Scientific Misconduct in Investigational Drug Trials
Shapiro, Martin F.
Charrow, Robert P.
New England Journal of Medicine. 1984 Mar 14; 312(11): 731-736.
A study of the administrative procedures used by the Food and Drug Administration (FDA) in auditing research records was undertaken to determine the incidence, nature, and contributing factors of investigator misconduct in clinical trials of investigational drugs. The work of 6.3% of the audited investigators had been judged to contain serious, but remediable deficiencies, while the research of 5.2% exhibited deficiencies that warranted disciplinary action. These violations included misrepresented or falsified data, nonadherence to protocols, lack of informed consent, and failure to seek institutional review board approval. Misconduct was attributed to incompetence or deceit for the purpose of achieving economic gain or academic advancement. The authors conclude with proposals to curb scientific misconduct. (KIE abstract)
Clinical Trials; Competence; Consent; Drug Industry; Drugs; Federal Government; Food; Fraud; Government; Government Regulation; Human Experimentation; Industry; Informed Consent; Investigational Drugs; Investigators; Misconduct; Motivation; Nature; Negligence; Prevalence; Professional Competence; Records; Regulation; Research; Review; Scientific Misconduct; Statistics; Survey;
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Shapiro, Martin F.; Charrow, Robert P. (1989-05-05)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 ...