IREx now includes an automated local considerations feature that streamlines information collected in the HRP surveys by pre-populating the data from a site’s Institutional Profile, based on study elements identified by the Reviewing IRB. First, the Reviewing IRB selects applicable study elements (e.g., children, genetic testing) and can add up to five custom questions on the HRP and/or PI surveys. Then, IREx will pull the relevant questions related to the study elements from the IP into the HRP Survey. The HRP and PI surveys will have a new section, Study Elements Relevant to Local Review, with pre-populated information from their Institutional Profile (IP) that applies or custom questions, which the Relying HRPP can confirm or edit as needed.
Category Archives: Local Considerations
Enhanced Feature: Modified HRP Survey now includes study elements banner/header
The HRP Survey now includes a study elements banner that notes the Reviewing IRB has identified the study element(s) that apply to the study and lists the elements. It mentions that questions and responses from the Relying HRPP’s Institutional Profile (IP) related to the study elements are pulled into the HRP Survey in the Study Elements Relevant to Local Review section, which can be edited by the Relying HRPP. However, any edits to these questions will not change the IP.
Enhanced Feature: Institutional Profile PDF removed from Local Considerations Export
The Institutional Profile (IP) PDF is no longer included in the local considerations export. This reduces duplicative review with information that may conflict on a per study basis now that relevant study elements, as indicated by the Reviewing IRB, is pre-populated from the IP into the HRP Surveys for revie
Updated Feature: Removed Alternate Local Consideration option from IREx Setup
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.
Updated Feature: IREx surveys and PDFs now support line breaks
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.
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 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.
New Feature: Amendment Content can now be indicated when uploading a study-wide amendment
For studies capturing local consideration updates, Reviewing IRBs and/or Study Managers will see a new ‘Amendment Content’ section on the Add Study-Wide Amendment dialog. The content areas are informed by the SMART IRB local considerations guidance documents.