Resources | SMART IRB

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
View the 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
How to Join 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
SMART IRB Regional Ambassadors 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. Reliance System Walkthrough [video] Online Reliance System FAQs Sample Reliance Request Form Getting Started with the Online Reliance System Webinar [video] View Slide Deck SMART IRB Online Reliance System Terms of Use and Privacy Policy Investigators/study staff: Request access	SMART IRB

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
Template Letter of Acknowledgement 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 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
Survey for Relying Site Study Teams 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 Survey for Relying Site Study Teams 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
Relying Institution PI 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 Institution PI Checklist as customizable Word document.	SMART IRB

For Institutional Review Board/Human Research Program Staff

Resource	Source
Implementing the SMART IRB Agreement Webinar [video] 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. Reliance System Walkthrough [video] Online Reliance System FAQs Sample Reliance Request Form Getting Started with the Online Reliance System Webinar [video] View Slide Deck SMART IRB Online Reliance System Terms of Use and Privacy Policy	SMART IRB
Template Letter of Acknowledgement 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
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
Sample Reliance Registry and Approval Workflow 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
Supporting Communication Between Institutions and Outside IRBs 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
CITI Module - Single Institutional Review Board (sIRB) Use and Administration: When Serving as an sIRB 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
View the 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
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
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
Emory IRB Reliance Agreement Worksheet 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 [video] 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
Sample Requirements for External Consent Templates 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. Online Reliance System FAQs Sample Reliance Request Form Getting Started with the Online Reliance System Webinar [video] View Slide Deck SMART IRB Online Reliance System Terms of Use and Privacy Policy Request access	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
Reliance System Walkthrough [video]	SMART IRB
CITI Module - Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record 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
Survey for Relying Site Study Teams 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 Survey for Relying Site Study Teams 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
Sample IRB of Record PI Checklist This document provides an example of an institution checklist to help an overall PI understand his/her responsibilities.	MetroHealth
For Relying Institution Study Teams
Survey for Relying Site Study Teams 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
Relying Institution PI 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 Institution PI Checklist as customizable Word document.	SMART IRB
Sample Addition of Site Form This document provides an example of information to collect when adding a site to a study.	University of Texas

Single IRB Review policy

Resource	Source
NIH Director's Statement on the NIH sIRB policy	NIH
NIH Guide Notice on the Final sIRB policy	NIH