Q: What is PAM?
A: PAM, or post approval monitoring, is required by both the Health Research Extension Act and the Animal Welfare Act. The IACUC is required to inspect all animal care and use facilities, including sites used for animal surgeries, every 6 months.
Q: Why do PAM?
A: The goals of PAM are to ensure animal well being, protect the Institution, provide a resource for the research community, facilitate science, and ensure regulatory compliance.
PAM is NOT the “Animal Police”, a replacement for the Institutional Animal Care and Use Committee and is not a new procedure or a new regulation. PAM has always been required of institutions performing research with animal subjects. There has been, however, a new emphasis on PAM and the program is carefully reviewed by outside agencies so it has moved more to the forefront in recent years.
Q: Is PAM the same as semiannual inspections?
A: Semiannual inspections are part of the PAM process. PAM also includes continuing protocol review, regular review of adverse or unexpected experimental outcomes, review of handling and usage records for controlled drugs, and observation of laboratory practices and procedures and comparison with approved protocols.
The goal of the post approval monitoring process is to review active protocols to ensure research is being conducted in accordance with what is written and approved. The laboratory is visited by the Compliance Coordinator occasionally with an accompanying veterinarian. Procedures on the selected protocol are observed and any drift away from the protocol is noted. The investigator then has the opportunity to correct any deviations by improving techniques or by submitting an amendment to the protocol.
The visit is as informal as possible and is an opportunity for the investigators to request any help they may need. Findings are reported at the next IACUC meeting. The report of the visit and any follow up visits are filed in IACUC office.
Q: Do I need to prepare for semiannual inspections?
A: The Einstein IACUC performs unannounced semiannual visits. The visitors will ask to see animal use areas within the lab and will ask about procedures performed including surgery and euthanasia. The will also ask to see controlled drug storage areas and usage records. The process takes only a few minutes. If any noncompliance is found, lab personnel and the Principal Investigator will be notified. A correction plan is expected and follow up inspection may be performed if deemed necessary. The inspectors will try to perform the inspection as quickly and with as little disruption as possible.
Q: Do I need to prepare for PAM visits?
A: Unlike semiannual visits PAM visits are scheduled ahead of time. The Principal Investigator and/or Laboratory Manager will be contacted by e-mail and a request will be made to view a specific type of procedure. Most often it will be surgical, animal care, or behavioral testing. Specific details about the process and specific protocol number being audited will be provided along with a copy of the checklist the PAM visitor will use.
Although it is not necessary to prepare for the visit, a review of the approved protocol to ensure compliance is recommended before the PAM visit occurs. As with the semiannual visits, any deviation from the approved protocol will be reported to the investigative staff and a correction plan will be requested. Follow up visits may occur if necessary.
Q: How are labs chosen for PAM visits?
A: Labs are chosen randomly, but certain procedures are chosen more frequently. These include surgery and behavioral testing. Satellite housing in laboratory space is also audited more frequently. Laboratories may also be inspected “for cause” which includes recommendations by veterinary staff or a report of noncompliance. This inspection process is exactly the same as the process used for randomly chosen labs.
Post Approval Monitoring Program
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