Single IRB (sIRB) and External IRB: Reliance Arrangements

Single IRB (sIRB) and external IRB are terms used to reference a legal arrangement allowing IRB regulatory review and oversight of a study by one IRB when multiple institutions have jurisdiction for the same research protocol (this is called “reliance”). Most federally funded multi-site or cooperative research requires the designation of a single IRB to serve as the reviewing IRB for all participating sites.

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 600+ 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 federally funded research where the University of Minnesota is the lead site, reference the below:

• Working with Advarra IRB as sIRB (UMN as Lead Site)
• 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 Budget Request Form: This questionnaire solicits information for developing a draft budget for sIRB submissions that will use Advarra.

University of Minnesota as IRB of Record (sIRB)

Complete the Single IRB Request Form to initiate a request for the UMN IRB to act as sIRB.

The University of Minnesota evaluates requests to serve as sIRB for multi-site / collaborative research on a case-by-case using “Checklist: Criteria for UMN Serving as sIRB (HRP-840).” 

All requests for the UMN to serve as the sIRB must be reviewed and approved by HRPP. UMN will not agree to act as sIRB in all cases. You should plan for alternative options such as another participating site or a commercial/independent IRB.

If the request is for a grant submission (e.g. NIH), submit the Single IRB Request Form well in advance of the grant submission due date to ensure time to review your request and determine if the UMN IRB is willing to act as sIRB.

Federally Funded Research sIRB Policy Resources 

Most federally funded multi-site/collaborative research projects located in the United States that require IRB oversight require the use of a single IRB starting January 20, 2020. The National Institutes of Health (NIH) implemented a variation of the Single IRB-of-Record (sIRB) policy that went into effect on January 25, 2018.

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

Job Aids for sIRB studies

The following job aids assist the overall study/lead UMN PI and study team to submit sIRB submissions in ETHOS.

• How to Create and Submit a Continuing Review Submission for an sIRB
• How to Create and Submit a Modification for an sIRB Study
• How to Create and Submit an sIRB Study
• How to Submit an RNI for a sIRB Study
• How to Submit/Add a Participating Site for a sIRB Study under UMN IRB Review
• New Multi-Site/Collaborative Research Participating Site Submission Checklist
• New Multi-Site/Collaborative Research Study Submission Checklist

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.
• sIRB Manual (pdf download): Comprehensive guide about roles, responsibilities, policies, procedures related to the conduct of Human Research that is overseen by the University of Minnesota’s Institutional Review Board (UMN IRB) when it serves as a single Institutional Review Board (sIRB) for multi-site/collaborative studies.
• External IRB Pre-Review and Updates: Worksheet used by IRB staff to screen external IRB submission materials.
• Local Context and Institutional Requirements Form: This form gathers information about a participating site (p-Site), specifically local context and institutional requirements to support the sIRB review.