FEDERAL WIDE ASSURANCE (FWA) REQUIREMENTS FOR SUBCONTRACTS

(Sent to C&G Representatives 8/28/01)

Effective February 28, 2001 the Office for Human Research Protection (OHRP) announced that all legally separate entities which engage in federally funded human subject research must obtain their own individual Federal Wide Assurance (FWA). For agencies which have a current Multiple Project Assurance, Single Project Assurance, Cooperative Agreement, Joint Assurance, or Interinstitutional Amendment, these types of assurances are still valid at existing sites until their expiration date or December 31, 2003 (whichever comes first).

Related to the new FWA announcement, NIH and other federal agencies are requiring that all domestic and foreign subcontractors that engage in human subject research must obtain an FWA number and IRB approval before work involving human subjects is conducted by them. Subcontract awards will not be issued by Contracts & Grants to subcontract sites which engage in human subjects research until evidence of FWA and IRB approval is provided.

In order to avoid delays which may result if FWA and IRB approvals are not in place at subcontracting sites, particularly when working with foreign entities who may not be familiar with the OHRP FWA requirements, it is recommended that Principal Investigators and administrators review the new FWA requirements, and that proposed subcontractors be advised to begin the FWA application process in advance of prime award funding. Procedures to obtain a Federal Wide Assurance can be found on the OHRP website at http:/www.hhs.gov/ohrp/assurances/assurances_index.html. Additional information on the Federal Wide Assurance requirements can be found on the UCSF CHR webpage at http://www.research.ucsf.edu/chr/about/hsppFWA.asp.