students

SMART IRB Reliance Agreements (SBER IRB)

The SMART IRB Agreement is a national master agreement that allows institutions to avoid having to negotiate individual IRB authorization agreements per study or group of studies. Participating Institutions may cede review of human subjects research to any other Participating Institution’s IRB under this agreement.

Investigators and institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.

  • Simplifies the selection of a single IRB for multisite studies
  • Manages communication between institutions and investigators
  • Tracks the status of requests
  • Clearly indicates what needs to be done next
  • Documents reliance arrangements for each study
  • Sites can be added to a reliance arrangement by amendment

Before beginning, check the Participating Institutions list to see if your collaborator’s institution is a member of SMART IRB.

Participating Institutions

    Request Investigator Access to SMART IRB

    Access to SMART IRB Reliance allows research investigators or their designee to submit requests for IRB reliance. Typically, the SMART IRB request is initiated by researchers whose “Home Institution” IRB will be requested as the Reviewing IRB (the IRB accepting the reliance of other IRBs), though this is not required.

    Request Investigator Access

    Initiating a Request in the SMART IRB Online Reliance System

    1. Log in to the Online Reliance System and click “New Request”.
    2. Provide information about your study:
    • Basic information about the research (title of study, a brief description)
    • Name of the Principal Investigator
    • Select the institution that you would like to serve as the Reviewing IRB
    • List funding sources
    • List the sites that will be engaged in human subjects research for the study
    • For each site, provide:
    • The site investigator’s name and contact information
    • Research personnel names and contact information
    • Information about research participants and research activities at the site
    • Upload supporting documents (PDFs only)
    • Research protocol
    • Consent templates
    • Other documentation
    1. Review the request for accuracy.
    2. Submit the request. You can log back in to the Online Reliance System to track the progress of your request. You will be notified by email once a reliance decision has been reached.

    Before Beginning Research Activities

    Reliance decisions in SMART IRB apply only to the determination of IRB reliance, and do not reflect IRB approval of the research project itself. Approval for each collaborating institution must be obtained from the Reviewing IRB 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 reviewed and approved, which is usually accomplished via a modification to the existing study.

    You will need to ensure you have documentation that:

    • The relying IRB has ceded review to the IRB of record; and
    • The IRB of record has approved a modification to add the site/collaborators.

    When Tufts SBER IRB cedes review to another IRB, it is the PI’s responsibility to send all IRB approval notices from the reviewing IRB to Tufts SBER IRB. This includes all subsequent modification and continuing review approval notices.