Administrative check-in is a periodic administrative review of ongoing research activities that do not require continuing review. While the regulations do not require continuing review for all studies, the Human Research Protection Program (HRPP) maintains responsibility for ensuring adequate oversight of ongoing research and must keep our research records current. The administrative check-in process will allow the ETSU HRPP to verify compliance with other requirements such as investigator and study staff training.
Review of Admin Check-in
Investigators are informed of the administrative check-in date in the initial study approval letter. Investigators will receive electronic reminders with instructions for how to submit the Admin Check-in xform in IRBManager. Review of the administrative check-in will be completed by IRB staff and will be documented in the study record.
- The conduct and compliance of any research activities carried out under their direction
- Providing sufficient documentation to the IRB and HRPP to make the necessary regulatory and ethical determinations needed to maintain IRB approval
- Training research study staff and ensuring they complete all IRB required training
- Submitting a study closure to the IRB when the research is completed
Where can I find the admin check-in date for my study?The Administrative Check-in date will be on your initial approval letter. Your subsequent reviews will be based on the date in your Protocol Page in IRBManager under the Protocol Site section. You will receive automated reminder notices from IRBManager as your Admin Check-in date approaches well.
How often does Admin Check-in occur?Exempt and most minimal risk research will no longer be issued expiration dates or require continuing review. Instead, the ETSU HRPP will require an annual administrative check-in to be submitted as long as the study remains active.
How do I submit the Admin Check-in?The study staff or PI should submit the Admin Check-in xform in IRBManager by the assigned date. It is a very brief form that asks about the study status and if any events have occurred that need reporting. In most cases, in only take about 5 minutes to complete. The IRB staff will review the form, and if no issues are found, you will receive an email acknowledgment.
What is the IRB looking for in their review?During the review of the Admin Check-in, IRB staff will verify current training requirements are met for study staff (i.e., CITI human subjects training, ETSU HIPAA training) and check to see if any new conflicts of interest have been disclosed. Additionally, the IRB staff will note whether any issues or events were reported such as new safety reports, protocol deviations, adverse events, etc. Any issues or incidents will be referred to the IRB Chair for consideration.