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.
Category Archives: FRL
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.
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.
New Feature: New local considerations survey to capture CCP Summary of Results
For EFIC studies, a fourth local consideration survey is required for study teams to provide a summary of results after implementing their Community Consultation Plan (CCP). The study teams can upload their CCP Summary of Results reviewed by their local HRPP to IREx for sIRB review and approval.
New Feature: New notification when site completes CCP Summary of Results Survey
A new email notification, ‘IREx Update: Site’s CCP Summary of Results Survey Complete’ is sent to the Lead Study Team/Study Managers to notify them a site has completed the required CCP Summary of Results Survey for an EFIC study. The sites’ status will display 4/4 surveys completed on the Status Summary tab. Study Managers can download uploaded documents from the local considerations export.
Updated Feature: Modified ‘IREx Access and Single IRB Instructions’ email for EFIC study
The ‘IREx Access and Single IRB Instructions’ email is modified for an EFIC study in IREx. The modified email includes instructions for local study teams to work with their local HRPP to develop a site-specific Community Consultation Plan (CCP).
Updated Feature: Modified HRP Survey for EFIC study
A new question is included on the HRP Survey for EFIC studies. The question asks the HRPP to confirm their review of the Community Consultation Plan (CCP) outlined by their local study team. This is to ensure the local HRPP has reviewed and offered their suggestions for the plan and an option to upload any documentation of review/recommendations for the CCP.
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: 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: 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.