The purpose of the Post-Approval Monitoring (PAM) Program is to ensure that research and teaching activities involving live, vertebrate animals are conducted in accordance with all applicable federal laws, regulations, policies, and are consistent with the Principal Investigator’s (P.I.) IACUC-approved Animal Care and Use Protocol and amendments. In addition to providing continuing IACUC regulatory oversight of animal activities, post-approval monitoring should also serve as a valuable educational tool with the goal of achieving a culture of compliance.
Any approved Animal Care and Use Protocol may be subjected to post approval monitoring, as follows:
- Approved projects will be selected and reviewed by the IACUC Staff under the authority of the IACUC. Projects may be selected randomly as generated from the PAM scheduling tool, they may be selected “for cause”, or by risk-based assessment to ensure adequate oversight of complex protocols (e.g., those involving surgical procedures, fluid regulation, Category E protocols, or field studies), and USDA-covered species. A minimum of 55 protocols per year will be selected. (This number was determined as a 10% representation of an average de novo protocol approval rate of 550 - 600 protocols per year, although the PAM program does no specifically focus on new projects).
- Multiple Major Survival Surgery (MMSS) - Every approved Animal Care and Use Protocol that involves multiple major survival surgery will be reviewed at least once after the protocol is approved. Typically the MMSS review will focus on surgical related record review and protocol comparison.
- Protocols approved with a condition (stipulation) - Every Animal Care and Use Protocol that has been approved with a condition will have the condition reviewed at least once with the P.I. or the P.I.’s designee.
- The IACUC office will coordinate with the P.I., the P.I.’s designee, or other appropriate individual (e.g., facility or laboratory manager, veterinarian, surgeon) to conduct the review. The PAM form can be used as a guide for conducting the review.
- Post-approval monitoring will generally include a meeting with the investigator or investigator’s staff and will be conducted by IACUC members, IACUC Staff, or members of the TRACS Veterinary Services on behalf of the IACUC. Post-approval monitoring may involve inspecting unique housing environments and/or specialized equipment, observing and monitoring procedures, observing animals, records review, or other activities deemed necessary by the IACUC.In all cases an educational and collaborative partnership with investigators and staff is expected.
- Any deficiencies or deviations from the approved protocol and amendments will be noted and corrective actions and timelines will be established at the time of the visit.
- The P.I. will be provided access to the IACUC approved report. The report will be submitted to the IACUC for review, discussion, and approval during a convened IACUC meeting.
- If the deficiency or deviation is considered significant, is not corrected within the allotted timeframe, or if there are repeated deficiencies or deviations, the IACUC will determine any further corrective action. AAALAC, OLAW, and/or USDA will be notified as appropriate, based on corrective action taken and per agency requirements.
Date: August 11, 2016
Enabled By: USDA/PHS
Supersedes: January 10, 2013