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.
Category Archives: Relying HRPP
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.
Updated Feature: New Document Types on Approvals
Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.
Updated Feature: Redesigned Resources Pages
We updated the Resources pages for logged in members so that helpful documents, like user manuals, are easier to find. The IREx Resource Pages are divided by user type and can be accessed from the top menu using the “Resources” link from on any page, or on the right side of the homepage. As a bonus, the pages are more visually pleasing.
New Feature: Tracking Combo Sites Now Supported in IREx
Combo Sites, defined as one study team engaging multiple FWAs for the same study, are now supported on IREx. In the past, SIRBs and Study Managers had no way to group sites together to ensure all documentation was in place before review. Moreover, relying sites had to duplicate information (e.g., PI Survey). Now, Combo Sites are marked with a blue link icon throughout IREx and have several features to ensure reliance documentation is completed by each FWA in the most streamlined way possible. For more information, please visit our resources page, organized by role on our menu toolbar and watch our Combo Site trailer on YouTube.
Updated Feature: Study Registration Redesigned and Questions Added for Participating Sites
TThe Study Registration page has been updated to give Participating Site HRPPs control of how their site is listed on a study. The new registration page allows the HRPP Liaison to confirm the site and PI listed, change the PI for your site, indicate that a different site is engaged by the PI, add additional FWAs for a single study team (“Combo Site”), or decline engagement in a study. Please visit our YouTube channel to watch a video on the new Study Registration process. Please visit our YouTube channel to watch a video on the new Study Registration process.
Updated Feature: Institutional Profile now allows Save & Return Later feature
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.
Updated Feature: PI Name Added to Participating Site IRB Dashboard
The Study Dashboard for Participating Sites has also been upgraded. It now includes a PI column. Participating Site HRPPs can sort studies by PI name in addition to study title, reviewing IRB, expiration date, and next step. This was a request from IREx users, as HRPPs can more easily identify a study based on the PI name than study title.
Updated Feature: Single Entry of Team Personnel Added by Study Manager
The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.
New Feature: Email Notifications for Updated Approvals
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.”