IREx updated the email sent to Reviewing IRBs, “IREx: Participating Sites Added to Study” when a Study Manager adds site(s) to a study that previously offered the SMART IRB V1/V2 reliance agreement. The email subject changed to “IREx: Action Required – Add Reliance Agreement.” This is to notify Reviewing IRBs they must log in to IREx and indicate another reliance agreement (e.g., SMART IRB V3.0) from the IREx Study Setup, since sites can no longer rely using the SMART IRB Agreement V1/V2 after March 17, 2025. This will allow the newly added sites to move forward and complete reliance.
Category Archives: Reviewing IRB
Updated Feature: Modified “Is Site Enrolling” question on Relying Site Approvals dialog for Initial Approvals
When uploading the Initial study approval for a relying site, Reviewing IRBs and Study Managers will notice the “Is Site Enrolling?” question has been updated to, “Will Site Enroll Participants?”. This ensures Reviewing IRBs and Study Managers mark ‘Yes’ when uploading the initial approval for sites had not started enrollment. However, for Study-wide amendments and Continuing reviews, this question will remain the same.
New Feature: Automating Local Considerations – Live Sept. 5, 2025
IREx now includes an automated local considerations feature that streamlines information collected in the HRP surveys by pre-populating the data from a site’s Institutional Profile, based on study elements identified by the Reviewing IRB. First, the Reviewing IRB selects applicable study elements (e.g., children, genetic testing) and can add up to five custom questions on the HRP and/or PI surveys. Then, IREx will pull the relevant questions related to the study elements from the IP into the HRP Survey. The HRP and PI surveys will have a new section, Study Elements Relevant to Local Review, with pre-populated information from their Institutional Profile (IP) that applies or custom questions, which the Relying HRPP can confirm or edit as needed.
New Feature: New ‘Confirm Study Elements’ step added to Checklist
A new ‘Confirm Study Elements’ step is added to the Reviewing IRB’s Checklist to capture study elements that apply to the study. The ‘Confirm Study Elements’ step is also added to the Study Manager Checklist when a Study-wide Amendment is created, allowing the Study Manager to make edits to the study elements as needed. Study elements include federally regulated and other elements related to state laws/local policies. Additionally, the Reviewing IRB and Study Manager can add up to five additional study elements/question(s) to the HRP and/or PI survey if “Other” is selected.
New Feature: Study elements history stored on Approvals tab
IREx will store the study elements history on the Approvals tab, next to the approval/review type. The study elements history can be used by anyone with study access to view which study elements were indicated and apply to the study per approval.
Enhanced Feature: “Confirm Study Elements” To Do status added on Reviewing IRB Dashboard
The Reviewing IRB Dashboard is now updated to include the Confirm Study Elements status on the To Do column. This status is to remind the Reviewing IRB to indicate the study elements that apply to the study.
Enhanced Feature: Institutional Profile PDF removed from Local Considerations Export
The Institutional Profile (IP) PDF is no longer included in the local considerations export. This reduces duplicative review with information that may conflict on a per study basis now that relevant study elements, as indicated by the Reviewing IRB, is pre-populated from the IP into the HRP Surveys for revie
Updated Feature: Removed Alternate Local Consideration option from IREx Setup
We removed the ‘A consent form generator will be used to build consents for sites’ option from the “How are sites’ consent forms being handled?” question in the IREx Setup. New studies moving forward will not have this survey option. However, any existing studies that selected this option previously will still be able to access their surveys as normal.
Enhancement: Updated Institutional Profile (IP)
IREx modified the Institutional Profile (IP) by replacing most file upload fields with text boxes and included new fields in Sections 1, 2, and 4. On May 20, 2025, all IPs were set to ‘Incomplete’, and HRPP Liaisons are required to complete the new text fields replacing the file uploads; answer the new questions in Sections 1 & 2; and review/update Section 4 if currently or plan to use IREx as the single IRB. Relying HRPPs will be required to update before they can cede reliance. The pop up Relying HRPPs see when their IP is incomplete is updated to include information about these changes. The IP PDFs on the IREx website is updated once new IP questions are completed.
Updated Feature: Allow to turn off site amendment approval notifications
Reviewing IRBs and Study Managers now have an option to check a box to turn off the email approval notification and updates for site amendments.