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Federalwide Assurance

ASU assurance number fwa 00009102

To be used for federally supported research conducted under the auspices of ASU.

Background information

All institutions engaged in human subjects research that is not exempt from 45CFR46, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance. The FWA is the only type of assurance accepted and approved by OHRP. The Assurance is a formal declaration to HHS that it will comply with the requirements set forth in 45CFR46, as well as the Terms of Assurance.

An institution becomes "engaged" in human subject research whenever its employees or agents

  1. obtain data about living individuals for research purposes through intervention or interaction with them, or
  2. obtain individually identifiable private information for research purposes. (45 CFR 46.102(d),(f))

In addition, awardee institutions are automatically considered to be "engaged" in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.

For more information about FWA’s, please refer to Office for Human Research Protections (OHRP) FAQ’s about Assurances.

To download forms including Individual Investigator agreements please visit OHRP's Assurances website. Researchers should also refer to Section II of ASU's Procedures for the Review of Human Subjects Research.

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