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Human Subjects Division (HSD)

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Biological Specimens

Research using biological specimens is not always considered Human Subjects Research. 

The SOP Human Subjects Research (linked at right) is intended to help researchers determine whether human subjects are involved in research that consists of obtaining private information (data) and/or biological specimens, according to federal, state, and UW definitions.

Most federal agencies have adopted a single, consistent, definition of human subject (45 CFR 46. 102(f)).  Under this definition, a human subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or by identifiable private information.  It is UW IRB policy to apply this definition to all research regardless of the source of any funding that is supporting the research. 

The Food and Drug Administration (FDA), however, includes individuals on whose specimens investigational drugs, devices or controls are used, even if the specimen is unidentified.  The UW IRB therefore applies this definition to only FDA-regulated research involving investigational drugs and devices.