3.22 Human Subjects: the Institutional Review Board

Any research involving human subjects should go before the Institutional Review Board (IRB), be it a classroom project, a thesis or dissertation, or a faculty member’s research—whether funded or not. Research, as defined by the federal regulations, is a systematic investigation designed to develop or contribute to generalized knowledge. The IRB is an independent committee approved by the National Institutes of Health. The board membership consists of experienced faculty from a variety of disciplines as well as expert lay persons not affiliated with the University. The IRB is required to review all protocols for projects involving human subjects for compliance with guidelines prescribed by federal and state regulations. The charge to the board is the protection of human subjects from “research risks” that may be physical, psychological, social, or legal. Fundamental concerns in protocol review are to assure that the subjects will be fully informed and freely consent to participate in the project, that their right to privacy is protected, and that all data collected will be held as confidential and published without identifiers.

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