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The Institutional Review Board (IRB) is a committee that reviews protocols involving research on live human beings. The IRB is essential for ensuring that humans participating in research as subjects are protected from physical, emotional and mental harm to the extent they agreed when entering a study. The IRB reviews studies by applying the three principles contained in the Belmont Report: Respect for Persons (autonomy), Beneficence, and Justice. The definition of human subjects for purposes of IRB review is defined in 45 CFR 46.102(f); and “research” is defined in 45 CFR 46.102. The common, lay definition of these terms is different than the regulatory definition, therefore, not all projects involving humans constitute human research that requires review by the IRB. Regulations and/or the Division of Research should be consulted when there are questions as to whether a study requires IRB review.
IRB meetings occur monthly, on the third Thursday of the month. Investigators should submit a complete application at least a month prior to the scheduled meeting during which they want review and approval. However, there is no guarantee that submitting an application a month prior to a meeting will ensure that the study will be reviewed and approved at that meeting, since other factors, such as issues with the application or training requirements, complicated nature of a study, or the need to secure expertise for review will prolong the study making it onto a meeting’s agenda. Please allow ample time for IRB review when planning.
The KCUMB Institutional Review Board may review protocols of external organizations, provided it has adequate expertise, subject to the following fee schedule:
The KCUMB Institutional Review Board reviews external studies in accordance with KCUMB’s policies, procedures, and standard operating procedures, unless negotiated otherwise.
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