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is an appropriately constituted group or committee that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research. In accordance with the U.S. Food and Drug Administration regulations, the IRBhas the authority to approve, require modifications in (to secure approval), or disapprove research. The board reviews all research involving human subjects to ensure that it is conducted in accordance with all federal, institutional, and ethical guidelines.