Reducing Single IRB Study Administrative Burden with a ‘Participating Site’ Portal

Introduction

In this case study, we look at how Bad Rabbit helped the Children’s Hospital of Philadelphia (CHOP) reduce PI burden by streamlining a common PI pain point: management of information required from participating sites in multisite studies where the PI’s organization is the single IRB of record. Bad Rabbit delivered an entirely new, purpose-built portal that automates much of this tedious work for PIs, and enables participating sites to submit information directly to the sIRB system. Automation of this work frees up valuable PI time, improves PI job satisfaction, and increases the quality of the information submitted.  

“This will save our PIs many hours of work per initial study where we’re the reviewing IRB and additional hours for continuing reviews on those studies. The interface itself is intuitive and super user-friendly. I love that you can access it on any smartphone or device.” – Heather Cathrall, Assistant Director, IRB Operations

The Situation

Historically, multisite research studies required IRB offices at each participating location to conduct their own review of both Protocol (the science being performed) and local context information (who is conducting the study and where) for their particular site. The introduction of single IRB - in which one IRB office provides regulatory review of the shared Protocol, and manages Location information - streamlines the process considerably. However, security and data confidentiality requirements usually prevent participating sites from submitting information directly to the sIRB’s software system, meaning that it must be collected, submitted and tracked manually. This complex and tedious task usually falls to the lead PI and their staff.

CHOP serves as the Single IRB of Record across an extensive and growing portfolio of multi-site studies. For them, PI administrative burden was clear:

  • For every approved multisite study, PI requests and collects site-specific surveys from each participating site.

  • The PI must then collate and submit via amendment to their institution’s IRB and wait for approval.

  • The PI would then gather and send information packets to all participating sites.

  • The above process would need to be repeated for continuing reviews.

PI time is costly and is of course best spent on research, but high PI administrative burden isn’t just a cost or efficiency issue. Institutions that launch initiatives to make PI life easier see a positive impact on PI retention, and can offer a more attractive working environment for prospective PIs. For CHOP and their PIs, the status quo was unscalable and untenable, and so they reached out to Bad Rabbit for help.

The Approach

At first, CHOP considered having participating sites make submissions directly to the IRB via the e-research system. However, institution data policies and security infrastructure made this challenging, and PIs would still need to be involved in collection and entry of some data. Bad Rabbit reviewed several technical approaches for this large and costly problem and proposed an innovative solution:

1) creating an entirely new, purpose-built sIRB portal, where participating site PIs could submit their location information safely and securely to CHOP’s IRB system.

2) customizing CHOP’s IRB system to accommodate a new information set - ‘Participating Site’ submissions - that could then be populated automatically by the portal.

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The Outcome

The client reports that the new portal “is going to make a big dent in PI administrative burden” and as noted they expect to save significant PI time on each study and continuing review. They are pleased with functionality and ease of use, stating that “it’s beautiful - the interface looks really nice, and it’s super user-friendly...even a new user understands quickly what they’re supposed to do.” In addition to directly reducing PI involvement in sIRB administration, Bad Rabbit’s solution speeds the overall process - “it increases direct communication – any time you take out a middle-person, things go faster.” The client also feels the project strongly reflects their commitment to reducing PI administrative burden - “it’s really great for our institution to say to PIs and participating sites, and even to other institutions that have this issue, hey, look at what we’re doing to solve this problem.”

A key challenge to overcome in this project was to enable direct submission of participating site information to the IRB RA software system while protecting the integrity and security of CHOP’s highly sensitive institutional data. This type of ‘tunneling’, where select system functions are made available securely outside of the institutional firewall, has many applications in RA, and Bad Rabbit makes frequent use of it to solve unique RA challenges. One example is Bad Rabbit’s PI Action Center, a streamlined mobile portal for PIs that lets them take action on RA tasks on any connected device without the overhead of typical research administration software.  

Do you have a unique research administration challenge that might benefit from a similar solution? Reach out to Bad Rabbit today for a free consultation.