UW Research

Step 3. Is Your Human Subjects Research Exempt from Regulations?

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.
  • Full details can be found in HSD’s guidance Exempt Research

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.

  1. Complete the questions marked “determination” on the standard IRB Protocol form or on the No Contact version of the form.
  2. 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. Do not attach any consent materials.
  3. HSD will assess your application and issue a formal determination.

Next step if you believe your research is likely not exempt

Determine whether the UW is “engaged” in the research.

More information