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Home Getting Started SIRB Implementation Plan – Step 2

Obtain Initial SIRB Approval

This step will walk you through what we will cover at your "Timelines & Milestones" meeting, and how to prepare for and submit your New Study Application to the University of Utah IRB for initial approval.

For Step 1, go to Develop Your SIRB Strategy.

Step 2a: Schedule the Meeting

We will work with you to schedule a meeting with the Responsible PI (R-PI), Study Manager, and your lead study team, if applicable. This meeting should be limited to key personnel who will be involved in preparing and submitting your New Study Application to the IRB. We will connect with your Participating Sites and their teams in a later step.

Your IRB Reliance Reviewer will send you an email that includes a Scheduling Poll to help facilitate scheduling. The meeting is held via Zoom, and usually takes about an hour to complete.

Step 2b: Review the Meeting Agenda

Generally, the Timelines & Milestones Meeting will cover the following topics:

  • Welcome and Introductions
  • Scope of Work and Fee Agreement for SIRB Services, and Fee Schedule
  • SMART IRB Reliance Agreement for R-PI team sites
  • Resources Orientation:
    • SIRB Process Overview
    • ERICA Systems Training:
      • How to get an ERICA Account
      • How to begin a New Study Application in ERICA
      • Introduction to the “Protocol Only” Review Model
      • Introduction to the ERICA Site-Control Model
      • The 2-part Consent Model and How to Prepare Documents for ERICA
      • ERICA Guidance and Status Key

Step 2c: Complete Action Items

 

Your action items after the Timelines and Milestones Meeting will include:

    • Review and sign the "Scope of Work and Fee Agreement for Single IRB Services" document after reviewing it with your legal counsel (if applicable).
    • Complete IRB Reliance Exchange (IREx) training.
    • Execute an IRB Reliance Agreement with the University of Utah (R-PI and Study Manager institutions only), via the IREx system.
      • Contact your own IRB/HRPP and initiate local processes, tell them to expect a notice from IREx.
    • Activate your ERICA and IREx accounts.
    • Complete Human Subjects Research trainings (e.g. CITI training).
    • Complete a COI disclosures (as applicable).
    • Begin a New Study Application in ERICA, and submit when ready.
    • After your initial fee invoice is received, pay the fee promptly.
      • Work with your IRB Reliance Reviewer to set up an ACH/Wire Transfer payment path, or be ready to request checks and mail them to the UU IRB.
    • Review ERICA Guidance and ERICA Status Key so you are prepared to track your application through the process.
    • Be ready to promptly respond to ERICA notices for revisions from the IRB staff or board members.
    • Begin adding sites to your study in IREx; assist your sites with completing IREx startup checklists. Do not notify the sites (i.e. send the Reliance Invitation) until after initial IRB approval has been posted.

 

While you are working on these items, the IRB will be:

  • Executing reliance with your lead sites.
  • Building your study in IREx and granting access to your Study Managers.
  • After the ERICA application is submitted, sending the fee invoice and completing the pre-review, board review, and initial approval.
  • Uploading the initial approval documentation into IREx.

Your "Step 2 To Do List"

 

  1. Complete the Scheduling Poll for the Meeting.
  2. Attend the "Timelines & Milestones" Meeting.
  3. Complete your action items and obtain initial IRB approval.

Frequently-Asked Questions

 

  • Responsible Principal Investigator (R-PI):
    The investigator at the local institution who is responsible for overseeing the conduct of the study at their site. The R-PI for an SIRB study is responsible for overseeing the study at all participating sites, ensuring compliance with institutional policies, applying and local requirements, maintaining appropriate study oversight, and serving as the primary point of contact between the study team, the reviewing IRB, and institutional stakeholders.

    Key responsibilities may include:

    • Ensuring local study activities comply with institutional requirements.
    • Overseeing study staff and research conduct at the site.
    • Coordinating with the reviewing (single) IRB regarding local context information and reportable events.
    • Maintaining required regulatory and study documentation.

    When the University of Utah is the SIRB for your research, the R-PI must be well-versed in how to use our electronic IRB application submission system (“ERICA”), as well as the IRB Reliance Exchange (IREx). The R-PI or their designee are responsible for training their personnel and participating sites in how to use these resources, as well.

  • Study Manager:
    This is the individual responsible for coordinating the administrative and operational aspects of the study's IRB reliance activities. The Study Manager supports the R-PI by preparing submissions, tracking approvals, coordinating communications among participating sites, and maintaining study records related to the single IRB arrangement.

    Key responsibilities may include:

    • Preparing and submitting reliance and IRB documentation.
    • Coordinating communications with the reviewing IRB and participating sites.
    • Tracking approval statuses, continuing review requirements, and study modifications.
    • Maintaining study regulatory files and documentation.

    When the University of Utah is the SIRB for your research, the R-PI must be well-versed in how to use our electronic IRB application submission system (“ERICA”), as well as the IRB Reliance Exchange (IREx). The R-PI may designate the Study Manager as responsible for training their personnel and participating sites in how to use these resources, as well.

  • IRB Reliance Reviewer:
    This is an institutional IRB or Human Research Protection Program (HRPP) representative who evaluates and facilitates reliance requests involving a single IRB. The IRB Reliance Reviewer assesses proposed reliance arrangements, confirms institutional requirements are met, and serves as a liaison between the institution and the R-PI.

    Key responsibilities may include:

    • Reviewing requests to rely on or serve as a reviewing IRB.
    • Assessing local institutional requirements and regulatory considerations.
    • Coordinating execution of reliance agreements when applicable.
    • Providing guidance to investigators regarding reliance processes and institutional expectations.
    • Assisting with navigation through the IRB approval process.

  • Participating Site Principal Investigator (pSite PI):
    The investigator responsible for the conduct of the research at a Participating Site (pSite) that is relying on the reviewing single IRB (SIRB). The pSite PI oversees study activities at their local site, ensures compliance with local institutional and regulatory requirements, and works with the Responsible Principal Investigator (R-PI), Study Manager, and reviewing IRB to support study oversight.

    Key responsibilities may include:

    • Leading and overseeing research activities at the participating site.
    • Ensuring study staff are appropriately trained and qualified.
    • Complying with local institutional policies and ancillary reviews.
    • Providing local context information and site-specific study details as needed.
    • Reporting events, protocol deviations, and other required information through established SIRB processes.
    • Maintaining required regulatory and study documentation for the participating site.

For Step 3, go to Onboarding Participating Sites.

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