Documents

Purpose

“Human subject” is defined by the University of Washington (UW) as follows:

• For all research: The UW uses the definition provided in the regulations of the federal Department of Health and Human Services (HHS; 45 CFR 46).
• For research regulated by the Food and Drug Administration (FDA): The UW applies the definition provided in the FDA regulations (21 CFR 56), as well as the HHS definition.

This document further describes the policies, and the UW's application of them in the use of humans as research subjects.