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.
Category Archives: Reviewing IRB
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.
New Feature: Agreement Checker Available to All Users
Our newest IREx Feature, the “Agreement Checker”, is a dynamic report page allowing you to list potential participating sites to see if they have signed the SMART IRB reliance agreement, joined IREx, and signed the sIRB’s Letter of Indemnification, if applicable. The list can also be exported into a comma-separated values (CSV) file. The Agreement Checker can be of particular help to sIRB’s who want to contact sites to complete agreements before a study is created in IREx, or for study managers gauging site readiness and preparing reliance instruction for sites (sample here). The “Agreement Checker” is located under the Resources section on the IREx homepage after logging into IREx.
Updated Feature: Enhanced Status Type When Uploading Approvals for Study Managers and sIRBs
The approvals upload page has been enhanced to better highlight the study’s approval status (approved vs. pending) for sIRBs and Study Managers. The new page layout is more intuitive, showing the status as the first question.
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.
Updated Feature: Redesigned Participating Sites Dialog for Study Managers and sIRBs
The Participating Sites Dialog, used by the SIRB or Study Manager to add participating sites to a study, has a new intuitive design. Here, a site can be added with the PI and/or Coordinator information. If the PI or coordinator is an existing IREx user, their information will be auto-filled. You can also add additional FWAs if one study team engages multiple FWAs (“Combo Site”). Please watch our 3-minute YouTube video to learn more about adding sites to a study.
Updated Feature: Enhanced Versions Box
The Approvals Versions box, located on the left-hand bar of a study page, has been enhanced so that studies with numerous sites can easily view SIRB approvals sorted by Relying Sites and sites who are Registered/In Progress. In addition, the Approvals Versions box now features a scroll bar so users can quickly navigate to view a site’s approval status.