New/Initial FWA

Alert: This area should only be used for a submission of a new FWA. Institutions that have filed an FWA with OHRP in the past should use a submission for a FWA "update/renewal".

Submission of a Federalwide Assurance (FWA) application to the Office for Human Research Protections (OHRP) must be done using this electronic submission system, unless your institution lacks the ability to do so electronically. If your institution believes it lacks the ability to submit its FWA application electronically, it must contact OHRP by email at IRBorFWA@hhs.gov or by telephone at (866) 447-4777 (see https://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html) and explain why it is unable to submit its FWA electronically.

An approved FWA is effective for 5 years; However, an institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. Any updates to the information in your institution's FWA must also be done electronically through the OHRP Electronic Submission System.

In submitting a new FWA application your first step should be to read and understand the Terms of Assurance at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html#sectiona. We recommend that you also print out and have available the instructions for filing your FWA application. These instructions can be accessed at: http://www.hhs.gov/ohrp/assurances/forms/index.html.

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Additional instructions for an electronic submission of a new FWA application are provided below:

1. You must have an e-mail address to use the electronic submission system. You will start the electronic submission process by clicking on the “Start a new FWA application” button above.
2. After obtaining your submission number, you will be able to access the new FWA application.
3. Item #6 of the FWA application requires your institution to designate an OHRP-registered institutional review board that it will rely upon to review the human subjects research to which the FWA applies. In this section, your institution designates all internally operated IRBs that will review research under the FWA. If your institution has no internal IRBs, designate the external IRB that reviews all of the research to which the FWA applies. Or, if multiple external IRBs are relied upon, list the external IRB that reviews the largest percentage of research to which the FWA applies. To complete item #6 of the application, you will need to know the OHRP-assigned eight-digit registration number for each IRB you designate on your institution’s FWA. Please see our website at https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc to search for a specific IRB registration number.
4. Complete all required (*) information fields.
5. Once you have entered information on each screen, click on the "Save and Continue" button to move to the next section.
6. Please be aware that if you have not saved information on a page before going to another page, you will lose the information you entered on the last screen.
7. Once all entries are made, please review all fields of the application to ensure the accuracy of the data and click "Submit." If you left any required fields blank, you will be prompted to correct those errors. If not, you will be prompted to print a copy of your submission for your record.
8. Once you "Submit" the electronic new FWA application, please verify that it has been submitted to OHRP for review. You can verify and check the status of an FWA submission online at https://ohrp.cit.nih.gov/search/docsearch.aspx. After you submit the application for a new FWA, it is assigned to OHRP staff for review.
9. The persons listed on the FWA including the submitter of the application, the Human Protections Administrator, and the Signatory Official will be notified by email when OHRP has approved the FWA update/renewal application. Receipt of the automated email notification depends on whether the correct email addresses were provided on the application. Please check spam or junk email folders if email notification is not received.
10. Please do not attempt another FWA application when there is already an electronic application being processed by OHRP.
11. The status of the FWA will be updated on OHRP’s public web database when OHRP approves the FWA application, and you have received email notification.
12. Unsubmitted applications are automatically withdrawn from the electronic submission system 30 days after the submission number was created. In such cases, applicants must request a new submission number and start another new FWA application.
13. The submission number used for the new FWA application closes out when OHRP processes and accepts the FWA.
14. Your institution must request a new submission number and create a password for any subsequent electronic FWA update/renewal applications.

You can track OHRP’s receipt of your application and the status of an FWA at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html.

You can find institutions that hold an FWA on the OHRP public web database at https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html.