ABSTRACT
Clinical drug trials represent research with human subjects. All research involving human subjects that is supported by the U.S. federal government or the results of which are to be used in applications for drug or device approval must be conducted in accordance with regulations promulgated by the U.S. Department of Health and Human Services (HHS) (1) and the U.S. Food and Drug Administration (FDA) (2). The regulations of both the HHS and the FDA require that an Institutional Review Board (IRB) “shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by [the] regulations” (3).
