What is Post Approval Monitoring?
Post Approval Monitoring is a thorough examination of key elements of an approved animal use protocol (laboratory, animal procedures, animal health monitoring records, training, use and handling of test articles, safety). The reviews are conducted to ensure animal subjects are cared for and used in compliance with the protocol.
What are the goals of the PAM process?
The primary goal of the PAM program is to ensure animal well-being and to maintain regulatory compliance. Associated with this, the process will facilitate the science by serving as a resource to the researchers. The PAM process is positioned to convey IACUC policies on matters of animal care and use, identify opportunities for improvement and make recommendations on how to achieve improvement. Ultimately, the PAM process will confirm that the manner in which animal procedures are performed and conducted under an approved protocol is consistent with what the IACUC approved.
What are the benefits that an Investigator may gain from the PAM process?
When scientific research involves animals, reliable and meaningful results depend on proper and consistent animal care and use. Animal protocols are reviewed and approved with the principles of humane care and use of animals in mind. Compliance with these principles is mandatory. Some benefits that may be gained from a PAM review, but are not limited to, are:
- Increased understanding of the regulations that guide our research projects
- Increased communication concerning Federal regulations and University policies
- Access to an individual to clarify the Federal regulations and University policies
How does the PAM process protect my research?
The PAM process enables correction of protocol issues or procedural inconsistency, internally, so that regulatory agency inspectors are less likely to find problems. It is in the best interest of the IACUC, DU and researchers to correct any issues in this way.
What are DU’s obligations to regulatory bodies?
In response to increasing oversight and consequences imposed by regulators, PAM has become a standard practice in laboratory animal program oversight. The IACUC is responsible for conducting a continuing review of approved protocols in accordance with Public Health Service Policy (IV.C.5) and Animal Welfare Regulations (Sec 2.31(d)). Drexel’s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW annually, promising that DU will conduct animal research in accordance with federal policy, and the Guide for the Care and Use of Laboratory Animals. In addition, DU must send a yearly record of its acquisition and disposal of animals by December 1st to the USDA. The USDA conducts unannounced inspections of animal care facilities and has the authority to stop research if it determines that investigators do not treat animals in accordance with the law. The records of the USDA reports and inspections are available to the public through the Freedom of Information Act.
Why do we need continuing AAALAC, International accreditation?
Many private funding sources strongly recommend that grantees receiving support have animal programs with AAALAC accreditation. It is generally recognized in the laboratory animal care and use community as commitment to excellence and an international symbol of quality. AAALAC accreditation requires that the program for animal care and use at Drexel meets the minimum standards required by law, but also that extra steps are taken to achieve excellence in animal care and use, which promotes scientific validity.
How are protocols selected for a PAM review?
The most common way is that protocols are selected from the pool of all approved protocols, randomly, based on risk criteria to some degree. Animal welfare risk factors include, but are not limited to; species, pain categories, survival surgery, food and fluid restriction, prolonged restraint, hazardous agent use, use of satellite facilities, breeding and previous compliance history. If a protocol has been selected for PAM review, it does not necessarily mean that something is wrong. Protocols can be selected for cause from a complainant and/or unexpected outcomes reporting.
How long will a PAM review take?
If documentation is complete and organized, the PAM checklist review will take approximately an hour or less. However, depending on the complexity of the protocol procedures, subsequent appointments may be required to observe procedures to complete a comprehensive assessment of the level of protocol compliance.
As the PI, what should I expect?
The PI/designee will be asked to provide records of the regulatory file, data collected and/or source documents that demonstrate the protocol is/was followed as approved. The QA/QI reviewer will ask questions about the protocol conduct and procedures. The PI or designee should report any problems or adverse events, if not already reported to the IRB. The scope of the review varies depending on the research and may include:
- A tour of the clinic, unit , laboratory, or procedure spaces
What are the possible outcomes?
There are several outcomes that could result from a QA/QI review. They include, but are not limited to:
- All procedures and documentation is compliant, no further action required
- Minor deficiencies were identified and recommendations for resolution are made. These are communicated to the PI and/or designee at an exit briefing and outlined in a report sent to the PI from QA/QI / Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. QA/QI will verify implementation of the action plan.
- Significant deficiencies were identified and recommendations for resolution are made. These are communicated to the PI and/or designee at an exit briefing and outlined in a report sent to the PI from the QA/QI/Office of Research. The PI will then send a response back to QA/QI with a plan and timeline to address the issues. QA/QI will follow up within a specified time frame to assure compliance.
When will I know the outcome?
The PAM reviewer will make every effort to communicate any concerns or deficiencies, and the severity level, at an exit briefing with the PI and/or designee. If this is not possible, the issue(s), recommendation for resolution, and timeline for completion will be sent in a report from the QA/QI/ Office of Research within 10 business days from the PAM review date.
What if the PI is unable to attend the scheduled PAM review meeting?
The preferred option is to meet at a mutually agreeable time for both the PAM reviewer and the PI/ research staff. If the PI is not able to attend, he/she may designate a representative for the PAM review.