Participating Institutions
including all CTSA hubs

Resources

Scroll through the resource list below, or click on a letter to jump to the first corresponding resource name.

All Resources

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Joining SMART IRB

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Setting up Reliance

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Implementing the Agreement

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For Funding Applications

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About Single IRB Review

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Study Teams

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Reviewing IRBs

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Relying Institutions

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IRB/HRPP Staff

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SMART IRB

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NIH

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Other

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Agreement, The SMART IRB (Version 2.0; finalized October 1, 2020)

Review the Master Common Reciprocal Institutional Review Board Authorization Agreement. As of October 1, 2020, any new signatory institution will sign SMART IRB Agreement v2.0.

Note: SMART IRB Agreement Version 1 (including versions 1.1. and 1.2) is compatible with v2.0; Participating Institutions that have signed v1 are not required to sign v2.0.To learn more about differences across versions of the SMART IRB Agreement read the Agreement Version Guide.

SMART IRB
Consultations: Expert Advice and Guidance

Prepare to serve as a Reviewing IRB or Relying Institution by consulting with an IRB experienced in the conduct, review, and oversight of multisite research.

SMART IRB
Evaluation Checklists for the Use of Central IRBs

These checklists are designed to assist organizations with adoption of a central IRB model, including institutional self-assessment of readiness, institution/sponsor evaluation of a central IRB, and central IRB evaluation of an institution.

Clinical Trials Transformation Initiative
FAQs (Updated April 2020)

Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.

SMART IRB
Fees and Costing Models under NIH sIRB Policy

Points to consider regarding charging, structuring, and justifying fees for single IRB review, as well as federal regulations on direct/indirect costs.

SMART IRB Harmonization Steering Committee
Institution v. IRB Responsibilities

A guide to the regulatory purview of a reviewing IRB and the role and responsibilities of Relying Institutions.

SMART IRB Harmonization Steering Committee

Joinder Checklist

An overview of the information required to generate your institution's Joinder Agreement.

SMART IRB
Joining SMART IRB

An overview of the requirements and processes for completing the SMART IRB Joinder process

SMART IRB
Letter of Acknowledgement, Template

If not using the SMART IRB Online Reliance System to coordinate and document study-specific reliance arrangements, institutions may use this template to document the Reviewing IRB and Relying Institutions for a specific study.

SMART IRB
Local Considerations: Institutional Profile

Captures institutional, local, and state requirements that a Reviewing IRB may need to apply to its review and oversight of studies on behalf of another institution as well as information about an institution's IRB(s), if applicable.

SMART IRB Harmonization Steering Committee

Local Considerations: Protocol-specific Document

Allows a Reviewing IRB to collect variations across participating sites regarding key information about study teams (e.g., training and conflicts of interests) and variations in study conduct (e.g., ancillary reviews required; HIPAA requirements; subject population).

SMART IRB Harmonization Steering Committee

Online Reliance System

Helps investigators and institutions request, track, and document reliance arrangements for each study.

SMART IRB
PI Checklist - SAMPLE

This document provides an example of an institution checklist to help an overall PI understand his/her responsibilities.

MetroHealth
SOP Manual, SMART IRB

Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.

SMART IRB
Start-up Package for NIH Grant Preparation

A suite of resources to help investigators prepare NIH grant applications that require single IRB review; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.

SMART IRB
Start-up Package for Relying Institutions

A suite of resources to help Relying Institutions understand and fulfill their roles and responsibilities in a single IRB arrangement; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.

SMART IRB
Start-up Package for Reviewing IRBs

A suite of resources to help Reviewing IRBs understand and fulfill their roles and responsibilities in a single IRB arrangement; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.

SMART IRB
Start-up Package for Study Teams

A suite of resources to ensure study teams understand and can fulfill their responsibilities related to single IRB arrangements; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.

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

Provides an overview of NIH's proposed revisions to the SMART IRB Agreement as well as how institutions can provide feedback. This is followed by a discussion regarding the pressures placed on institutions as a result of the COVID-19 pandemic, how single IRB can be leveraged to facilitate research review and compassionate-use protocols, and the consequences of institutions putting research studies on hold, both for Reviewing IRBs and Relying Institutions.

View Slide Deck

SMART IRB
Webinar: SMART Talk - Resources for Training Study Teams in Single IRB

Provides an overview of training materials and resources developed by SMART IRB that are designed to help investigators and study teams successfully plan for and navigate single IRB review arrangements for their studies; panelists also discuss their experiences preparing study teams for single IRB review, including best practices and lessons learned.

View Slide Deck

SMART IRB
Webinar: SMART Talk - Single IRB and the Review of Research Involving Children

A discussion of the differences that arise between Reviewing IRBs and Relying Institutions surrounding pediatric research, such as differences in assent processes, age of assent, pregnancy testing, risk assessment, and state laws. Panelists speak about their experiences, including how they work with institutions to address disagreements and potential areas for flexibility and harmonization.

View Slide Deck

SMART IRB