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NPC-SPECIFIC INSTRUCTIONS FOR A FEDERALWIDE ASSURANCE (FWA) AND MOU
Updated July 2010
Each VA-affiliated nonprofit research and
education corporation (NPC) that administers research
involving human subjects is required to obtain an approved Department of
Health and Human Services (DHHS) Office of Human Research Protections (OHRP)
Federalwide Assurance (FWA). An NPC may not “share” an FWA with a VA
medical center or a university; each NPC must have its own FWA.
Further, an NPC's FWA must be signed by a designated NPC official such
as the executive director or board chair or president. If the
signatory is also a VA employee, he or she should sign using their NPC
title.
VA FWA guidance pertaining to non-VA
institutions, including NPCs, is provided in VHA Handbook 1058.03 (see
section 8) which may be accessed from
http://www1.va.gov/vhapublications/
Underlying the FWA, there must be a written document detailing
each institution’s respective responsibilities in assuring oversight.
OHRP maintains that in the event of an investigation, it will hold an
institution responsible only for oversight for which it is legitimately
responsible. However, respective responsibilities must be
specified in an agreement between an NPC and its respective VAMC.
If the VAMC uses a university IRB, there must also be an MOU with the
university.
The MOU is not part
of the FWA application, but it is likely to be the first one
investigators will request if they ever conduct a site visit.
Although there is no official guidance
regarding an NPC FWA MOU, the Office of Research Oversight (ORO)
recommends that MOUs should be
renewed at
least every three years and updated as needed when personnel changes
occur. The facility medical center director must sign the MOU on
behalf of VA.
Click
here for sample MOUs - one for a VA IRB and one for a university IRB
- that may be modified as needed to suit local circumstances to satisfy
the MOU requirement. [Note: This MOU is intended only to address OHRP
requirements. It is not intended to be a comprehensive statement
of VA/NPC human subject oversight relationships or responsibilities.]
Information about FWAs and
detailed application instructions are available on the
OHRP web site. NPCs should be sure to read the
OHRP "TERMS OF THE FEDERALWIDE ASSURANCE (FWA) " found at
http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm
Questions should be directed
to OHRP.
NPCs are required to send a copy of
their executed FWA to:
Office of Research Oversight (10R)
Dept of Veterans Affairs
810 Vermont Avenue, NW, H Street
Building
Washington, DC 20420
Contact: Priscilla A. Craig (202)
266-4572
priscilla.craig@va.gov
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