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.
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  
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.
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 Context Survey  
A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.
SMART IRB
Online Reliance System
Helps investigators and institutions request, track, and document reliance arrangements for each study.
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.
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.
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.
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
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. Check our homepage for upcoming webinars.
SMART IRB
Webinar: Implementing the SMART IRB Agreement
An overview of how to implement the SMART IRB Agreement for studies at your institution. Check our homepage for upcoming webinars.
SMART IRB
Webinar: Responsibilities of Relying Institutions
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
Webinar: Serving as a Reviewing IRB
Guidance for institutions preparing to serve as a Reviewing IRB under the SMART IRB Agreement. Check our homepage for upcoming webinars.
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

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