Unanticipated Adverse Event Policy
The AACUC Unanticipated Adverse Event Form must be completed for reporting any adverse or unanticipated event affecting animals used in research, testing or teaching.
Principal Investigators should contact the AACUC Program Manager and Program Veterinarian when adverse events occur. The Program Veterinarian can assist in assessing the situation, seeking resolutions, and helping with the report. Consultation with the Program Veterinarian MUST occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control (such as administration of analgesics) is not possible.
Definition of an unanticipated or adverse event: Any event not consistent with routine expected outcomes that results in unexpected animal welfare issues (death, disease, distress).
Examples of events that MUST be reported include, but are not limited to the following:
- Animal death or illness from spontaneous disease not related to activities approved on a protocol.
- Unexpected animal death or injuries related to approved animal activities (e.g., allergic reactions, broken limbs, complications during or recovering from surgery, sudden death).
- Death, disease, or distress due to equipment failure or natural disaster.
The Adverse Event must be reported to the AACUC via the Office of Research Compliance verbally or in writing within 24 hours of identification of the event. An Adverse Event Report Form must be completed and submitted to the AACUC in a timely manner.
It is Montana State University policy that the procurement, housing, care, and use of animals should conform to the Guide for the Care and Use of Agricultural Animals in Research and Teaching and other relevant federal or state policies and procedures. The policy applies to all research and teaching involving the use of agricultural animals whether funded from external or internal sources.
References
American Dairy Science Association, the American Society of Animal Science, and the Poultry Science Association.
Guide for the Care and Use of Agricultural Animals in Research and Teaching. Fourth Edition. Champaign, IL. 2020 p10
AACUC Approval Date: 8/22/23
Review Date: 8/22/23
Issue Date: 9/1/23