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Participating Institutions
including all CTSA hubs

Glossary

Learning Center

for IRB and HRPP Administrators

The videos and companion resources below are designed to help IRB and HRPP administrators and staff successfully manage single IRB arrangements.

SMART IRB Start-Up Packages

These packages contain a suite of resources to help you understand and fulfill your roles and responsibilities in a single IRB arrangement. Each package provides a guide describing how and when to use the included resource as well as links to online tools and further information.

See also: Start-up Packages for Study Teams.

Getting Started with SMART IRB and the Online Reliance System

A brief introduction to SMART IRB and an overview of the features of the SMART IRB Online Reliance System.

Online Reliance System Walkthrough

A brief introduction to SMART IRB and an overview of the features of the SMART IRB Online Reliance System.

SMART IRB Resources for IRB and HRPP Personnel

Guide to SMART IRB’s resources to help IRB and HRPP personnel document reliance arrangements, get started as a Reviewing IRB, and educate and work with study teams.

Visit the Resources Section for a full listing of tools, templatess, guidance, and checklists.

SMART Talk: Monthly Community Forum

A resource for IRB and HRPP professionals navigating and implementing sIRB review; visit the home page for upcoming sessions.

The Impact of Single IRB on Study Teams

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Introducing SMART IRB Reliance Agreement v3.0

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The Impact of Single IRB on HRPPs

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Reconsidering Local Considerations: Recommendations for Harmonization

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Single IRB Review Implementation: Persistent Challenges and Possible Solutions

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Exploring the Financial Aspects of Single IRB

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Single IRB Workflow From Beginning to End

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Is it Yours or Mine? Pinpointing Responsibilities in a Single IRB Situation

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Everything You Wanted to Know about Single IRB but Were Afraid to Ask…Part Deux

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A Conversation with the FDA and OHRP about Single IRB

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Single IRB and Noncompliance - A Case Study

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Everything You Wanted to Know about Single IRB but Were Afraid to Ask

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A Conversation with the Department of Defense (DOD), Department of Energy (DOE), and Department of Veterans Affairs (VA) about Single IRB

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Serving as a Reviewing IRB for a Large Multisite Study

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Where We’ve Been and Where We’re Heading

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Single IRB from the Perspective of Research Teams

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A Conversation with NIH and OHRP about Single IRB

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When You’re Not the Reviewing IRB – The Impact of Using External IRBs

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Single IRB for Social, Behavioral, and Education Research

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Using AAHRPP’s I-9 Standard to Guide Reliance Arrangements

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Single IRB Resources: What, When, Why, and How to Use Them

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Reviewing IRBs: Working with Relying Institutions and Study Teams

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Harmonization – Conflicts of Interest and sIRB Review

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Harmonization – Ancillary Reviews and Single IRB

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sIRB Issues Related to Planned Emergency Research

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The All of Us IRB - Insights from a Unique Single IRB

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Harmonization - Post-Approval Auditing & sIRB Review

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Harmonization - Continuing Review & sIRB

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Relying Institution Roles, Responsibilities, and Opportunities

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Single IRB and the Review of Research Involving Children

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Practical Issues and Pragmatic Solutions for the IRB Reliance Process

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Resources for Training Study Teams in Single IRB

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2-part Session: NIH Proposed Updates to the SMART IRB Agreement & sIRB Considerations in the Context of COVID-19

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Tackling Informed Consent Under the Single IRB Model

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Harmonization – Responsibilities Associated with the Review of Study Personnel

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A Follow-Up Conversation: Getting Ready for the 2020 Single IRB requirements

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Operationalizing an HRPP under Single IRB

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Managing Reliance with the SMART IRB Online Reliance System

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Harmonization - Reportable Events

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Getting Ready for the 2020 Single IRB requirements

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Single IRB Boot Camp: a How-to Guide with SMART IRB

This online session, held February 7 & 9, 2023, provided training for IRB and HRPP personnel on successful implementation of the sIRB review model and demonstrated how to leverage SMART IRB resources to achieve that success. Watch session recordings and download slides below.

sIRB Boot Camp Day 1

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sIRB Boot Camp Day 2

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Training for Investigators and Study Teams

Use this suite of training videos and resources as is, or customize to reflect local processes and policies.

Visit the Investigator and Study Team Learning Center to view available materials; send investigators here for self-guided learning.

Download presentations (no audio) to use for local training sessions or customize to reflect local processes.

To download the presentations with embedded audio, please use the links below: