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.
Category Archives: Relying HRPP
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.
New Feature: Introducing Indemnification Tracking in IREx
IREx now supports Letter of Indemnification (LOI) Tracking. The LOI is a unique agreement between the Reviewing IRB and participating institutions concerning indemnification and related terms, if required, when using the SMART IRB Agreement. Both Reviewing IRBs and Participating Sites can use IREx to easily track the status of their LOI agreements. Reviewing IRBs can track which institutions have signed their LOI and, if they choose to, store the executed agreements in IREx. Participating Sites can view which LOIs they have signed for other institutions.
New Feature: Institutional Profiles Download is Publicly Available
The IREx Institutional Profiles (IPs) are now publicly available for download as a PDF on the IREx Members Page of the public website. The new PDF will include a time-stamp for the date the IP was last updated.
The IREx IP contains basic information about an institution that others can use to determine if they feel comfortable relying on, or serving as the Reviewing IRB for, that institution. In addition to creating greater transparency among HRPPs and IRBs, making the IPs publically available will facilitate and streamline the single IRB process by making information more readily available. Moreover, this fosters high-quality information sharing between institutions.
New Feature: IRB Dashboards
IRB Dashboards provide a snapshot of an IRB Liaison’s studies and next steps in IREx — helping Reviewing IRBs and Participating Site HRPPs/IRBs manage their studies.
There are two dashboards: one for studies where your site is the Reviewing IRB and another showing when your site is listed as a Participating Site. On each, the last column on the dashboard shows the Liaison’s next step, if any are outstanding. The dashboards are sortable by any column, and clicking on the To Do will take you to the study where you can complete the step.
New Feature: Downloadable Study-Specific Reliance Plan (SSRP)
As requested, the Study-Specific Reliance Plan (SSRP) is now included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP. Participating Site HRPPs can also download a PDF of the SSRP from the site-specific info button on a given study.
New Feature: Downloadable Documentation of Reliance Letter
A PDF of the Official Documentation of Reliance Letter is now available as a download on the Site-Specific Info button on a given study. Participating Site HRPPs can also access this PDF from the Study-Specific Reliance Plan view. Click Site-Specific Info> View Reliances (SSRP)> Letter of Reliance. As always, the letter will continue to be included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP.