Understanding Engagement in Research
As defined by the federal guidance
IRB review is only required when a person and/or site are engaged in human subjects research, as defined by federal guidance.
When requesting to cede IRB review to a non-UW IRB or requesting UW HS IRBs serve as IRB of record for an external person or site, study teams are encouraged to review OHRP’s Guidance on Engagement in Research. Personnel may be engaged in research if they will:
- Obtain informed consent
- Administer study interventions
- Interact with subjects
- Work with identifiable data/specimens/images
If you are unsure whether someone is engaged in human subjects research, please contact the HS IRBs’ Reliance Team for assistance.