Federalwide Assurance (FWA) for the Protection of Human Subjects

Alert: This area should only be used for a submission of a new FWA.

Submission of a Federalwide Assurance (FWA) application to the Office for Human Research Protections (OHRP) must be done using this electronic 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 telephone or email (see http://www.hhs.gov/ohrp/assurances/status/contact/index.html) and explain why it is unable to submit its FWA electronically.

An approved FWA is effective for 5 years; however, when information changes on the FWA, an update should be submitted to OHRP. After approval, 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.

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

  1. You must have an e-mail address in order to use the electronic submission process. You will be guided through the electronic submission process at the bottom of the screen.
  2. A part of the FWA is the designation of the internal institutional review board(s) that will review the human subjects research covered by your institution's FWA; or, if your institution does not have an internal IRB designation of the external IRB that will review all research to which the FWA applies or, if your institution relies relies on multiple external IRBs, the external IRB that will review the largest percentage of research to which the FWA applies. Any IRB relied upon to which this applies must be registered with OHRP. If you need to check to see if the IRB you intend to designate on the FWA is/are registered, you need the registration number for a specific IRB, please see our website at http://ohrp.cit.nih.gov/search/search.aspx. To complete this electronic form you will need to know the OHRP-assigned registration number for each IRB you designate on your institution's FWA.
  3. You will need to be sure all required (*) information fields are completed.
  4. Once you have entered information on each screen and proofread all data fields, click on the "Save and Continue" button to move to the next section.
  5. You may use the tabs at the top of the screen for quickly moving from section to section of the FWA form. However, 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.
  6. Once all entries are made, please proofread all fields of the FWA form to ensure the accuracy of the data and then 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.
  7. You may begin entering information for an electronic submission and then find you are not ready to "Submit" it to OHRP for review. In this case, you may save the data entered and return at a later time to complete the submission. Be sure you have recorded your submission number for later use.

You may track receipt of your document at http://ohrp.cit.nih.gov/search/search.aspx. All approved FWAs may be found at http://ohrp.cit.nih.gov/search/search.aspx

With the electronic submission process, the submitter, the Human Protections Administrator, and the Signatory Official will be notified automatically by e-mail as soon as OHRP has approved your institution's FWA. Of course, this is dependent upon e-mail addresses being provided for each of these individuals.

If your institution's FWA includes designating an external IRB, the information provider and the Chair on the IRB registration will be notified and informed of the designation of their IRB on your FWA. Before an external IRB is designated on an FWA, there must be an agreement in place between the institution or organization operating the IRB and the FWA institution outlining the roles and responsibilities of each party. A copy of this agreement should be maintained by each party and available to OHRP upon request. OHRP provides a sample document, an IRB Authorization Agreement, at http://www.hhs.gov/ohrp/assurances/forms/iprotsup.rtf.

Note: You must request a submission number for each separate electronic FWA you send to OHRP. The submission number is only good until OHRP approves the FWA associated with that submission. After approval of an electronically submitted FWA, you must request a new submission number for subsequent electronic updates/renewals. Also, please do not attempt to update/renew an FWA when there is already an electronic record pending OHRP approval. The changes you request with each electronic submission are not transferred to OHRP's database until the FWA is approved. When the FWA is approved, you will receive an e-mail notification.

Submitting a new FWA

If you need a submission number to begin a new FWA submission, click on “I Need a Submission Number” below.

Note: if you do not return to use the submission number within 30 days, it will be withdrawn from the system, and you will have to request a new submission number.

I Need a Submission Number

Update a new FWA

If you previously began data entry, and are now ready to edit further and/or submit a new FWA submission, click on “I Have a Submission Number” below.

Note: if you do not return to complete your submission within 30 days, it will be withdrawn from the system, and you will have to request a new submission number and begin entering all of the data again.

I Have a Submission Number

Forgot Submission Number and/or Password

If you started the electronic entry for your institution's FWA but can't remember your submission number and/or your password, enter the e-mail address where your submission number was sent.


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