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high-quality review for new studies

Support for rapid establishment of single IRB is provided for assigned trials initiated in the HEAL Pain ERN. 
HEAL Pain ERN Goal: Establish a network that functions in a unified, consistent, and standardized manner.
Utah DCRC Goal: Create a comprehensive, cohesive, single IRB process and operating system that will support multicenter studies on a national level.

 

  • The University of Utah IRB (UUIRB) serves as the SIRB for the Utah Data Coordinating Resource Center. We are an AAHRPP-accredited IRB that provides high-quality review for new studies from a wide array of specialties and disciplines. The University of Utah has joined the SMART IRB Master Authorization Agreement, allowing for a streamlined SIRB reliance process with the more than 900 institutions who have also joined. The UUIRB has an established process for engaging with site investigators and HRPP representatives in order to secure IRB reliance and approval for each participating site. Use of the UUIRB as an SIRB provides investigators with access to the ERICA Online System, an electronic system that streamlines submission, review, communication, and documentation for studies. Additionally, investigators have access to a comprehensive SIRB consultation process for navigating issues related to study design, methods, and consent documentation for multicenter studies.

    Recent policy changes by the NIH and DHHS require the use of a single IRB of record for multicenter research to reduce redundant IRB review, streamline ongoing IRB reviews and approvals, and to streamline investigator submission processes. The HEAL Pain ERN has established three single IRBs, which are based on the SMART IRB Authorization Agreement to provide SIRB services to a funded multicenter clinical trial.

    For each study, the HEAL Pain ERN SIRB will also provide resources, tools, and a web-based platform, IRB Reliance Exchange (IREx), to operationalize the SIRB. The goal is to ensure all site investigators understand the process for initiating the use of an SIRB at their local institution, as well as how to submit and report to the SIRB from initial submission to study closeout.

  • The Utah SIRB and DCRC offer the following resources:

    • Established workflow and process to carry out SIRB activities
      • Reliance Consultation services available to help investigators initiate a SIRB model for their multi-site studies
      • Initial review for studies include any of the vulnerable populations described in the Common Rule as well as many others. Our reviews follow all regulations and policies from DHHS, FDA, OHRP, HIPAA, DOD, and more
      • Ongoing review services ensure that research can be updated and re-approved in a timely manner
      • Review of reportable problems and events ensure the protection of participants and the integrity of the research
    • A nationally scalable model (Site Control Model) for SIRB activities
    • Educational materials for lead study teams and relying sites
    • SIRB coordination to support study teams with:
      • SIRB submission and approval
      • Human Research Protections Program (HRPP) approval and activation
      • Utah DCRC will provide SIRB navigation for the trials it supports

The IRB work is led by Dr. Ann Johnson, IRB Director and Jeri Burr, DCRC Program Director, under the direction of PI, Dr. J. Michael Dean.

Jeri, Ann, & Mike.