CTSC Regulatory Knowledge and Support Core: IRBRely Supplement Update

 

A major initiative that the CTSC is participating in is the IRBRely project, under an NCATS supplemental grant award to the Dartmouth Center for Clinical and Translational Science.  The specific aim of this CTSA supplement is eliminate redundancies and inefficiencies in the IRB review process for multi-site clinical trials on a national level by developing and testing the contextual and informatics infrastructure required to support a major IRB reliance “network” within the United States.  This activity is congruent with the proposed aims of the CTSC’s Regulatory Knowledge and Support Core from our last competitive renewal. Additionally this supplement was designed to support Federal draft policy issued December 2014, as well as the more recent HHS Notice of Proposed Rule Making issued September, 2015, in which NIH intends to promote, and in some cases mandate, the use of a single IRB for multi-site clinical trials which take place in the United States.  

The work proposed in this supplemental grant builds upon the success of the prominent regional CTSA collaborative IRB review models developed and tested by Harvard Catalyst, The Ohio Collaborative (including the Cleveland CTSC’s “facilitated review process”/HUB informatics system), Wisconsin IRB Collaborative, UC Braid, University of New Mexico, University of Texas, and Vanderbilt University.  The Cleveland CTSC plays a major role in the project, providing significant personnel support and input into the project management committees (executive, regulatory, informatics and evaluation groups).

Over the past grant period (September, 2014-August, 2015), the IRBRely project has accomplished the following:

  • Selection of low-risk multi-site clinical trial registry to test Reliance Network processes and workflow (“The Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry”) with Duke University being invited to be the IRB of Record on a national level.

    • Under the Network’s SOPs, the Clinical Trial PI’s home site (Duke University) is serving as the “reviewing IRB”

    • 15 sites of ~60 CARRA sites participating in the Reliance Network text to compare processes and metrics

  • Master IRB Reliance Agreement has been completed and disseminated to more than 15 centers as part of the initial pilot project;

  • Standard Operating Procedures (SOPs) have been circulated to the 15 pilot institutions participating in the project following extensive reviews and edits by the executive and regulatory committees of the IRBRely project; and

  • Development of support informatics framework including:

    • Pilot implementation of “IRBrely” website (hosted by Dartmouth) to support participation in reliance network.  CTSC Informatics personnel significantly supported development of framework;

    • Development of “cede review” prototype” (by Harvard, Wisconsin, and CTSC) as a demonstration prototype of a centralized system for submitting and reviewing requests, for communication of actions, for automatic reminders, for reporting, for tracking and metrics; and

    • Development of “joinder process” (by Harvard and CTSC) to present process and workflow information that institutions will need to participate in the national reliance network.

The original grant period for this supplement has ended.  We believe that there is a strong opportunity to carry forward unspent funds with a focus on continuing to develop and implement the informatics framework between October 2015 and April 2016.  The CTSC Informatics Team will continue to partner with Harvard and Dartmouth to pilot test the software and eventually implement it under the auspices of a clinical trial protocol that has been processed through the IRBRely network.  It is believed that following this supplemental grant no-cost extension period that the IRBRely Network can go live with being to review multi-intuitional clinical trial that provide access to  current research on a national level in a simple and efficient manner on a national level.  

The supplement executive committee will meet to discuss the future plans for the project including planning for PCORnet studies, and subsequent executive responsibilities for Reliance Network maintenance including revisions to SOPs, QA/QI review, ensuring communication between participating sites and model for financial sustainability.  Finally Philip Cola, Director of CTSC Regulatory Knowledge and Support Core, has agreed to serve as a member on the Scientific Board of a recently submitted Trial Innovation Center grant entitled “TICRely” in support of the Dartmouth CTSA.  TICRely will serve as an extension of the exciting program outlined above for the national IRBRely group.  IRBRely is a significant achievement, one that will dramatically improve the national landscape for multicenter clinical research.  Subsequently, TICRely will take this activity to the next level and the CTSC will once again be positioned to support the extension of these national innovations in human subject protection.