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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

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