Resources

All Resources

Joining SMART IRB

Implementing the Agreement

About Single IRB Review

Setting up Reliance

For Funding Applications

Study Teams

Reviewing IRBs

Relying Institutions

IRB/HRPP Staff

SMART IRB

NIH

Other

Agreement, The SMART IRB  
Review the Master Common Reciprocal Institutional Review Board Authorization Agreement.
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
Consent Template Requirements (when using an external IRB) – SAMPLE  
This document provides an example of step-by-step guidance to revise informed consent form templates when relying on an external IRB.
University of Pennsylvania
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
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  
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
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 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
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 IRB Resources for IRB and HRPP Personnel
Guide to SMART IRB’s resources to help IRB and HRPP personnel document reliance arrangements, get started as a Reviewing IRB, and educate and work with study teams.
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.
View Slide Deck  
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.
View Slide Deck  
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.
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.
View Slide Deck  
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.
View Slide Deck  
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.
View Slide Deck  
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.
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
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.
View Slide Deck  
SMART IRB