For some studies, the institution serving as the Reviewing or Single IRB (sIRB) is not the lead site for the study. To distinguish roles and provide greater specification, IREx now allows the sIRB to identify a Lead Site. This information will be displayed in the first tab in IREx, now called the “Study-wide Approvals Tab”.
Category Archives: Relying HRPP
Updated Feature: Getting Started Checklist Revamped
Some steps of the HRPP Getting Started Checklist can be edited after you have completed them. To make this clearer, we added a pencil icon to those steps. HRPPs will see a pencil next to Add/Edit Study Team, Confirm Institutional Profile, Complete HRP Survey, and Validate PI Survey. We also added a “See Status Summary” link on the participating site HRPP and study team Getting Started checklists to provide quick access to the Status Summary tab, which is now available to all participating sites on a study.
Updated Feature: Updates to Status Summary Export
IREx helps manage Letters of Indemnification (LOIs) for institutions that require them when serving as the sIRB. On a given study, the sIRB can track whether or not a site has signed their LOI on the Status Summary tab and the Status Summary Export. Now, the Status Summary export will also include the date participating sites signed the LOI. Additionally, the Status Summary export has been updated so that the date of initial approval is always included. The export still includes the most recent approval date, if there are approvals beyond the initial approval.
Updated Feature: Renamed Tabs
You will notice some rewording of the study page tabs. The first, blue tab is now titled Study-wide IRB Approvals (before called “Reviewing IRB Approvals”) because these documents are relevant to all sites. The second, orange tab is now titled Site-specific IRB Approvals (before called “Relying Site Approvals”) because it captures documents for each site. Both tabs retain the same functions as before but are more appropriately named.
Updated Feature: Up to Date IREx Resources
It has been a busy season in IREx with many updates, so the resources below now reflect the new features.
New Feature: Participating Sites can View Status Summary
Participating Site HRPPs and Study Teams now have a new tab “Status Summary” tab where they can visualize their site’s progress completing the steps towards sIRB approval. This tab is view only – no actions are completed on the tab. Participating Site HRPPs and PIs will continue to complete their steps on the Getting Started Checklist, which also has a navigation link to the Status Summary called “View Status Summary”. This feature is expected to bring transparency and clarity to participating sites as their HRPPs and study teams works towards reliance.
Updated Feature: Tracking Changes to the Local Considerations HRP Survey
The Human Research Protections (HRP) Survey and PI Survey are key parts of capturing local considerations. When Participating Site HRPPs edit the PI or HRP Survey, an email notification is now sent to the Study Manager indicating what was changed on the survey. This feature is expected to help ensure Study Managers distinguish what was changed and ensure their requested changes were made appropriately.
Updated Feature: Modified Continuing Review Documentation for Studies Closed to Enrollment
Although studies that are designated as Greater than Minimal Risk (GTMR) require consent forms, IREx now allows for the input of GTRM Continuing Reviews that are reviewed via the expedited review process. A consent form is no longer a required document for these reviews to better facilitate, for example, studies that are closed to enrollment. This change helps accommodate nuances of different phases of study conduct.
Updated Feature: Local Considerations Complete Notification Now Includes Outstanding Steps
In May we added “Complete Agreements” to the Relying HRPP Getting Started checklist. This feature allows sites to document and complete local considerations while their legal counsel is reviewing and executing any outstanding agreements, if needed. Sites are not allowed to document reliance or cede review until the agreements are complete, but, if a site completes local considerations before their agreements are complete, we now include in the email any outstanding steps that should be completed before the site is submitted to the sIRB for review, such as “Complete Agreements” or “Cede Review”.
New Feature: Include date local considerations surveys were “Updated”
Sometimes Study Managers (SMs) or sIRBs need PSites to make changes to the local considerations they provided in IREx. Before receiving sIRB approval for a study, PSite HRPPs and PIs can make these edits to the Human Research Protection (HRP) and PI surveys (Note: PIs can only make edits before their HRPP validates their answers). IREx will now track when updates were made by the PI or HRPP and include this date on the Status Summary tab so Study Managers can see when the information was last updated.