Reviewing IRBs now have a ‘Request Agreements’ step on their Getting Started Checklist when selecting ‘sIRB only’ in the study setup for whom can use IREx to send instructions for executing the required agreements. Reviewing IRBs will also have a new ‘Manage Agreements’ step on their checklist if there are sites with incomplete agreements listed on the study – when clicked, the Manage Agreements dialog will open for the Reviewing IRB to enter executed agreements for relying sites.
Category Archives: Agreements/ Reliance
New Feature: Allow to resend ‘Request Agreements’ notification
Reviewing IRBs and Study Managers can resend the Request Agreements notification to sites with incomplete agreements. From the Status Summary’s Agreement column, use the drop down and press ‘Request Agreements’ to resend a notification. The button and pop-up will show the last date the request agreement notification was sent for the site.
New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies
Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:
- Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
- Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.
Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.
Updated Feature: Letter of Reliance now included in Local Considerations Export
The Letter of Reliance is now included in the Local Considerations Export for sites, along with the HRP and PI Surveys, the SSRP, and the Institutional Profile.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
New Feature: Data exports for sIRBs and Relying Site HRPPs
sIRB and HRPP liaisons can now export a csv file to quickly view and analyze data for studies, including dates for registration, reliance, and approvals. The sIRB can utilize the export to evaluate processes and assess efficiency (time to approval) and workload (number of relying sites). Relying HRPPs can also export data to efficiently view all studies in which they are participating, the SIRBs serving for those studies, and dates for registration, reliance, and approvals. Access this feature through the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards under “Exports.”
Updated Feature: Enhancements to the Agreement Checker
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.
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.
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.