Federalwide Assurances (FWAs)
Instructions for filing a Federalwide Assurance for the Protection of Human Subjects (FWA) with the Office for Human Research Protections (OHRP)
Your first step should be to read and understand the Terms of Assurance at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html.
Please also read VHA Handbook 1058.03 Assurance of Protection for Human Subjects in Research.
VHA Handbook 1058.03 requires that the Facility Directors and Network Directors, as signatories on the FWA and the VA Addendum to the FWA, complete OHRP FWA Online Training Modules located at http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp
Although the OHRP website indicates one module is recommended for signatory officials, VHA ORO requires that all three modules be taken once every 3 years.
Directors and Network Directors should log in and print each certificate and provide copies to the requesting research office and ORO.
Go to http://ohrp.cit.nih.gov/efile/
If your VA Facility has NEVER had a FWA, select NEW FWA.
If your VA Facility had a FWA in the past that was deactivated and your VA Facility wishes to restart a human research program, please contact Priscilla Craig in ORO on 202 632-7624 or firstname.lastname@example.org for instructions.
To Renew/Update the FWA:
An "update/renewal" to an FWA should be submitted when there are changes in your institution's FWA information on record with OHRP (e.g., change in Signatory Official or Human Protections Administrator (HPA)/contact person, addition/deletion of an IRB, or changes in mailing addresses). VHA Handbook 1058.03 requires that changes be submitted within 30 days of a change. The FWA must be renewed every 5 years.
Your first step should be to read and understand the Terms of Assurance at http://www.hhs.gov/ohrp/assurances/assurance/filasurt.html.
Select "RENEWAL FWA" on the Left side of screen.
Select “I NEED ELECTRONIC SUBMISSION NUMBER”.
Follow instructions to obtain a submission number and a password. The submission number and password will be used one time. The password is created each time you update.
Make the necessary changes to the FWA. Once all entries are made, please proofread all fields of the FWA form to ensure the accuracy of the data. Your updates will be shown on a summary screen. At the prompt on the summary screen select "SAVE AND EXIT".
NEW!! Effective with OHRP’s announcement of Monday June 20, 2011, submission of the FWA to OHRP is completely electronic, including the signature of the Institutional/Signatory Official, the Facility Director.
VA Requires ALL IRBs used by the VA Facility to be designated on the FWA. This requirement is stricter than the OHRP requirement.
The Director should read the Terms of Assurance and manually sign the FWA and the VA Addendum.
To get to OHRP's e-file system, follow this link: http://ohrp.cit.nih.gov/efile/.
Procedure for Electronic Signing of the FWA:
-Go to FWA (tab at top center of screen)
-Go to Renewal FWA (left side of screen)
-Scroll down, Click on “I have a Submission Number”
-Enter submission number and password
-Scroll through to Institutional/Signatory Official’s certification and signature.
-Read and check the box
-Follow procedure all the way through, e-sign, submit and print the hard copy
Obtain the Director’s and Network Directors signatures on the paper forms.
Return the package to the Research Office to send to the Network for signature of VA Addendum.
Research/IRB Office should keep copies.
After the Network Director signs off, send the FWA and the signed VA Addendum via PDF to Priscilla Craig at email@example.com.
ORO will e-file a copy.
Call or write Priscilla BEFORE contacting OHRP if questions about the FWA or problems with the e-file procedure. 202 632-7624.
When OHRP has completed action, the Human Protections Administrator and the Signatory Official designated on the FWA will receive an automated email from OHRP. OHRP will not return signed hard copies.