Step 1: Determining if IRB Approval is Required

Research is defined in the Code of Federal Regulations (CFR) as "a systematic investigation designed to develop and contribute to generalizable knowledge." 

This includes experiment, study, evaluation, demonstration, or survey that establishes, discovers, or confirms information. Assessments and quality improvement activities generally do not create generalizable knowledge that would be considered research, such as management quality improvement surveys on staff which are not used outside of the department.

If the answer here is "No", then IRB approval is not required. 

If the answer here is "Yes", please go to Question #2

A human subject is defined by the Code of Federal Regulations (CFR) as:"a living individual about whom an investigator

1) obtains data through intervention or interaction with the individual or

2) identifiable private information."

The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable state and local law and is not directly regulated by the federal human subject regulations.

 

This would include:

• Interactions with human subjects (participants)
• Interventions (behavioral or medical)
• Surveys with human subjects (participants)
• Analyzing identifiable private information or identifiable biospecimens from human subjects. This includes datasets from previous human subjects research projects which will be analyzed for another purpose other than the initial intended purpose.

 

If the answer to any of this question is "Yes", you must submit an IRB application and research (recruitment, collecting of data, analyzing private records or biospecimens) must not begin until IRB approval is given.

If the answer is "No", you do not need IRB approval for research. Ensure you do not need IACUC or IBC approval for any research being conducted. 

This depends on the research being conducted and your affiliation with WKU. 

If you are a WKU Student, Staff, or Faculty member and your research meets the definition of human subjects research you need IRB approval for your research. 

If you are not a WKU Student, Staff, or Faculty member you do not need WKU IRB approval unless a WKU member is on your research team. However, if you are conducting research at WKU as an External Researcher you must get approval through the department, dean, or director of the appropriate area for your target population. 

If you are unsure if you need WKU IRB approval please reach out to The Office of Research Integrity at ori@wku.edu or 270-745-3360