Definition of misconduct

Scientific misconduct has been defined as fabrication, falsification, plagiarism, or deception in proposing, carrying out or reporting results of research and deliberate, dangerous, or negligent deviations from accepted practice in carrying out research. It includes failure to follow established protocols, if this results in unreasonable risk, and also the facilitating of misconduct by collusion in, or concealment of, such action by others. Misconduct does not include honest error or honest differences in the design, execution, interpretation, or judgement in evaluating research methods or results [5,10].

The types of misconduct most likely to be encountered in clinical trials are data fabrication and data falsification within a collaborating centre [6,11]. This is important, because such misconduct is usually intended to conceal inefficiency and missing data rather than to distort the results of a trial. We therefore restrict ourselves to commenting on misconduct within a collaborating centre.

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