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OHRP Guidance – FWA Instructions – U.S. Institutions

U.S. Department of Health and Human Services

Office for Human Research Protections

Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States

Version Date 06/06/2005

The Federalwide Assurance (FWA) is an assurance of compliance with the federal regulations for the protection of human subjects in research. It is approved by the Office for Human Research Protections (OHRP) for all human subjects research conducted or supported by the Department of Health and Human Services (HHS). The FWA is also approved by OHRP for Federalwide use, which means that other departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research that they conduct or support.

Institutions engaging in research conducted or supported by federal departments or agencies other than HHS should consult with the department or agency that is conducting or supporting the research for guidance regarding whether or not the FWA is appropriate for the research in question.

Each institution that is engaged in HHS-conducted or -supported human subjects research must submit an FWA to OHRP. In general, an institution is engaged in human subjects research whenever:
(a) the institution’s employees or agents intervene or interact with human subjects for research purposes;

(b) the institution’s employees or agents obtain individually identifiable private information about human subjects for research purposes; or

(c) the institution receives a direct HHS award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.
For more information to determine whether or not an institution may be engaged in HHS-conducted or -supported human subjects research, please review the OHRP guidance on Engagement of Institutions in Research on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm.

The FWA Signatory Official must be authorized to represent and commit the entire institution and all of its components to a legally-binding agreement.


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