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.
Category Archives: Study PI
New Feature: New notification when site’s Community Consultation Plan (CCP) is accepted by the Reviewing IRB
A new email notification, ‘IREx Update: Community Consultation Plan Accepted and Next Steps’ is to notify study teams when the sIRB has accepted their CCP and to initiate the plan. The notification will also include next steps for the principal investigator and study contacts on reporting the plan’s results.
Updated Feature: Modified PI Survey for EFIC study
A new question is included on the PI survey for EFIC studies. The question allows the study team to upload their proposed Community Consultation Plan (CCP) after it has been reviewed by their local HRPP. This allows the study team to use IREx to submit the plan to the sIRB for review. The Study Team Member or Coordinator can complete the PI Survey but the PI must attest and when changes are made.
Updated Feature: Study Manager Checklist for EFIC
On EFIC studies, the Study Manager Checklist step ‘Upload Relying Site Approval’ will be renamed to ‘Upload Relying Site Accepted CCP or Approval’. This is to let the Study Manager know a site can either receive the Reviewing IRB’s acceptance of their local Community Consultation Plan or receive initial study approval depending on which stage the site is at in the EFIC process.
Updated Feature: PI and Study Team Members Checklist for EFIC
The PI and Study Team Members’ Checklist will include new steps when participating on an EFIC study. The steps include Awaiting CCP Acceptance and Upload the CCP Summary of Results.
New Feature: The ‘Onboarding’ Tab is now available on all studies
Previously called the ‘Documents’ tab, the ‘Onboarding’ tab is an easily accessible place for Relying Sites to find any additional documents (i.e., Reviewing IRB SOPs, Reviewing IRB Communication Plans, Part 2 Consent Forms) that were uploaded by the Reviewing IRB or Study Manager to help facilitate sites’ local submission process.
Reviewing IRBs and Study Managers can upload additional documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.
Relying Sites that do not have initial approval will default to the Onboarding tab when accessing the study page. Relying sites will be able to access these documents, along with their sIRB instructions, for the life of the study.
Update Feature: Updated the sIRB Instructions to reference the ‘Onboarding’ tab
Sites receive the sIRB instructions in the “IREx Access and Single IRB Instructions” email when they are notified about the study. The purple text on the sIRB Instructions has been updated to say, “The overall/lead site approval is available in IREx on the Approvals tab of the study page. Use the Onboarding tab to view any additional documents shared by the sIRB and/or lead study team. Use these documents to prepare your local submission and initiate the reliance process at your site.”
Updated Feature: Relying sites can now edit the HRP and PI Survey after receiving Initial Approval
Prior to February 2024, the HRP and PI Survey was not editable after a relying site received initial approval in IREx. Now, the Relying HRPP can edit both the HRP and PI Survey and the relying site Study Team Members and PI can edit the PI Survey after initial approval, as needed. Editing the surveys in IREx helps align any site changes. IREx will notify the Reviewing IRB and Study Managers when changes to the surveys are made.
Updated Feature: Updated Study Team Getting Started Checklist
Relying site study teams now have a ‘Awaiting Reviewing IRB Approval’ step on their Getting Started Checklist. This step was added to let the PI and Coordinator know that after completing their steps in IREx, the next step is waiting for the sIRB to approve their site.
Updated Feature: Renamed ‘Add Site Coordinator Access’ from the Approval History tab
The ‘Add Site Coordinator Access’ menu option on the Approval History tab, has been renamed to ‘Add Study Team Access’. The Reviewing IRB and Study Managers can now give additional or new PIs access to the study using the ‘Add Study Team Access’ dialog at any time. Previously, they were only able to give coordinators access.