Learning Center

SMART Talk: Monthly Community Forum

For IRB/HRPP professionals & study teams

SMART Talks bring together SMART IRB Participating Institutions and content experts to discuss emerging issues, persistent challenges, lessons learned, and best practices related to single IRB review.

2025

What to Expect When You’re Expecting SMART IRB Reliance Agreement V3.0

Ready, Set, Go: SMART IRB Reliance Agreement V3.0 & the New Reliance System

2024

The New SMART IRB Reliance System

Single IRB Lessons Learned (or the Secrets of Single IRB Success)

Pondering Post-Approval Monitoring for Single IRB: FDA-Regulated Research Edition

An Update on SMART IRB Reliance Agreement v3.0

Understanding DOD and DOE Requirements for Single IRB Implementation

Understanding VA Specific Requirements for Single IRB Implementation

The Impact of Single IRB on Study Teams

2023

Introducing SMART IRB Reliance Agreement v3.0

The Impact of Single IRB on HRPPs

Reconsidering Local Considerations: Recommendations for Harmonization

Single IRB Review Implementation: Persistent Challenges and Possible Solutions

Exploring the Financial Aspects of Single IRB

Single IRB Workflow From Beginning to End

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

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

2022

A Conversation with the FDA and OHRP about Single IRB

Single IRB and Noncompliance - A Case Study

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

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

Serving as a Reviewing IRB for a Large Multisite Study

Where We’ve Been and Where We’re Heading

Single IRB from the Perspective of Research Teams

A Conversation with NIH and OHRP about Single IRB

2021

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

Single IRB for Social, Behavioral, and Education Research

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

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

Reviewing IRBs: Working with Relying Institutions and Study Teams

Harmonization – Conflicts of Interest and sIRB Review

Harmonization – Ancillary Reviews and Single IRB

sIRB Issues Related to Planned Emergency Research

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

2020

Harmonization - Post-Approval Auditing & sIRB Review

Harmonization - Continuing Review & sIRB

Relying Institution Roles, Responsibilities, and Opportunities

Single IRB and the Review of Research Involving Children

Practical Issues and Pragmatic Solutions for the IRB Reliance Process

Resources for Training Study Teams in Single IRB

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

Tackling Informed Consent Under the Single IRB Model

Harmonization – Responsibilities Associated with the Review of Study Personnel

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

2019

Operationalizing an HRPP under Single IRB

Managing Reliance with the SMART IRB Reliance System

Harmonization - Reportable Events

Getting Ready for the 2020 Single IRB requirements

Copyright ©2025 The President and Fellows of Harvard College

This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N950C00008.
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