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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, and to obtain review by ORO prior to submission to OHRP.
VA Medical Centers are strongly encouraged to use the OHRP electronic submission system (ESS) for submission of IRB Registrations and Federalwide Assurance applications and renewals. If OHRP is aware that ORO has not approved the IRB registration or FWA submission, OHRP staff will not process the application/update. 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 ORO 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 OHRP 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 automated email to each site individually by OHRP. OHRP does not mail hardcopies of signed/executed FWAs.
A. Federalwide Assurance (FWA) and VA Addendum:
Facilities may file FWA renewals or updates electronically or via hard copy/fax. Please follow the instructions below.
Electronic Submissions:
1. Go to OHRP E-File website at http://ohrp.cit.nih.gov/efile/. Select the option you want from the left side. Request a submission number and a password. If you already have an FWA your information is already in the system and you would select Update/Renew even if you have never updated electronically before.
2. Update your FWA. Before submitting select SAVE AND EXIT.
Call Priscilla Craig at ORO VACO at 202 266-4572. She will review online before you submit. Usually you will receive "same day" service.
3. Once approved you may go back in to your update and VERIFY AND SUBMIT.
You will be prompted to print a hard copy that your Facility Director will sign. Your Facility Director and Network Director will also sign the VA Addendum.
4. The signed FWA and VA Addendum are sent to Priscilla Craig via PDF at priscilla.craig@va.gov. Original signatures are not required BUT the signatures may not be delegated for short term absences of your signatory officials. Other documentation may be required for example:
a. Evidence of completion of OHRP FWA Online Training Modules (all three) by the Facility Director and Network Director once every three years.
b. Memorandum of Understanding (MOU) if the VA facility uses an IRB operated by another institution.
5. Priscilla will process with OHRP. She serves as the Liaison with OHRP and is the contact for VA for all FWA and IRB Registration questions. She is able to assist with data entry problems in the ESS and with FWA and IRB registration questions. Please do not call OHRP for Assurance matters as a first call.
Per agreement with OHRP, FWAs and IRB registration transactions will not be processed by OHRP without the approval of ORO.
6. The status of pending submissions can be viewed on http://ohrp.cit.nih.gov/search/asearch.asp#ASUR. When OHRP has completed processing the VA Facility Director and the Human Protections Administrator will receive automated email notifying them.
7. Requirements for managing the FWA, VA Addendum, the IRB Registration, training requirements and any applicable Memoranda of Understanding (MOUs) are contained in VHA Handbook 1058.03 "Assurance of Protection for Human Subjects in Research"
Hard Copy/Fax Submissions:
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) 266-4560 or (202) 266-4595.
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 by faxing the completed form via fax to Priscilla Craig (ORO) at number (202) 266-4560 or (202) 266-4595. Electronic filing is strongly 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 within 30 days of change.
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) 266-4572.
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