Resources

The tools and resources in this section are provided to assist institutions in joining SMART IRB and to help IRB and HRPP representatives and study teams develop processes and procedures for using SMART IRB for their studies.

Thank you to the institutions that have agreed to share their resources. Have a resource to share? Contact us at gro.britrams@pleh

For Institutions Interested in Joining SMART IRB
Resource Source
The SMART IRB Agreement  
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
SMART IRB SOP Manual  
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
SMART IRB FAQs  
Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
SMART IRB
Joining SMART IRB
An overview of the requirements and processes for completing the SMART IRB Joinder process.
SMART IRB
Joinder Checklist  
An overview of the information required to generate your institution's Joinder Agreement.
SMART IRB
Guidance for Affiliates  
A decision tree to help an affiliate of another institution determine how to join SMART IRB.
SMART IRB
Ambassadors, SMART IRB Regional
Need help joining and implementing the SMART IRB Agreement? Ask your ambassador.
SMART IRB
Using the SMART IRB Online Reliance System
Resource Source
Online Reliance System
Institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
SMART IRB
Implementing the SMART IRB Agreement: Start-up Package
Resource Source
SMART IRB SOP Manual  
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
SMART IRB FAQs  
Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
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
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 SMART IRB Agreement Implementation Checklist as a customizable Word document. 
SMART IRB
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
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
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
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, Relying Institution  

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 Institution PI Checklist as customizable Word document. 
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
Grant Applications: Template Description of SMART IRB  

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

SMART IRB
For Institutional Review Board/Human Research Protection Program Staff
Resource Source
Implementing the SMART IRB Agreement Webinar

An overview of how to implement the SMART IRB Agreement for studies at your institution. Check our homepage for upcoming webinars.

View Slide Deck  
SMART IRB
Online Reliance System
Institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
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
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
Grant Applications: Template Description of SMART IRB  

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

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
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
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
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
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
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
Reference Documents
The SMART IRB Agreement  
Review the Master Common Reciprocal Institutional Review Board Authorization Agreement.
SMART IRB
SMART IRB SOP Manual  
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
SMART IRB FAQs  
Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
SMART IRB
For Reviewing IRBs
Resource Source
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
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
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
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
Serving as a Reviewing IRB Webinar

Guidance for institutions preparing to serve as a Reviwing IRB under the SMART IRB Agreement. Check our homepage for upcoming webinars.

View Slide Deck  
SMART IRB
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
For Relying Institutions
Resource Source
Responsibilities of Relying Institutions Webinar

Guidance for institutions preparing to serve as a Relying Institution under the SMART IRB Agreement. Check our homepage for upcoming webinars.

View Slide Deck  
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
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
For Study Teams
Resource Source
Online Reliance System
Institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
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
Grant Applications: Template Description of SMART IRB  

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

SMART IRB
Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record - 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
Considerations for a Single IRB Model
Video presentation covering key considerations when using a single IRB.
University of Utah
For Lead Study Teams
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
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
For Relying Site Study Teams
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.
SMART IRB
PI Checklist, Relying Institution  

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 Institution PI Checklist as customizable Word document. 
SMART IRB
FAQs for Research Teams - Relying on an External IRB  

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

SMART IRB
Addition of Site Form - SAMPLE
This document provides an example of information to collect when adding a site to a study.
University of Texas
NIH Requirements