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: Reviewing IRB
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.
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.