InfoEd IRB Module Updates Go-Live on December 16th!
The IRB Office is EXCITED to announce that the updates to the IRB module of InfoEd will go-live December 16th. The updated system will help streamline IRB submission and review processes, making it easier to keep track of your protocols and communications with the IRB staff, and streamline the review process.
| IS TRAINING AVAILABLE?
Research Integrity & Compliance will offer weekly training opportunities both in-person and online via WebEx or Teams. They are open to all UConn faculty, staff, and students. A recorded session will be made available for those unable to attend in person. Sign-up links for both in-person and online training sessions are located on our InfoEd Training session webpage. |
WHAT WILL BE DIFFERENT?
- Consolidated Smart Forms: With this update, the 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.
- Updated Protocol Templates: Comprehensive protocol templates will be introduced with enhanced instructions to help research teams understand what the IRB is looking for up front with the goal of reducing back and forth during the review process and reducing the time from submission to approval.
- Responding to IRB Feedback: System enhancements will make it easier for study teams to respond to IRB feedback. IRB staff will add comments directly into the electronic form for study team review and response. Modified e-forms and the documents uploaded within them can be compared against historical versions within the system. These enhancements will greatly reduce the need for submitting clean and tracked changes versions of documents.
- Routing: Routing will be 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) will 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 will be two types of amendments: Personnel Changes and 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 will allow the IRB office to identify personnel changes at a glance so that they are quickly processed.
- Ancillary Reviews: In the current process, IRB staff identify whether additional reviews (e.g., Privacy, ITS, Biosafety, etc.) are needed and initiate the review during the pre-review process which does not begin until it is the submission’s “turn” in the queue. In the updated system, there are questions built into the application form that will determine the need for most ancillary reviews and automatically inform the responsible office that a review is needed. This upfront process will help streamline review times.
- Reportable Information/Events: All reports of issues that arise during research or information that is required to be reported to the IRB will be reported using a single smart form. There will no longer be 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.
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 (starting on February 25th, 2025) or with the next submission to the IRB (for studies without continuing review). A study migration guide is forthcoming.
The following studies will need to be migrated:
- Studies that received approval or exemption determination from UConn Storrs IRB prior to the system updates;
- 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;
- Determinations that a project is not research or projects that are determined not to involve human subjects (aka NHSR determinations);
- 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:
- Enrollment is closed,
- Interactions and Interventions with participants are complete,
- Data collection is complete, and
- Analysis of identifiable information and/or identifiable biospecimens for the purposes of the current research is complete.
- 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.
How-To Guides with step-by-step instructions will also be made available including:
- InfoEd Guide for Researchers
- InfoEd Guide for Ancillary Reviewers
- InfoEd Guide for Department Reviewers
- InfoEd Guide for IRB Members
Keep visiting these dedicated InfoEd Update webpages for updated information.