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.
Category Archives: October 2025
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: Modified HRP Survey now includes study elements banner/header
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.
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. |