Health and Human Services Homepage

  U.S. Department of Health and Human Services | National Institutes of Health

Reliance & Single IRB (sIRB) Resources


Getting Started


Workflow Diagrams

There are Currently No Attachments

Presentations

Presentation - What You Need to Know About Single IRB Review: Principles and Practice (Part 1) - July 2020

Presentation - What You Need to Know About Single IRB Review: Principles and Practice (Part 2) - August 2020

Presentation - ORSC Protocol Navigator Procedures Workgroup 2022: Overview: NIH Multi-Site Protocol Processes - July 2022

Presentation - The Single IRB Model at the NIH: Principles, Processes, and Pitfalls - November 2023

NIH HRPP Policy Framework

100 - Policy - NIH HRPP

105 - Policy - IRB Reliance

109 - Policy - FWA Coverage



Agreement Requests


Request a Reliance Agreement

Use the link below to request a Reliance Agreement when an NIH Study Team wants to rely on an external IRB or an NIH Study Team wants external Participating Sites to rely on the NIH IRB.


Reliance Agreement Request Form

There are Currently No Attachments

Request a Federalwide (FWA) Coverage Agreement

Complete this form if you are an NIH PI/designee and you want the NIH to extend its FWA to an investigator who will either be leaving, or has left, the NIH.

There are Currently No Attachments




NIH is Lead Study Team using NIH IRB as the Reviewing IRB (sIRB)




For consent templates please navigate to the IRB Templates page.

There are Currently No Attachments




NIH as Participating Site Study Team & Relying on an External IRB (sIRB)


There are Currently No Attachments

Relying on WCG IRB (formerly WIRB)

There are Currently No Attachments


Guidance - Using NIH funds to Pay for Advarra or WCG IRB Services.pdf 

Video - WIRB Orientation for Investigators and Research Team


Relying on Advarra

There are Currently No Attachments


Guidance - Using NIH funds to Pay for Advarra or WCG IRB Services.pdf 

Video - Advarra Orientation for Investigators and Research Team




sIRB Mandates


The NIH sIRB Policy

Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

NIH Single IRB Policy in the Context of the Intramural Research Program

NIH Single IRB Policy in the Context of the Intramural Research Program: Seeking an Exception

New Process for Requesting Exceptions to the NIH Single IRB Requirements


Revised Common Rule: Cooperative Research

The Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)





Revised Common Rule, 2018 Requirements, 45 CFR 46

OHRP Guidance Engagement of Institutions in Human Subjects Research (2008)

Search for Federalwide Assurances
Return to top