The Role of Data Audits in Detecting Scientific Misconduct-Reply

Martin F. Shapiro, MD PhD; Robert P. Charrow, JD
JAMA. 1990;264(1):36. doi:10.1001/jama.1990.03450010039020.
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In Reply.—  Dr Heersink insists that, when audits have raised serious questions about misconduct in investigational drug research, the physician should be "presumed innocent until proved guilty" and "should not be stripped of his or her livelihood and reputation" by arbitrary bureaucratic judgment. We agree that investigators should not be subject to disciplinary action without due process of law. Constitutional rights, though, cannot be applied in a vacuum. This is especially true of due process, which requires a careful balancing of the individual and societal interests at stake. Thus, the process that is due an individual, including the nature and timing of any hearing, will be a function of such factors as the type of rights arguably implicated by the proposed governmental action and the danger to society if prompt governmental action is not taken.Where the rights are minimal and the public health is imperiled, government has an obligation


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