Research fraud and misconduct Health Dictionary

Research misconduct is de?ned as behaviour by a researcher that falls short of good ethical and scienti?c standards – whether or not this be intentional. For example, the same data may be sent for publication to more than one medical journal, which might have the e?ect of their being counted twice in any META-ANALYSIS or systematic review; or the data may be ‘salami sliced’ to try to make the maximum number of publications, even though the data may overlap. Fraud in the context of research is de?ned as the generation of false data with the intent to deceive. It is much less frequent than carelessness, but its incidence is estimated as between

0.1 and 1 per cent. A ?gure of 1 per cent means that, in the United Kingdom at any one time, maybe 30 studies are being conducted, or their results published, which could contain false information. Examples include forged ethics-committee approval, patient signatures and diary cards; fabricated ?gures and results; invention of non-existent patient subjects; or sharing one electrocardiogram or blood sample amongst many subjects.

Research fraud should be ?rst suspected by a clinical-trial monitor who recognises that data are not genuine, or by a quality-assurance auditor who cannot reconcile data in clinical-trial report forms with original patient records. Unfortunately, it often comes to light by chance. There may be suspicious similarities between data ostensibly coming from more than one source, or visits may have been recorded when it was known that the clinic was shut. Statistical analysis of a likely irregularity will frequently con?rm such suspicion. The motivation for fraud is usually greed, but a desire to publish at all costs, to be the original author of a medical breakthrough, to bolster applications for research grants, or to strengthen a bid for more departmental resources are other recognised reasons for committing fraud.

In the USA, those proved to have committed fraud are debarred from receiving federal funds for research purposes or from undertaking government-funded therapeutic research. The four Nordic countries (Denmark, Finland, Norway and Sweden) have committees on research dishonesty that investigate all cases of suspected research misconduct. In the United Kingdom, an informal system operated by the pharmaceutical industry, using the disciplinary mechanism of the General Medical Council (GMC), has led to more than 16 doctors in the past ten years being disciplined for having committed research fraud. Editors of many of the world’s leading medical journals have united to form the Committee on Publishing Ethics, which advises doctors on proper practice and assists them in retracting or refusing to publish articles found or known to be false. (See ETHICS; ETHICS COMMITTEES.) Where an author does not o?er a satisfactory explanation, the matter is passed to his or her institution to investigate; where an editor or the committee is not satis?ed with the result they may pass the complaint to the appropriate regulatory body, such as the GMC in Britain.