The Institutional Review Board (IRB) is one component of the human subjects protection system. Established in response to various catastrophes and atrocities involving human subjects, the IRB is a unique combination of individuals. Guided by state and federal regulations, local institutional policies and ethical standards, the IRB is the ideal advocate for human subjects participating in research studies. This review will address the fundamental issues relating to the evolution of the human subjects protection system, the principles of IRB organization and the elements of an IRB review.
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