Guidance for Management Plan Development

Purpose

This guidance document supports IACUC Policy 017 by outlining expectations for the development of management plans submitted in response to identified noncompliance or unexpected adverse events or outcomes.

Management plans are corrective action documents intended to address the underlying cause of an issue, protect animal welfare, and prevent recurrence.

When a Management Plan Is Required

The IACUC may require a management plan when:

Noncompliance with IACUC policies, procedures, or protocol requirements has occurred
An unexpected adverse event or outcome has been identified
Corrective actions are necessary beyond immediate remediation

General Principles

Effective management plans should:

Be specific to the event and circumstances
Address root cause(s), not only symptoms
Include clear, achievable corrective actions
Demonstrate how recurrence will be prevented
Be proportional to the severity and complexity of the issue

There is no single template; plans should be tailored to the situation.

Required Components

Management plans should clearly describe the following:

Event Summary
- Brief description of what occurred
- Identification of the underlying cause(s), if known
Immediate Corrective Actions
- Actions taken to protect animal welfare
- Any temporary measures implemented
Preventive Measures
- Describe how recurrence will be prevented, which may include one or more of the actions listed below

Examples of Preventive and Corrective Actions

Training and Retraining
- Targeted retraining of specific personnel
- Refresher training on procedures, techniques, or animal monitoring
- Documentation of completed training
Protocol Review and Clarification
- Review of protocol requirements with research staff
- Revision of internal lab procedures to align with the approved protocol
- Submission of a protocol amendment, if necessary
Oversight and Monitoring
- Increased PI or supervisory oversight
- Temporary audits or checklists
- Enhanced post procedure or health monitoring
Standard Operating Procedures (SOPs)
- Development or revision of SOPs
- Improved documentation practices
- Clear assignment of responsibilities
Communication and Education
- Regular lab meetings addressing compliance expectations
- Improved communication between research staff and veterinary personnel

Documentation and Follow Up

Management plans should identify:

Who is responsible for each corrective action
How completion will be documented
Any proposed timelines for implementation

The IACUC may request follow up information or verification to confirm successful implementation.

IACUC Review

The IACUC will review management plans to determine whether proposed corrective actions are sufficient to address the issue and prevent recurrence. Plans may be approved, require revision, or trigger additional oversight as appropriate.

Educational and Non Punitive Approach

Management plans are intended to promote compliance, accountability, and continuous improvement. The IACUC's focus is on protecting animal welfare and supporting responsible research practices and not assigning blame.

Formatting and Submission

Management plans should be submitted as formal documents (e.g. letterhead, signed by the PI, attached to an email as a PDF) to facilitate presentation to the full committee and for record keeping processes. Please submit plans to: IACUCvisits@osu.edu.