To make reading easier for all HRPPs (and nicer-looking PDFs), the IREx IP now supports line breaks in open text fields. Line breaks appear in the web view and PDFs of the Institutional Profile (along with the HRP and PI surveys). Liaisons can edit existing/completed IP and HRP survey responses to include line breaks, and the breaks will appear after submitting the changes.
Category Archives: Reviewing IRB
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.
New Feature: Import contacts in IREx using Import Template
Reviewing IRBs and Study Managers can now import relying site study contacts into IREx in bulk. While this feature is available to use on any study, it may be best to use on studies with a large number of sites. For more information and instructions, view the Import Site Contacts Quick Guide.
Updated Feature: Allow users to Replace Draft protocol documents until approval is published
When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.
Updated Feature: Managing Combo Sites
Reviewing IRBs and Study Managers can now easily modify their sites that engage multiple FWAs, known as Combo Sites in IREx. On the Sites tab, deleting a Combo Site will now display the Manage Combo Sites dialog, which allows you to select sites you want to delete and/or add a site by using the +Add Site button.
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: An ‘EFIC’ bubble displayed on study pages and on the list of search results is to indicate a study is an Exception from Informed Consent study
An ‘EFIC’ (Exception from Informed Consent) bubble appears next to study titles on each study page and when searching studies and to indicate which studies are EFIC-supported.
Updated Feature: Dates captured for EFIC studies now included on exports
The Participating Site Report and Status Summary Tab Report now includes columns that capture dates when the CCP was submitted, reviewed, and approved for an EFIC study. The exports will also include dates the study teams complete the CCP Summary of Results Survey and date PI Attested to the summary. Reviewing IRBs can access the reports from the Export menu on the Reviewing Site’s Studies Dashboard. Relying HRPPs can access their reports from the Participating Site’s Studies Dashboard. The Status Summary Tab Report is available for Reviewing IRBs and Study Managers on the Status Summary Tab.
Updated Feature: Participating Site report now separated by review type
The Participating Site Report is now separated by review type (Initial & Closed, Continuing Review, and Amendments). Reviewing IRBs can access the reports from the Export menu on the Reviewing Site’s Studies Dashboard. Relying HRPPs can access their reports from the Participating Site’s Studies Dashboard.