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: 

  1. 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: https://www.ohio.edu/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. 

  1. Details to Include in Reports:  

For Deviations: 

  • A) When: Date of occurrence  

  • B) What: Brief description of the deviation  

  • C) Where: Location of the deviation  

  • D) Who: Individual(s) involved   

  • E) Immediate Actions (if any): Steps taken in response (e.g., halted procedure, notified personnel, secured animals)  

  • F) Notifications: Indicate whether LAR Staff, Director, Attending Veterinarian were notified 

For Adverse Events: 

  • A) When: Date of occurrence  
  • B) What: Brief description of the adverse event  
  • C) Where: Location of the event  
  • D) Who: Individual(s) involved  
  • E): Animal ID(s):  
  • F) Immediate Actions (if any): Steps taken in response (e.g., paused procedure, notified staff, secured animals)  

  • G) Notifications: Indicate whether LAR Staff, Director, Attending Veterinarian were notified 

     

  1. 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. 

 

  1. 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.