Guidance on Activities That Require IACUC Approval
Number: IACUC-GUID-001
Responsible Office: Office of Research and Creative Scholarship (ORCS)
Applies to: Principal Investigators Conducting Animal Research
1. Purpose
The purpose of this guidance is to help investigators determine when their work requires review and approval by the Institutional Animal Care and Use Committee (IACUC). This ensures that all activities involving live vertebrate animals conducted under the 91次元’s oversight are ethical, scientifically justified, and compliant with federal, state, and institutional requirements.
2. Background
The 91次元 is obligated to follow:
- Public Health Service (PHS) Policy
- USDA Animal Welfare Regulations
- The Guide for the Care and Use of Laboratory Animals
- Institutional Animal Welfare Assurance
- AAALAC International
These directives require the IACUC to review, approve, and oversee any activity involving live vertebrate animals used in research, teaching, testing, or training. No animal work may begin until an Animal Use Protocol (AUP) has been reviewed and approved by the IACUC.
Failure to obtain IACUC approval before starting animal activities is considered noncompliance and may result in:
- Suspension of activities,
- Reporting to federal agencies,
- Loss of funding,
- Institutional sanctions
3. Activities Requiring IACUC Review and Approval
Lab Animal Research
All use of animals in educational or training settings at the 91次元 requires IACUC approval. This includes activities such as teaching animal handling, husbandry, or research techniques. Approval is needed even if the project is not intended for publication, will not advance another research goal, or does not contribute to generalizable knowledge. The Institutional Animal Care and Use Committee (IACUC) oversees all animal care and use activities conducted by UM faculty, staff, students, visitors, and affiliates—including those at UM Western and Montana Tech.
Wildlife Research and Field Studies
The IACUC requires submission of a Wildlife Animal Use Protocol for any study involving wild animals in their natural habitat if the procedures may cause harm or significantly alter the animals’ behavior. This includes activities such as trapping, capturing, physically or chemically restraining animals, and performing invasive procedures that may cause stress—such as temporarily removing animals from nests or habitats.
Observational Studies
If field studies are purely observational and do not involve capture, handling, or invasive procedures, an Observational Wildlife Animal Use Protocol must be submitted for IACUC review. These types of studies must not involve any activity that harms or disrupts the animals' normal behavior.
Use of Animal Tissues or Naturally Shed Materials
91次元 faculty may use animal tissues obtained from other investigators with an approved Animal Use Protocol (AUP), or collect naturally shed materials such as hair, feathers, antlers, or feces. To qualify for use, these samples must not come from animals that were manipulated, altered, or euthanized specifically for proposed research.
Privately Owned Animals used in Teaching, Research or Exhibition
Privately owned animals used in research, teaching, clinical trials, or exhibitions are subject to the same IACUC review requirements as institution-owned animals. This includes compliance with both the Public Health Service (PHS) Policy and the Animal Welfare Act (AWA), which apply to all live vertebrate animals regardless of ownership.
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Procurement of Custom Antibodies
Antibodies are considered customized if produced using antigen(s) provided by the investigator or at the request of the investigator (i.e. not purchased as a pre-made catalog item off-the-shelf). Procurement of custom antibodies requires IACUC oversight.
Collaborative or Off-Site Research
IACUC oversight applies when:
- UM personnel work with animals at another institution,
- UM funds support animal activities,
- UM owns or is responsible for the animals,
- Data from animal procedures will be used by UM investigators.
- Work is being conducted at UM main or satellite facilities.
Documentation such as a Memorandum of Understanding (MOU) or reliance agreement may be required.
4. Review, Approval and Version History
|
Version |
Date |
Description of Changes |
Approved By |
|---|---|---|---|
|
1.0 |
August 20, 2020 |
Creation |
IACUC Committee |
|
2.0 |
May 19, 2025 |
Review and Update |
IACUC Committee |