Reliance Request

Reliance refers to the use of an institutional review board (IRB) outside of the University of Minnesota to conduct the regulatory review and oversight of a study.

Reliance arrangements can require a complex and lengthy negotiation process. The HRPP is responsible for negotiating and coordinating the execution of IRB reliance agreements. This includes obtaining review by legal counsel, as needed, and signature of the U of M institutional official.

Submit a reliance request if a project or study involves collaboration with sites or personnel outside of the University of Minnesota and you would like to use a single IRB for review of the research.

Resources

Use the following resources to prepare a reliance request:

• How to Submit a Reliance Request
  Detailed, step-by-step guides on how to submit a reliance request for a new study, updating your study/site after external IRB approval.

• How to Submit Updates for Studies Relying on an External IRB
  Detailed, step-by-step guides on how to submit updates in ETHOS for studies relying on an external IRB.

• How to Update Previously-Approved for Reliance Submissions for External IRB Review Already “Approved” in ETHOS
  The ETHOS upgrade in January 2018 affected reliance submissions previously approved for external IRB review. This job aid provides detailed instructions on how update those submissions.

• Single IRB
  Detailed guidance and resources for information on NIH single IRB review for multi-site studies and information about sIRB review for UMN studies, including working with Advarra IRB

• How to Work with Advarra IRB
  Detailed guidance and resources for information on working with Advarra IRB.

• Advarra sIRB Requirements
  This document outlines Advarra IRB’s statement of compliance, a summary of qualifications, the communication plan between the local site, local IRB, lead site, and sIRB.

• Advarra NIH Budget Questionnaire
  This questionnaire solicits information for developing a draft NIH budget for sIRB submissions that will use Advarra.

• Relying on Quorum
  Detailed instructions and guidance for relying on Quorum.

• Frequently Asked Questions
  Frequently received questions about reliance requests.

• New Submission Checklist for Reliance Submissions
  Checklist of documents and information needed to submit a reliance request to use an external IRB.

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.

• External IRB Pre-Review and Updates
  IRB staff use this worksheet to screen External IRB submission materials

• Criteria for External IRB Reliance
  IRB staff use this worksheet to determine eligibility when reviewing requests to rely on an External IRB.

for a new study, updating your study/site after external IRB approval