What is an Adverse Event (AE)?
An adverse event is any unanticipated or unforeseen incident inconsistent with the routine expected outcomes of a protocol that leads to animal welfare concerns — including death, disease, pain, or distress. Adverse events may occur within sanctioned animal activities or spontaneously as a result of allergic reaction, equipment malfunction, disease, or other causes.
24-hour reporting requirement
All animal deaths — whether reportable as an adverse event or not — must be reported to the Attending Veterinarian within 24 hours of discovery. The Adverse Event Form must also be submitted within 24 hours of observing any unanticipated event.
Mandatory AV consultation
Contact the Attending Veterinarian immediately if pain or distress exceeds what is approved in the protocol, or if interventional control (such as administering analgesics) is not possible.
Scope of reporting
Adverse event reporting is required for all research involving animals at the University of Montana. This requirement applies regardless of where the research takes place and includes:
- Laboratory and animal facility-based research
- Field studies involving wild-caught, free-living, or captive field-housed animals
- All other research or educational activities involving vertebrate animals
Field researchers are expected to report adverse events in the same manner and within the same timeframes as laboratory-based researchers. If you are unsure whether an event requires reporting, contact the Attending Veterinarian or IACUC Office.
When to report
Principal Investigators are required to complete and submit the Adverse Event Form for any unforeseen or negative incident affecting animals involved in research, testing, or educational activities. This includes events that occur:
- During approved protocol procedures
- As a result of equipment malfunction or facility issues
- Spontaneously due to disease, reaction, or other causes
Role of the Attending Veterinarian
The Attending Veterinarian (AV) is your primary resource when adverse events occur. The AV can help assess the situation, explore resolutions, and facilitate the reporting process. Consultation is mandatory when pain or distress exceeds approved protocol limits or when interventional control is not possible.
Commitment to compliance and care
Reporting adverse events is essential to maintaining institutional credibility, fostering a culture of care, and ensuring animal welfare. By adhering to this policy, researchers demonstrate their dedication to the ethical treatment of animals and the integrity of their work.
Need guidance?
Attending Veterinarian: Pam Broussard, DVM
- Email: pam.broussard@umontana.edu
- Phone: 406-552-9599
IACUC Director: Linda Hicks, CPBCA, CPIA
- Email: iacuc@umontana.edu
- Phone: 406-243-6395