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CRC153: Institutional Review Board in Clinical Research – 3 credits

Examines the historical development, regulatory roles, responsibilities and functions of Institutional Review Board (IRB) membership and related stakeholder relationships. Comparisons of different IRB organizational and operational designs in relation to emerging technologies and implications for future research will be reviewed. Special emphasis on developing an understanding of the complexity of IRB roles, the implementation of state, national and international regulations and guidelines, and potential conflicts associated with the conduct of human research. Includes IRB functions, related regulations, ethical issues, current and future operational trends. Prerequisites: None.