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. You do not need to complete CITI human subjects training to submit an application for exemption. However, if it is determined that your protocol needs a higher level of review, you will be required to complete a new protocol submission and include certification of CITI training. 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).
“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:
- Evaluating the use of accepted or revised standardized tests
- Testing or comparing a curriculum or lesson
- A program evaluation of pharmacy continuing education
- 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
- Interviewing public officials about a local or global issue
- Analyzing de-identified tissue samples or data set
- Analyzing de-identified national test scores
- Analyzing census data about aging or housing
- Research conducted in established or commonly accepted educational settings outside of Seattle University, involving normal educational practices
- research on regular and special educational instructional
- research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom management
- 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.