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.
Category Archives: Relying HRPP
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: Relying HRPP Getting Started Checklist reflects agreements offered by SIRB.
When an SIRB offers an IAA or MOU on a study, it will be reflected on the Relying HRPP’s Getting Started checklist. The agreement must be negotiated and executed outside of IREx. The agreement will appear complete in the Getting Started Checklist after the SIRB enters a date executed for the Relying Institution.
New Feature: Relying Site HRPPs receive email when their site can indicate reliance.
If a Relying HRPP registers for a study but has incomplete reliance or indemnification agreements, the Relying HRPP can confirm their local study team and complete local considerations. However, they cannot indicate reliance until all reliance and/or indemnification agreements are executed. Now, IREx will send an email notification to the Relying HRPP when the sIRB indicates all the required agreements have been executed. This email lets the Relying HRPP know they can indicate reliance.
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.
New Feature: sIRBs Can Reset SSRPs
Single IRBs (sIRBs) now have the ability to reset and edit an accepted Study-Specific Reliance Plan (SSRP) for Relying Institutions. When this happens, the Relying Institution is notified of specific changes that were made and can log in to accept the revisions. Then, IREx sends an email, “Relying HRPP Accepted Revised SSRP,” to the sIRB and Relying Institution once the reset SSRP is accepted. Additionally, the date when the revised SSRP was accepted will be reflected on the Status Summary tab and export. (Of note: the sIRB also maintains the ability to edit the SSRP for a Relying Institution before it is accepted.)
As a reminder, the SSRP, used to document how the flexible elements of the SMART IRB Agreement will be implemented, is established when the sIRB creates a study in IREx. Relying Institutions indicate reliance on the sIRB by accepting the SSRP.
Updated Feature: New Document Types on Approvals
Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.
Updated Feature: Redesigned Resources Pages
We updated the Resources pages for logged in members so that helpful documents, like user manuals, are easier to find. The IREx Resource Pages are divided by user type and can be accessed from the top menu using the “Resources” link from on any page, or on the right side of the homepage. As a bonus, the pages are more visually pleasing.
New Feature: Tracking Combo Sites Now Supported in IREx
Combo Sites, defined as one study team engaging multiple FWAs for the same study, are now supported on IREx. In the past, SIRBs and Study Managers had no way to group sites together to ensure all documentation was in place before review. Moreover, relying sites had to duplicate information (e.g., PI Survey). Now, Combo Sites are marked with a blue link icon throughout IREx and have several features to ensure reliance documentation is completed by each FWA in the most streamlined way possible. For more information, please visit our resources page, organized by role on our menu toolbar and watch our Combo Site trailer on YouTube.