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UNL IRB Authorization/Reliance Agreement Workflow

This workflow helps investigators identify whether UNL will serve as the Reviewing or Relying IRB for a multi-site research project. Many factors play into the outcome — including project complexity, expertise needed, and the number of collaborating sites. Decisions to enter into an Authorization/Reliance Agreement are completed by the Institutional Official via notification from the IRB Reliance Coordinator. Always discuss multi-site projects with the UNL IRB before any agreements are made. Contact: unlreliance@unl.edu · (402) 472‑1839

NIH Proposal Guidance for Human Subjects and sIRB Requirements can be found on the RCS Website: research.unl.edu/researchcompliance/guidance-topics-a-z/

SMART IRB Registration is completed online at smartirb.org. Note: SMART IRB is not always utilized — contact the UNL IRB to confirm whether it applies to your project.

Follow the path that applies to your project

  1. Q1 Is the proposed project Exempt or Non-Exempt?
    1. → Exempt
      Stop. Exempt research does not require an Authorization/Reliance Agreement. No further action needed.
    2. → Non-Exempt

      Continue to Q2.

      1. Q2 Will this project have Federal Funding?
        1. → No
          1. Q3 Will the Lead PI be UNL affiliated?
            1. → Yes
              UNL is likely the Reviewing IRB.

              Continue to the shared steps below.

            2. → No
              Contact the UNL IRB to discuss the appropriate path forward.
        2. → Yes

          Continue to Q4.

          1. Q4 Will UNL be the Prime Awardee?
            1. → Yes
              Submit a New Project Form, then notify the UNL IRB (via Email, Phone, or NUramp).

              Continue to the shared steps below.

            2. → No
              UNL is likely the Relying IRB. Submit a Determination Form.

              Continue to the shared steps below.

All non-exempt paths continue here

PI confirms with the UNL IRB who will serve as the Reviewing IRB. The Reviewing IRB may be one of the following institutions:
UNL UNMC Boys Town SMART IRB Member Institution Other
Submit project materials to the Reviewing IRB.
If UNL is the Reviewing IRB: Submit all project information via NUramp for full review.
If another institution is the Reviewing IRB: Once approval is received, copies of all materials — including the approved protocol, consent documents, and supporting documents — must be submitted to the Relying IRB for acceptance. The Relying IRB reserves the right to conduct its own review. Only UNL-affiliated persons need to be listed on the protocol “shell” application.
Complete the appropriate project submission:
New Project — UNL is the Reviewing IRB: Submit a New Project Form with all participating sites listed.
New Project — UNL is the Relying IRB: Submit a Determination Form with all documents from the Reviewing IRB.
Ongoing projects involving multi-site research: Discuss with the UNL IRB on a case-by-case basis to determine next steps.
Important: Review and approval/acknowledgement are managed through the usual processes. No research can take place until final approval has been received, regardless of the status as Reviewing or Relying IRB.