either:
- Full Committee Review (FCR), or
- Designated Member Review subsequent to Full Committee Review (DMR/S/FCR) as described below.
B. Designated Member Review (DMR)
The Designated Member Review process may be used for protocol reviews and amendments when FCR is not required. All IACUC members must receive sufficient information about the proposed activity and have the opportunity to request FCR. Committee members are given three (3) business days to request FCR. If no member requests FCR within this timeframe is considered silent assent, indicating agreement that the protocol or amendment may be reviewed using the DMR process. If no member requests FCR during this period, the IACUC Chair may assign one or more qualified members to serve as designated reviewers.
Designated reviewers may:
- Approve the protocol
- Require modifications to secure approval
- Refer the protocol to Full Committee Review
Designated reviewers may not withhold approval. If multiple designated reviewers are assigned, approval must be unanimous.
The following submissions are not eligible for DMR:
- New protocols
- De Novo (three-year renewal) submissions
- Amendments involving changes in pain/distress categories (D or E)
- Amendments involving pilot studies
- Amendments involving exceptions to the Guide for the Care and Use of Laboratory Animals, including:
- Prolonged physical restraint
- Food or water restriction
- Social housing exceptions
- Housing outside approved facilities for more than 12 hours
- Deviations from standard husbandry practices
C. Designated Member Review (DMR) Subsequent to Full Committee Review (FCR) (DMR/S/FCR)
In accordance with guidance from the Office of Laboratory Animal Welfare (OLAW) and NOT-OD-09-035, the IACUC may utilize Designated Member Review subsequent to Full Committee Review (DMR/S/FCR) when modifications are required to secure approval.
During a convened meeting with a quorum present, if a majority vote of the quorum present determines that modifications are required to secure approval, the revised protocol item may be reviewed by DMR/S/FCR according to the stipulations below.
If all members of the IACUC are present at the convened meeting:
- The motion must be approved by unanimous vote of all members of the IACUC to have the revised protocol item reviewed and approved by DMR Subsequent to FCR.
If all members of the IACUC are not present at the convened meeting:
- The motion must be approved by unanimous vote of all members present at the meeting at which the modifications are developed/delineated to have the revised protocol item reviewed and approved by DMR Subsequent to FCR,
AND
- All current and newly added members of the IACUC must have previously agreed in writing to the standard process outlined in this policy in which a quorum of members present at a convened meeting may decide by unanimous vote to use DMR Subsequent to FCR when modification is needed to secure approval (see Appendix A).
If the above stipulations are not met, the IACUC may review and approve the revised protocol item following standard FCR or DMR processes. To use DMR in this context, all members of the IACUC, including those absent from the meeting, must have the revised protocol item made available to them, and must have the opportunity to call for FCR. If FCR is requested, then the protocol item must be reviewed by FCR.
D. 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 the University of Montana Attending Veterinarian, in accordance with IACUC approved policy IACUC-POL-014.
Examples include:
- Anesthesia or analgesic changes
- Euthanasia methods
- Housing modifications
The veterinarian serves as a subject matter expert verifying that the proposed change is consistent with IACUC-approved policies and appropriate for the species.
E. Observational Studies
Studies that are purely observational (no manipulation, interaction, or interference with animals) are typically exempt from regulatory review under federal policy but remain subject to institutional oversight.
These protocols undergo:
- Pre-review by the IACUC Office and Attending Veterinarian
- Distribution to the IACUC committee for a three-business-day comment period
Once all concerns are resolved, the protocol may be administratively approved by the IACUC office.
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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Ad Hoc Consultants
The IACUC may invite ad hoc consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC committee.
Conflict of Interest
IACUC members who are the PI or have another potential conflict (spouse, affiliated with the grant, etc.) will be recused from the meeting room during consideration of those protocols and cannot contribute to the constitution of a quorum.
For DMR reviews, IACUC members with a potential conflict will not be assigned to review those protocols.
If a member is inadvertently assigned to a protocol for which they have a conflict of interest, it is their responsibility to notify the IACUC Chair and/or the IACUC Office and recuse themselves from review of that protocol.
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
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.
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 that do not alter the study objectives, do not increase animal pain, distress, or invasiveness - May be eligible for VVC (IACUC-POL-014).
- 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.
Suspension of Protocols
- The IACUC may halt or 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 (IACUC-POL-009) 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.
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.
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).
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.
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
- NOT-OD-09-035 – Guidance to IACUCs Regarding Use of Designated Member Review Subsequent to Full Committee Review.
- Veterinary Verification and Consultation (VVC), IACUC Policy #014
- Reporting Requirements to Regulatory Authorities and Accreditation Agencies, IACUC Policy #009
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 |
|
4.0 |
May 12, 2026 |
Addition of DMR/S/FCR and change in review period for DMR |
IACUC Committee |