Animal Tissue Use and Sourcing
Number: IACUC-POL-027
Responsible Office: Office of Research and Creative Scholarship (ORCS)
Applies to: Principal Investigators Conducting Animal Research or All animal research and teaching protocols involving live vertebrate animals
1. Purpose
This policy explains when the use of animal tissues requires IACUC review and approval and when it is exempt. It also outlines the process for documenting exemptions for activities that do not require an Animal Use Protocol (AUP).
2. Policy
The IACUC oversees activities involving live vertebrate animals. In some cases, researchers may use tissues that were collected for unrelated purposes or obtained after animals were euthanized for other approved reasons. In these situations, IACUC approval may not be required. For this policy, “tissue” includes organs, cells, embryos, biopsies, blood, body fluids, or similar materials from animals.
3. Procedure
IACUC approval is required when:
- Live animals are manipulated, treated, or handled specifically to obtain tissue for a research or teaching activity.
- Animals are euthanized specifically to collect tissue for a research or teaching activity.
In these cases, the UM investigator must submit an Animal Use Protocol (AUP) to the IACUC before any work begins.
An IACUC approved AUP is not required when:
- Tissue was collected for unrelated clinical, teaching, or research purposes under another approved protocol.
- Tissue is obtained from animals euthanized for reasons not related to the new activity.
- Tissue is purchased commercially or obtained from a slaughter facility or vendor.
However, UM investigators must complete a Tissue Use form with the IACUC office for review. Review is completed by the IACUC office and does not have to go through formal IACUC review.
4. Shipping, Receiving and Transport of Animal Tissues
The shipping and receipt of animal tissues or specimens must comply with all applicable federal regulations and safety requirements.
- Principal Investigators (PIs) must follow U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) regulations related to the importation of animals, tissues, or materials that could carry exotic livestock or poultry disease agents, as well as restrictions on importing plant or plant-derived materials.
- PIs must comply with Public Health Service Foreign Quarantine Regulations (42 CFR 71.54), which govern the importation and transfer of materials that may contain human disease agents or vectors. U.S. Fish and Wildlife Service regulations also apply when relevant.
- These regulations do not apply to non-infectious materials such as formalin-fixed tissues, sterile cell cultures, or other preserved specimens when there is no indication that they contain infectious agents of animal or public health concern.
5. Responsibilities
- Investigators must ensure proper handling, biosafety practices, and awareness of any zoonotic risks associated with tissue use.
- Investigators are responsible for ensuring compliance with all applicable institutional and regulatory requirements.
6. References
- U.S. Department of Agriculture, Animal and Plant Health Inspection Service: eFile
- PHS Policy on Humane Care and Use of Laboratory Animals
7. Review, Approval and Version History
|
Version |
Date |
Description of Changes |
Approved By |
|---|---|---|---|
|
1.0 |
April 11, 2006 |
Initial policy creation |
IACUC |
|
2.0 |
September 12, 2017 |
Review |
Heivilin |
|
3.0 |
November 26, 2025 |
Review and rewrite |
Hicks |