Raising Suspicions with the Food and Drug Administration: Detecting Misconduct

This article describes the clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. BIMO performs routine random inspections, and on occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. While monitoring is one way to decrease misconduct, training is also another option, and this approach helps to ensure that all individuals involved understand the rules and the consequences of research misconduct.