As you travel the long, often winding and shadowy trail of initiating a new study across multiple sites, you may suddenly find a fork in the path to your welcoming mead hall – a requirement to use a single IRB (sIRB). From afar it seems simple enough to traverse, but what does it really mean to use a single IRB? How do your sites get approved for the study and, if there’s only one sIRB, how do you get sites their approval documents from the sIRB?

Fortunately, the IRB Exchange (IREx) is a freely available web-based portal for lead study teams to manage and streamline sIRB documentation and coordination for their studies.

First, let’s consult the rune stones and examine how sIRB review works. To combat the Grendel-like trolls of trial management, such as duplicative reviews and burdensome bureaucracy, the use of a Single Institutional Review Board (sIRB) was mandated in 2018 by the NIH and the Office of Human Research Protections for federally funded multi-site research studies.  While it sounds simple and the goal is laudable, implementing an sIRB can be shrouded in mystery, and to those of us who have had to navigate that path,  involve some pain. Although the study will have only one IRB of record (the sIRB), each study site’s human research protection program must still provide critical local information before the sIRB issues approval for the site: Whether there are conflict of interests, adequate resources, study teams have the necessary training and qualifications, etc. This involves persistent coordination, communication, and documentation.

To the rescue, like a mythical figure of old, has come the Beowulf of single IRB review management.  Wielding the sword of harmonization, IREx has been cutting its way through the confusion and establishing an easy, free, and centralized system for managing single IRB documentation for over a decade, thanks to continuous NIH funding since 2011.  Long before the NIH mandated the use of an sIRB, VUMC was given funding to explore novel IRB models.  In 2012  IRBshare was launched, which would evolve over time into IREx.  The IREx platform has amassed 458 institutional sites who have joined the platform with over 485 multi-site studies.

The IRB Reliance Exchange grew out of the need to standardize the single IRB review process across institutions. When you’re on the lead study team of a multisite study implementing a single IRB, you must communicate the sIRB plan of attack to sites, capture local nuances about each site, submit sites to the sIRB for ultimate approval, and inform the sites when sIRB approval is granted, and that’s just the beginning of the battle!

The lead study team is a critical component to successfully and smoothly executing the sIRB review process.  IREx arms those warriors of regulatory compliance for the battle by capturing reliance and local review documentation in a centralized portal so lead study teams have everything needed to submit sites to the sIRB for review. Through automated notifications, IREx apprises sIRBs, study teams, and participating sites of the progress made and how much of the battle is yet to be fought.

If all of this still sounds daunting, don’t worry – IREx users consistently report that IREx is easy to use because it automates communications and the tracking of site progress via dashboards.  Moreover, IREx has incredible YouTube videos, regular trainings for lead study teams, and live user support is available on a regular and as-needed basis for IRB and lead study team staff.  It’s freely available to all US institutions and has gone a long way toward bringing single IRB reliance out of the dark ages by supporting the single IRB process with its automated communications and robust tracking tools. Make your study team’s process and toolkit battle-ready with the many resources we have to offer here: https://www.irbexchange.org/

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IRB Reliance Exchange

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IREx is a freely available, web-based portal supporting single IRB review documentation and coordination for multi-center clinical trials. https://www.irbexchange.org/p/ Contact us at admin@irbexchange.org