Application Form for Exemption from IRB Review

Instructions for Submission to the IRB

Carefully evaluate whether your protocol qualifies as an exempt activity. (If your protocol does not qualify as a minimal risk or exempt activity, it must undergo full review.) Conditions for qualifications can be found on the Exempt Checklist [download Word doc].

Note: If your research involves only nonidentifiable specimens or data, it may be considered Research not Involving Human Subjects. If so, submit the Human Subjects Research Determination Form and Protocol Disposition Form only.

Ethical Considerations:  New questions were added to the Exempt Checklist for the IRB to determine that the protection of participants in research exempt from applicable federal regulations are in place.

Clarification of Exemption 4: Exemption 4 applies if an investigator accesses publicly available data containing personal health information (PHI), but takes away de-identified information only. For example, a study in which a doctor (1) goes into a medical records department and looks at identifiable data, but (2) records information on a form that does not include any participant identifiers and therefore cannot re-identify a person, is exempt.

Once you have made this decision, continue with the application process as follows:

Complete the Protocol Disposition Form, Exemption Checklist and Funding Source Supplement Form (if funded).

• Protocol Disposition Form Updated November 16, 2009
• Exempt Checklist updated February 11, 2008
• Funding Source Supplement Form Updated November 16, 2009

The IRB now requires ONLY the ORIGINAL DOCUMENTS for processing your IRB application.

• Protocol Disposition Form
• Exempt Checklist
• Funding Source Supplement Form (if funded)
• Funding Proposal or description of research activity (if no funding)

All new applications require division head sign-off on the Protocol Disposition Form by either the Associate Director or the Department Head. Clinical Division Applications must first be routed through the Protocol Office, (206) 667-4520.

Your application may be word processed, as long as the format is followed, or you may type the information into the form. You may also submit double-sided copies.

Please contact the Review Office if you have any questions regarding this paperwork. We are prepared to assist anyone who may need advice. Your cooperation in all of these matters is much appreciated and helps to process your materials more rapidly.

Once the exempt application receives final approval, the IRO will forward one copy of the approved documents to the Contact Person.

Approval Period

Exempt studies receive an approval period for five (5) years as long as approved procedures are followed. At the end of the five (5) years, a new Exempt application will need to be reviewed for continuation.  For instructions, please see above in Instructions for Submission to the IRO.  The IRO will send you a reminder notice through interoffice mail several weeks before the end of the five (5) year expiration date.