IACUC Interim Procedure 001: Managing Noncompliance and Animal Welfare Concerns
Purpose: To provide clear guidance for reporting deviations or adverse events during the transition to the Cayuse system, ensuring compliance with IACUC standards and the welfare of research animals.
Scope: This procedure applies to all researchers and staff involved in animal research protocols, particularly those who have not yet backfilled their protocol shells in Cayuse.
Procedure:
- Reporting Noncompliance, Deviations, or Adverse Events:
a. For Users with Backfilled Protocol Shells in Cayuse: - Submit an amendment in Cayuse to inform the IACUC about the deviation or adverse event. - Refer to the How to Guide for Submitting Deviations or Adverse Events for detailed instructions: /research/ao-how-guide-004-how-submit-deviation-or-adverse-event-report
b. For Users Without Backfilled Protocol Shells in Cayuse: - Promptly report the deviation or adverse event within 24 hours of the incident via email to compliance@ohio.edu. - Include the required details as specified below.
- Details to Include in Reports:
a. For Deviations: - Location of deviation - Date of occurrence - Reported by - Description of deviation - Impact assessment: - Impact on risk/benefit ratio - Impact on data integrity - Impact on continuation of the protocol - Explanation of the reason for deviation - Steps taken to address the deviation - Corrective actions to prevent recurrence - Notification details: - Who was notified (IACUC, Attending Veterinarian, or both) - Date of notification
b. For Adverse Events: - Animal ID - Date and time of event - Location of event - Outcome (e.g., Treated/Recovered, Treated/Euthanatized, Treated/Ongoing, or Fatal) - Relation of the event to research/teaching activities - Detailed description of the event - How the event/problem was managed - Corrective actions to prevent future occurrences
- Notification and Follow-Up:
a. All reports must be reviewed by the IACUC and/or IACUC subcommittee as appropriate and in accordance with SOP 001: Managing Noncompliance & Animal Welfare Concerns.
b. Corrective actions will be documented and communicated to ensure continuous improvement and compliance.
- Transition Plan Review:
a. All researchers are encouraged to expedite the backfilling of protocol shells in Cayuse to streamline reporting.
b. Researchers who report an adverse event or deviation through the interim process are required to complete the backfill of their submission within 30 days of the initial report. During this backfilling process, researchers must incorporate the details of the report into their final submission.
Effective Date: This interim procedure is effective immediately (4/04/2025) and remains in place until all users have transitioned to the Cayuse system.