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Submission of Federalwide Assurances (FWA) and Institutional Review
Board (IRB) Registrations for VA Facilities
In February 2005, the Office for Human Research Protections (OHRP ) announced that all Federalwide Assurance (FWA) applications and Institutional Review Board (IRB) registrations may be filed electronically. For VA-specific instructions on how to complete the application forms, please see "Completing the FWA Forms ."
It is each VA Medical Center’s responsibility to know when to renew or update the FWA and the IRB registration.
VA Medical Centers are encouraged to use the OHRP electronic submission system (ESS) for submission of IRB Registrations and Federalwide Assurance applications and renewals. The VA Office of Research Oversight (ORO) and OHRP have worked out a system whereby OHRP staff do not review and process any IRB registrations (or FWA applications) submitted via the ESS without having documentation from ORO (Priscilla Craig) that the office has reviewed and approved each submission. This same policy holds true for VA submissions received in hard copy. The ESS is a much more efficient way to submit documents to OHRP and for OHRP to review and process them. Most importantly, submission via the ESS ensures that documents are in OHRP on a certain date and in the queue for processing awaiting ORO approval. The ESS is monitored daily for IRB submissions and FWA applications. The web site for filing electronically with OHRP is http://ohrp.cit.nih.gov/efile/.
Confirmation/Approval of new, renewed or updated FWAs and IRB Registrations will be communicated via email to each site individually by OHRP. OHRP does not mail hardcopies of signed/executed FWAs.
OHRP and ORO require the original signature by the Signatory Official (Facility Director) on the last page of the FWA and a signed VA Addendum, found on the ORO website. The signed pages may be faxed to ORO at (202) 565-9194. Processing will not be completed without these signatures. The signatures may not be delegated.
A. Federalwide Assurance (FWA) and VA Addendum:
ORO manages the FWA program in VA and is the contact/liaison for OHRP. With the new electronic filing with OHRP , VA facilities can follow one of the two following options:
Facilities may file FWA renewals or updates electronically or via hard copy/fax. Please follow the instructions below.
For ELECTRONIC submission:
| 1. |
Print a copy of the completed electronic FWA (e-FWA) submission. The Signatory Official must sign the last page of the e-FWA and the Signatory Official and VISN Director must sign the VA Addendum. Note: When you are e-filing, OHRP will not accept the signature page from the manual form. The e-FWA signature page is easily identified by OHRP as an electronic submission and provides them with needed information to retrieve the document from their system. Additionally, it assures that the text on the signature page is accurate.
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| 2a. |
Fax the signed signature page for the e-FWA and the VA Addendum to ORO, Attn: Priscilla Craig, Health Science Specialist, at (202) 565-9194. ORO will sign the VA Addendum and fax the complete FWA to OHRP. OR
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| 2b. |
Prior to submitting your e-FWA to OHRP, you may call or e-mail Priscilla with your submission number and she can review the e-FWA online before the signatures are obtained. |
| 3. |
Once Priscilla has notified you that your e-FWA is okay, go online to your e-FWA and click on "Submit." |
| 4. |
Print the signature page and obtain the necessary signatures as instructed in item 1 above, and fax the signature pages as instructed in item 2a above. |
For HARD COPY/FAX submission:
| 1. |
Complete the FWA and VA Addendum Forms in hard copy. Obtain signatures of Director and Network Director and fax to Priscilla Craig in ORO at (202) 565-9194.
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B. IRB Registration, Renewal and Update
For VA-specific instructions on completing the IRB form, see "Completing the IRB Registration Form ."
IRB Registrations for VA-operated IRBs may be filed electronically with OHRP or completed via fax to ORO, Priscilla Craig at fax number (202) 565-9194. Electronic filing is preferred; however, ORO must review the submission for conformance with VA requirements before OHRP takes action on the update.
VA requirements for IRB Update are more stringent than OHRP. VA requires annual update, or update of changes of the IRB membership.
Status of the FWA or IRB submission
The status of any IRB or FWA submission (hard copy or ESS) can be monitored by the submitting institution on the OHRP website at http://ohrp.cit.nih.gov/search/logqry.asp, such that if the processing of an IRB or FWA submission appears to be taking too long, the institution can contact Priscilla A. Craig or OHRP to determine the status of the document. If a VA submission sits in the queue too long without hearing from Priscilla, OHRP staff will contact her. For questions contact Priscilla A. Craig, Health Science Specialist, ORO, via email at priscilla.craig@va.gov or by calling (202) 565-8162.
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