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.
Category Archives: Agreements/ Reliance
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: 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.
Enhanced Feature: Study Managers Can View SSRP Documents from Status Summary
Study Managers can now use the Status Summary Tab, which provides an overview of sites’ progress completing the steps towards sIRB approval, to access Study-Specific Reliance Plan (SSRP) documents. Under the Reliance Decision column of the Status Summary, a site will have a green Completed status, which when clicked, will open the SSRP page. This page shows the SSRP survey responses agreed upon by the sIRB and site, a copy of the letter of reliance, and a PDF of the SSRP responses.
Updated Feature: Reviewing IRB access to Site-Specific SSRPs PDFs
In December, IREx added a PDF of the site-specific SSRP to the Local Considerations export. Now, the SSRP PDF is available for download from the Status Summary tab when you click on the Reliance Decision for a site. This is an additional way to review details of a site’s SSRP for a study. The name of the file includes the participating site’s name.
New Feature: SSRP Included in Local Considerations Export
A PDF of each site’s Study-specific Reliance Plan (SSRP) is attached to the Notification of Reliance email sent when the SSRP is accepted by a site; however, sIRBs were previously unable to download site-specific SSRPs from within IREx. Now, the Local Considerations (LC) export will include a PDF of each site’s SSRP. The LC export will continue to include each site’s Institutional Profile, HRP survey and PI survey, if LC are being captured in IREx, as well as any documents uploaded to those surveys.