The HRP Survey now includes a study elements banner that notes the Reviewing IRB has identified the study element(s) that apply to the study and lists the elements. It mentions that questions and responses from the Relying HRPP’s Institutional Profile (IP) related to the study elements are pulled into the HRP Survey in the Study Elements Relevant to Local Review section, which can be edited by the Relying HRPP. However, any edits to these questions will not change the IP.
Category Archives: FRL
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
Bug Fixes – October 6, 2025
| Fixed: Added an error message to let the user know when SSRP is not working at the moment and to notify the IREx admins. |
| Fixed: Allow NIH IRP sites to sign SMART V3. |
| Fixed: Can no longer replace protocol when uploading a site amendment. |
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.
Bug Fixes – August 4, 2025
| Fixed: The Site Updates tab on the Approvals dialog now shows the correct site selection. |
| Fixed: Add close button ‘X’ on the Confirm IP dialog. |
| Fixed: Modified lead site initial approval notification to no longer reference zip files. |
| Fixed: Able to add HRPP member from the ‘Add HRRP Staff/Members’ dialog on the homepage. |
Updated Feature: Agreement Checker available on the public website
The Agreement Checker tool is now available on the IREx public website. It allows anyone – not just IREx users – to check and download the status of participating sites’ required agreements based on the single IRB selected. Lead study teams may find this tool useful in gauging site readiness.
Updated Feature: SMART IRB V3 column added to Participating Institutions page
The IREx public Participating Institutions page now has a column to track sites that have joined SMART IRB agreement V3.0.
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.
Bug Fixes – June 2, 2025
| Fixed: If SSRP reset for SMART V1/V2, allow relying site to re-confirm SSRP for SMART V1/V2 |
| Fixed: Change ‘Updated’ status color in Reliance Decision column to grey |
| Fixed: Display SSRP V1/V2 for Multisite Liaisons that relied on SMART IRB V1/V2 |