Single IRB Research and Deferral Requests

Overview

The University of Arizona participates in multiple agreements that provide flexibility for researchers when working with collaborators at other institutions on non-exempt studies.

The Human Subjects Protection Program (HSPP) requires a single IRB (sIRB) review for collaborative, non-exempt human subjects research involving multiple institutions funded or supported by federal agencies that have adopted the revised Common Rule. Please consult with the HSPP if you have questions about whether your project qualifies as a multi-site sIRB study.

The appendix form below is used when the UA is the IRB of record (i.e., the “Reviewing” IRB) for another site (“Relying” IRB). Once the parent study has been approved as a multi-site study, a participating site (pSite) needs to be created and submitted to the IRB for approval. 

Along with the pSite submission, the IRB will review the following:

  • Appendix for Multi-Site Research Form;
  • Site PI CV;
  • Documentation of human research training for all research personnel listed on the Multi-Site Appendix Form;
  • All site-related materials (i.e., site-specific consent forms, recruitment, data collection, and participant materials) as applicable; and
  • Any other site-specific requirements and/or approvals.  

Each pSite must have a separate Appendix for Multi-Site Research Form uploaded to eIRB.

The following templates can be used when drafting consent forms for pSites where the University of Arizona will act as the IRB of record: 

The form below is used when the UA is deferring oversight to an outside IRB (i.e., UA IRB is the “Relying” IRB). This submission type is called a “deferral submission.” Materials that need to be submitted with a deferral submission include:

  • IRB Protocol for Projects Using External IRBs;
  • Local UA/Banner consent form (in Word format);
  • IRB of record approval (for non-commercial IRBs);
  • Sponsor protocol (if applicable);
  • PI CV;
  • Advisor/Department/Scientific and ancillary approvals (as applicable); and
  • Appendix for Waiver or Alteration of Consent or PHI Authorization Form for pre-screening purposes (if applicable).

The University of Arizona HSPP has standardized consent template language with various commercial IRBs to include required institutional language. The agreed-upon templates, organized by reviewing IRB, are below. If the approved study is not using an IRB listed below, and the study is conducted at Banner or with Banner resources, use the University of Arizona Medical Consent Form. Otherwise, use the consent form as approved by the IRB of record.

SMART IRB

The University of Arizona is a member of SMART IRB. When a site is part of SMART IRB, a reliance agreement—also known as an institutional agreement (IA or IAA)—can be established by completing the materials on the SMART IRB website, or by signing a SMART IRB Letter of Acknowledgement (LOA): 

First, check if the site is a member of SMART IRB:

SMART IRB Participating Institutions

Typically, the SMART IRB request is initiated by the researchers whose "Home Institution" IRB will be requested as the Reviewing IRB.

If you have never used the SMART IRB online reliance system, you must first create a new account through SMART IRB. As a UA investigator, your institution will be the "University of Arizona."

Please allow time for your SMART IRB administrator to complete this request. 

Review SMART IRB's User Guide for Creating a New Reliance Request for additional instructions.

 SMART IRB process

 

Traditional Reliance Agreements

If the research project is not using SMART IRB or another partner institution with which we already have an existing agreement in place (as outlined in the guidance on Single IRB Review), then a traditional reliance agreement is required. 

When a request is submitted for review, the HSPP will route the reliance agreement to the appropriate person for signature. Below are templates that should be used when a reliance agreement is required:

IRB Reliance Agreement - UA Reviewing IRB

The UA Reviewing IRB Reliance Agreement should be used when the UA IRB will act as the IRB of record for the external site conducting research.

IRB Reliance Agreement - UA Relying IRB

The UA Relying IRB Reliance Agreement should be used when the UA IRB is ceding or deferring its review to another IRB of record.

Individual Agreement - Federally or Industry Funded

This Individual Agreement should be used when an independent person (not affiliated with a specific institution) will be engaged in federally-funded or industry-funded research.

Individual Agreement - Not Federally or Industry Funded

This Individual Agreement should be used when an independent person (not affiliated with a specific institution) will be engaged in research that is not federally or industry funded.

Except under the terms specified in the Single IRB Review guidance, and in unique circumstances approved by HSPP, the UA IRB is not able to serve as the sIRB or defer to a sIRB when:

  • UA is not engaged in the research, or
  • UA IRB, or an outside IRB, has determined that the study is exempt or reviewed under a flexible review. In these cases, each investigator must obtain approval from their local IRB.