The WKU Institutional Review Board (IRB) does not charge fees for protocol reviews, consultations, or application assistance. We have become aware of external, third-party companies targeting researchers and offering IRB application assistance for a fee. Our IRB office provides comprehensive support throughout the entire application process at absolutely no charge to WKU faculty, staff, or students. Our staff is available to help you complete your IRB application, navigate the submission system, and address any needed revisions. Third-party consultants have no special access to or influence over the IRB review committee, and the Office of Research Integrity will never discuss your IRB application with an unauthorized third party. Paying a fee to a third-party consultant will not expedite or guarantee the approval of your study. Sharing your draft protocols or participant materials with external companies may compromise your intellectual property or violate institutional data security policies. For help with your IRB application, please reach out to us at ori@wku.edu or 270-745-3360.
Human Subjects (IRB)
All research that involves human subjects (participants) (i.e. survey, experimental, evaluation, biomedical research, use of human subject data) must be approved by the Institutional Review Board (IRB), according to the University's Assurance of Compliance Agreement with the Department of Health and Human Services.
The Institutional Review Board is responsible for maintaining institutional compliance with the U.S. Office of Human Research Protections (OHRP) regulations regarding the use of human subjects in research.
A human subject (participant) is defined by the Code of Federal Regulations (CFR) as "a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information."
Research is defined in the Code of Federal Regulations (CFR) as "a systematic investigation designed to develop and contribute to generalizable knowledge."
Examples of activities that constitute research include:
- any study intended to result in publication or public presentation;
- any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish; or
- any use of an investigational drug or device.
Thus, human subjects research includes but is not limited to survey and interview research, experimental studies, observational research, as well as evaluation studies if results are made publicly available through presentation or publication.
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