Guidance for Reporting Unexpected Adverse Events or Outcomes

Purpose

This guidance document supports IACUC Policy 017 by describing when, how, and what information must be reported to the IACUC when an unexpected adverse event or outcome involving animals occurs.

Reporting of such events allows the IACUC to assess animal welfare impacts, determine whether corrective actions are needed, and prevent recurrence. Reporting is a nonpunitive process focused on regulatory compliance, continuous improvement, and humane animal care.

Scope

This guidance applies to all IACUC approved activities involving live vertebrate animals conducted under the oversight of The Ohio State University, regardless of funding source or performance site.

Definition: Unexpected Adverse Event or Outcome

An unexpected adverse event or outcome is any undesirable or unintended occurrence involving animals that:

Is more severe, more frequent, or different in nature than anticipated in the approved protocol; or
Suggests that animal pain, distress, injury, or morbidity may not be adequately controlled as described and approved.

Unexpected adverse events or outcomes may occur with or without noncompliance and may involve animals, equipment, personnel, or procedures.

Events That Must Be Reported

Examples of reportable unexpected adverse events or outcomes include, but are not limited to:

Unanticipated animal death or morbidity
Unexpected severity or frequency of pain or distress
Procedural complications not described in the protocol
Animal injury related to equipment malfunction or handling
Protocol deviations that result in animal welfare concerns
Failures of analgesia, anesthesia, or post procedure monitoring
Any event that may reasonably indicate that the approved protocol no longer adequately addresses animal welfare

When in doubt, investigators are encouraged to report the event or consult with the IACUC or Attending Veterinarian.

Timing and Method of Reporting

Unexpected adverse events or outcomes must be reported promptly after discovery, generally within 24 hours when feasible.

Reports must be submitted to the IACUC and the clinical veterinarian. To do this, the PI or research team should email (preferred) or call the IACUC Office: iacucinfo@osu.edu, 614-292-4494.

Required Information

Reports should include sufficient detail to allow the IACUC to understand the event and assess next steps. At minimum, include:

IACUC protocol number and title
Date the event occurred and date discovered
Species and approximate number of animals affected
A factual description of what occurred
Immediate actions taken to address animal welfare concerns
Whether veterinary care was provided and by whom
Any apparent contributing factors
Whether a management plan will follow (if applicable)

If information is not immediately available, submit the report with known details and provide supplemental information when available.

Management Plans

Some unexpected adverse events or outcomes may require submission of a management plan describing corrective actions and measures to prevent recurrence. When required, management plans should be submitted within the timeframe specified by the IACUC and prepared in accordance with the Guidance for Management Plan Development.

Events That Do Not Require Reporting

The following generally do not require reporting unless they occur at an unexpected frequency or severity:

Expected clinical signs or outcomes described in the approved protocol
Anticipated complications that occur at a rate consistent with protocol expectations
Routine veterinary treatments or husbandry interventions

Assurance of Nonpunitive Review

Reporting unexpected adverse events or outcomes is essential to maintaining compliance and protecting animal welfare. The IACUC evaluates reports to improve oversight and prevent recurrence, not to assign blame. Timely, transparent reporting will be considered a positive indicator of responsible research conduct.