Participating Institutions
including all CTSA hubs

Glossary

Resources

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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
Conflict of Interest Review Processes for sIRB Review

This guidance addresses the responsibilities of a Relying Institution and a Reviewing IRB/Reviewing IRB Institution in the COI review process, including specific guidance to assist in determining and managing COI, as well as answers to FAQs.

SMART IRB Harmonization Steering Committee
Continuing Review Process and Single IRB

Recommendations for harmonization of the sIRB continuing review process, including the regulatory basis for continuing review, implementation of OHRP and FDA guidance in a single IRB context, and the responsibilities of Reviewing IRBs, Relying Institutions, Overall PIs, and Relying Site Investigators as they relate to the continuing review process.

SMART IRB Harmonization Steering Committee
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 December 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: 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
Post-Approval Auditing: Sample For-Cause Audit Notification Checklist

This checklist is intended for use by the Reviewing IRB when requesting a for-cause audit of a study subject to single IRB review; the Reviewing IRB should send a written notice of the requested audit to the SMART IRB POC, with a copy to the Overall PI and Site Investigator, when appropriate. For more information about using this resource, see the Harmonization Steering Committee’s guidance, Post-Approval Auditing for Studies Subject to Single IRB Review.

SMART IRB Harmonization Steering Committee
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.

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SMART IRB
Webinar: SMART Talk - Harmonization - Ancillary Reviews and Single IRB

A discussion of proposed recommendations from the SMART IRB Harmonization Steering Committee’s Ancillary Review Working Group, including: a definition of the term “ancillary review” and which ancillary reviews affect single IRB review, as well as recommendations for the timing of these reviews, potential centralization of some ancillary reviews, and allocation of responsibilities.

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SMART IRB
Webinar: SMART Talk - Harmonization - Conflicts of Interest and sIRB Review

Panelists discuss proposed recommendations from the SMART IRB Harmonization Steering Committee’s Conflict of Interest (COI) Working Group, including the information that Relying Institutions should provide to the Reviewing IRB, the Reviewing IRB's role in the COI management process, and considerations when a Relying Institution does not have a COI management process.

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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.

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SMART IRB
Webinar: SMART Talk - Reviewing IRBs: Working with Relying Institutions and Study Teams

Panelists discuss some of the unique situations they have encountered, lessons they have learned serving as a Reviewing IRB, and practices they have developed to help Relying Institutions navigate the reliance process and external study teams understand their responsibilities under the single IRB model. Regardless of how you interface with the single IRB model – as a Reviewing IRB, Relying Institution, or study team – watching this session will help you anticipate and address some of the challenges you may encounter.

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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.

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SMART IRB
Webinar: SMART Talk - Single IRB for Social, Behavioral, and Education Research

Revisions to the Cooperative Research provision in the Common Rule mean more social, behavioral, and education research (SBER) must identify a single IRB to review multisite research. This SMART Talk explores the unique challenges in applying single IRB to SBER, including exemptions, as panelists discuss their experiences and how their organizations approach sIRB review for SBER.

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SMART IRB
Webinar: SMART Talk - Single IRB Resources: What, When, Why, and How to Use Them

Panelists discuss SMART IRB resources (and beyond!) that are available to help IRBs and HRPPs implement single IRB arrangements. The session covers a range of resources for documenting reliance arrangements, getting started as a Reviewing IRB, being an informed Relying Institution, and educating and working with study teams – including how and when to use these resources. Our two newest SMART IRB Ambassadors, who know the single IRB trenches well, share their experiences and insights about using these resources to facilitate efficient and effective processes.

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SMART IRB