Researchers may request a study review type, but according to Federal regulations, the IRB must evaluate the protocol and make the final determination regarding the appropriate level of review. The following checklists will help determine the researcher’s initial request.

After reviewing the checklist and FAQ sheet, if you believe your study qualifies as exempt, please complete and submit the Application for Exemption from IRB Review.  Exemption applications usually take no more than 2-3 business days to process and issue an exemption letter (unless it is determined that the study should be elevated to a higher level of review).

Exempt Protocols

“Exemption” does not mean a project is exempt from evaluation. Even if the project falls into one of the six categories outlined below, Federal regulations stipulate that a researcher or anyone affiliated with the research may not determine exemption status.  Therefore, all human subjects studies must be submitted to the IRB office, without exception. See also SU IRB FAQ Expedited vs. Exempt.  Exempt protocols do not go to the full board and are conducted on a rolling basis (i.e., monthly deadlines do not apply). Processing averages within four working days of receipt by the IRB.

To qualify as exempt, research activities must (1) present no more than minimal privacy, psychological, and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the following categories:

Category 1

• Evaluating the use of accepted or revised standardized tests
• Testing or comparing a curriculum or lesson
• A program evaluation of pharmacy continuing education

Category 2

• Surveying teachers, nurses, or doctors about a technique or an outcome
• Interviewing managers about a management style or best practice
• Conducting a focus group about an experience or an opinion of a community program
• If you are completing evaluation project for graduation/academic requirement, then IRB review is needed

Category 3

• Interviewing public officials about a local or global issue

Category 4

• Analyzing de-identified tissue samples or data set
• Analyzing de-identified national test scores
• Analyzing census data about aging or housing

Category 5

• Research conducted in established or commonly accepted educational settings outside of Seattle University, involving normal educational practices
•  research on regular and special educational instructional strategies
•  research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  

Category 6

• Taste testing whole grain food products
• Comparing taste or smell of molasses, cheese or milk
• Sampling texture of ice cream

Examples of Non-Research Activities

• Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge.
• Interviews of individuals where questions focus on things not on people (eg. questions about policies, general facts about an organization or business).
• Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living individual (e.g. data sets available on the web that do not require any sort of privacy/confidentially agreement or special request procedure, newspaper accounts, census data held in public libraries, published school test scores). However, if access to the data is limited to researchers, and not publicly available, then IRB review is needed.
• Single case studies in which all data already exists. However, if this includes medical record review, there may be obligations under HIPAA privacy law.