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: FRL
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.
Bug Fixes – December 1, 2025
| Fixed: No longer sending the “IREx Access and Single IRB Instructions” email to the lead study PI. |
| Fixed: Updated resource links on “IREx Access and Single IRB Instructions” email. |
| Enhanced: Include funding/sponsor on “IREx Access and Single IRB Instructions” and “Action Required: Please Complete Agreement(s) for sIRB study” email notifications |
New Feature: Relying HRPPs can download the SSRP PDF before ceding review
If desired, Relying HRPPs can now download a printable PDF of the Study-specific Reliance Plan (SSRP) that includes a date and signature line. When a Relying HRPP clicks “Indicate Reliance” on their Checklist, they will see a PDF button at the bottom that will capture the most recent SSRP changes and includes a blank signature line and date. This will allow the relying site to have a signed copy of the SSRP, as necessary.
Enhancement: Include Reviewing IRB name on SSRP PDF
New SSRP documents will include the “Reviewing IRB: [Reviewing IRB Institution Name]” at the top of the SSRP PDF.
Enhancement: Project ID can be found on the study page
When viewing a study on IREx, the unique IREx project ID can be found in the URL and in the Info tool tip.
Bug Fixes – November 3, 2025
| Fixed: Add close button ‘X’ on SSRP dialog. |
| Fixed: Display PI Survey ‘Other’ study element question and response on the read only view of the PI survey and on PDF export. |
| Enhanced: Modified HRP Survey to include a file upload field for Additional SSRP Documentation (Optional). |
| Enhanced: Email Study Managers when a relying site approval is pushed to IREx via API. |
| Enhanced: No longer automatically publishing relying site approvals sent via API allowing lead study teams to review approval before notifying sites. |
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.