In preparation for the implementation of improvements to the InfoEd IRB module, the UConn IRB office has initiated a project to identify and administratively close out studies that are no longer active and those for which IRB approval has expired. Study teams may receive notifications as we go through this process. Most of the correspondence will be notification of an administrative closure which should be retained with your study records. However, please review the correspondence because we will be asking investigators who have a study with a recent lapse in approval to reply and indicate whether they intend to continue/submit a continuation.

The IRB office is actively working on improvements to our forms, templates, and guidance. Please visit our IRB Submissions, Forms & Templates page prior to creating a submission to ensure that you are using the most current versions of our forms and templates.

Additional messages about the InfoEd IRB module updates will be forthcoming.

If you have any questions, please contact irb@uconn.edu.

The UConn IRB office is pleased to announce the following changes to UConn’s CITI training requirements and our related processes.  Our intent is to reduce the number of times that submissions are returned for changes, streamline review cycles, and reduce burden. These changes were effective Monday, November 20, 2023, for new submissions to the IRB and for those that have not yet undergone Intake review.

• Ideally CITI human subjects training should be complete and current at the time of IRB submission for all study personnel so that missing or expired trainings do not hold up the approval.  However, the IRB Office will no longer return a submission at the Intake review if the only issue is missing or expired training(s). An email will instead be sent to the PI informing them of who has missing/expired training(s) and noting that the training(s) must be completed before the study can be approved. Investigators will also be given the option to remove any non-essential personnel from the submission and to add them back on via a personnel amendment once the research is approved and training is complete.

 

• When personnel have completed CITI training elsewhere, but the individual has not yet affiliated with UConn -Storrs and Regional Campuses in their CITI profile, investigators will be given the options of either having them affiliate in CITI so that their training becomes visible to the IRB Office (preferred) or uploading a copy of their CITI Completion Report (not a CITI Training Certificate) into the InfoEd study record. The Completion Report lists the modules that were completed and when. The IRB Office will review the Completion Report and determine whether the training is current (within 3 years) and meets UConn’s requirements or is substantially equivalent (meaning that at least 70% of the modules align).

 

• For studies that are subject to NIH’s Good Clinical Practice (GCP) Training policy, the UConn IRB Office will no longer require proof of CITI GCP training with IRB submissions.  Instead, Principal Investigators will be responsible for ensuring that study personnel have completed the training, that it is refreshed at least every three years, and for maintaining the proof of training. If a study that is subject to the policy has a Post Approval Monitoring (PAM) visit, the PI may be asked to provide the documentation of GCP training for verification. Proof of training should also be provided to other appropriate parties upon request (e.g., other IRBs, SPS, NIH).

 

We are in the process of updating our webpages and other materials to reflect these changes.  Questions about training requirements can be directed to irb@uconn.edu.

 

Improvements to InfoEd: The project to make improvements to InfoEd is progressing well with all forms undergoing basic testing and revisions to ensure that the logic is functioning properly, and that content appears as expected. Work is also being done on the workflow within the system and other aspects of system set-up. We expect to soon be able to do some more advanced testing and will be reaching out to Investigators and IRB Members to assist with the testing and to provide feedback from their perspectives. Announcements will be forthcoming as we continue to make progress.

 

BRANY IRB: The UConn IRB office would like to remind study teams that new externally funded studies and studies with more than 2 collaborating sites or investigators/study personnel should be submitted to BRANY IRB after an administrative review by the IRB Office to validate consistency with UConn requirements. Please note that this includes both faculty and student research. For more information, including a process overview and BRANY-specific protocol and consent templates, please visit the following IRB webpage: https://ovpr.uconn.edu/brany-irb/.

 

We would also like to clarify that collaborating sites refers to universities and other organizations who are engaged in the research. The term “Collaborating sites” is not intended to encompass external facilities (e.g., K-12 schools) or spaces (e.g., lab space) who have agreed to provide access to their facilities/space for research activities but are not engaged in the research itself.

 

Feedback from investigators thus far has been largely positive, but we are working on a few improvements related to feedback we have received. If you have feedback to share, please reach out to the interim IRB Manager, Karen Christianson, or to the IRB Reliance Team. Feedback is always welcome and appreciated. Questions/feedback can also be sent directly to the BRANY IRB Point of Contact, Vanessa Rodriguez, at vrodrguez@brany.com or 516.514.2445.