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Glossary

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

Review the Master Common Reciprocal Institutional Review Board Authorization Agreement. This is the current version of the SMART IRB 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.

Note: Additional changes have been incorporated into a revised SMART IRB Reliance Agreement Version 3.0, which is currently available for a second review period – Learn More.

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 June 2022)

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
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
Recommendations for the Harmonization of Ancillary Reviews

Best practices for defining ancillary reviews and recommendations for centralizing certain reviews as well as for the timing of reviews and allocation of responsibilities in an sIRB context. Zip file includes guidance as well as implementation checklist for centralizing ancillary reviews.

SMART IRB Harmonization Steering Committee
Reviewing IRB Policies – Model Template

A A Reviewing IRB may use this template to identify the key policies that Relying Institutions, Site Investigators, and Lead Study Teams must follow when the single IRB review model is used.

SMART IRB
Single IRB Boot Camp: a How-to Guide with SMART IRB – Day 1

This online session, held February 7, 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. Topics covered include: reliance requests; using the SMART IRB Agreement; what HRPPs need in place for single IRB review; and a demonstration of the SMART IRB Online Reliance System.

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SMART IRB
Single IRB Boot Camp: a How-to Guide with SMART IRB – Day 2

This online session, held February 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. Topics covered include: communication; training study teams; harmonization guidance; and resources and education to support institutions and investigators.

View Slide Deck

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

A discussion on single IRB with representatives from the DOD, DOE, and VA. These agencies have been working closely with SMART IRB on updates to the SMART IRB Agreement to allow them to join the Agreement. During this session, experts from the DOD, DOE, and VA discussed how the agencies are implementing the single IRB requirement.

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SMART IRB
Webinar: SMART Talk - A Conversation with NIH and OHRP about Single IRB

Confounded by the revised Common Rule Cooperative Research provision? Nervously navigating the nuances of the National Institutes of Health (NIH) Single IRB Policy? In this session, experts from NIH and the DHHS Office for Human Research Protections (OHRP) address key things you need to know to understand and comply with federal single IRB requirements.

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SMART IRB
Webinar: SMART Talk - An Update on SMART IRB Reliance Agreement v3.0

This SMART Talk provides an update on the status of SMART IRB Reliance Agreement v3.0. The SMART IRB Team presented feedback received and additional proposed revisions that reflect and are responsive to feedback from SMART IRB Participating Institutions and others in the research community, along with the discussion of next steps.

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SMART IRB
Webinar: SMART Talk - Exploring the Financial Aspects of Single IRB

To charge or not to charge, that is one of the single IRB questions! We explore the financial aspects of the NIH Single IRB Policy and discusses whether institutions are charging for single IRB review (and, if so, the process they use) and how to assist researchers in identifying single IRBs, as well as any budget needs to consider when they are preparing proposals for federal funding.

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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 - Introducing SMART IRB Reliance Agreement v3.0

This SMART Talk provides current and potential Participating Institutions with an orientation to the proposed updates to the SMART IRB Reliance Agreement and why they are being put forward. The changes reflect and are responsive to other requests and feedback from existing Participating Institutions and others in the research community. Importantly, many of the revisions will allow additional federal agencies (Department of Defense, Department of Energy, and Veterans Affairs) to join the SMART IRB Reliance Agreement.

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SMART IRB
Webinar: SMART Talk – Pondering Post-Approval Monitoring for Single IRB: FDA-Regulated Research Edition

Panelists will explore the issues single IRB poses for post-approval monitoring in general, as well as those specific to FDA-regulated research. These include monitoring for industry-funded studies as compared to small, minimally funded or unfunded investigator-initiated trials and, more broadly, key differences in monitoring for funded and unfunded research. Our panelists will look into their crystal ball for a future when an FDA single IRB mandate is in place and discuss monitoring considerations for some of the trickier types of FDA-regulated studies, such as research that involves investigator-held INDs and IDEs or the exception from informed consent and community consultation (i.e., planned emergency research.)

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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 - Serving as a Reviewing IRB for a Large Multisite Study

To be or not to be the Reviewing IRB – that is the question! Many institutions have evaluated their capacity and determined that their IRBs can only act as the Reviewing IRB for studies with a limited number of sites. Others have taken the plunge and served as Reviewing IRB for studies involving 10 sites, and many more. The panelists for this session discuss what is needed to scale single IRB review when you are working with a significant number of sites, as well as what your institution should consider before deciding whether to take on the role of Reviewing IRB for a large multisite study.

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SMART IRB
Webinar: SMART Talk - Single IRB and Noncompliance - A Case Study

Handling noncompliance can be quite complicated when it happens at an institution whose own IRB is overseeing a study. Overlay single IRB on a noncompliance case, and the complexity can increase exponentially. This SMART Talk explores the roles and responsibilities when noncompliance happens under the single IRB model, highlights a real life example of how a Reviewing IRB and Relying Institution worked together to address noncompliance, and discusses how to identify noncompliance through audits, monitor for continuing noncompliance, and implement corrective action plans in the single IRB world.

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SMART IRB
Webinar: SMART Talk - Single IRB Review Implementation: Persistent Challenges and Possible Solutions

The SMART IRB Team recently published an article that reported the findings of a workshop we held in 2022 that examined why single IRB review remains problematic and proposed possible solutions. Jonathan Green, the lead author, provided an overview of the paper and, along with other participants in the workshop, discussed some of the key challenges single IRB continue to present and how they might be addressed.

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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 from the Perspective of Research Teams

Just as IRBs and institutions have had to change or develop new processes to implement single IRB (sIRB) review, study teams have had to adapt to this new IRB review landscape. This session focuses on the impact of sIRB review on study teams and how Reviewing IRBs and Relying Institutions can help them to successfully navigate sIRB review. You’ll also hear directly from investigators and study team members who share their first-hand experiences and lessons learned, as well as support measures that have proven particularly helpful.

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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
Webinar: SMART Talk - Single IRB Workflow From Beginning to End

The mandates for use of single IRB for review of multi-site research has affected how researchers, IRBs, and institutions have approached human subjects research processes. This SMART Talk will examine key actions and responsibilities for Reviewing IRBs and Relying Institutions by walking hypothetical multi-site studies through the single IRB workflow, from when a researcher writes a protocol or prepares and submits a grant through the end of a study.

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SMART IRB
Webinar: SMART Talk - Understanding DOD and DOE Requirements for Single IRB Implementation

Do you ever wonder why Federal Agencies have agency-specific IRB requirements when those same agencies have agreed to follow the Common Rule and require use of a single IRB unless an exception applies? Have you also wondered how a Federal Agency determines whether an exception applies to multi-site studies and how that exception is applied, especially when multiple federal agencies are involved with the same multi-site study? In this SMART Talk you will learn learn more about myths vs. reality on how the U.S. Department of Defense (DOD) and U.S. Department of Energy (DOE) apply the cooperative research provisions (single IRB requirements) and agency-specific requirements to academic university IRBs, independent (commercial) IRBs, and other federal agency IRBs approving DOD or DOE research.

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SMART IRB
Webinar: SMART Talk - Understanding VA Specific Requirements for Single IRB Implementation

Do you ever wonder why Federal Agencies have agency-specific IRB requirements when those same agencies have agreed to follow the Common Rule and require use of a single IRB unless an exception applies? Have you also wondered how a Federal Agency determines whether an exception applies to multi-site studies and how that exception is applied, especially when multiple federal agencies are involved with the same multi-site study? In this SMART Talk you will learn more about myths vs reality on how the U.S. Department of Veterans Affairs (VA) applies the cooperative research provisions (single IRB requirements) and agency-specific requirements to academic university IRBs, independent (commercial) IRBs, and other federal agency IRBs approving VA research.

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SMART IRB
Webinar: SMART Talk - When You’re Not the Reviewing IRB – The Impact of Using External IRBs

With its codification in the revised Common Rule, the use of a single IRB has become ubiquitous, and this has had a significant impact on institutions that rely on external IRBs. Our panelists discuss how they’ve structured their institutions’ human research protection programs in response to work with external IRBs and address considerations for: setting up a reliance program, working with a range of IRBs, and keeping local IRB members engaged when their review responsibilities change

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SMART IRB
Webinar: SMART Talk - Where We’ve Been and Where We’re Heading

The SMART IRB Agreement was launched in September 2016. In that short time, almost 1000 institutions have signed on to this master reliance agreement. In late 2021, SMART IRB surveyed the community to assess its utility as well as areas that continue to present challenges for single IRB. During this session, we review that survey and SMART IRB’s plans to address key issues, including planned revisions to the SMART IRB Agreement and promotion of harmonized processes across institutions.

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SMART IRB