Use of Single and Commercial IRBs

CIRB review

Per the UNMC IRB website:

What is Single IRB?

The single IRB (sIRB) policy is an NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018, especially those that involve multi-site non-exempt human subjects research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites.

What are the options for awardees to comply with the single IRB policy?

An NIH award recipient has several possible options for complying with the NIH single IRB policy including having the IRB at one of the participating sites agree to serve as the single IRB, using an independent IRB, including the IRB of a non-participating site, or using the IRB as required in the Funding Opportunity Announcement (FOA) or Request for Proposal (RFP) (for example, certain cancer clinical trials funded by the National Cancer Institute (NCI) are required to use the NCI Central IRB (CIRB)).

How do I request UNMC serve as the Single IRB for my study?

UNMC IRB provides Reliance Consultation services to help investigators initiate a SIRB model for their multisite studies. This meeting is the first step in setting up a SIRB process at UNMC. Even if you aren't sure about your funding or only want to get a better feel for what the UNMC IRB can offer, this meeting can get you started.  

Once you submit a reliance request (available on the UNMC IRB website) You will be contacted to set up a meeting by phone or in-person. Note that this meeting should include at least one investigator on the study, as well as any key study personnel (coordinating center staff) involved in the regulatory process.

This meeting will help determine if UNMC IRB is a good fit for the study and provide you with guidance on your roles and responsibilities when using the SIRB model. 

For more information on the background, policy, or FAQs, visit the NIH FAQs page. To request UNMC serve as the sIRB, please complete a Single IRB Request Form.

What is SMART IRB? SMARTIRB

The SMART IRB Online Reliance System is designed to harmonize and streamline the IRB review process for multisite studies, while also serving as a roadmap for institutions to implement the National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research, which took effect on January 25, 2018.

Joining SMART IRB

  • Joining and using SMART IRB is free, and is designed to reduce the time and effort involved in negotiating reliance agreements between institutions and collaborators. The University of Nebraska Medical Center has already been registered with SMART IRB.

Using the Online Reliance System

  • This system allows investigators and institutions the capability to manage study-specific reliance agreements throughout all steps of the reliance process. The Overall Principal Investigator (PI) of a multisite study works with the Points of Contact (POCs) for each participating institution involved in the study to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research. Please email the UNMC Pediatric IRB for the current POC and for further assistance in getting started.

SMART IRB Resources

  • There are a variety of resources available for all participants in the reliance process, including study teams, reviewing IRBs, relying institutions, and more. Please visit the SMART IRB Resources page for more information, including standard operating procedures, forms, and webinars designed to familiarize users with the Online Reliance System.