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A Federalwide Assurance (FWA) is a declaration of compliance with federal regulations for the protection of human subjects in research. The federal Office for Human Research Protections (OHRP) approves FWAs for all human subjects research conducted or supported by the Department of Health and Human Services.
What is the purpose of the FWA?
A Federal Wide Assurance (FWA) provides assurance that the institution receiving HHS support will follow HHS regulations for human subjects found in 45CFR46. Institutions engaged in DMID human subjects research must obtain a FWA.
Which requires the federal wide assurance of compliance?
When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and docHubing institutional review board (IRB) review and approval.
What is the purpose of the assurance of compliance?
An assurance of compliance indicating that the institution will comply with the Terms of the FWA. An institution outside of the U.S. also must assure that it will comply with one or more procedural standards whenever it engages in research covered by the FWA.
Is the FWA is legally binding?
Each institution engaged3 in research covered by The Common Rule is required to provide written assurance that it will comply with The Common Rule. This written, legally binding assurance is called the Federalwide Assurance (FWA).
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The Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.
What is assurance of compliance with Title VI of the Civil Rights Act of 1964?
The sub-grantee, contractor, subcontractor, successor, transferee, and assignee shall comply with Title VI of the Civil Rights Act of 1964, which prohibits recipients of federal financial assistance from excluding from a program or activity, denying benefits of, or otherwise discriminating against a person on the basis
What is the difference between an IRB and an FWA?
Registering an institutional review board (IRB) and obtaining a Federalwide Assurance (FWA) are related but separate processes. An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP.
Related links
Federal Assurance of Compliance | Institutional Review Board
A. This institution is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National
Dec 27, 2012 The purpose of this Staff Manual Guide (SMG) is to provide FDA staff with a process to help evaluate whether a clinical investigator who has
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects
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