Post-approval monitoring

Benefits of Post-Approval Monitoring 

The relationship of the researcher and the IACUC does not stop at the end of the protocol review. Once a protocol is approved, the IACUC is charged with creating a mechanism for continued oversight. Post-approval monitoring (PAM) programs can meet this requirement in a variety of ways. At UNTHSC, the IACUC has developed the Post-Approval monitoring Audit. Benefits of this audit program include:

    • A tool for building relationships with investigative staff
    • A mechanism to ensure animal well-being
    • Opportunities to provide recommendations that could refine procedures
    • Recognizing ways to communicate teachable moments

Post-Approval Monitoring Types

At UNTHSC we have created a robust PAM Program, implementing three types of audits creating a more holistic approach.

Document Review Laboratory Audit Procedure Observation
An audit of the documentation associated with the protocol. This audit will review protocol documents (including training records and animal number logs), as well as, animal study records. A meeting with the PI may occur after the document review to discuss the records, seek clarifications, or discuss any findings. A traditional audit in the animal use laboratory with a discussion of various aspects of the research project with the PI and laboratory members. A checklist will be used to conduct this audit. At the conclusion of the audit, the audit team will discuss any findings or recommendations with the PI. The PI will also be given an opportunity to ask any questions.  An interactive audit, where an audit team will observe procedures associated with the protocol. At the conclusion of the audit, the audit team will discuss any findings or recommendations with the PI. The PI will also be given an opportunity to ask any questions. 


What’s the difference between the PAM Audit and Semi-Annual Inspections:

While Semi-Annual Inspections are a form of post-approval monitoring, there is a difference between the Semi-Annual Inspection and the PAM Audit. Semi-Annual Inspections comply with the requirements of the Animal Welfare Act Regulations (AWR’s) in §2.31(c)(2) and the PHS Policy in IV.B.2. There are some overlap in similarities with the semi-annual inspections and the PAM audit, and as such, in effort to reduce confusion, PAM Audits are not conducted in the months of Semi-Annual Inspections (April, October). However, there are differences, as described below:

    • The Semi-Annual Inspection has specific requirements within the regulations; whereas, the regulations allow for flexibility in continual oversight, in which we utilize the PAM Audit Program as one of the mechanisms to meet this requirement.
    • One requirement for a semi-annual inspection according to the regulations, it has to occur at least once every six months. There is no indication of specific frequency for a PAM audit within the regulations. With the recent harmonization of the Animal Welfare Act Regulations with the PHS Policy in response to the 21st Century Cures Act, at UNTHSC, we no longer require an annual review of protocols regardless of species. As such, we have strengthened our PAM Program to allow for a PAM audit to occur more than once within the life cycle of the protocol.
    • In Semi-Annual Inspections, we focus more on the facilities where animals are housed/ used, where as, the PAM audit focuses more on the protocol related activities.
    • Semi-Annual Inspections include the vivarium, whereas, PAM audits, while we may visit the vivarium during the procedure observation, for the most part the vivarium is not the focus for the PAM audit.

How to Prepare for a PAM Audit:

Protocols are selected on a monthly basis for PAM audits, with the exception of April and October, as described above. PI’s are notified via email if their protocol(s) are selected for an audit. The email will indicate the type of audit that will occur, and request any information at that time the PI will need to provide to the Audit Team. Here are some recommendations to have a successful audit:

    • Respond quickly to the audit request, along with any information requested.
    • Review protocol to ensure all procedures are appropriately described.
    • Review checklists provided that will be used to conduct the audit.
    • Prepare any questions you may have for the IACUC Office.
    • Respond quickly to any recommendations or corrective actions needed after the audit.

Resources for a PAM Audit: