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 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 U of A is Acting as IRB of Record for Other Institutions/Sites
The form below is used when the U of A is the IRB of Record (the U of A IRB is the “Reviewing” IRB) for another site (“Relying” IRB). Once the parent study has been approved to become a “multi-site” study, a Participating Site (pSite) needs to be created and submitted to the HSPP for approval. Along with the pSite submission, the IRB will review the Appendix for Multi-Site Research Form, which should be uploaded to eIRB with the site PI CV, verification of Human Subjects Training for all research personnel listed on the Multi-site Appendix, and all site-related materials (i.e., site-specific consent and recruitment materials) as applicable.
Appendix for Multi-Site Research
Each pSite needs to have a separate Appendix for Multi-Site Research uploaded to eIRB.
The following consent form templates can be used when drafting consent forms for pSites where the University of Arizona will act as the IRB of Record.
- pSite Medical Consent Form Template
- pSite SBS Funded Consent Form Template
- pSite SBS Unfunded Consent Form Template
sIRB Review Forms - When U of A is Deferring to an Outside IRB of Record
The form below is used when the U of A is deferring oversight to an outside IRB of Record (the U of A 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 U of A/Banner consent form (in Word format);
- IRB of record approval (for non-commercial IRBs);
- Sponsor Protocol (if applicable);
- PI CV;
- Advisor/Departmental/Scientific and ancillary approvals as applicable; and
- Appendix for Waiver or Alteration of Consent or PHI Authorization Form for pre-screening purposes (if applicable).
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.
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). 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 Request Investigator Access through SMART IRB. As a U of A investigator, your "Home Institution" will be the "University of Arizona."
Please allow time for your SMART IRB administrator to complete this request.
Review SMART IRB's Checklist for Initiating a Request in the Online System for instructions on submitting a reliance request.
Smart IRB Letter of Acknowledgement (LOA) – U of A Reviewing
Smart IRB Letter of Acknowledgement (LOA) – U of A 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. 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 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 - U of A Reviewing IRB
The IRB Reliance Agreement (U of A Reviewing IRB) should be used when the U of A IRB will be the IRB of Record for the external site conducting human research.
IRB Reliance Agreement - U of A Relying IRB
The IRB Reliance Agreement (U of A Relying IRB) should be used when the U of A 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- or industry-funded human research.
Individual Agreement - Non-Federally or -Industry Funded
This Individual Agreement 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 U of A IRB is not able to serve as the sIRB or defer to a sIRB when:
- U of A is not engaged in the research, or
- U of A 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.