REPORTING ADVERSE EVENTS

Animal Care and Use manual defines that adverse events or unexpected outcomes for animals assigned to approved protocols must be reported to the appropriate veterinary staff and to the IACUC in a timely manner.

The use of animals in research, testing, and teaching may occasionally result in unanticipated adverse events that affect the health and welfare of animals.

IACUC views the failure to report an adverse event by animal research personnel as a non-compliance incident, and it will be addressed by the IACUC on a case-by-case basis.

Definition

An adverse event is an incident that results in unexpected pain, distress, or death of an animal under the Orbeli Institute Animal Care and Use program when it meets one or more of the following criteria:

  • The event is occurring at a frequency greater than described in the approved IACUC protocol
  • The event is not identified as a clinical element in the approved IACUC protocol
  • The event is not protocol related but instead may be the result of issues with animal facility physical conditions or housing malfunctions, weather-associated conditions, or shipping.

Procedures

When an adverse event occurs, the project personnel or animal care staff must follow the process outlined below:

  1. Provide immediate care (or euthanasia, if warranted) for the animal. Any clinical issue, regardless of the severity, must be reported to the veterinary staff.
  2. Promptly notify Animal Facility Manager
  3. Notify the IACUC within 24 hours of the discovery of the adverse event.
  • For protocol-related adverse events, the Principal Investigator (PI) is responsible for reporting. If the PI is not available, research personnel (preferably senior project personnel) should report to IACUC, cc’ing the PI
  • For facility- or other non-protocol-related adverse events, the Animal facility manager is responsible for reporting to the IACUC, cc’ing the PI.
  • Reports should be emailed to IACUC and should include:
  • Protocol number
  • Species and number of animals involved
  • Event description
  • Confirmation that veterinarian was contacted
  • Steps that have been taken and steps that will be taken to prevent future occurrence