OHRP Revises Federalwide Assurance


The Office for Human Research Protections recently revised its Federalwide Assurance application form. Institutions engaged in federally funded human subject research should take note of these changes and consider making appropriate modifications to internal policies and procedures.

The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) announced on June 20, 2011, a revised Federalwide Assurance (FWA) form and process, which is applicable to institutions participating in federally funded human subject research activities. Institutions that engage in human subject research that is conducted or supported by any U.S. federal department or agency that has adopted the Common Rule are required to hold current FWAs, unless otherwise exempt from this requirement. Institutions that either currently hold or anticipate requiring an FWA should carefully review the Terms of Assurance and consult legal counsel to address compliance with regulatory requirements under the FWA prior to submitting an FWA application.

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