The University of Arizona

Single IRB Research and Forms

Overview

The University of Arizona participates in multiple agreements that provide flexibility for researchers when working with collaborators at other institutions. Please review our guidance on Single IRB Review that explains our collaboration agreements, and 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, even if utilizing single IRB review for a study, there are obligations for IRB Fees and Other Approvals Required with your submission to the HSPP.

A multi-site study is a study that involves multiple institutions engaged in the research project. The Human Subjects Protection Program determines whether or not the site is engaged in the human research. 

Single IRB Review Forms

The forms below are for when the UA is the IRB of record (Reviewing IRB) for another site (Relying IRB). These supplemental forms are needed along with other required forms.

Appendix for Multi-Site Research
This form should be used when the University of Arizona IRB will review research activities for an investigator or research staff who are not affiliated with the University. This form is NOT needed if each research site will obtain their own IRB approval. Each additional site will need to have its own Appendix for Multi-Site Research.

Multi-Site List of Research Personnel
Site specific list of Senior/Key personnel, as defined by the National Institutes of Health, must be included on the Multi-Site List of Research Personnel and have current CITI training before they may conduct any activities related to the human research. Each additional site will need to have its own Multi-Site List of Research Personnel.

Multi-Site Renewal/ Closure of Human Research 
This document should be completed by each site for which the UA IRB is the IRB of record. It will need to be provided alongside the Renewal/Closure for Human Subjects that is submitted.

SMART IRB

The University of Arizona has taken the initiative to become a member of SMART IRB. SMART IRB is a platform which institutions may use to rely upon each other for IRB review. By utilizing SMART IRB, additional agreements typically are not necessary between the hundreds of institutions that are members thereby reducing the requirement to route additional paperwork. Check the Participating Institutions list to see if your collaborator's institution is a member of SMART IRB.

Access to SMART IRB allows research investigators or their designee to submit requests for IRB reliance. Typically, the SMART IRB request is initiated by the researchers whose "Home Institution" IRB will be requested as the Reviewing IRB (the IRB accepting the reliance of other IRBs). 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 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 has issued many resources for investigators using its services:

Traditional Reliance Agreements

If the research project is NOT using SMART IRB or another partner for which we already have an existing agreement (see guidance document above), then a Reliance Agreement is needed. The Human Subjects Protection Program 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 in place.

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 – Ceding Review

The IRB Reliance Agreement (Ceding Review) should be used when the UA IRB will be ceding 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.

Consent Template Language 

The University of Arizona HSPP has standardized consent template language with various commercial IRBs to add in 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 Dignity Health

CIRB Boilerplate UA

NMDP

WIRB