The Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform or 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.
Northwestern University Smart IRB Process
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+. 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. If the request is for Northwestern to serve as the IRB of Record for an External IRB/Site, the “Brief Description” question of the eIRB+ application should state 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, please contact email@example.com.
The Smart IRB reliance process can be completed via two methods:
Online Reliance System
The online Smart IRB reliance system allows research teams to submit an electronic request to utilize the Smart IRB master reliance agreement for the reliance process. 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 (https://reliance.smartirb.org/invitations/new).
Upon approval and 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 IRB 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.
Please note: 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.
Additional resources are available on the Smart IRB webpage (https://smartirb.org/resources/).