Document Detail

Raising suspicions with the Food and Drug Administration: detecting misconduct.
MedLine Citation:
PMID:  20842536     Owner:  NLM     Status:  In-Process    
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.
Michael R Hamrell
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Publication Detail:
Type:  Journal Article     Date:  2010-09-15
Journal Detail:
Title:  Science and engineering ethics     Volume:  16     ISSN:  1471-5546     ISO Abbreviation:  Sci Eng Ethics     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9516228     Medline TA:  Sci Eng Ethics     Country:  England    
Other Details:
Languages:  eng     Pagination:  697-704     Citation Subset:  E; IM    
MORIAH Consultants, 4481 Paloma Lane, Yorba Linda, CA 92886-2832, USA.
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MeSH Terms
Comment In:
Sci Eng Ethics. 2010 Dec;16(4):705-11   [PMID:  21052860 ]

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