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.
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Notes
Good Clinical Practice at FDA: Metrics, Guidances, Initiatives and Strategies. Presentation by David LePay at Drug Information Association EuroMeeting, March 2009.
Presentation in 2003 on dealing with misconduct titled ‘Misconduct in Research -Innocent Ignorance or Malicious Malfeasance’ by Stan Woollen, formerly of the FDA.
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Acknowledgments
Presented at the Conference on “Statistics, Images, and Perceptions of Truth: Detecting Research Bias and Misconduct,” University of Alabama at Birmingham, September 14–15, 2006.
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Hamrell, M.R. Raising Suspicions with the Food and Drug Administration: Detecting Misconduct. Sci Eng Ethics 16, 697–704 (2010). https://doi.org/10.1007/s11948-010-9232-4
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DOI: https://doi.org/10.1007/s11948-010-9232-4