SMART IRB & IREx
The Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB), is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is not an IRB, but a master reliance agreement which has over 580 participating institutions. The SMART IRB master reliance agreement replaces the need to have an individual Institutional Authorization Agreement (IAA).
Northwestern University is a participating institution of SMART IRB and this method can be utilized to complete the reliance process for a study being conducted with another SMART IRB participating institution. Please review the list of Participating Institutions to see if your collaborator is a member of SMART IRB. Additional resources are available on the SMART IRB Learning Center webpage.
How to Use SMART IRB for Reliance Agreements
In order to request use of the SMART IRB master reliance agreement for the reliance process, a new study submission should first be submitted in eIRB+. We do not actively monitor the SMART IRB Online Reliance System nor do we sign SMART IRB Letter of Acknowledgements via email. Please ensure that your eIRB+ submission includes the following information for efficient review and processing:
- A drafted SMART IRB Letter of Acknowledgement OR inclusion of the SMART IRB Online Reliance Platform project ID (choose one).
- If the request is for Northwestern to serve as the IRB of Record for an External IRB/Site, the protocol should include the "Multi-Site and Collaborative Research" section and explicitly state which sites will utilize SMART IRB for the reliance process
- If the request is for Northwestern to cede review to an External IRB Request, the eIRB+ application should reflect the name of the requested IRB of Record and that SMART IRB will be utilized for the reliance process.
Any questions regarding the feasibility of the Northwestern IRB serving as the IRB of Record for a multi-site study or ceding review to an External IRB, should be directed to firstname.lastname@example.org.
Using the SMART IRB Letter of Acknowledgement (LOA)
The SMART IRB Letter of Acknowledgement (LOA) allows research teams to utilize a paper or electronic document to execute reliance agreements under the terms of the SMART IRB master reliance agreement. This document follows a similar process as other types of reliance agreements. Each site will need to sign a separate LOA with the proposed IRB of Record.
Each institution that participates in SMART IRB typically has their own preferred template. Whichever site is the proposed IRB of Record will often request their template be used. The Northwestern template contains signatures lines and per our local process and we kindly request signature lines be added to any LOA template for our consideration:
Using the SMART IRB Online Reliance System
The SMART IRB online reliance system allows research teams to submit an electronic request to execute reliance under the terms of the SMART IRB master reliance agreement. The request is typically initiated by the lead study team whose IRB will be serving as the IRB of Record for all sites. Each person requiring access to the online reliance system will need to submit a separate request for access to the system.If you've requested access and haven't received confirmation within a week please contact email@example.com
- Request Access: https://reliance.smartirb.org/users/sign_up
- Sign In: https://reliance.smartirb.org/users/sign_in
If you are a part of the lead study team, the next steps are required to proceed with the request in the online system:
- Basic information about the research (title of study and a brief description)
- Name of Principal Investigator
- List the engaged sites which are requesting to cede review to the IRB of Record
- Identify activities and study team personnel at each site
- Upload the research protocol and consent form templates
Before Beginning Research Activities
Reliance decisions in SMART IRB apply only to the determination of reliance and do not reflect IRB approval for the research project itself. Approval for each collaborating institution must be obtained from the overall IRB of Record prior to beginning research with that site or its collaborators.
If the reliance request was initiated after the reviewing IRB approved the study, the addition of sites and/or collaborators will need to be specifically review and approved, which is usually accomplished via a modification to the existing study.
The IRB Reliance Exchange (IREx) is a web-based platform, supported by the Duke/Vanderbilt Trial Innovation Center (TIC), to facilitate Single IRB documentation, communication, and the exchange of information. Northwestern University is a participating institution of IREx and this method can be utilized to complete many study related processes for studies with other IREx participating institutions.
IRBs, coordinating centers, and study teams use IREx for following features:
- Document and track reliance arrangements between FWA-holders and component sites
- Execute reliance agreements under the terms of the SMART IRB master reliance agreement
- Track participating site progress towards initial IRB approval
- Streamline and centralize the capture of participating sites’ local considerations on a study-by-study basis
- Centrally manage participating site approval documents from initial approval through study close
- Facilitate communications to participating sites when actions are required
- Automate notifications to participating sites of new approvals and upcoming continuing reviews
For more information please reference the following IREx resources: