
Federalwide Assurance (FWA) Registration Instructions
VHA Directive 1058, dated November 8, 2024, requires that VA medical facilities engaged in non-exempt human subjects research covered by the requirements of the Federal Policy for the Protection of Human Subjects must hold a valid FWA approved by the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). Information on filing and updating FWAs is available at: Instructions for Filing/Updating an FWA for the Protection of Human Subjects with HHS OHRP.
NOTE: VA medical facilities planning to initiate a new research program must obtain prior approval from the VHA Office of Research & Development pursuant to VHA Directives 1200.02 and 1200.05.
Questions regarding the VHA policy requirement that VA medical facilities engaged in non-exempt human subjects research must hold a valid FWA may be directed to ORO’s Education and Data Analytics Workgroup at OROEDA@va.gov.