Reporting Adverse Events

Policy

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.

Background

The use of animals in research, testing, and teaching may occasionally result in unanticipated adverse events that affect the health and welfare of animals. Federal regulations and professional standards mandate that these occurrences are promptly reported to the veterinary staff and IACUC. IACUC is subsequently responsible for determining what must be reported to regulatory agencies, if protocol revisions should be pursued, or if additional actions (e.g., training, veterinary consults) are necessary. To ensure animal welfare, effective and prompt communication is essential in this reporting process.

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

Definitions

An adverse event is an incident that results in unexpected pain, distress, or death of an animal covered by the University CAM policy that 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 may not be protocol related but instead may be the result of issues with physical plant or housing malfunctions, weather-associated conditions, or shipping.

Procedures

When an adverse event occurs, the project personnel or animal care staff must follow the procedures 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.

• ACP-Lab Office: 217-333-2564
• ACP-Ag Office: 217-265-6790
• Large Animal Clinic: 217-333-2000

2. Promptly notify ACP-Ag (acp-ag@illinois.edu) or ACP-Lab (acp-vdl@illinois.edu).

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 facility or farm manager is responsible for reporting to the IACUC, cc’ing the PI.
• Reports should be emailed to IACUC (iacuc@illinois.edu) and should include:

1. Protocol number
2. Species and number of animals involved
3. Event description
4. Confirmation that the appropriate ACP veterinarian was contacted
5. If possible, steps that have been, or will be, taken to prevent future occurrence.

Following a discussion by the IACUC, a determination will be made whether the event is significant or serious enough to be reportable to outside agencies or institutions. Notification to the appropriate agencies will occur after a full discussion by the IACUC.