Step 3. Is Your Human Subjects Research Exempt from Regulations?
This is the third of four steps in determining whether your planned activity requires IRB review.
Why this matters
- If HSD determines that your human subjects research qualifies for exempt status, you do not need to obtain Institutional Review Board (IRB) approval.
- The answer to this question determines which regulations and requirements govern your research.
Criteria for exempt status (summary)
- Your research involves no more than minimal risk to your subjects.
- Your research methods must fit into one of several categories.
- Your research is not governed by the regulations of the Food and Drug Administration.
- There are some limits on the use of deception, prisoner subjects, and children subjects.
If you believe your research may qualify for exempt status
Follow these directions for a determination about whether your research qualifies for exempt status. HSD staff are the only individuals authorized at the UW to make exempt determinations.
- Complete the circled questions on the standard IRB Protocol form or on the No Contact version of the form.
- In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place.
- HSD will assess your application and issue a formal determination.
Next step before submitting an application, if you believe your research is likely not exempt
- Contact your HSD Team or send an email to firstname.lastname@example.org if you have questions or want guidance. Identify your department in your email.
- WORKSHEET: Exempt Determination (Old Common Rule)
- WORKSHEET: Exempt Determinations (Revised Common Rule)