What is SMART IRB?

SMART IRB is the National Reliance Initiative developed in partnership between Harvard Catalyst and NIH to support single Institutional Review Board (“IRB”) review in facilitation of multi-site human subjects research. Free of charge and open to all who meet eligibility requirements, SMART IRB provides fast and efficient models for comprehensive single IRB review across all types of human subjects research. Key components of SMART IRB include:

• SMART IRB Reliance Agreement (“SMART IRB Agreement” or the “Agreement”), the nation's premier reliance agreement that permits Participating Institutions to cede review of human subjects research to other Participating Institutions’ IRBs. The Agreement sets forth the authorities, roles, and responsibilities of Participating Institutions and their IRBs when ceding or providing IRB review. The Agreement was designed to meet the regulatory requirements for documentation of the respective compliance responsibilities of institutions and IRBs participating in an IRB reliance relationship, and is in compliance with the 2018 requirements of the final revised Common Rule 45 CFR 46. Learn more by visiting our website to learn more about:
  • Version 3.0 Agreement
  • Steps to Join
     
• Reliance System, a centralized portal to request, track, and manage single IRB arrangements under the SMART IRB Agreement
  • Reliance System Login
  • Reliance System User Guides
     

• Harmonization efforts to align policies, processes, and workflows to ensure strategic, efficient, and cooperative approaches to ensure multi-site research under a single IRB goes smoothly. Learn more about our Harmonization efforts including whitepapers on a wide arrange of topics at our Harmonization page

   

• Resources & Education including a robust array of materials used across the country. Check out our highly utilized materials like our Communication Plan, Implementation Checklist, Letter of Acknowledgment, SOP, or more at our Resource Library! Also be sure to check out other educational offerings, including: 
  • Learning Center
  • SMART Talks
  • Boot Camp
     
• National Experts including a network of ambassadors to support adoption and implementation of IRB reliance across the nation. Find your SMART IRB Ambassador today, or contact our helpdesk:
  • SMART IRB Ambassadors
  • Contact Us

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