IREx released a second local considerations module to accommodate studies where consent documents are created by the Reviewing IRBs / Coordinating Centers. In this new module, Participating Sites will enter their local consent language directly into IREx as they would like it to appear on the consent form. Then, the final consent document will be generated on behalf of Participating Sites by the Reviewing IRB or Coordinating Center. Additionally, this new local context module provides a CSV download of all survey responses.
Category Archives: Reviewing IRB
New Feature: Capture Study-Specific Local Context from Participating Sites
IREx released a local context/local considerations module to allow Reviewing IRBs to centrally capture study-specific local considerations for each site, using standardized surveys and questions aligned with national sIRB initiatives.
The local considerations module has two surveys: 1) The Human Research Protections (HRP) survey asks about requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local site ancillary reviews, relevant to the specific study or trial that would affect the conduct or approval of the research at your institution, as well as the consent form for this study. This is completed by the Participating Site HRPP Liaison; and 2) the PI survey asks about the conduct of the study at your site and is completed by the Participating Site PI. The Participating Site HRPP must verify the PI survey responses.
New Feature: Getting Started Checklists
IREx released user-specific checklists (“Getting Started Checklists”) on each study to help IRBs and study teams navigate their reliance-related steps. The checklists are role-specific and auto-hide once all the steps have been completed for a given study.
View Getting Started Checklists here.
New Feature: Multi-site Liaisons for users overseeing multiple FWAs
IREx supports institutions that oversee or provide HRPP functions for multiple FWAs using the Multi-Site Liaison feature. IRB/HRPP Liaisons can be set up as “Multi-Site Liaisons” to manage multiple FWAs with one user account. Multi-Site Liaisons can easily manage Institutional Profiles for each FWA, as well as indicate reliance and access approval documents each FWAs, even within a single study, in IREx. Contact the IREx team to be set up as a multi-site Liaison.
New Feature: Status Summary Tab
The Status Summary Tab provides an overview of status of all Participating Sites listed on a study. Use this tab to track each site’s progress towards sIRB review as they sign on to the required agreements to begin reliance and indicate reliance on the Reviewing IRB. This tab is available to the Reviewing IRB Liaisons and Lead Study Team Members.
Find and List FWA Component Sites on a Study
IREx supports affiliated institutions that are listed as component sites on an FWA. Components do not have separate accounts in IREx. Instead, their access is managed by the FWA holder’s Liaison(s) and share an Institutional Profile with the FWA-holding institution. IRB Liaisons can manage their FWA components using the components button on the IREx homepage. To list a component site on a study, the Reviewing IRB or Study Manager can search for components by name or FWA number using the Add a Site box in the Edit Participating Site window.
System Enhancements – March 3, 3017
Enhanced: Reviewing IRB Liaisons and IREx Study Managers can list individual Participating Sites on a study in IREx without creating a network or consortium.
Official Documentation of Reliance Email
IREx sends an official documentation of reliance email to the Reviewing IRB Liaisons, Participating Site HRPP Liaisons and Study Team Members.
This email is sent after the Participating Site HRPP Liaison has accepted the Reviewing IRB’s study-specific reliance plan (SSRP). A PDF of the letter of reliance is attached to this email.
Add draft documents on study creation
IREx allows Reviewing IRB Liaisons to upload draft documents such as draft protocols and informed consent documents during study creation. These documents are visible on the Reviewing IRB approvals tab to all Participating Sites and are labeled as drafts. Users receive a pop-up warning before they download the documents letting them know that the documents have not yet been approved by the sIRB.
sIRBs that are not participating research sites on a study
IREx has been updated to support scenarios where the Reviewing IRB institution is not a participating research site or is not the lead site for a given study. During study creation, the sIRB can now indicate whether or not they are a participating site.