This guidance is intended to (1) provide an explicit description of how the University of Washington Human Subjects Division (HSD) applies the definition of research for all activities except those that are regulated by the Food and Drug Administration (FDA) and promote consistency of determinations within HSD forward in time. Determinations based on this guidance may be inconsistent with some determinations made in the past.
Update link to OHRP QI guidance – 01.31.2020
Information from revised Common Rule added; QA/QI examples removed – 09.28.2018
Updated case study definition – 08.07.2017