The Agreement Checker is a helpful tool on the IREx homepage which helps see if potential sites have already executed reliance and broad indemnification emails for a selected sIRB. We have made enhancements to make this tool easier to use and more visually appealing. There is added informational text explaining that sites are only required to execute one reliance agreement offered on a study, even if they have executed multiple. The SMART 1, SMART 2, and Other Reliance columns have been shaded to show that all are considered a reliance agreement. The Other Reliance Agreement and Indemnification columns have been updated with an easy-to-spot ✔️check mark symbol. The csv export includes the full FWA number.
Category Archives: Reviewing IRB
Updated Feature: Site-Specific Approval dates show for a review that has not been approved
When sIRB or SMs add a submitted and reviewed date, these dates now show even if there is no approval yet. This can help Relying Site study teams stay informed about whether the review has been submitted to the SIRB.
Updated Feature: Email notification includes helpful guidance when new sites added
When a site that has not joined IREx is listed on a study, the “Participating Sites Added to Study” email now includes helpful text to guide how the site HRPP/IRB can initiate access for their site through the Join IREx page. This is an existing email sent to Reviewing IRBs and SMs if either party adds new sites to a study, but now updated for clearer guidance.
Updated Feature: Updated training links
Training links have been updated to go to our comprehensive training page, which includes helpful live and on-demand (via YouTube) trainings for all users.
Updated Feature: Enhancements to Document Organization and Display
Approval Documents in both Study-wide and Site-specific IRB approval tabs now include a “date uploaded” column and are sorted by ascending uploaded date. Now it is clearer which documents have been carried forward from past approvals and which documents are new.
Updated Feature: Added Site Amendment button on Study Wide Approvals tab for sIRBs and study managers
Study managers and sIRBs can now add a site amendment straight from the Study-Wide Approvals Tab under the Manage Version button.
New Feature: How-to videos are embedded in the IREx Setup on Agreements tab.
Two videos are embedded in the IREx Setup on the “Agreement” tab to help sIRBs know (1) what agreements can be offered on a study and how to add them and (2) how to offer a non-SMART IRB Agreement to an existing study.
Updated Feature: Agreement Checker includes other Broad Reliance Agreements.
The Agreement Checker, which can be accessed from the IREx homepage after logging in, has been updated to reflect whether relying sites have executed any non-SMART reliance agreements with the selected single IRB. The Agreement Checker also reflects whether relying sites have executed a broad indemnification agreement with the selected single IRB. Study-specific agreements are not reflected in the Agreement Checker since execution of those agreements cannot count towards other studies.
Updated Feature: An 8-digit FWA is now required when listing a new site that does not exist in IREx on the Participating Site dialog.
Occasionally an sIRB or Study Manager adds a site to their study that does not yet exist in IREx (i.e., the site does not pop-up when typing their name). The FWA number will be required to add this site to IREx, as this information helps ensure the institution has an active FWA, which is the minimum standard for participating. A link to the OHRP FWA database is provided for reference.
Updated Feature: Participating Sites Dialog distinguishes whether site has joined IREx.
In order to help sIRBs and Study Managers know they need to request a site join IREx before the site can provide reliance and local review documentation in IREx, the Participating Sites dialog will now include the following text for sites that have not signed the IREx Terms of Use:
Let this site know their HRPP/IRB needs to initiate IREx access for their site here.