SMART IRB
SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) 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; rather, it's a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Learn more
June 29, 2022As recently published, the IREx platform helps operationalize the single IRB (sIRB) mandate (doi:10.1017/cts.2022.376). More than 30 sIRBs are using IREx for over 450 studies with 2600 reliances, and new sIRBs use IREx each year given its utility for lead study teams and coordinating centers. IREx standardizes the sIRB process, automates communications, captures documentation from sites, and
April 28, 2022With hundreds of participating institutions—including all CTSA hubs—SMART IRB continues to facilitate reliance for multisite studies across the U.S., including more than 300 studies related to COVID-19. Investigators, study teams, and administrators at both reviewing and relying institutions can review the SMART IRB Agreement and access free resources on our website (www.smartirb.org). Next up
-Harvard Medical SchoolThe required use of single IRB review for most federally funded research has had a significant impact on human research protection programs. More institutions cede IRB review than serve as Reviewing IRBs. Panelists for this SMART Talk will explore the effects on institutions of relying on external IRBs, what processes institutions should have in place to oversee their research portfolios even when
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-Harvard Medical School
Panelists will discuss differences that arise between Reviewing IRBs and Relying Institutions surrounding pediatric research, such as assent process, age of assent, pregnancy testing, risk assessment, and state laws. Hear experts talk about their experiences, how they work with institutions to address disagreements, and potential areas for flexibility and harmonization Speakers: Lori Roesch, Human
The videos and companion resources are designed to help IRB and HRPP administrators and staff successfully manage single IRB arrangements: Implementing the SMART IRB Agreement Serving as a Reviewing IRB Responsibilities of Relying Institutions Online Reliance System Walkthrough Getting Started with SMART IRB and the Online Reliance System SMART IRB Resources for IRB and HRPP Personnel SMART Talk
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The videos and companion resources in the Learning Center are designed to help investigators and study teams successfully plan for and navigate single IRB review arrangements for their studies. Questions about local processes and policies are best addressed by your institution’s SMART IRB Point of Contact. Videos: Introduction to Single IRB Review and SMART IRB Overview of the NIH Single IRB
-Harvard Medical SchoolCancelled: Single IRB Boot Camp: A How-to Guide with SMART IRB This daylong boot camp is intended to train IRB and HRPP personnel in the successful implementation of the single IRB model including how to leverage SMART IRB resources. We have had to cancel this event. Please check out our website www.smartirb.org for future date. Thank you!