Post Approval Monitoring

Federal regulations charge Rutgers University with ensuring and advancing animal welfare, while supporting our faculty’s scientific research. A part of the university’s charge is to provide continuing oversight of research involving animals through ongoing reviews. Rutgers University Animal Care unit has established a Post-Approval Monitoring (PAM) program to support this compliance requirement.

PAM works alongside both of the university’s IACUCs to support the ongoing review of such research. PAM helps the University fulfill this requirement in two ways: First, through managing the semiannual assessment inspections of research facilities, 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 provides an opportunity for PAM 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.

It should be noted that PAM is not a substitute for any of the IACUC’s responsibilities or duties. Instead, PAM assists the committees in performing program and facility review more effectively. PAM is designed to build bridges, encourage partnership, enhance education, and ensure animal well-being. PAM provides constructive means toward animal welfare, and it welcomes suggestions from researchers to ensure that state-of-the-art methods are taken into account toward the creation of best practices.

Background

• Protocols are selected randomly, for cause, or by risk-based assessment to ensure adequate oversight of more involved, complex protocols.
• Post approval monitoring is generally performed by IACUC office staff and/or CMR staff.

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.

Forms

Please note: All documents require a Net-ID login to access.

PAM PI Self-Evaluation Form - Feb 2020