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InfoEd Updates

InfoEd IRB module updates were implemented on December 16, 2024.

The IRB Office is pleased to announce that the long-awaited updates to the IRB module of InfoEd were implemented on December 16th. The updated system streamlines IRB submission and review processes, and makes it easier to keep track of your protocols.

 

IS TRAINING AVAILABLE? 

Training sessions are available and open to all UConn faculty, staff, and students. Please contact Nick Lacafta (nicholas.lacafta@uconn.edu) for information about upcoming sessions. A recorded session will be made available soon for those unable to attend in person.

WHAT IS DIFFERENT?

  • Consolidated Smart Forms: The prior electronic application forms (e.g., IRB-1, IRB-5, IRB-7, IRB-9) have been consolidated into a single Main Application form that uses logic to drive your experience. If the IRB determines that a different level of review is required, you will not need to start from scratch, you will simply modify the review type and answer the additional questions that populate.
  • Responding to IRB Feedback: System enhancements make it easier for study teams to respond to IRB feedback. IRB staff can add pre-review comments directly into the electronic form for study team review and response. IRB staff can also compare new and historical versions of e-forms and the most documents uploaded within them reducing the need to submit clean and track changes versions of documents.
  • Routing: Routing is automated; submitters will not have to add the PI and Department Head to the route for review and sign-off. Automated emails will inform study teams as the submission moves through routing and when it arrives to the IRB.
  • Personnel Roles: Personnel roles (i.e., PI, Co-I, Student Investigator, Correspondent) drive who on a study team is able to edit, manage, and submit submissions to the IRB and who will be included on system messages and IRB correspondence. All submissions other than personnel changes and reportable events will be automatically routed to the PI for review and sign-off.
  • Amendments: There are three types of amendments: Personnel Changes, Transition Amendments (for transitioning to the new form), and regular Amendments (for changes to the study itself or study materials). Only one amendment can be in process at any given time. Differentiating the amendment types allows the IRB office to identify personnel changes at a glance so that they can be prioritized.
  • Ancillary Reviews:  Questions are now built into the application form that determine the need for most ancillary reviews (e.g., Privacy, Information Security) and automatically inform the responsible party that a review is needed.
  • Reportable Information/Events: All reports of issues that arise during research or information that is required to be reported to the IRB are now reported using a single smart form. There are no longer separate forms for Adverse Events and Protocol Deviations.
  • Administrative Check-Ins: Exempt studies, studies that do not require submission of a continuing review application, and studies overseen by external IRBs will receive periodic notices to either complete an administrative check-in or a study closure. This will allow the University to have current information about studies and to be able to accurately report.
  • IRB Reliance: Requests for UConn to cede IRB review to another IRB, including BRANY IRB, will now be initiated in InfoEd. Requests for UConn to serve as the IRB of record for other entities are initiated outside of the system using the Request for UConn to Serve as the IRB of Record Form on the IRB Reliance – General webpage. Please see the IRB Reliance pages (IRB Reliance – General, BRANY IRB) for additional information.

WHAT DOES THIS MEAN FOR EXISTING STUDIES?

Most existing studies will need to be migrated to the updated application form for the system to work as intended. Migration will be required before continuing review or with the next submission to the IRB (for studies without continuing review). A Study Migration Guide with detailed information and instructions is available here: https://ovpr.uconn.edu/services/research-it/infoed/human-subjects-module/.

The following studies need to be migrated:

  • Open studies that received approval or exemption determination from UConn Storrs IRB prior to the system updates (December 16, 2024);
  • Open studies that were approved by an external, non-UConn IRB, that have a record in InfoEd.

The following projects do not need to be migrated:

  • Research studies that are closed;
  • Activities that received a Not Human Subjects Research (NHSR) Determination;
  • Projects for which data collection is complete and the only remaining activities are data analysis;
  • Projects that can be closed because they no longer involve human subjects.

Investigators are encouraged to close studies that are eligible for closure as soon as possible. Studies are eligible for closure when:

  1. Enrollment is closed,
  2. Interactions and Interventions with participants are complete,
  3. Data collection is complete, and
  4. Analysis of identifiable information and/or identifiable biospecimens for the purposes of the current research is complete.
  5. When the UConn IRB is serving as the IRB of record for other sites, the study may be closed when all sites meet the above criteria.

Simply maintaining identifiable data/biospecimens without using, studying, or analyzing the data/biospecimens does not require an open protocol with the IRB.

WHERE CAN I LEARN MORE? 

The IRB Office (irb@uconn.edu) is always available to answer any questions you may have.

User Guides with step-by-step instructions are available including:

  • Study Migration Guide
  • User Guide for Researchers
  • User Guide for Ancillary Reviewers
  • User Guide for Department Reviewers