Post Approval Monitoring

 

Purpose

The Institutional Animal Care and Use Committee IACUC) recognizes that ensuring compliance with approved animal care and use protocols is an important aspect of a laboratory animal program. The purpose of a post approval monitoring (PAM) program is to work with investigators to facilitate their animal research and to be proactive in identifying potential problems in their compliance with active IACUC protocols. The PAM program at UConn Health will operate under the acronym PAWS: Post-Approval Animal Welfare Support.

Action

1. All PAM will be under the supervision of the IACUC and will be performed by a designated Compliance Liaison Officer (CLO) accompanied by one voting member of the animal Care Committee.  A minimum of 12 reviews will be performed per year.

2. All active animal care and use protocols are eligible for PAM review. Criteria which may increase the frequency of PAM protocol review include:

  • Animal use in pain categories D or E
  • Significant personnel changes
  • Significant increases in protocol activity
  • The use of biohazards and/or carcinogens
  • The use of physical restraint
  • The use of food and/or water restrictions

3. A summary of the findings of PAM reviews during a given month will be reported to the IACUC at its monthly meeting.

4. The PAM program consists of the following areas:

  • Semi-annual inspections;
  • Unannounced drug inspection visits;
  • Observation of procedures:
  • Records review;
  • Housing room inspections;
  • Review of new protocols with investigative staff prior to first use; and
  • Any aditional activity deemed to be appropriate by the IACUC and/or IACUC staff.

5. The PI and the senior research staff for the reviewed protocol are required to be present during a PAM review to facilitate the review; this likely depends upon the activity being reviewed.

6. Issues that pose a significant threat to animal welfare will be referred immediately to the attending veterinarian for resolution and also to the IACUC for further investigation.

7. A written report of the monitoring results, including suggested corrective actions, will be brought to a meerting for review by the IACUC.

8. The PI will have 28 calendar days from the IACUC meeting date of the discussion of the initial PAM review to respond to any identified deficiencies and recommended corrective actions. Investigators who disagree with PAM review results, recommendations, or corrective actions can appeal their concerns to the IACUC.

9. The IACUC chair (or designee) will review and approve the PI’s responses. If the PI’s responses are not acceptable, the IACUC chair (or designee) will seek further revisions and the PI will have 14 additional days to respond.

10. If the PI does not respond to the inspection findings of the PAM activity conducted within the appropriate time frame as outlined above, the ACC will then decide on how to proceed.

Effective Dates:   June 6, 2024 thru June 30, 2027