Please be aware that this notice is being coordinated jointly by NAVREF and the Nonprofit Program Office (NPPO).

Background:  In accordance with VA requirements, all NPCs conducting clinical research must have a Federalwide Assurance (FWA) in place with the HHS Office of Human Research Protections. (See

http://www.navref.org/library/Federalwide_Assurance_Process.htm)

Further, NPCs must execute an MOU with their respective VAMC - and with the university if using a university IRB - detailing each institution's respective responsibilities in assuring oversight.

According to recent Office of Research Oversight (ORO) reviews, it appears that some NPCs have not executed the necessary MOU.  ORO recently confirmed that the sample MOUs on the NAVREF web site are the preferred templates for NPC use for compliance with the OHRP requirement (see http://www.navref.org/library/Federalwide_Assurance_Process.htm).  These templates were also reviewed by OHRP in 2002 and found to be acceptable.

Recommendation:  NAVREF and the NPPO encourage NPCs to verify that they have a current FWA and an executed MOU in place.  If not, follow the FWA instructions on the OHRP web site and/or use the sample MOUs on the NAVREF web site to expedite execution at the earliest possible opportunity.