Adverse Event Reporting

IACUC SOP: 304-00, Effective Date: 01/17/2025, Last Revision: 01/17/2025

Overview/Purpose

This SOP describes the process that the Institutional Animal Care and Use Committee (IACUC) follows when an unanticipated adverse event or outcome is reported involving animals in research and teaching activities.

Definitions

• Unanticipated Adverse Event or Outcome: Unexpected illness, injury, or death of animals used in research or teaching that was not specifically identified in the IACUC approved protocol or IACUC approved SOP/SMP.

Requirements

• Unanticipated adverse events and outcomes related to research and teaching activities must be reported promptly by the principal investigator to the IACUC along with the plan to mitigate recurrence if applicable.
• Clinical concerns unrelated to research or teaching activities (e.g. scrapes, cuts, fight wounds in rodents, ulcerative dermatitis, barbering) that occur at routine levels for the species do not require notification to the IACUC.  The veterinary staff must notify the IACUC if the concerns exceed routine levels based on their professional judgement.
• IACUC Staff will consult with the Chair or Vice-Chair of the IACUC and the Institutional Attending Veterinarian (AV) to determine the next steps based on the initial information provided.
• If further information is needed, an IACUC member, appointed subcommittee, or IACUC staff member may discuss the event with appropriate personnel. If the incident is related to noncompliance, the event will be referred to the non-compliance review process.
• The IACUC will be informed of all reports of unanticipated adverse events or outcomes at the next convened meeting to determine if additional information or further action is needed.
• IACUC Staff will prepare draft letters to investigators, regulatory agencies, and AAALAC as applicable. Letters to investigators are signed by the IACUC Chair. Written reports to regulatory agencies will be submitted through the Institutional Official.

Article ID: 82
Created: February 3, 2025
Last Updated: February 3, 2025

Online URL: https://ohiostateresearch.knowledgebase.co/article/adverse-event-reporting-82.html