July 2004

What is an assurance?

An assurance is a type of contract obtained by an institution like the University of Arizona with a federal governmental agency. This contract establishes the standards for research conduct and in reality is the commitment of the institution to comply with the federal regulations governing human subjects research. In addition, the institution certifies that the research has been reviewed and approved by an Institutional Review Board.

Why does the University of Arizona need an assurance?

In order for an institution to receive federal funding for research involving human subjects, the institution must have on file an approved assurance with the Office of Human Research Protections (OHRP).

What happens if we have a federally funded project and the work includes another site that does not have an assurance?

If the other site is not “engaged” in the research project and they do not have an assurance, they do not need to have their own assurance. If they are “engaged”, they will need to contact the Human Subjects Protection Program for assistance in acquiring an assurance from OHRP.

How do I know if the other site is “engaged”?

OHRP has written guidance on whether a site is considered “engaged” or not. Generally sites become “engaged” when their employees:

• Intervene or interact with living individuals for research purposes
• Obtain or access individually identifiable information for research purposes
• Release individually identifiable private information, or permit investigators to obtain individually identifiable private information, without subjects’ explicit written permission.

The University of Arizona has a Federal-Wide Assurance (FWA) with OHRP formalizing our commitment to protect human subjects and we are held responsible for all research involving human subjects covered under this assurance. Therefore, it is essential that the University of Arizona informs the research community about and understands the commitments made in our FWA.

*Cohen, J. M. (2002). OHRP Federal-Wide Assurance. In R. Amdur & E. Bankert (Eds.), Institutional review board: Management and function (pp. 313-315. Sudbury, MA: Jones and Bartlett.