Raising Suspicions with the Food and Drug Administration: Detecting Misconduct

TitleRaising Suspicions with the Food and Drug Administration: Detecting Misconduct
Publication TypeJournal Article
Year of Publication2010
AuthorsHamrell, MR
JournalScience & Engineering Ethics
Volume16
Issue4
Pagination697-704
Type of ArticleArticle
Publication Languageeng
ISSN Number13533452
Accession Number55613095
KeywordsClinical , data management , FDA , Fraud , Human Research Subjects , MEDICINE , Misconduct , SCIENCE , United
AbstractThis 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.
NotesHamrell, Michael R. 1; Email Address: michael@moriahconsultants.com; Affiliation: 1: MORIAH Consultants, 4481 Paloma Lane, Yorba Linda, CA 92886-2832, USA; Source Info: Dec2010, Vol. 16 Issue 4, p697; Subject Term: CLINICAL trials; Subject Term: MISCONDUCT in office; Subject Term: FRAUD; Subject Term: UNITED States; Author-Supplied Keyword: Clinical research; Author-Supplied Keyword: FDA oversight; Author-Supplied Keyword: Fraud; Author-Supplied Keyword: Misconduct; Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 8p; Document Type: Article
DOI10.1007/s11948-010-9232-4
Short TitleRaising Suspicions with the Food and Drug Administration: Detecting Misconduct
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