Post Approval Monitoring (PAM)

Function of PAM

PAM works alongside Rutgers Universities IACUCs to support ongoing review of research. PAM functions in two ways: First, through managing the semiannual assessment inspections of research facilities, as required by the Federal regulations; second, by reviewing the research activities involving animals through the post-approval monitoring process. Since protocol approval is prospective in nature, post-approval monitoring takes place after the commencement of research (started upon approval of the research protocol by the IACUC).

Post-approval monitoring also provides an opportunity for PAM personnel to communicate with the research staff, review approved protocols, suggest and provide additional training, review the documentation, and observe research procedures as they are being performed. This enables the university to not only ensure compliance, but also benefits researchers who receive constructive feedback toward animal welfare practices. PAM is respectful and constructive and should be viewed as an opportunity for communication, education, and relationship development between the user groups (i.e., the PIs, research personnel, and animal care staff), the IACUC, and PAM personnel.

 

Background:

  • Protocols are selected randomly by IACUC staff member, Veterinary or care staff. They may be selected for cause or by risk-based assessment to ensure adequate oversight of more involved, complex protocols.
  • Post approval monitoring is generally performed by compliance team member or IACUC research liaison and it is essential if lab personnel familiar with research is available during the visit.

Topic:

  • PAM inspection may involve but not limited to review of approved protocols, documentation review, inspect housing environments, observe animals and any other activities considered essential by IACUC.

Process:

  1. IACUC office will coordinate the visit with PI by email, confirming date and time of the inspection.
  2. PAM Team may use Post-Approval Monitoring checklist to conduct their visit
  3. Upon completion of the audit, conclusion briefings will be shared with the PI or designee and/or lab member to confirm the accuracy and findings from the visit.  Any protocol deviation or problem conditions that were found will also be shared with the Lab staff member during this briefing.  
  4. Official report summarizing findings from PAM visits will be sent to PI and/or designee and submitted to IACUC for review and approval during a convened IACUC meeting.  PI must login to eIACUC system to view their concerns and address them by the due date as listed.

 

For inquiries related to post approval monitoring contact:

Damir Hamamdriz, D.V.M., Ph.D.
675 Hoes Lane West, Room 115
Piscataway, NJ 08854
Office: 732-235-6084
iacuc-pam@ored.rutgers.edu