title: Raising suspicions with the Food and Drug Administration: detecting misconduct.
abstract: 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. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. 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. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.
authors.affiliation: MORIAH Consultants, 4481 Paloma Lane, Yorba Linda, CA 92886-2832, USA. michael@moriahconsultants.com
authors.forename: Michael R
authors.initials: MR
authors.lastname: Hamrell
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D032984:Ethics, Research / Q000193:education; D006805:Human Experimentation / Q000941:ethics* / Q000592:standards; D006801:Humans; D040541:Marketing; D012107:Research Design / Q000592:standards*; D015871:Scientific Misconduct; D014481:United States; D014486:United States Food and Drug Administration