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What is a Federalwide Assurance (FWA) and when is it required?

assurance federalwide fwa
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What is a Federalwide Assurance (FWA) and when is it required?

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An FWA is an institution or organization’s assurance to the federal government that human subject research conducted at that site is in compliance with federal regulations pertaining to the protection of human subjects. CWRU or CWRU-affiliated investigators, who are performing federally-funded human subject research at site(s) that do not have an assurance with the federal government, are responsible for coordinating the FWA application process for such sites and for obtaining proper documentation for CWRU, who acts as the grantee. This website was constructed to help investigators perform this role. Could you provide some examples of when a FWA may be required? Example #1: A UH psychiatric investigator has applied for an NIMH grant. The research requires that the investigator have access to patient files that are located in a hospital in India. The investigator requires access to identifiable information about living individuals. In giving the investigator access to this information,

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