We removed the ‘A consent form generator will be used to build consents for sites’ option from the “How are sites’ consent forms being handled?” question in the IREx Setup. New studies moving forward will not have this survey option. However, any existing studies that selected this option previously will still be able to access their surveys as normal.
Category Archives: IREx Study Setup
New Feature: Reviewing IRBs can enable turning off approval notifications
To give more flexibility to Reviewing IRBs and Study Managers in their communication with study teams, IREx now allows for approval notifications to be turned OFF on a study-by-study, approval-by-approval basis. A new question in the IREx Setup, “Would you like to allow turning off study notifications?” lets Reviewing IRBs enable this feature and allow turning off IREx approval notifications and updates for the lead site/overall study and relying sites. Turning off notifications can be useful when making corrections (date correction, updated document) to an existing approval.
New Feature: SMART IRB Agreement V3.0 now supported in IREx
As of March 17, 2025, institutions must join SMART IRB Agreement V3.0 to establish any new reliance agreements with SMART IRB. IREx will update SMART IRB V3.0 signatory statuses to ensure HRPPs can cede review without delay. For existing IREx studies, Reviewing IRBs must designate SMART IRB Agreement V3.0 as the reliance agreement in the IREx Setup for sites that have NOT yet ceded review. The Reviewing IRB and Relying sites CANNOT cede review in IREx until both have signed SMART IRB V3.0.
Updated Feature: Modified text on IREx Setup
On the IREx Setup, Review & Submit tab, text modified from…
- “The reviewing IRB is NOT participating in the study” to “The reviewing IRB is NOT the lead site” if the sIRB selected ‘No’ to the question, “Is the Lead Site also at the Reviewing IRB Institution?”
- “Local context collected by CIRB” to “Local context collected by sIRB” if selected, ‘Sites will provide consents for sIRB review (e.g., using a template) OR study will not have consents.’ to the question “How are sites’ consent forms being handled?”
New Feature: IREx now supports Exception from Informed Consent (EFIC) studies
IREx now supports studies using the EFIC process. Using IREx to implement your EFIC workflow helps lead study teams track sites in various stages of the EFIC process; standardizes and centralizes EFIC documentation for the sIRB and relying HRPPs; and provides sites with clear EFIC processes and approval statuses. When setting up the study, Reviewing IRBs can select EFIC as an option in the IREx Setup. Study team can now upload their local Community Consultation Plan (CCP) to IREx’s PI Survey and Relying HRPPs can confirm review of the local CCP in the HRP Survey. After the sIRB reviews and accepts the site’s CCP, Study Managers can share the Reviewing IRB’s acceptance of the site’s local CCP to IREx and to begin implementing the plan. Watch this video and read this announcement to learn more.
New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study
In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.
New Feature: Reviewing IRBs can now upload additional documents to share with sites
Reviewing IRBs can now indicate in the IREx Setup if they’d liked to provide additional documents to help facilitate the site’s local submission process. This question is found on the SIRB Instructions tab of the IREx Setup and defaults to ‘No.’ If selecting ‘Yes,’ the Reviewing IRB will be required to upload additional documents and a new ‘Documents’ tab will appear on the study page for all users to access the additional documents.
New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies
Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:
- Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
- Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.
Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.
New Feature: How-to videos are embedded in the IREx Setup on Agreements tab.
Two videos are embedded in the IREx Setup on the “Agreement” tab to help sIRBs know (1) what agreements can be offered on a study and how to add them and (2) how to offer a non-SMART IRB Agreement to an existing study.
New Feature: Capture any reliance agreements in IREx.
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.