Research Misconduct Identified by the US Food and Drug Administration

Abstract

As part of the drug approval process, the US Food and Drug Administration (FDA) regularly inspects clinical trial sites involved in FDA-regulated research to determine the degree to which these sites conform to regulations. The FDA regulations intend to ensure, among other things, that scientists adhere to good clinical practice and that they protect the rights of human participants. Such inspections often yield useful information about the reliability and quality of the clinical data produced at a clinical trial site.