Federal Wide Assurance (FWA)
The University of Pittsburgh holds a Federal-wide Assurance with the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (DHHS). FWAs are required for every institution that is “engaged” in Federally-supported human subject research. An FWA is an agreement with DHHS to review and approve research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations at 45 CFR Part 46.
An institution that receives a direct DHHS award to support research is automatically considered to be “engaged”, even if all of the activities involving human subjects are carried out by a subcontractor or collaborator. In this case, the awardee institution is ultimately responsible for protecting human subjects under the award. It can be difficult to determine when an institution is “engaged” in research.
It is recommended that you contact the IRB for guidance when working with sites outside of University of Pittsburgh.
IRB
