Post Approval Monitoring

Purpose:

After the Institutional Animal Care and Use Committee (IACUC) has approved a protocol, it has the responsibility to ensure that procedures are carried out in the laboratory or classroom as described in the protocol.

Post-approval monitoring (PAM) is a comparison of the actual activities occurring under an approved protocol against the written protocol document, and includes the protocol-associated documents such as surgery records, animal orders, number of animals used, drugs used etc.

PAM is essential in order to ensure the well-being of animals involved in research and teaching activities, to ensure that activities are conducted in compliance with the regulations and standards of state and federal agencies and to ensure that activities are consistent and conducted in compliance with IACUC approved protocols as well as ETSU policies.

At ETSU, PAM is accomplished in several ways and by various groups. 

Continuing Annual Review of protocols:

After the initial approval of a protocol, it is re-reviewed annually by the IACUC Coordinator.  If significant changes are required, the PI will submit the necessary forms through OneAegis.  

Purchase of animals:

All warm-blooded vertebrate animals to be used for teaching, research, or testing at ETSU must be purchased or otherwise obtained through the DLAR. Animals will not be ordered, imported or otherwise acquired without an IACUC approved animal study protocol. According to the ETSU Animal Procurement policy the Director of the DLAR is responsible for approving the source of all animals to be housed in the animal facilities. 

Monitoring and documentation of numbers of animals used

All animal orders are entered into the DLAR data management system before they are placed with the vendor. This program tracks the species and number of animals approved in each pain/distress category for each protocol as well as the quantity ordered and received.  PIs are notified when they are approaching their approved quantity so that they can submit a request for additional animals through OneAegis.  For in-house breeding colonies animals are entered into the data management system on the day they are weaned and the above limits are applied.  All animals/cages must be identified with cage cards listing the PI, the location, the animal species and strain and the animal study protocol number. From this cage card each animal can be traced to an approved animal study protocol. 

Monitoring of experimental procedures

1. By the IACUC: A subcommittee of the IACUC visits animal use laboratories at least once a year; laboratories where survival surgeries are performed are visited every 6 months. During these visits records on experimental procedures, anesthesia, analgesia, euthanasia and personnel training are reviewed for consistency with the approved protocol. The Subcommittee also monitors use of sterile procedures for survival surgeries and the expiration date on drugs used. 
2. By the DLAR: The trained DLAR staff provides routine day-to-day observation and monitoring of animal conditions and of animal research activities in the animal facilities. The Attending Veterinarian maintains a DEA license.  Dispensation records are maintained in the animal use laboratories.
3. Policy for Reporting and Investigating Noncompliance with Animal Care and Use Policies: Everyone at ETSU has the responsibility to report potential noncompliance with ETSU policies on animal care and use. No employee, member of the Institutional Animal Care and Use Committee (IACUC), or laboratory personnel shall be discriminated against, or be subject to any reprisal, for reporting noncompliance with ETSU animal care and use guidelines. The IACUC will review and investigate any concern involving the care and use of animals arising from reports received and determines what actions are needed to correct a deficiency.