Help us optimize this website! A couple minutes of your time could help us make information architecture and design improvements. Take our user experience survey.

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 that involves multiple institutions funded or supported by federal agencies that have adopted the revised Common Rule. Please consult with the HSPP if there are questions if your project qualifies as a multi-site sIRB study.

Review guidance on Single IRB Review for information about collaboration agreements, obligations, and submission requirements for single IRB review.

For multi-site research supported by the National Institutes of Health (NIH), please review the NIH Single IRB Policy for Multi-Site Research.

Remember, if utilizing a single IRB review for a study, there are obligations for IRB Fees and Other Approvals Required with your submission to the HSPP.

sIRB Review Forms - when UA is acting as IRB of Record for other institutions/pSites

This form below is used when the UA is the IRB of record (the UA IRB is the “reviewing” IRB) for another site (“Relying” IRB). Once the parent study has been approved to become a “multisite” study, a pSite will need to be created and sent to the HSPP for approval. Along with the pSite submission, the IRB will review the Appendix for Multisite Research form to be uploaded in eIRB along with the site PI CV, verification of Human Subjects Training for everyone listed on the Multisite Appendix, and all site-related materials (i.e., site-specific consent and recruitment materials) as applicable.

Please note: each additional pSite will need to have its own Appendix for Multi-Site Research uploaded to eIRB.

The following consent form templates can be used when drafting consent forms for Participating Sites (pSites) where the University of Arizona will act as the IRB of Record. 

sIRB Review Forms - when UA is deferring to an outside IRB of Record

This form below is for when the UA is deferring oversight to an outside IRB of record (the 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 the IRB Protocol for Projects Using External IRBs, PI CV, local UA/Banner consent, Advisor/Departmental/Scientific and Ancillary approvals as applicable, and if applicable, the Appendix for waiver or Alteration of Consent or PHI Authorization for pre-screening purposes.

 

Consent Templates

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 outside IRB listed below and the study is conducted at Banner or with Banner resources, please use the University of Arizona Medical Consent Form. Otherwise, use the consent form as approved by the IRB of record.

Advarra

CIRB Boilerplate

Jaeb Adult-Parental

Jaeb Assent

NMDP

WCG IRB, Inc.

Establishing Institutional Reliance     

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”, “IAA”) can be established by completing the materials on the Smart IRB Website, or by signing the Smart IRB Letter of Acknowledgement (LOA) Click here to check to see if the Participating Institution is a member of SMART IRB.

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 Request Investigator Access through SMART IRB. As a UA investigator, your "Home Institution" will be "The University of Arizona."

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

Please review SMART IRB's Checklist for Initiating a Request in the Online System for instructions on how to submit a request for reliance.

Please review this flowchart on the SMART IRB process at the UA IRB.

Smart IRB Letter of Acknowledgement (LOA) UA reviewing

Smart IRB Letter of Acknowledgement (LOA) UA relying

 

Traditional Reliance Agreements

If the research project is NOT using SMART IRB, or another partner, for which we already have an existing agreement as described in the guidance on Single IRB Review, then a traditional Reliance Agreement (also known as an “institutional agreement, “IA”, “IAA”) is needed. The HSPP will route the Reliance Agreement to the appropriate person for signature when a request is submitted for review. Below are templates that should be used when a Reliance Agreement is required and SMART IRB will not be used or the agreement is with a partner for which we do not already have an existing agreement.

IRB Reliance Agreement - UA Reviewing IRB

The IRB Reliance Agreement (UA Reviewing IRB) should be used when the UA IRB will be the IRB of Record for the external site conducting human research.

IRB Reliance Agreement - UA Relying IRB

The IRB Reliance Agreement (Ceding or deferring Review) should be used when the UA IRB is ceding or deferring its review to another IRB of Record.

Individual Agreement - Federally or Industry Funded

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

Individual Agreement - Non-Federally or -Industry Funded

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

Exempt/Flex Review Studies

Except under the terms specified in our guidance on Single IRB Review, 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.

Subscribe to the UArizona Impact in Action newsletter to receive featured stories and event info to connect you with UArizona's research, innovation, entrepreneurial ventures, and societal impacts.

Subscribe now