NPC-Specific Instructions for a Federal Wide Assurance (FWA) and MOU
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/
FWA Memorandum of Understanding (MOU)
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 documents 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.]
Central IRB MOU
NPCs administering studies that have been approved by VA's Central IRB must have an MOU with the Central IRB along with FWA clarification that NPCs can administer trials approved by the Central IRB.
VA's NPPO has requested that all NPCs have an MOU with VA's Central IRB to allow NPCs to administer any study approved by the Central IRB without delay. In addition, NPCs should be aware that VA's Office of Research Oversight must approve NPC FWA renewals prior to OHRP approval.
General Information on FWAs
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