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: Agreements/Reliance
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.
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: New steps added to the Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Request Agreements’ step on their Getting Started Checklist when selecting ‘sIRB only’ in the study setup for whom can use IREx to send instructions for executing the required agreements. Reviewing IRBs will also have a new ‘Manage Agreements’ step on their checklist if there are sites with incomplete agreements listed on the study – when clicked, the Manage Agreements dialog will open for the Reviewing IRB to enter executed agreements for relying sites.
New Feature: Allow to resend ‘Request Agreements’ notification
Reviewing IRBs and Study Managers can resend the Request Agreements notification to sites with incomplete agreements. From the Status Summary’s Agreement column, use the drop down and press ‘Request Agreements’ to resend a notification. The button and pop-up will show the last date the request agreement notification was sent for the site.
New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies
Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:
- Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
- Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.
Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.
Updated Feature: Letter of Reliance now included in Local Considerations Export
The Letter of Reliance is now included in the Local Considerations Export for sites, along with the HRP and PI Surveys, the SSRP, and the Institutional Profile.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
New Feature: Data exports for sIRBs and Relying Site HRPPs
sIRB and HRPP liaisons can now export a csv file to quickly view and analyze data for studies, including dates for registration, reliance, and approvals. The sIRB can utilize the export to evaluate processes and assess efficiency (time to approval) and workload (number of relying sites). Relying HRPPs can also export data to efficiently view all studies in which they are participating, the SIRBs serving for those studies, and dates for registration, reliance, and approvals. Access this feature through the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards under “Exports.”