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.
Category Archives: Reviewing IRB
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.
Updated Feature: Continuing Review reminder notification cc’s Study Managers and clarifies what action is needed.
Study managers will now be cc’d on the email reminder sent out when a study is nearing the expiration date listed in IREx. This email notification serves as a reminder to upload the continuing review approval to IREx to ensure the approval statuses for sites stay up-to-date. The email also now includes a hyperlink to the quick guide for uploading continuing reviews.
New Feature: Capture any reliance agreements in IREx.
SIRBs can now use IREx to track broad or study-specific reliance agreements, such as an IRB Authorization Agreement (IAA) or MOU, for sites who are unable to join SMART IRB. These reliance agreements can be designated as “broad” – to be used across multiple studies – or “study specific” – for use on a single study only. An sIRB can offer both SMART IRB plus another reliance agreement on the same study; when this happens, Relying Institutions that are part of SMART IRB will automatically default to using SMART IRB so no additional tracking is needed.
Updated Feature: SIRBs can now track study-specific indemnification.
SIRBs have been able to track the use of broad indemnification agreements, such as Letters of Indemnification (LOIs), since February 2019. Now, SIRBs can utilize IREx to track study-specific indemnification agreements. When indemnification is required on a study, an “Indemnification” column will appear on the Status Summary tab, and Relying Institutions will be unable to rely until the SIRB indicates the indemnification agreement has been executed.
Updated Feature: SIRB Liaisons have “Agreement Manager” on the Status Summary tab.
When an IAA, MOU, or other institution-specific reliance agreement or indemnification agreement is offered by the SIRB on a study, an “Agreement Manager” appears on the Status Summary tab for the SIRB. The sIRB uses the Agreement Manager to track the agreement status of Relying Institutions on a study. The sIRB can indicate which Relying Institutions will use their reliance and/or indemnification agreements and track when agreements are sent and executed.
Updated Feature: Notification of Reliance indicates when non-SMART IRB reliance agreement is used.
If another reliance agreement (e.g., IAA, MOU) is offered by the SIRB, Relying Institutions that execute that agreement and indicate reliance will see the name of the SIRB’s reliance agreement in the email and attached PDF.
Updated Feature: Agreement Dashboard located on the IREx Homepage.
All HRPP Liaisons have access to the Agreement Dashboard from the IREx Homepage. This dashboard reflects all reliance and indemnification agreements for one’s site on three tabs where HRPPs can track (1) non-SMART reliance agreements one’s institution is offering when serving as the SIRB; (2) indemnification agreements their institution is using when serving as the SIRB; and (3) reliance and/or indemnification agreements their institution has or is expected to sign when relying on an SIRB for a study.