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July 4, 1990

The Role of Data Audits in Detecting Scientific Misconduct

Author Affiliations

Newburyport, Mass

Newburyport, Mass

JAMA. 1990;264(1):35-36. doi:10.1001/jama.1990.03450010039018

To the Editor.—  Regarding the article1 about Food and Drug Administration audits, I was particularly disturbed by the authors' proposal to suspend investigators "prior to any hearing." Further, "the burden of proof would be on the investigator to demonstrate that he or she should not be disqualified."This proposal appears to turn a centuries-old principle of jurisprudence on its head. The accused used to be presumed innocent until proved guilty. Why should an individual be stripped of his or her livelihood and reputation by nothing more than the arbitrary judgment of a bureaucrat? Why should the burden of proof not rest with the accusers? Why should they not have to give sufficient objective evidence to demonstrate the incompetence or dishonesty of investigators?The answer given by Shapiro and Charrow is that "shifting the burden of proof to the investigator should reduce the cost to the FDA of a