Post Approval Monitoring (PAM)
The goal of post-approval monitoring (PAM) at Georgetown University (GU) is to work with research staff members to confirm accurate and consistent protocol performance in a collegial and unobtrusive manner. Additionally, PAM offers investigators (PI’s and/or research personnel) assistance and resources to successfully navigate IACUC policies, and processes. See IACUC policy Post Approval Monitoring and Evaluation Form
What is PAM?
- Continuing IACUC oversight of animal activities is required per the Guide(Guide pages 33-34) and monitoring animal care and use is required by the PHS Policy. The Georgetown IACUC address this requirement through a post approval monitoring (PAM) program where we compare the practices described in approved protocols and SOPs against the manner in which they are actually conducted. Conducting post approval monitoring is common in animal care and use programs and will help to ensure the safety of the research animals, appropriate descriptions and supporting documents are executed as approved, and any changes and/or adverse events are reported.
- PAM is meant to be beneficial at preventing noncompliance and counseling PIs on IACUC requirements and policies.
Why was my lab selected?
- The majority of protocols are selected randomly. Studies may be randomly selected from all approved and active protocols, without cause. A study may be selected more than once in a given year if a “for cause” review is deemed necessary (i.e. At the IACUC’s request from a review, part of an investigation for non-compliance, upon PI’s request).
- Protocols that are pain class E, have USDA covered species, or considered higher risk to the animals, are more likely to be selected. Should a PI have multiple protocols, it is possible that each protocol may be selected individually or all protocols may be reviewed at once.
What should I expect?
PAM process:
- Laboratories may be selected randomly, for cause, at the request of the IACUC, veterinary staff, animal care staff or lab personnel.
- The initial visit/discussion will occur via a zoom meeting. At this meeting the protocol details and current experiments will be discussed/reviewed. From this meeting it will determine what further review will occur (e.g. lab inspection, records review, procedure observation, etc.).
- PAM personnel visit the laboratory (if applicable) and may visit the animal room where the animals are housed, and PI labs where procedures are performed. Veterinary staff may also participate in the visit.
- Procedures on the selected protocol(s) may be observed and any drift from the approved protocol(s) is noted.
- Procedures and protocols will be reviewed by the PAM team in lieu of or in addition to an observation. The PAM Team may provide protocol change recommendations to ensure consistency, avoid duplicative information, and/or increase flexibility within the protocol.
- The Post-Approval Monitoring Evaluation Form will be used to conduct the review.
- Findings are discussed with the PI at the end of the evaluation. The investigators are given the opportunity to make corrections by modifying techniques and/or by submitting an amendment to their protocol(s).
- The PAM team will provide report to the IACUC of the outcome of each PAM visit. A letter will be provided to the PI with the results of the visit.