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: March 2021
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: 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.
Bug Fixes – March 2, 2021
| 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. |