Adverse Event Form

The Animal Care and Use 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 seek assistance from the Attending Veterinarian (IACUC) or Program Veterinarian (AACUC) when adverse events occur. S/he can assist in assessing the situation, seeking resolutions, and helping with the report. Consultation with the 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). Unexpected death includes an increased number of deaths over what was stated in the approved protocol.

• Death, disease or distress due to equipment failure or natural disaster.

The Adverse Event Form should be completed and submitted within 24 hours of observing the event.

Questions regarding the use of this form should be directed to the IACUC or AACUC Chair or the IACUC or AACUC Program Manager.