Single IRB (sIRB) & External IRB: Requests & Process

The University of Minnesota IRB may serve as the Single IRB (sIRB) for federally funded multi-site or collaborative research or allow reliance on an external IRB for IRB review and oversight. All requests must be reviewed and approved by the HRPP. To learn more about the process, refer to the Investigator Manual (HRP-103) (download) and sIRB Manual (HRP-803) (download).

To request UMN IRB to serve as sIRB, complete 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.
 

Job Aids for Reliance on an External IRB

The following job aids assist the UMN PI and study team to submit reliance on external submissions in ETHOS:

• 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
   

Working with Advarra IRB as the External IRB

If a PI is approved to utilize Advarra IRB as the external IRB, the following resources are available:

• Working with Advarra IRB
• Advarra Submission Checklist for Multi-Site Research
• Selection of sIRB for NIH Funded Research & Communication Plan
• Advarra NIH Budget Request Form
• Advarra Submission Checklist
   

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. Do not submit an sIRB study unless you have received explicit approval from the HRPP indicating that the UMN IRB will serve as sIRB.

• 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

We also recommend reviewing the following documents from the HRPP Toolkit Library:

• 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.
• Criteria for UMN Serving as sIRB: Checklist used by IRB staff to evaluate whether the UMN IRB can serve as the sIRB.
• Criteria for External IRB Reliance: Checklist used by IRB staff to evaluate whether the UMN IRB will allow reliance on an external IRB.
• PI Attestation Form for Relying on an External IRB: Form signed by the UMN PI to attest to their role and responsibilities for a study that relies on an external IRB.
• PI Attestation Form for UMN to Serve as sIRB: Form signed by the UMN PI to attest to their role and responsibilities for a study where UMN IRB will serve as sIRB.
• Local Context Review for Relying on an External IRB: Worksheet used by IRB staff to conduct a local context review for UMN submissions that will rely on an external IRB for IRB review and oversight.
• 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.