Category Archives: Reviewing IRB

New Feature: Streamlined Study Setup and Notification Preferences

FRL, IREx Study Setup, October 2018, Reviewing IRB

IREx has streamlined how studies are created by Reviewing IRBs. Now Reviewing IRBs can quickly create a study with only four pieces of information: the study title, the sponsor name and a draft protocol and protocol version number.

Reviewing IRBs can also now indicate which of their Liaisons is the “Primary Liaison” for a given study. Other site Liaisons can receive notifications or opt out of all notifications for the study. However, all Liaisons will still have access to the study in IREx, and the Primary Liaison and email preferences can be updated at any time.

New Feature: Institutional Profiles Download is Publicly Available

FRL, Institutional Profile, October 2018, Relying HRPP, Reviewing IRB

The IREx Institutional Profiles (IPs) are now publicly available for download as a PDF on the IREx Members Page of the public website. The new PDF will include a time-stamp for the date the IP was last updated.

The IREx IP contains basic information about an institution that others can use to determine if they feel comfortable relying on, or serving as the Reviewing IRB for, that institution. In addition to creating greater transparency among HRPPs and IRBs, making the IPs publically available will facilitate and streamline the single IRB process by making information more readily available. Moreover, this fosters high-quality information sharing between institutions.

New Feature: IRB Dashboards

August 2018, Dashboard, FRL, Relying HRPP, Reviewing IRB

IRB Dashboards provide a snapshot of an IRB Liaison’s studies and next steps in IREx — helping Reviewing IRBs and Participating Site HRPPs/IRBs manage their studies.

There are two dashboards: one for studies where your site is the Reviewing IRB and another showing when your site is listed as a Participating Site. On each, the last column on the dashboard shows the Liaison’s next step, if any are outstanding. The dashboards are sortable by any column, and clicking on the To Do will take you to the study where you can complete the step.

Update: Aligning the IREx Study-Specific Reliance Plan with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit

Agreements/ Reliance, April 2018, FRL, Relying HRPP, Reviewing IRB, Study-specific Reliance Plan (SSRP)

IREx’s Study-Specific Reliance Plan (SSRP) was harmonized with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit, which documents how the Reviewing IRB and Participating Site HRPPs will handle any flexible elements of the reliance agreement such as auditing, SOPs, insurance, external reporting, etc. This does not impact existing reliance relationships. The updated SSRP will only appear for studies created on or after April 25.

New Feature: Local Context Module 2

April 2018, FRL, IREx Study Manager, Local Considerations, Reviewing IRB

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.

New Feature: Capture Study-Specific Local Context from Participating Sites

February 2018, FRL, Local Considerations, Relying HRPP, Reviewing IRB

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.