Office for Research Protections | IRB | QA
Reminder: IRB Studies Lapsed for 45 days will be closed
As outlined in the Investigator Manual, IRB-reviewed studies that have been lapsed for more than 45 days will be administratively closed. Once closed, these studies cannot be re-opened and a new IRB submission would have to be completed to continue any human research activities.
HRPP began enforcing this administrative closure of studies lapsed for more than 45 days at the start of this year. Please pay close attention to reminders from the CATS IRB system, and remember that research data cannot be collected when a study has lapsed.
RNIs for Routine Post-Approval Reviews
The Research Quality Assurance (RQA) and Quality Assurance (QA) teams are making a process change to the submission of audit results to the IRB for directed audits and routine post-approval reviews (PARs). RQA serves the College of Medicine research community and Quality Assurance assists investigators at the University Park and Commonwealth Campus locations. Both teams collaborate to ensure consistency in quality assurance practices across the commonwealth.
Previously, RQA and QA submitted directed audit and PAR reports as Reportable New Information (RNI). Moving forward, PIs will need to submit the RNI themselves to facilitate communication with the IRB for any potential follow-up. An RNI is required for all directed audit reports and any PAR reports that include findings, including self-evaluations via HRP-430/439.
Following an audit, a report will be shared with the PI and study team. PIs will have an opportunity to comment on the report prior to finalizing and submitting to the IRB. Any required Corrective and Preventive Actions plan (CAPA) will be indicated in the report, and the PI will be provided with a CAPA template. It will then be the responsibility of the PI to submit the report and any required CAPA as an RNI. This will allow for smoother communication and follow-up between the IRB and study team. Quick guidance on how to submit an RNI in CATS IRB is available.
PAR reports with no findings will not be submitted. RQA will provide guidance regarding the RNI submission process when working with the research team. The QA team at University Park will follow the same process.
Researchers at University Park and the Commonwealth Campuses can find more information about PARs on the Quality Assurance website, found here: https://www.research.psu.edu/postapprovalreviews
More information about RQA can be found on their website linked here: https://research.med.psu.edu/research-support/research-quality-assurance/