Update or Renew a Federalwide Assurance (FWA)

Institutions that have previously filed an FWA with OHRP generally should submit an FWA update/renewal application. OHRP requires institutions to renew or update 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. Whenever an FWA is updated or renewed, the institution should ensure all information on the application is current and accurate.

Obtaining a submission number is the first step to access an application to update or renew an FWA.

  1. Go to the site: http://ohrp.cit.nih.gov/efile/FwaRenew.aspx
  2. Scroll down to the bottom of the screen and click on “I need a submission number”
  3. Enter the following where indicated:
    1. Your institution’s eight-digit FWA number
    2. The Signatory Official’s (SO’s) last name last provided to OHRP
    3. The Human Protections Administrator’s (HPA’s) last name last provided to OHRP
    4. Your e-mail
    5. A password with a mix of upper- and lower-case letters and numbers or special characters
    6. 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

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

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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