9. Post-Approval Monitoring

The Post-Approval Monitor (PAM) reviews previously approved animal studies. This is required by federal law to ensure continuing compliance after a proposed animal activity is approved by the IACUC. Selection of protocols/studies for PAM reviews will be done randomly or "for cause," e.g., if complaints or concerns are received by the IACUC.

As a best practice, prior to starting a new study, PIs are strongly encouraged to sit down with their staff and students to review the protocol that is about to begin. The actual IACUC approved protocol document should be reviewed in detail so that the staff are aware of the commitments made to the IACUC by the PI, as this represents a binding contact between the PI, the university and the federal government, which has been stated elsewhere in this tutorial. This heightened level of communication between PI and staff is very significant in improving research quality and enhancing the results of reviews. The protocol then needs to be made available in or near the workspace or lab so that it may be referenced as needed. Clear and accurate record-keeping, especially regarding animal use, breeding, and treatment, further improves the quality of research and facilitates PAM reviews.

Reviews will include, but are not limited to, review of study records and animal health records, observations of animal handling and technical procedures, assurance of accessibility to the approved protocol (e.g., a copy of the actual document as approved by the IACUC) by study personnel, and interviews with the PI and study staff.

At the time of scheduling the PAM appointment, the PI will be instructed as to all relevant animal use data, including animals used to date, health records, etc., to prepare for the meeting, and a brief explanation of the process will also be provided.

Findings and/or recommended corrective action items will be reported by the Post-Approval Monitor to the IACUC for review and action as necessary.