The Role of Data Audits in Detecting Scientific Misconduct: Results of the FDA Program
Shapiro, Martin F.
Charrow, Robert P.
JAMA. 1989 May 5; 261(17): 2505-2511.
The authors studied the data audit program of the Food and Drug Administration, the only federal agency that routinely monitors clinical trials for signs of misconduct. Their objectives were to determine if the frequency of detected misconduct is diminishing; to determine if the FDA is disciplining all investigators who engage in misconduct; to examine the utility and legality of policy options that might diminish the frequency of misconduct in drug trials; and to determine whether a data audit program like that of the FDA might be an option for monitoring research funded by the Department of Health and Human Services. They conclude that, while the FDA program has been associated with a reduced frequency of detected misconduct, additional strategies that might further diminish misconduct in drug trials include certifying clinical investigators, competitive application for research contracts, limiting the number of research subjects, and penalizing manufacturers for misconduct. (KIE abstract)
Accountability; Biomedical Research; Clinical Trials; Competence; Contracts; Clinical Investigators; Consent; Drug Industry; Drugs; Economics; Evaluation; Federal Government; Food; Fraud; Government; Government Regulation; Health; Human Experimentation; Industry; Informed Consent; Investigators; Misconduct; Peer Review; Physicians; Professional Competence; Public Policy; Punishment; Regulation; Research; Research Subjects; Review; Scientific Misconduct; Standards; Statistics;
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