Post-Approval Monitoring

The intent of the program is to enhance the quality and integrity of research practices, to increase communication between investigators, the IACUC, and animal program staff, and to foster an educational partnership among these groups to ensure animal welfare. Continuing IACUC oversight of approved IACUC protocols is required by federal regulations.

All IACUC approved protocols may be subject to a PM visit during their three year approval period. The following types of IACUC protocols may be considered “higher risk” and therefore may be subject to more frequent PM visits.

• Active protocols involving more than momentary pain/ distress (pain categories D and E)
• USDA and AAALAC covered research protocols
• Protocols which involve chemical or biological hazards
• Protocols with a history of noncompliance
• Protocols which describe exceptions to standard
• For cause monitoring as a result of a formal investigation or concern reported to the IACUC committee

• Review the PM checklist sent at the time of scheduling
• Review approved current protocols
• Ensure records are readily available for review including any of the following:
  • Personnel training records
  • Surgical records and/or anesthesia records
  • Post-operative monitoring/analgesia records
  • Health monitoring records for any monitoring described in the Pain and Distress section of the protocol
  • Weight records – if weight loss is described as an experimental endpoint or weight monitoring is described in the protocol.
  • Breeding records
  • Animal use records (animal number tracking)

The PI and relevant research personnel responsible for performing protocol experiments, hands-on procedures and/or surgeries, data and recordkeeping should be present during the Post-Approval Monitoring visit. It is not required that the PI be present for the visit, but it is encouraged. If personnel present for the visit are unable to answer some questions, the PI may be contacted following the visit. Note, the PI is ultimately responsible for the activities associated with the study and approved IACUC protocol.

Protocols are selected for PM based on risk assessments as described and outlined above. Once a protocol is selected, the PI will receive an email from PM personnel to schedule the visit. The visit itself will take between 30 minutes- 1 hour to complete depending on the number of active protocols, protocol complexity and the number of questions asked. A standard checklist is used to assess the protocol and animal research practices. The checklist is provided to the PI prior to the inspection. PM personnel may also ask the PI/research staff to provide a description of one surgery and/or procedure on the protocol to ensure current processes are congruent with the written protocol. The monitor will compare the verbal description with the approved protocol, as well as IACUC approved standards, SOPs, and relevant regulations and advise if any changes to current practices or amendments are needed. Once the visit is completed, a written report will be provided within approximately one week. If responses are required, the PI will have approximately 2-4 working weeks (15-30 days) to respond depending on the issues identified. After responses are received, the report is provided to the IACUC committee for review. If there are further questions from the committee PM personnel will follow up with the PI as needed. If there are no questions or requested revisions, the report will be finalized and saved to the protocol file.

Minor items which require correction will be included in the post-approval monitoring report for the PI to formally respond. Any significant deficiencies which immediately impact animal health and welfare will be reported to the IACUC committee as soon as possible utilizing established adverse and noncompliance reporting processes.

Please email iacuc_office@ncsu.edu with any questions.