Category Archives: FRL

Updated Feature: SIRB Liaisons have “Agreement Manager” on the Status Summary tab.

Agreements/ Reliance, FRL, March 2021, Reviewing IRB, 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.

Agreements/ Reliance, FRL, Getting Started Checklists, March 2021, Relying HRPP

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.

Agreements/ Reliance, Email Notifications, FRL, March 2021, Relying HRPP

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: Agreement Dashboard located on the IREx Homepage.

Agreements/ Reliance, FRL, March 2021, Relying HRPP, Reviewing IRB

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.

Bug Fixes – March 2, 2021

FRL, March 2021, System Enhancements/ Bug Fixes
Fixed: Liaisons and Study Managers are carbon copied (cc’d) on all site approval emails.
Fixed: Agreement checker reflects sites that have executed agreement with the named SIRB.
Fixed: Sites that have signed SMART IRB version 2 display “SMART 2” on the Status Summary tab.
Fixed: Multisite Liaisons do not see the Multisite Liaison Dashboard (“Your Sites” tab) when serving as the SIRB.
Fixed : All Lead Study Team contacts are carbon copied (cc’d) on all site approval emails.

New Feature: sIRBs Can Reset SSRPs

Agreements/ Reliance, FRL, Relying HRPP, Reviewing IRB, September 2020, Study-specific Reliance Plan (SSRP)

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.