Post Approval Monitoring Policy
I. Purpose
The purpose of this policy is to describe methods for continuing IACUC oversight of animal activities as required by federal laws, regulations and policies. The Post Approval Monitoring program will enhance the IACUC’s ability to monitor approved procedural activities, provide information about programmatic risks and associated issues and convey practical corrective plans for the identified risks.
II. Scope
This policy applies to Principal Investigators (PI) and all individuals involved in research animal care and use at MSU.
III. Definitions
PAM: Post Approval Monitoring
IV. Process
PAM will be performed regularly to ensure that ongoing animal work conducted at MSU is conducted in accordance with IACUC approved protocols, institutional policies, and procedures. PAMs may be conducted for any of the following reasons:
- Requested by the IACUC.
- Risk-based.
- Issue-based.
- Random selection.
V. Procedures
The IACUC, veterinary, animal care and compliance staff, or the IACUC designee may all conduct PAM. PAM may be conducted utilizing a variety of methods depending upon the nature of the activities and goals of the monitoring. Typical methods for PAM may include all, but are not limited to, the following activities:
- Advance review of an approved protocol.
- Interviews with PIs, research, veterinary and husbandry staff.
- Comparison/verification of animal numbers.
- Reviews of training methods/records.
- Breeding colony management.
- Reviews of records for consistency with the protocol and institutional policies.
- Review of animal/use study areas.
- Inquiries about unanticipated adverse events.
- Confirmation of appropriate medical surveillance participation.
The findings of any type of PAM review will be shared with applicable individuals, the IACUC and regulatory oversight agencies as needed.
References
ILAR Journal, Volume 49, Issue 4, 1 January 2008, Pages 402–418
IACUC Approval Date: 05/16/2018
Review Date: 5/26/2022
Issue Date: 05/27/2022