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The Role of Data Audits in Detecting Scientific Misconduct

Stuart L. Nightingale, MD; Frances O. Kelsey, PhD, MD
JAMA. 1990;264(1):36. doi:10.1001/jama.1990.03450010039019.
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To the Editor.—  The article by Dr Shapiro and Mr Charrow1 usefully high-lighted a major program that the Food and Drug Administration (FDA) operates to ensure that valid and reliable data are submitted to the agency and that the rights of human subjects of research are protected. It should be emphasized, however, that the focus of the FDA's program is not on "scientific misconduct" per se; rather, it reviews the work of clinical investigators to ascertain compliance with FDA investigational new drug regulatory requirements. The authors state that some investigators were able to continue to conduct drug trials after what is described as flagrant violations of recognized norms of research, and they decry the fact that it takes so long for the FDA to "discipline" investigators who are negligent or who have submitted false data. While it is true that the disqualification process can be protracted, largely to


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