To view or add other study team members to a study in IREx, Relying HRPPs or PIs press “Verify Study Team Access” in their Getting Started Checklist.
Additionally, we rearranged the Study Team Contacts dialog to make it easier to see which study team members already have access to the study. Now users with access are listed on the left side of the dialog, and you can add new users using “Add A Contact” on the right side of the dialog.
The goal of the IREx API is to exchange data between a single IRB’s (sIRB) local electronic IRB (e-IRB) system and the IRB Reliance Exchange (IREx). Given that IREx captures (a) all the information an sIRB needs to review and grant initial IRB approval for a participating site and (b) the actual IRB approval information and documents for participating sites, the IREx API will facilitate bi-directional data exchange. The sIRB can pull participating site information from IREx into its e-IRB system for review and push participating site approvals to IREx to facilitate sIRB communications and approval notifications.
Institutions wishing to complete or make iterative updates to their Institutional Profile can now press “Save & Return Later” to publish what was completed or updated without having to complete the entire profile. This helps make it easier for HRPPs to make quick updates.
The Study Dashboard for Reviewing IRBs now includes an IRB number column. Reviewing IRB Liaisons can sort studies according to IRB number in addition to study title, number of participating sites, number of approved sites, expiration date, and next step. This was a request from IREx users, as sIRBs often use IRB numbers to quickly identify studies and organize their tasks.
In the past, the Reviewing IRBs had to contact an IREx Administrator in order to edit an existing approval (e.g., add/correct an approval document). Reviewing IRB Liaisons are now able to do so at any time. When an approval is edited, an email will notify Relying HRPP Liaisons and study team personnel specifying the changes made. This feature makes it easier for Reviewing IRBs to correct information on IREx while also maintaining clear communications about changes.
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.
A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”
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”.
After local considerations are completed, additional information or clarifications may be necessary from relying sites. IREx has always notified the sIRB and Study Manager when Local Considerations are updated. Now, this notification will include a detailed table outlining the changes that were made to each survey.
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.
