The intent of the revised Common Rule requiring institutions to rely on a single IRB (sIRB) for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
“This mandatory requirement came with very little guidance on how to operationalize it,” says Barbara DeCausey, MPH, MBA, adding this has led to inconsistencies in how the sIRB review process is managed. “Since use of the sIRB is not new, many institutions and organizations already had processes in place, but these varied.”
Inconsistent processes can cause delays for researchers as they navigate appropriate sIRB and human research protection program (HRPP) contacts, how they are expected to document local reviews, who is coordinating the submission of sites' information to the sIRB, and how sites access their approval documents from the sIRB. Outside researchers must comply with protocols, consent forms, and submission and review processes of IRBs with which they are not familiar.
“There is also concern that the reviewing IRB may not have the knowledge to review and approve research for another institution,” says DeCausey, director of Virginia Tech’s HRPP.
For example, local and state laws, along with institutional policies, must be considered. DeCausey says until more guidance is available, institutions should encourage researchers required to use a sIRB to contact the HRPP or IRB office early to seek guidance. Also, ask IRB members from the local sites to serve as consultants to ensure local requirements have been addressed. Finally, communicate with the HRPP or IRB office staff of collaborating institutions to learn about their requirements. For instance, academic institutions may have created specific policies related to students participating in research.
“This is also a great way to identify any state or local laws and institutional policies that need to be factored into the review,” DeCausey adds.
The IRB Reliance Exchange (IREx) is a web-based platform to facilitate communication and documentation, now used by more than 35 single IRBs and 414 participating sites. “The national single IRB mandate has defined the expectations for single IRB review. Great resources, like the SMART IRB platform, help sites define institutional and study team responsibilities,” says Todd Rice, MD, MSc, co-author of a recent paper on this topic.1
The SMART IRB platform provides a contractual reliance agreement, which sites use to distinguish each party’s responsibility. The IREx serves as a centralized hub for all the communication and the exchange of information and documentation. Information can be updated with automated communication, which ensures all appropriate parties are notified of important developments and approvals.
“It creates a central location, making it easier for IRBs and researchers to collect, document, and disseminate the regulatory information that they need to run the multicenter trial using a single IRB,” says Rice, vice president for clinical trial innovation and operations at the Vanderbilt Institute for Clinical and Translational Research.
The IREx platform helps coordinate the many pieces of documentation needed for the sIRB to review and approve a participating site. “It helps organize, automate, and coordinate all of the IRB documentation and communication for the study,” Rice says.
Still, many study teams do not even realize IREx exists. “The paper is meant to describe the platform and the operational gaps it fills so entities coordinating multicenter studies under a single IRB know they can leverage it,” Rice says.
REFERENCE
1. Serdoz ES, Edwards T, Pulley J, et al. The IRB reliance exchange (IREx): A national web-based platform for operationalizing single IRB review. J Clin Transl Sci 2022;6:e39.
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
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