File a New Federalwide Assurance (FWA)

File a New Federalwide Assurance (FWA)

Institutions that have never filed an FWA with OHRP in the past may submit a new, initial FWA application. Institutions must submit all FWAs, including new FWAs, electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically. If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why it was unable to submit its FWA electronically.

The 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. The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, to remain active. Any renewal or update that is submitted and approved by OHRP begins a new 5-year effective period.

Obtaining a submission number is the first step to access an application to file a new FWA.

  1. Go to the site: http://ohrp.cit.nih.gov/efile/FwaStart.aspx
  2. Click ‘I need a submission number”
  3. Enter the following where indicated:
    1. Your email address
    2. A password created for the submission
    3. Password confirmation
  4. Click the “Submit” button
  5. Once you receive the submission number in your email:
    1. Repeat step 1 above
    2. Click “I have a submission number”
    3. Enter the submission number and the password
    4. Click the “Submit” button
    5. Complete and submit the FWA application

Reference copies of the FWA application form, terms of the FWA, and instructions can be accessed at: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/index.html

Frequently Asked Questions (FAQs) on the Assurance Process can be accessed at: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/assurance-process-faq/index.html.

A short tutorial on the Assurance process can be accessed at: https://youtu.be/N-MmuqHJOnE

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