Management of fraud

France and most European countries have been strangely absent from the debate concerning management and official sanction of individual cases of fraud, whatever the field of research. This is due both to a tendency of the

Figure 12.1 Possible times and implications of fraud in clinical trails on medicinal products.

countries to hide such problems, and to the absence of precise and well-codified rules, and it is true for both biomedical research and for clinical trials on medicinal products. Nevertheless, like many US and European research institutions, the principal medical body in France, INSERM, has implemented procedures to respond to allegations of scientific misconduct. This part of the chapter is based on recommendations on scientific integrity, made in 1998 by an INSERM group of experts7-8 and on papers by the Délégation à l'Intégrité Scientifique (Office of Scientific Integrity) and its head, Déléguée Général Martine Bungener.9

INSERM is a French national institute in charge of research in biomedical and health fields. It includes more than 260 units and 9500 people, one third being directly employed by the Institute. For comparison, the Centre National de la Recherche Scientifique (CNRS), has a committee for scientific ethics, Comité d' Éthique pour les Sciences (COMETS), created in 1994, which has a consultative capacity concerning "good scientific practice" and the rules relating to research deontology, such as fraud, capture of scientific results, and plagiarism. Individual situations are the responsibility of the Director General but COMETS is requested to advise the Director General to select the CNRS mediator (appointed for a three-year non-renewable term) or an investigational committee to oversee the case if there is any question of a breach of scientific integrity.

A different approach has been adopted by INSERM. The Director General of INSERM, Claude Griscelli, created the Délégation à l' Intégrité Scientifique in January 1999 after allegations of fraud, in 1997, concerning the head of a research unit.10 The group of experts appointed at that time made recommendations,7 which are described below and contain three main aspects:

• definition of scientific misconduct

• recommendations on preventive actions based on:

• information for researchers

• good research practice

• good publication practice

• appointment of a "scientific integrity officer" (délégué à l'intégrité scientifique) assisted by a multidisciplinary staff and nine regional mediators to respond to and instruct possible allegations of scientific misconduct involving INSERM personnel, any person working in an INSERM unit or people involved in collaborative work (such as the Centre National de la Recherche Scientifique, INRA, industry) or contract with INSERM.

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