Some relying HRPPs, wanted to be able to download a printable PDF of the SSRP and have a 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.
Category Archives: Relying HRPP
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.
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: 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: 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.
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: IREx surveys and PDFs now support line breaks
To make reading easier for all HRPPs (and nicer-looking PDFs), the IREx IP now supports line breaks in open text fields. Line breaks appear in the web view and PDFs of the Institutional Profile (along with the HRP and PI surveys). Liaisons can edit existing/completed IP and HRP survey responses to include line breaks, and the breaks will appear after submitting the changes.
New Feature: SMART IRB Agreement V3.0 now supported in IREx
As of March 17, 2025, institutions must join SMART IRB Agreement V3.0 to establish any new reliance agreements with SMART IRB. IREx will update SMART IRB V3.0 signatory statuses to ensure HRPPs can cede review without delay. For existing IREx studies, Reviewing IRBs must designate SMART IRB Agreement V3.0 as the reliance agreement in the IREx Setup for sites that have NOT yet ceded review. The Reviewing IRB and Relying sites CANNOT cede review in IREx until both have signed SMART IRB V3.0.
New Feature: IREx now supports Exception from Informed Consent (EFIC) studies
IREx now supports studies using the EFIC process. Using IREx to implement your EFIC workflow helps lead study teams track sites in various stages of the EFIC process; standardizes and centralizes EFIC documentation for the sIRB and relying HRPPs; and provides sites with clear EFIC processes and approval statuses. When setting up the study, Reviewing IRBs can select EFIC as an option in the IREx Setup. Study team can now upload their local Community Consultation Plan (CCP) to IREx’s PI Survey and Relying HRPPs can confirm review of the local CCP in the HRP Survey. After the sIRB reviews and accepts the site’s CCP, Study Managers can share the Reviewing IRB’s acceptance of the site’s local CCP to IREx and to begin implementing the plan. Watch this video and read this announcement to learn more.
New Feature: An ‘EFIC’ bubble displayed on study pages and on the list of search results is to indicate a study is an Exception from Informed Consent study
An ‘EFIC’ (Exception from Informed Consent) bubble appears next to study titles on each study page and when searching studies and to indicate which studies are EFIC-supported.