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Office of Research Oversight

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Federalwide Assurance (FWA) Registration Instructions

Instructions for Filing/Updating an FWA for the Protection of Human Subjects with the U.S. Department of Health and Human Services for Human Research Protections (HHS-OHRP)

The facility must ensure Office of Research and Development (ORD) and Office of Research Oversight (ORO) approval are obtained prior to applying for a new FWA, reactivating a previous FWA, or changing their IRB(s) record.

NOTE: Please contact orofwa@va.gov before contacting HHS-OHRP with questions about the FWA or problems with the e-file procedure.  ORO serves as the liaison to HHS-OHRP and has access to the submission database.

FAQS on the FWA, VA Addendum for an FWA, and IRB Roster Updates can be found here: FAQs on VHA Directive 1058.03, FWAs, IRB Registration and MOUs.

Update/renewal required:

An updated FWA must be submitted prior to the expiration of the FWA approval period or within 60 days of administrative or programmatic changes in the facility’s FWA information on record with HHSOHRP (i.e., change in Signatory Official or Human Protections Administrator (HPA)/contact person, change in the name of the institution or change in the primary IRB of record required by 1058.03 to be on the FWA).  All programmatic changes necessitating a change to a VA medical facility’s VA FWA Addendum, as required by ORO, must be submitted to ORO within 90 days of a change.  Modifications to the FWA for changes in telephone, address or email do not require a revision to the VA Addendum.  Changes in the medical facility Director also require revision or amendment of any MOU(s) for IRBs required to be designated on the FWA.

Timeline:

VHA Directive 1058.03 requires that changes to the FWA must be submitted within 60 days of a change to ORO FWA staff for review to ensure submission to HHS-OHRP within 90 days of the change.  HHS-OHRP requires that the FWA be renewed every 5 years, before the expiration date.  Every update begins a new 5-year period. The VA FWA addendum must be submitted and approved by ORO within 90 days of a change. ORO prefers the VA FWA addendum to submitted to ORO at the same time.  Changes to MOUs for IRBs that are required to be designated on the FWA, such as amendments to update a new medical facility Director, must be submitted to ORO within 30 days of execution.

Prior to Submitting:

      1.  The medical facility Director and Human Protections Administrator (HPA) should review and understand the Terms of Assurance at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html 
 
      2.  The medical facility Director is responsible for being familiar with the requirements set forth in the Common Rule and the ethical principles governing human subjects research as outlined in the Belmont Report (accessible at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report).  NOTE:  A summary of the aforementioned requirements and principles is available on HHS-OHRP's website at https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals/index.html/assurance-training.

      3.  The medical facility Director, HPA and any individual submitting the FWA (initiator) should familiarize themselves with VHA Directive 1058.03 - Assurance of Protection for Human Subjects in Research.

      4.  The facility must ensure ORD and ORO approval are obtained prior to applying for a new FWA, reactivating a previous FWA or changing their IRB(s) record.

Submitting:

      1.  Go to http://ohrp.cit.nih.gov/efile/.  Review the welcome and instructions on the "Home" tab.  If there are questions concerning what should be entered on the FWA form, the form instructions are located at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-form-2017/index.html.

      2.  Select the "FWA" tab on the top of the page.

      3.  On the far left of the page select the type of submission:
              a.  Select "NEW FWA" if the VA Facility has never had an FWA and only after ORD and ORO have fully approved a new or reactivated program.
              b.  If the VA Facility had a FWA in the past that was deactivated and wishes to restart a human research program, please contact orofwa@va.gov for instructions.
              c.  Select "RENEWAL FWA" if the facility needs to update/renew the FWA.

      4.  Select "I need a Submission Number" and follow instructions to obtain a submission number and a password.  Ensure that the submission number and password are recorded for reentry and submission after ORO approval.  A new number and a new password are created each time an updated is entered.  WRITE THEM DOWN so they are not forgotten.

      5.  Make necessary changes to the FWA.  Once all entries are made, carefully proofread all fields of the FWA form to ensure the accuracy of the data.  The updates will be shown on a summary screen.
              a.  Refer to VHA Directive 1058.03 for information regarding determining the VHA Facility IRB of record.
              b.  IMPORTANT: At the prompt on the summary screen select "SAVE AND EXIT".

      6.  Email orofwa@va.gov for online review PRIOR to submission.  If this is not done, it is possible HHS-OHRP will not process the FWA or will return it.  In the email to orofwa@va.gov include the name of the facility, the submission number, the password, and the changes made.

      7.  After ORO has reviewed the FWA submissions and given approval to proceed, the FWA maybe signed by the medical facility Director either digitally upon submission or with a wet signature over the electronic name on the FWA after the FWA is submitted to HHS-OHRP.

      8.  Reenter HHS-OHRP’s e-file system as described above using the previously recorded submission number and password.
              a.  Complete a final accuracy check.
              b.  Scroll through to the Institutional/Signatory Official's certification and signature.
              c.  Read and check the box. (see item 7 above). The initiator may check the medical facility Director’s signature box.
              d.  Submit FWA.

      9.  Print FWA (If the FWA is not printed, the FWA does not fully submit for HHS-OHRP to process).

After submitting:

      1.  Send the FWA and the VA Addendum to the medical facility Director for review and signature. Research/IRB Office should keep copies.  Changes in the medical facility Director also require revision or amendment of any MOU(s) for IRBs required to be designated on the FWA and must be submitted to ORO within 30 days of execution. See VHA Directive 1058.03 §§5.f(10)(b) and 7.d(2). An MOU update for new medical facility Director can be as simple as the medical facility Director signing a separate document noting that they concur with the content of the MOU. For example, “Amendment #1: [date] I am the Director of [x facility] effective [date]. I have read this MOU and concur with no changes.” All parties to the MOU would sign this amendment and attach to the original MOU. 
    
      2.  After the medical facility Director reviews and signs the VA Addendum and amended MOU (if appropriate) and they are returned to the Research Service, a copy of the FWA and signed VA Addendum and amended MOU(s) must be emailed to orofwa@va.gov.

      3.  ORO will e-file a copy, sign the VA Addendum to the FWA, and return a signed copy to the facility.

When HHS-OHRP has completed action, the HPA, the Signatory Official and the individual submitting the FWA will receive an automated email from HHS-OHRP.  Initiators should be sure that the automated email address is in their contacts as sometimes the VA facility firewall will reject it as spam.  OHRPElectronicSubmissionSystem@mail.nih.gov.

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