Reporting Adverse Events and Protocol Deviations
The IACUC must be notified of an unanticipated adverse event affecting animals involved in research, teaching, testing or outreach and/or a deviation from an approved IACUC protocol. An adverse event is any occurrence of an unforeseen event that negatively impacts the welfare of animals, usually involving pain, distress or death of an animal. A protocol deviation is any departure from methods approved in an IACUC protocol or the conduct of animal-related activities without appropriate IACUC review and approval. A principal investigator (PI) or facility manager is expected to file an official report no later than 7 calendar days after the identification of an adverse event or protocol deviation using the attached “Adverse Event or Protocol Deviation Report Form.”
It is strongly recommended that a PI or animal facility manager promptly call or email the IACUC when there is an event that may impact or has impacted animal welfare, prior to filing an official report. Preliminary reports may also be made anonymously via the confidential hotline (see here). Timely notification allows the IACUC and Attending Veterinarian to help assess the situation, find resolutions, and implement corrective actions. Consultation with the Attending Veterinarian must occur when adverse events or protocol deviations result in pain or distress that is beyond the anticipated level described in the protocol or when interventional control, such as analgesics, is not possible.
Consult with ORA if you are unsure whether an event needs to be reported to the IACUC. The following are a few examples of reportable events:
- Unexpected animal death or injuries related to approved animal activities (e.g., allergic reactions, broken limbs, complications during or recovering from surgery, sudden death).
- Animal morbidity or mortality in excess of that described in the approved IACUC protocol.
- Facility or equipment failure that has a negative impact on animal welfare.
- Entrapment; overexposure to heat source(s); inadequate analgesia or antibiotic use.
- Implementing protocol amendments prior to obtaining IACUC approval.
- Any intentional or unintentional use of animals that was not described in the approved IACUC protocol.
- Failure to adhere to procedures within an IACUC-approved protocol.
The following are a few examples of situations that do not need to be reported to the IACUC:
- Injury/illness unrelated to approved procedures and being treated by clinical veterinarians
- Death or morbidity of animals as expected and described in the approved IACUC protocol.
Phone: 208-885-6162 (ORA main line)
The Protocol Deviations and Adverse Event form can be submitted through email or you can fill out a form in VERAS for a specific protocol.