Research misconduct

Although misconduct does, unfortunately, occur in clinical trials, allegations of misconduct are uncommon [5]. The true scale of the problem is not, however, known, although an anonymous survey of its members conducted by the International Society for Clinical Biostatistics showed that the majority of participants were aware of a fraudulent project, but did not know whether the organization they worked for had a formal system for handling suspected fraud [6]. Allegations must be taken seriously because misconduct affects our responsibilities to, and our credibility with, patients, the scientific community and the public. It also brings the medical and scientific professions into disrepute. Several surveys have shown that a number of researchers know of cases of misconduct that have not been reported [7]. Allegations must be fully investigated and reports of confirmed misconduct made publicly available. The public must be protected and must have confidence in research results; they ought to be able to assume that researchers are honest and reliable. Correspondingly, researchers themselves must be protected from frivolous and malicious accusations. There is now international recognition of the need to tackle the problems honestly and realistically [8].

The primary responsibility for establishing and maintaining standards and ensuring probity and integrity rests with the relevant professional bodies, senior investigators and employing institutions [9]. This requires guidelines, training in their use, and supervision.

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