UF IRB QA/QI Program Team Offers New Tool
Researchers and study staff, please be on the lookout for a new tool from the UF Institutional Review Board (IRB) Quality Assurance/Quality Improvement Program team (UF IRB QA/QI). UF IRB QA/QI will soon be rolling out its Post-Approval Monitoring (PAM) self-assessment survey tool.
While the initial roll-out of the PAM self-assessment survey tool will target greater-than-minimal-risk studies, the tool can be used for any study type and requests from the QA/QI team to conduct self-assessments may extend beyond greater-than-minimal-risk studies.
In addition to QA/QI-requested PAM assessments, the PAM survey tool (Word document) is also available on the IRB website so that study teams may download and use the tool to conduct self-assessments of any of their studies anytime. The UF IRB encourages researchers to conduct self-assessments at least annually.
As part of its quality improvement initiative, the IRB QA/QI team currently conducts informed consent reviews of Full Board, greater-than-minimal-risk studies approximately 6 months after approval. Study teams receive an email request to submit up to 5 of their most recently signed informed consent forms for review. Soon, as part of that initiative, study teams will also be asked to complete the PAM self-assessment tool.
The PAM self-assessment survey tool lets researchers conduct self-assessments of their IRB approved projects to ensure the studies are conducted in compliance with approved procedures and IRB, university, and federal regulations and policies. In addition to QA/QI-requested PAM assessments, the PAM survey tool is also available so that study teams may download and use the tool to conduct self-assessments of any of their studies anytime.
The primary purpose of post-approval monitoring is to improve UF researcher regulatory compliance. The information gathered during PAM is used by the IRB and the IRB QA/QI team to monitor the implementation of approved protocols, to identify areas that need improvement, to correct or target opportunities for education, to gather information for continuous quality improvement of UF IRB procedures and processes, and to improve our customer service.
The QA/AI Program team is always available to answer questions and provide guidance regarding the Post-Approval Monitoring self-assessment survey tool. Get in touch with us by calling 352-273-9600 or by e-mailing us.
