This Worksheet provides assistance for individuals who wish to determine whether an activity is human subjects research. If it is not human subjects research, IRB review and approval are not required. UW policy allows researchers to make this determination themselves, using this Worksheet as a guide. To ask HSD to make the determination: See the SOP Human Subjects Research Determination.
Removed all references to Confidentiality Agreements and to state law RCW 42.48 – 07.28.2019
Added the exclusion of Public Health Surveillance Activities from “research” due to recent guidance. – 01.18.2019
Total remodel of form. Now includes hide/show guidance and references to the revised Common Rule. – 10.26.2018
Updated references to case reports – 08.07.2017
Updated links – 05.15.2017