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
- 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.
- The
PAM Team will send an initial email to the lab
to schedule the PAM visit.
- During
the visit, procedures on the selected protocol(s) are observed, and any
drift from the approved protocol(s) is noted.
- 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.
- The
PAM Team will report the results of the visit to the IACUC at a convened
meeting.
- After
the review by the IACUC, a formal communication of any findings and
recommended corrective actions will be sent to the lab.
- 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