Post Approval Monitoring
IACUC – IBC – IRB
The University of Texas Rio Grande Valley (UTRGV) Post Approval Monitoring (PAM) Program supports the institution's efforts to ensure that ethical and regulatory requirements are followed according to institutional policies and procedures and local, state, and federal regulations and guidelines. This program is designed to improve the quality of the research by ensuring congruency between what is described in the approved protocol and what occurs during the actual performance of research activities. The PAM Program has three pillars:
The purpose of the PAM is to promote research best practices on studies approved or under reliance agreement by the UTRGV:
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee (IBC)
- Institutional Review Board (IRB)
The program serves as an internal review process for proactively identifying and assessing potential problems and for developing and providing educational support and training to research personnel.
The PAM program aims to verify and document:
- the rights and well-being of research participants.
- the humane treatment of animals.
- safeguards for human health and the environment.
- availability of assistance for researchers to maintain or improve the quality and integrity of the research.
- compliance with institutional, local, state, and federal regulations and guidelines.
- congruence between approved protocol and research activities.
- the identification of resources for educational support to investigators and the research community.
For more information about Post-Approval Monitoring, please see Post-Approval Monitoring Standard Operating Procedure.
Criteria for PAM Selection
All active approved protocols are eligible for PAM protocol review in one of the following selections:
- Routine - An annual random sample of a percentage of the active protocols will be selected, focusing on the criteria such as federally funded and regulated, high-risk studies, changes in research personnel, involving invasive technics, carryout in multiple sites, among others.
- Direct - Studies with non-compliance reports or concerns and/or designated by the respective regulatory committee.
Overview of the Protocol Review Process
Protocols can be selected randomly or directed in response to concerns. Once selected, the Principal Investigator (PI) will be notified and will coordinate the visit with the PAM Monitor. The PAM Monitor will visit the laboratory or research facility and meet with the PI and/or research personnel. During the visit, the PAM Monitor may observe the research procedure, review documents, and interview the research team. After the visit, the PI will receive a report containing the findings from the PAM visit. The PI will be given an opportunity to make corrections by modifying techniques or submitting an amendment to their protocol(s). The PAM process will be considered complete only after all the necessary corrective actions have been taken care of.
Resources for Researchers
- IACUC General PAM visit description
- IACUC PI Self-Assessment
- IBC/HBA General PAM visit description
- IBC/HBA PI Self-Assessment
- IRB General PAM visit description
- IRB PI Self-Assessment for Social, Behavioral, and Educational Research
- IRB PI Self-Assessment for Clinical Research
FAQ
A PAM visit may be unannounced, especially in the case of a Directed (For-Cause) PAM visit.
The documents will be destroyed according to UTRGV policy (ADM 10-102) using the Records Management Office.
UTRGV is following the federal, state and local regulation and guidelines for the protection of human subjects in research, animal used in research and teaching, and researchers, which requires the oversight of regulatory research.
Based on the federal, state and local regulation and guidelines, the regulatory committees can rely on a third party to support their continuing oversight.
Directed PAM are due to a non-compliance concern or consistent non-compliance events that need to be verified, then all PI protocols can be designated for PAM direct visit.
Regulatory committees are not directly involved in the PAM visit but will be notified in the case of non-compliance. An annual report with aggregated findings will be provided to the regulatory committees.
Our institution signed an agreement to rely on the other institution IRB for approval and promised to provide monitoring with PAM/QA program.
Corrective and Preventive Action (CAPA) Plan
A Corrective and Preventive Action Plan (CAPA) ensures high-quality research by implementing good research practices. The CAPA Plan should identify the root cause of existing or potential problems, provide corrective actions, and establish a mechanism to prevent reoccurrence. A successful CAPA can protect the rights and welfare of animals, participants, and researchers and ensure reliable data. CAPA plan should be submitted as non-compliance PI Self-report, as a results of PAM findings, or external audit/inspection. If the CAPA plan submission is a PI self-report or as a result of PAM findings, the CAPA plan needs to be submitted along with the Reportable Events and New Information (RENI) form via email to the regulatory committee. This is mandatory for any major deviations and/or (if applicable) Unanticipated Problems (UPs) identified in the conduct of a study. When submitting a CAPA plan resulting from an external audit/inspection, it is important to follow the guidelines provided by the auditors. It is also necessary to include any required forms and send a copy of the plan to the regulatory committee via email. In some cases, the external auditor may provide their own CAPA form to replace the standard one.
For CAPA plan in Clinical Research, please use the forms and instructions from the Office of Clinical Research.
For the CAPA plan in IACUC, IBC, or IRB in non-clinical research or Social, Behavioral, or Education Research (SBER), please read the CAPA Standard Operation Procedures (SOP) and complete the CAPA form. Please submit the form to the respective regulatory committee via email.
CAPA Submission:
- IACUC – iacuc@utrgv.edu
- IBC – ibc@utrgv.edu
- IRB – irb@utrgv.edu
Contact
Mirayda Torres-AvilaAssistant Director Post Approval Monitoring Compliance
956-665-2093
mirayda.torresavila@utrgv.edu