Single IRB (sIRB) and External IRB: Reliance Arrangements

Single IRB (sIRB) and external IRB are terms used to reference a legal arrangement between two or more institutions to allow for IRB regulatory review and oversight of a study by one institution’s IRB for one or more other institutions when multiple IRBs have jurisdiction for the same research protocol (this is called “reliance”). Some funding agencies, such as NIH, and research consortia increasingly encourage or require the designation of a single IRB to serve as the reviewing IRB for all participating sites in multi-center research studies.

You can reference Reliance Arrangements Frequently Asked Questions (FAQ) for more information about reliance.

Reliance Request: Relying on Another IRB

Reliance refers to the use of an institutional review board (IRB) outside of the University of Minnesota (external IRB) to conduct the regulatory review and oversight of a study. Approval to rely on an external IRB requires an administrative review by HRPP including submitting a new study request in ETHOS and execution of a reliance agreement.

Requests to rely on an external IRB are reviewed on a case-by-case basis. Various factors are considered in determining eligibility to rely on an external IRB such as risk level of study and whether the other institution is accredited.

Request Use of an External IRB

Use the following resources to submit a request for the use of an external IRB:

• Inquire about the Use of External IRB
• Criteria for External IRB Reliance
• Create and Submit a New Study/Site for External IRB
• New Study Submission Checklist for Reliance Submissions
• Submitting Updates in ETHOS – External IRB Study/Site - Job Aid 

Current Reliance Arrangements

The University of Minnesota currently has reliance arrangements in place with Advarra and NCI CIRB, among others. The University is also signed onto the SMART IRB Agreement, joining a network of 500+ Participating Institutions. Refer to the resources below for more information on working with external IRBs:

• How to Rely on Advarra
• How to Rely on NCI CIRB
• How to Rely on National Marrow Donor Program
• How to Rely on other Academic IRBs

If you are using Advarra as the sIRB for NIH funded research reference the below:

• Working with Advarra IRB as NIH sIRB
• Advarra sIRB and Communication Plan: This document outlines Advarra IRB’s statement of compliance, a summary of qualifications, and the communication plan between the local site, local IRB, lead site, and sIRB.
• Advarra NIH Budget Request Form: This questionnaire solicits information for developing a draft NIH budget for sIRB submissions that will use Advarra.

University of Minnesota as IRB of Record (sIRB/CIRB)

The University of Minnesota IRB will not, at this time, serve as the sIRB/IRB of record for multi-site studies and other institutions/sites engaged in human research. Efforts are currently underway to evaluate and prepare for the U of M to serve in this role and more information will be made available as that process advances.

NIH sIRB Policy Resources 

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, that involve multi-site non-exempt human participant research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites.

• Detailed guidance: Single IRB Review: NIH sIRB Policy and Common Rule
• Request a Letter of Support for your NIH Grant Application

Additional Resources from the Toolkit

• Human Research Determination Worksheet: Assistance for determining whether an activity is human research and how it is regulated.
• Engagement Determination Worksheet: Assistance for designated reviewers making engagement determinations about an institution or site’s engagement in human research.
• Investigator Manual: Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota (see Page 75-80).
• External IRB Pre-Review and Updates: Worksheet used by IRB staff to screen external IRB submission materials.