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Completing the Federalwide Assurance (FWA) Application for VA Medical Centers and Health Care Systems
Each institution that is engaged (see definition of "engaged" at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm)in Department of Veterans Affairs (VHA) supported or conducted human subject research must file and maintain a Federalwide Assurance (FWA). The FWA Signatory Official (Director, VAMC or HCS) is authorized to represent and commit the entire institution and all of its components to this legally-binding agreement.
The Office of Research Oversight (ORO) serves as the liaison and contact between VA Medical Centers and OHRP. In this way ORO helps to speed OHRP processing time, and facilitate answers to VA questions.
Follow the instructions below for each item on the FWA application. The correct version of this form is OMB No. 0990-0278 Approved for use through 01-31-2008. You can download the correct forms from this website. You should also review the Frequently asked Questions and Answers material found at http://www.hhs.gov/ohrp/humansubjects/assurance/afaq.htm.
"New Filing" versus "Update or Renewal"
Indicate by an [x] whether this is either: 1) a "New Filing", or 2) an "Update or Renewal" of an already existing FWA. Your application is a "New Filing" if this is your institution has never filed for a FWA. If your institution already has an approved FWA or an inactive FWA with a previously assigned number, the form should be appropriately marked as an "Update or Renewal" and include your institution's FWA number.
ITEM #1 - Institution Filing Assurance
- Type or print the legal name of the institution (or the name the institution uses in doing business) that is providing the Assurance. Please do not provide both names in this section. Use the same name consistently on all FWA revisions and IRB registration revisions. If the same name is not used consistently OHRP may hold up the application to ask if your facility is making a formal name change. Alternate names may be used in Item #2.
- Type or print the city and state where the institution is located.
- Type or print the DHHS Institution Profile File (IPF) code and the Federal Entity Identification Number (EIN; tax number), if known. OHRP does not assign these numbers; they are assigned by other federal departments or agencies for certain tracking purposes. OHRP requests these numbers to distinguish between similar institutions and to try to avoid approval of multiple assurances for a given institution. If you are not aware of your institution's IPF code or EIN, you may leave these items blank. The numbers are not required for FWA processing.
ITEM #2 - Institutional Components
Type or print the names of all components of the institution identified in item #1 that will be covered by the FWA, including any alternate names used by your facility or components. For example, in Item #1 your facility may wish to use the full n ame of Albert Einstein VA Medical Center. Item #2 should also list the alternate name of VA Medical Center, City, State.
Components are generally defined as parts of your institution that may be viewed as separate organizations, but remain part of the legal entity or institution.
List the major components of your institution that are likely to be involved in human subjects research at some time and that may recruit participants to VA research. These components may operate under the supervision of your medical center but have a different name. For example, a veterans counseling center, a nursing home, a community-based outpatient clinic (CBOC). CBOCs operated by a non-VA organization, but used by VA patients through a contract with the clinic are not covered under the VA FWA. They should not be listed. Please refer questions to Priscilla A. Craig at (202) 565-8162.
At this time, VA does not use the Individual Investigator Authorization Agreement in use by OHRP. Any institution or investigator collaborating with VA must be covered by a FWA or other federally issued assurance, such as those issued by the Department of Defense (DOD), or the Department of Energy (DOE). Questions on the assurance may be addressed to ORO.
ITEM #3 - Statement of Principles
Indicate by an [x] the statement of ethical principles that govern your institution in fulfilling its responsibilities for the protection of the rights and welfare of human subjects in research. In VA, the Belmont Report is the preferred statement of ethical principles for the protection of human subjects in research.
ITEM #4 - Applicability
- Review the Terms of the Federalwide Assurance (FWA) for Domestic (U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm to obtain an understanding of the regulatory requirement that will be applied to federally-supported or -conducted human subjects research.
- This section asks about the regulatory standards that your institution applies to all research, regardless of source of support. Indicate with an [x] that your institution elects to apply the Common Rule (e.g., 45 CFR 46, Subpart A) to all human subjects research regardless of source of support. VA has not codified Subparts B, C, and D in 38 CFR 16. All VA research is considered to be Federally supported.
ITEM #5 - Designation of Institutional Review Boards (IRBs)
Designate the Institutional Review Board(s) (IRB) of record for this assurance. You must indicate at least one IRB in this section. Please ensure that all designated IRBs are registered, or are in the process of registration, with OHRP prior to submitting the FWA application. OHRP does not take action on a FWA application until all designated IRBs are registered and assigned IRB Registration numbers. If the registration of the IRB was in process when you submitted your FWA, OHRP will insert the IRB Registration number.
IRBs may be added or removed from the FWA. Whenever an IRB is added or removed from the FWA, all designated IRBs should appear on the FWA update. VA policy for the types of IRBs that may be used is found in VA Handbook 1200.5 “Requirements for the Protection of Human Subjects in Research” and in the VA Memorandum from the Chief Research and Development Officer (9/23/04).
To determine if an IRB is registered with OHRP, you may contact ORO or go to the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#IORG and search.
If your institution relies on another institution's IRB, this arrangement must be documented in writing between the two institutions. VA does not use the OHRP IRB Authorization Agreement. VA uses a Memorandum of Understanding (MOU) as the document that describes the terms and conditions of the relationship. The MOU must be kept on file at the institutions and available for review by OHRP upon request, but it should not be submitted with the FWA application. Please see the section on MOUs in VA.
In general, VA IRBs may serve as IRBs of record for their own institution , VA Non-Profit Research Corporations (NPC), or another VA facility. VA IRBs may not serve as IRBs of record for non-VA institutions, including affiliated medical or dental schools or private or commercial/contract research organizations (CROs). For questions/ clarification on this, contact the VA Office of Research and Development (ORD) or ORO.
ITEM #6 - Human Protections Administrator
Designate the individual who will serve as the Human Protections Administrator (HPA) (i.e., the primary contact person for human subjects protection issues) for your institution. The HPA should exercise operational responsibility for your institution's program for protecting human subjects in research and be familiar with the daily operations of the program. The HPA should have comprehensive knowledge of all aspects of your institution's system of protections for human subjects, as well as be familiar with the institution's commitments under the FWA and play a key role in ensuring that the institution fulfills its responsibilities under the FWA.
When considering who should be appointed as HPA, it is important to remember that the duration of an FWA is 3 years and that a FWA covers all human subjects research at the VAMC
Type or print the full name, degree(s), institutional (e.g., administrative) title, institution, telephone and fax numbers, e-mail address, and full mailing address for the HPA. The e-mail address is very important, as this will provide the means for effective communication from OHRP (e.g., sending of new information regarding the FWA). If any of these fields are not available, please indicate accordingly rather than leaving the field blank.
ITEM #7- Signatory Official
The Institutional title may vary, but in VA the Signatory Official must be the facility Director, CEO, or Health Care System Director. The Director has the authority to commit the entire institution named in the FWA application, as well as all of the institutional components listed under Item #2, to a legally binding agreement. Entities that the Signatory Official is not legally authorized to represent may not be covered under the FWA. This individual must also have the authority to assure compliance of the institution and all of its components to the Terms of the Assurance. The signature may not be delegated except in circumstances where VHA has appointed an "Acting" Director temporarily.
The VA Addendum contains Item 7A and 7B to the FWA. This two-page addendum is for the VAMC Director, the Network Director, the FWA Program Manager in ORO, and the Chief Officer, ORO.
The signature of the Signatory Official and the date of the signature must be provided on the FWA. The FWA and VA Addendum with the original signatures must be submitted through ORO to OHRP.
Type or print the full name, degree(s), institutional (e.g., administrative) title, institution, telephone and fax numbers, e-mail address, and full mailing address for the Signatory Official. The e-mail address is very important, as this will provide the means for effective communication from OHRP (e.g., sending of new information regarding the FWA). If any of these fields are not available, please indicate accordingly rather than leaving the field blank.
ITEM #8 - DHHS Approval
Leave this item blank. This section is for use by OHRP for approval of the FWA.
VA Medical Centers are encouraged to file electronically. However, please review and proofread all materials to be submitted and ensure that all parts of the FWA application are complete and accurate. Applications that are complete will facilitate quicker review and approval by both VA and OHRP. Incomplete documents may delay processing and approval of the FWA.
OHRP will not take action on an electronic submission until the signed signature pages and VA addendum are received. Please submit a printed copy of the FWA application and VA Addendum single-sided and with the original signature of the Signatory Official(s) by express mail or fax to ORO at:
Priscilla A. Craig
Health Science Specialist
Office of Research Oversight (ORO)
811 Vermont Avenue, NW, Suite 574 (10R)
Washington , DC 20420
(202) 565-8162 (office)
(202) 445-8849 (cell)
(202) 565-9194 (fax)
Notification of Approval of a FWA
Notice of approval of a FWA will be sent by OHRP via e-mail to the Signatory Official and the Human Protections Administrator if e-mail addresses were provided for them on the FWA application. OHRP no longer sends hardcopy confirmation of approval.
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Update and Renewal of Federalwide Assurances
Whenever there is a change in information on file with the Office for Human Research Protections (OHRP) regarding your institution's Federalwide Assurance (FWA), an update to the FWA must be submitted through the VA Office of Research Oversight (ORO) to OHRP. Submission may be electronic or hardcopy.
Renewal of your institution's FWA is required at the end of the 3-year effective period. It must be submitted with the signature of the Institutional Official.
Please submit signature pages of the FWA and accompanying VA Addendum on single-sided pages by express mail or fax to ORO at:
Priscilla A. Craig
Health Science Specialist
Office of Research Oversight (ORO)
811 Vermont Avenue, NW, Suite 574 (10R)
Washington , DC 20420
(202) 565-8162 (office)
(202) 445-8849 (cell)
(202) 565-9194 (fax)
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