What does the administrative closure of the old paper studies mean?

Answer

Background Information
On September 18, 2023, the University of Illinois Urbana-Champaign launched the IRBOnline system to modernize IRB processes and ensure proper documentation to meet human subject research regulatory requirements.  To meet these requirements, in addition to all new projects being submitted in the IRBOnline system, all previously approved projects that remain active were required to be "transitioned" to the IRBOnline system.  The transition plan was first introduced to the UIUC campus, inclduing a deadline, via presentations beginning in August 2023.  Researchers were regularly informed of the pending deadline and effective October 31, 2024 all IRB applications that had not been reviewed and approved within the IRBOnline system have ben closed and archived.  
 

What does "administrative closure" mean? 
Functionally, there is no difference between an administrative closure and an expiration.  An administrative closure means that the IRB closed the study for administrative reasons, the study did not expire, and it is not being closed due to any concerns for participant safety and welfare.

Once a study has been closed, no human-subject research activities may be conducted.  The standard rules and regulations apply as to what activities require IRB approval.  Generally speaking, once a study has been closed, researchers cannot have any interactions with participants (for purposes of the project), cannot collect any new data, and cannot analyze identifiable data.  Please review the OPRS website for standard policies and regulations regarding the definition of human subject research.  
 

Can I reopen this study? 
If you would like to continue research procedures after a study has been administratively closed, please submit a New Study Application in IRBOnline.  For more information please see https://oprs.research.illinois.edu/news/updated-guidance-completing-new-study-application. 
 

I already transitioned my project, why am I getting a closure letter now? 
Manually tracking all of the transitions and closures has been quite a large task, OPRS staff may have overlooked sending you a letter originally or may have made a mistake in tracking the letter when they sent it.  Regardless, no additional communication with OPRS is needed, file this letter away as part of your research records and be assured that at this time all records with OPRS have been closed and archived.  
 

This is the same project; it doesn't make sense to say that my project has been closed.  
The IRB number is just a way to administratively track IRB-reviewed research projects.  What really matters is that any human-subject research-related activities are approved by the IRB.  Federal regulations require researchers to maintain all of their IRB communications as part of their research records.  If you are keeping all the required documentation about the study, you will have an audit trail showing your original IRB approval letter, approved IRB applications, new IRB approval letter, new IRB approved application, and closure letter for the original paper application (and eventually closure of the IRBOnline application).  As long as you can show that the two numbers are related (because the activities are the same or similar) your records will be complete.  Auditors understand that the IRB number is just an administrative tool to track the approvals.  Additionally, OPRS has published an official letter on its website that can be used to explain the transition to any program officers or auditors should that be required.  

I was finished with this project a long time ago, why am I getting this closure letter now? 
When we were using the paper IRB applications, everything had to be tracked and documented manually.  This is a huge benefit of IRBOnline!  It is possible that the OPRS records were never updated when you finished the project either because you didn't report it to us or we missed it and inadvertently did not send you a closure letter.  Just keep this new letter as part of your research records for the project to document that the IRB has officially closed the project.  
 

My study was closed and before the new application was approved in IRBOnline one of the research team members still performed some research activities.  What do we do? 
If a research team member conducts any research activities that are not approved by the IRB at the time, that is considered non-compliance.  The PI is responsible for ensuring only IRB-approved research activities occur - which includes having an active, current IRB approval at the time of the research activities.  However, deviations do happen.  The deviation will need to be reported to the IRB, but this can only happen once the new application has been approved.  

To report research activities that occurred without IRB approval:
Once the study has been approved in IRBOnline, submit a Report Form using the report type "Non-compliance" to report a deviation of research activities that occurred without IRB approval.  You will follow the standard report form process.  Please make sure to specify exactly what activities occurred without current IRB approval.  The standard report form review process will be followed.  
 

Why did we have to re-submit and have our projects re-reviewed? 
As has been previously mentioned, the IRBOnline system is modernizing the UIUC research enterprise and helping make our research infrastructure support the innovative research that occurs at UIUC.  Part of that support includes ensuring that all currently active human-subject research projects meet federal regulations and that UIUC has the appropriate documentation on file to maintain those projects.  

Some of the active paper applications were reviewed and approved by the IRB over 20 years ago.  There have been numerous changes to the protocol forms during that time and many research regulation changes, including a major overhaul in 2018 of the Common Rule which governs all human-subject research.  The previously approved projects were generally not updated to meet the new requirements or institutional policies once originally approved.  Additionally, OPRS, the IRB, and UIUC have been unable to confirm appropriate documentation and meet all reporting requirements due to the manual review process that is required with paper applications.  

By submitting all projects into IRBOnline, the University of Illinois Urbana-Champaign is ensuring that as an institution we have all of the documentation needed to meet our federal institutional reporting requirements, as well as ensuring the IRB has met its regulatory requirements as well as accreditation requirements.  PIs can also now rest assured that they will have all of the documentation needed if any questions arise from funding agencies, regulators, or journal editors.