Office of Research Oversight
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.
As of November 8, 2024, there is no longer a requirement for VA medical facilities to prospectively provide the VHA Office of Research Oversight (ORO) with a copy of their approved FWAs on file with HHS OHRP nor a requirement for a VA FWA addendum to be submitted to ORO. However, a copy of a facility’s most up-to-date FWA on file with HHS OHRP must be provided to ORO promptly upon request. 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.
