Federal Wide Assurance

**Semantic type:** Qualitative Concept

**Definition:** Under the Department of Health and Human Services (DHHS) human subjects protection regulations (at 45 C.F.R. 46.103), every institution engaged in human subjects research that is funded or conducted by DHHS must obtain an Assurance Of Compliance approved by the Office for Human Research Protections (OHRP). This Assurance Of Compliance, when granted, is called a Federalwide Assurance. Both "awardee" institutions and collaborating "performance site" institutions must file Assurances.

**Synonyms:** - FWA - Federalwide Assurance