Standard on Post Approval Monitoring
This standard describes Post Approval Monitoring (PM) at NC State. Post-Approval Monitoring is procedural and/or documentation monitoring or reviews of previously approved protocols to confirm, enable, and encourage compliance with established federal regulations and institutional standard operating procedures (SOPs) and Policies, Regulations and Rules (PRRs). PM can be briefly defined as any effort focused on determining what happens to animals after IACUC approval has been granted for their use in research, teaching, or testing. The intent of the PM 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. Any persons involved with the care and use of animals in research or teaching at the University including, but not limited to Principal Investigators, researchers, animal handlers, students and facility staff may be involved in the PM process.
Standard
This document is intended to focus on the formal PM process, but the IACUC recognizes that informal PM is conducted via other mechanisms including but not limited to:
- Animal husbandry or veterinary staff reporting facility concerns or protocol deviations
- Semiannual IACUC inspections
- Training activities conducted by the Institutional Trainer, veterinarians, or facility personnel
Formal PM involves procedural or documentation reviews of previously approved IACUC protocols to confirm compliance with established federal regulations and institutional standard operating procedures (SOPs) and Policies, Regulations and Rules (PRRs).
PM will be conducted on behalf of the IACUC committee by IACUC staff. Veterinary staff, additional IACUC staff or IACUC members may also attend.
Reviews may include:
- Examination of surgical and study areas
- Review of breeding, training, anesthetic, surgical, euthanasia, monitoring, and procedure records. Other records may also be indicated depending on the protocol.
- Observation and/or discussion of surgeries and procedures in comparison with IACUC approved protocols.
All IACUC approved protocols may be subject to PM. Criteria which may increase the frequency of PM review include:
- 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
When not conducted “for cause” the PI will be contacted by PM personnel in advance to schedule a visit. Personnel conducting the animal research should be present for the PM visit. During the visit, research records will be reviewed and approved protocols discussed. A checklist may be utilized for consistency. Following the visit, a report will be sent to the PI with notes of the visit, including any items requiring correction or recommendations for improvement. The PI will have approximately 2-4 working weeks (14- 30 days) to respond to the report in writing for items requiring correction unless a significant deficiency, any situation that is or may be a threat to the health or safety of the animal, is identified. Any identified significant deficiencies will be reported promptly to the IACUC committee through established reporting mechanisms. Examples of items identified may include but are not limited to incongruency between current research practices and the written IACUC protocol, research practices not adhering to written IACUC standards, incomplete observations and/or monitoring records, lack of personnel training records, or additional training needed due to lack of proficiency in a technique on the protocol. Corrections may require a protocol amendment. Once responses are received, the report will be available for review at the next IACUC meeting. PM personnel will notify the PI if any further action is required following IACUC review. If no further comments are received, the PM report will be finalized.