Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

  • About HHS
  • Programs & Services
  • Grants & Contracts
  • Laws & Regulations
  • Radical Transparency
  • Big Wins
  • About OHRP
  • Regulations, Policy & Guidance
  • Education & Outreach
  • Compliance & Reporting
  • News & Events
  • Register IRBs & Obtain FWAs
  • SACHRP Committee
  • International
Breadcrumb
  1. HHS
  2. OHRP
  3. Register IRBs & Obtain FWAs
  4. Text Version - Registering an IRB and Obtaining an FWA:
  • IRB Registration
    • IRB Organizations
    • Initial IRB Registration
    • Update/Renew Registration
    • IRB Registration Process Frequently Asked Questions (FAQs)
    • Videos for Filing IRB Registrations
  • FWAs
    • File a New FWA
    • Update/Renew FWAs
    • Assurance Process Frequently Asked Questions (FAQs)
    • Videos for Filing FWAs
  • IRB & FWAs Status
  • Forms

Text Version - Registering an IRB and Obtaining an FWA:

Step 1: Start. Go to Step 2

Step 2: Does your institution want to obtain a Federalwide Assurance (FWA) so that it may receive federal support for research involving human subjects? If Yes, go to Step 3.  If No, go to Step 7.

Step 3: Your FWA must use an institutional review board (IRB) that is registered with OHRP.  Have you identified a registered IRB that will review proposed research for your institution?  If Yes, go to Step 4.  If No, go to Step 6.

Step 4: Have the IRB registration number ready for use in completing the FWA submission, and then: Go to Step 5

Step 5: Submit information for the FWA to OHRP at http://ohrp.cit.nih.gov/efile/FwaStart.aspx.

Step 6: Will your institution rely on a registered IRB operated by another organization? If Yes, go to Step 8.  If no, go to Step 7

Step 7: Does your institution want to register an institutional review board (IRB)? If Yes, go to Step 10.  If No, go to Step 9.

Step 8: Does your institution have an authorization agreement with the organization that operates the IRB? If Yes, go to Step 4.  If No, go to Step 11.

Step 9: Stop! You do not need to use this system.

Step 10: Register your institution’s IRB at

http://ohrp.cit.nih.gov/efile/IrbStart.aspx

and then either:

(1) Go to Step 4  and use the IRB registration number in obtaining your institution’s FWA, or

(2) Arrange to provide IRB review for another institution, by going to Step 11

Step 11: Establish an IRB Authorization Agreement with the IRB organization/IRB that will review proposed research for your institution, or with the institution that will rely on your organization's IRB for its FWA.

(A model agreement is available here)

Then the institution obtaining the FWA should: Go to Step 4.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed March 18, 2016
Back to top

Subscribe to Email Updates

Receive the latest updates from the Secretary and Press Releases.

Subscribe
  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy
HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

Follow HHS

Follow Secretary Kennedy