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Policy: Reporting Adverse Events (IACUC)

Policy: Reporting Adverse Events (IACUC)

Purpose

The intent of this policy is to clarify the procedures for reporting adverse events or unexpected outcomes.

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 IACUC protocol-covered animal 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. Immediate care must first be provided for the animal, if warranted.
  2. The appropriate Attending Veterinarian for AACUP or DAR must be promptly notified to ensure the animal receives veterinary care. Any clinical issue, regardless of the severity, must be reported to the veterinary staff.
    • DAR Office: (217) 333-2564
    • AACUP Office: (217) 265-6790
  3. IACUC must be notified within 24 hours 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 non-protocol related adverse events, the facility or farm manager is responsible for reporting to IACUC, cc’ing the PI.
    • Reports should be e-mailed to IACUC (iacuc@illinois.edu) and should include:
      1. If possible, steps that have or will be taken to prevent future occurrence
      2. Confirmation that the attending veterinarian was contacted
      3. Event description
      4. Species and number of animals involved
      5. Protocol Number

Supplemental information may be requested by the IACUC at a later date.

Approved: 12/3/19

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