WORKSHEET Human Subjects Research Determination
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.
Change Notes
Clarify requirements when the data are identifiable per HIPAA but not identifiable per the Common Rule – 10.31.2024
Move content from PDF to Word; moderate reorganization and wordsmithing throughout – 01.26.2023
Clarify requirements for public health surveillance exception; remove section 1 on WA state law; remove guidance about distinguishing OCR vs RCR definitions – 11.23.2021
Updated information about decedents and Washington State law RCW 70.02 – 06.24.2021
Add reminder about UW Office for Youth Programs review – 11.02.2020