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Health and Human Services Homepage

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

Office of Human Subjects Research and Protection Home page
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  • Created by Pauly, Kelly (NIH/OD) [E] on Mar 26, 2024

Getting Started


Workflow Diagrams

Decision Tree - IRB Oversight for my NIH Protocol - Who needs it and How to Get it 08.2024.pdf349 kB
Workflow Diagram - NIH is Lead Study Team and Reviewing IRB 10.01.2020.pdf93 kB
Workflow Diagram - NIH is Participating Site and Relying on an External IRB 10.01.2020.pdf99 kB

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

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OHSRP

Office of Human Subjects Research Protections
6700B Rockledge Drive
Suite 4300
Bethesda, MD 20817 USA
OHSRP - (301) 402-3713
irb@od.nih.gov
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