Step 3. Is Your Human Subjects Research Exempt from Regulations?
This is the third of five steps in determining whether your planned activity requires IRB review and, if yes, by which IRB.
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.
- You will obtain consent from subjects for accessing or obtaining their identifiable health care information maintained in Washington State (for example, from UW Medicine) or their identifiable records from certain Washington State agencies and public institutions of higher education (including the UW).
- There are some limits on the use of deception, prisoner subjects, and children subjects.
Some types of research (for example, medical records reviews) that might be considered exempt in other states cannot be classified as “exempt” in Washington State because of two Washington State laws about accessing identifiable records without the consent of 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 email@example.com 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)