Resources

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

Ambassadors, SMART IRB Regional

Need help joining and implementing the SMART IRB Agreement? Ask your ambassador.

SMART IRB

Communication Plan for Single IRB Review

Institutions can use this template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams.

Download the Communication Plan for Single IRB Review as customizable Word document.

SMART IRB

Communications Between Institutions and Outside IRBs – Considerations Document

This document outlines legal and ethical responsibilities in the oversight of clinical trials, providing a starting point for decoupling institutional and IRB responsibilities.

Clinical Trials Transformation Initiative

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 Content Recommendations for Single IRB Review

This table outlines recommendations for the information Reviewing IRBs should collect for continuing review and includes recommendations about who should provide the information to the Reviewing IRB; the table is extracted from Single IRB Continuing Review Process: Recommendations for Harmonization.

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

FAQs for Research Teams - Relying on an External IRB

Provides helpful hints for study teams whose institutions have agreed to rely on an external IRB.

SMART IRB

FAQs for Research Teams - Relying on an External IRB (Word Template)

Institutions may use this template to create guidance for study teams whose research study is ceded to an external IRB.

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

Grant Applications, Template Description of SMART IRB

Provides language for researchers and their institutions to adapt for federal grant applications.

SMART IRB

Grant Submission and Review Guidance

This document provides a comparison of the process differences due to the NIH sIRB Policy.

SMART IRB

Implementation Checklist for use of the SMART IRB Agreement

This checklist highlights the flexible provisions of the SMART IRB Agreement and allows a Reviewing IRB to document which options they will implement as part of the Ceded Review.

Download the Implementation Checklist as a customizable Word document.

SMART IRB

Informed Consent Documents: Inserting Local Context Language

This guidance describes the different roles that may be involved in inserting local context language in informed consent documents.

SMART IRB

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

IRB Reliance Agreement Worksheet - SAMPLE

This worksheet walks the user through a series of yes/no questions to determine whether a reliance agreement is necessary/appropriate.

Emory University

IRB Support Letter Model Language

Provides language for IRBs/HRPPs to adapt to provide a letter of support for grant applications.

SMART IRB

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

Joining SMART IRB: Guidance for Affiliates

A decision tree to help an affiliate of another institution determine how to join SMART IRB.

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 (Login to create/update in Joinder)

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.

Download the Institutional Profile Form

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

Local Context Survey

A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.

Download the Local Context Survey as a customizable Word document.

SMART IRB

NIH Director's Statement on the NIH sIRB policy

NIH

NIH Guide Notice on the Final sIRB policy

NIH

NIH Policy on the Use of a Single IRB for Multi-Site Research Costs

NIH

NIH sIRB Policy - collected resources

NIH

Online Reliance System

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

SMART IRB

Online Reliance System: Sample Reliance Request Form

SMART IRB

Online Reliance System: Support Center

SMART IRB

Online Reliance System Terms of Use and Privacy Policy

SMART IRB

Online Reliance System Walkthrough

SMART IRB

Overall PI (and Lead Study Team) Checklist

This checklist helps an Overall PI (and Lead Study Team, where applicable) understand and fulfill his/her responsibilities, particularly for studies using the SMART IRB SOPs, which require identification of a Lead Study Team.

Download the Overall PI (and Lead Study Team) Checklist as customizable Word document.

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 for Studies Subject to Single IRB Review

Identifies best practices and provides tools to support for-cause and not-for-cause audits of studies under a single IRB arrangement. Zip file includes guidance as well as checklists and a template report.

SMART IRB Harmonization Steering Committee

Post-Approval Auditing: Sample Audit Checklist

This checklist is intended to be completed by the QA/QI team as they perform an audit of a study subject to single IRB review. 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

Post-Approval Auditing: Sample Audit Report Template

This template report is intended to help the auditing QA/QI team summarize audit report findings for studies subject to single IRB review. 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

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 to Advance the Use of Central IRBs

These recommendations were developed through an examination of barriers to the use of central IRBs for multicenter clinical trials.

Clinical Trials Transformation Initiative

Reliance Registry and Approval Workflow - SAMPLE

This flowchart shows the University of California system’s process for creating a new study when using IRB reliance.

UC System Reliance Registry

Relying Site Investigator Checklist

This checklist helps site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution.

Download the Relying Site Investigator Checklist as customizable Word document.

SMART IRB

Relying Site Study Team Survey

The Overall Principal Investigator and/or Lead Study Team may use this survey to obtain key information from a relying site study team to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB.

Download the Relying Site Study Team Survey as a customizable Word document.

SMART IRB

Reportable Events: Recommendations for investigator-initiated multisite studies

Recommendations and considerations for reviewing noncompliance and unanticipated problems and ensuring prompt reporting.

SMART IRB Harmonization Steering Committee

Responsibilities Associated with the Review of Study Personnel

Recommendations for ensuring study personnel are appropriately trained and qualified to conduct the research under review when using a single IRB arrangement.

SMART IRB Harmonization Steering Committee

Reviewing IRB Instructions for Relying Institution Point(s) of Contact

A Reviewing IRB may use this template to communicate to Relying Institution Points of Contact (POCs) key information about the reliance arrangement as well as next steps after finalizing the arrangement.

SMART IRB

Reviewing IRB Instructions for Relying Site Study Teams

A Reviewing IRB may use this template to communicate key information to Relying Site Study Teams about the reliance arrangement and next steps after finalizing the arrangement.

SMART IRB

Single Institutional Review Board (sIRB) Use and Administration: When Serving as an sIRB - CITI Module

The Collaborative Institutional Training Initiative (CITI) Program offers a module about serving as the IRB of Record. Full access requires a subscription.

CITI

Single IRB Model, Considerations for a

Video presentation covering key considerations when using a single IRB.

University of Utah

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: 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.

View Slide Deck

SMART IRB

Webinar: Implementing the SMART IRB Agreement

An overview of how to implement the SMART IRB Agreement for studies at your institution.

View Slide Deck

SMART IRB

Webinar: Responsibilities of Relying Institutions

Guidance for institutions preparing to serve as a Relying Institution under the SMART IRB Agreement.

View Slide Deck

SMART IRB

Webinar: Serving as a Reviewing IRB

Guidance for institutions preparing to serve as a Reviewing IRB under the SMART IRB Agreement.

View Slide Deck

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

Provides updates on the new Common Rule requirements for single IRB, including exceptions, and discusses strategies to assist institutions with the transition to single IRB review for clinical and non-clinical research.

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SMART IRB

Webinar: SMART Talk - Getting Ready for the 2020 Single IRB requirements

Provides a brief overview of the New Common Rule requirements for single IRB and identifies key strategies to assist institutions with the transition to single IRB review, including for non-clinical research.

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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 - Harmonization - Continuing Review & sIRB

Recommendations from the SMART IRB Harmonization Steering Committee’s Continuing Review working group, including the roles and responsibilities of the Reviewing IRB, Relying Institutions, and study teams as they relate to continuing review in a single IRB context.

View Slide Deck

SMART IRB

Webinar: SMART Talk - Harmonization - Post-Approval Auditing & sIRB Review

Proposed recommendations from the SMART IRB Harmonization Steering Committee’s Post-Approval Auditing Working Group, including best practices and tools for research oversight through for-cause and not-for-cause audits of clinical research studies being conducted under an sIRB arrangement.

View Slide Deck

SMART IRB

Webinar: SMART Talk - Harmonization - Reportable Events

Recommendations from the SMART IRB Reportable Events working group, including harmonized definitions, policies, and procedures for prompt reporting of noncompliance and unanticipated problems for studies using a single IRB.

View Slide Deck

SMART IRB

Webinar: SMART Talk – Harmonization – Responsibilities Associated with the Review of Study Personnel

Recommendations from the SMART IRB Harmonization Steering Committee for ensuring study personnel are appropriately trained and qualified to conduct the research under review.

View Slide Deck

SMART IRB

Webinar: SMART Talk - Managing Reliance with the SMART IRB Online Reliance System

Experts share tips for success and discuss recent updates to the system, including perspectives on integrating the Online Reliance System into local sIRB processes.

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SMART IRB

Webinar: SMART Talk - Operationalizing an HRPP under Single IRB: what’s different, what’s the same, and the known unknowns

Panelists discuss the importance of separating IRB responsibilities from other HRPP responsibilities, as well as strategies for doing so.

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SMART IRB

Webinar: SMART Talk – Practical Issues and Pragmatic Solutions for the IRB Reliance Process

Panelists discuss pragmatic approaches to issues related to the IRB reliance process, as well as communication strategies for reliance arrangements. Topics covered include information collected when ceding review and when serving as a Reviewing IRB, communication with study teams, and reporting requirements.

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SMART IRB

Webinar: SMART Talk – Relying Institution Roles, Responsibilities, and Opportunities

Explores how relying on external IRBs affects an institution, including: what processes institutions should have in place to oversee their research portfolios even when they are reviewed by an external IRB, how to help study teams understand what it means to rely on an external IRB, and some best practices and lessons learned.

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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 - sIRB Issues Related to Planned Emergency Research

Planned emergency research presents unique challenges for a single IRB arrangement, especially in terms of distribution of responsibilities between the Reviewing IRB and Relying Institutions; learn from colleagues who have navigated these waters before, including perspectives from academic institutions and an independent IRB.

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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 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 - Tackling Informed Consent Under the Single IRB Model

A discussion of key issues Reviewing IRBs need to address in the review of informed consent documents and approaches for making the process manageable.

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SMART IRB

Webinar: SMART Talk - The All of Us IRB - Insights from a Unique Single IRB

A discussion of the challenges the All of Us IRB faced and addressed regarding innovative approaches to informed consent and recruitment, working with local context issues, engaging participants, and managing the single IRB process.

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SMART IRB

Webinar: SMART Talk - Using AAHRPP’s I-9 Standard to Guide Reliance Arrangements

Whether or not an institution is accredited, the I-9 standard can serve as a helpful resource when serving as a Reviewing IRB or a Relying Institution. In this session, panelists provide an overview of the AAHRPP I-9 standard and explain how any institution can use it to identify and implement effective policies and procedures in support of single IRB arrangements.

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SMART IRB