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Policy#: 529-232

Title: AUP PROCEDURES: Scheduled Post Approval Monitoring

Effective: 10/9/2023

Link: http://redit.ucr.edu/OrApps/RED/Policies.aspx?k=92

I: Related Policies and Guidance

529-224: IACUC Review of Animal Use Protocols (AUPs)

529-205: Investigation and Resolution of Non-Compliance Involving Vertebrate Animals

529-276: Satellite Housing

 

II: Background and Purpose

The purpose of the Post-Approval Monitoring (PAM) Program is to ensure research and teaching activities involving live vertebrate animals are conducted in accordance with all applicable federal and state laws, accreditation bodies, and University policies and to ensure they are consistent with the Principal Investigator’s (P.I.) approved animal use protocol (AUP).

 

In addition to providing a continuing review of IACUC approved procedures, PAM aims to promote a collegial relationship between the IACUC and the researchers to facilitate quality research while enhancing compliance.

PAM is conducted as collegially and informally as possible by the PAM Team and is an opportunity for investigators (PIs and/or research personnel) to request any help or information they may need regarding IACUC policies and guidelines.

 

III: Process

During an AUP review, any Committee member or IACUC administrative staff may recommend monitoring a particular procedure or activity after approval. The IACUC will determine if PAM should be initiated separately from the mandated semiannual inspection process for any IACUC approved procedure.

During semi-annual inspections, all protocols and satellite facilities are subject to a basic PAM. A more in-depth PAM may be called for due to semi-annual inspection findings.

 

IV: Procedure

  1. The IACUC will appoint a PAM Person/Team to review procedures or activities approved on an AUP. An IACUC Analyst and a veterinary team member will usually carry out PAM.
  2. The PAM Team will send an initial email to the lab to schedule the PAM visit.
  3. During the visit, procedures on the selected protocol(s) are observed, and any drift from the approved protocol(s) is noted.
  4. An exit briefing will be provided at the end of the visit, emphasizing the positives and any preliminary or minor findings. Any serious animal welfare concerns observed during the visit will prompt an end to the visit and procedure and will be reported to the Attending Veterinarian, IACUC Chair, and IACUC Office Manager, where an investigation will be initiated.
  5. The PAM Team will report the results of the visit to the IACUC at a convened meeting.
  6. After the review by the IACUC, a formal communication of any findings and recommended corrective actions will be sent to the lab.
  7. Follow-up visits are conducted to document that any findings highlighted during the first visit have been rectified.


References:

NIH Guide for the Care and Use of Laboratory Animals, pages 33-34

PHS Policy IV.B.4, 6-8; C.1-7

 

Originally adopted 7/14/2008; updated 10/9/2023