The basic problem in France and most European countries

Despite first appearances, France is not different from other countries. For this reason, it is always preferable to prevent scientific misconduct before it occurs, because the consequences of fraud are not easy to correct afterwards. Indeed, while a posteriori control can confirm or deny the validity of results, there may still be substantial financial costs and wasted data in economic and public health terms.

The situation differs for clinical trials on medicinal products where Afssaps is directly involved; public health and/or patients must be protected, and in biomedical research the consequences of the scientific misconduct vary enormously with the project and research domain. However, the basic principle should be the same: ethics in science, good clinical/research practices, and proper training should be developed in France or in Europe as a whole. Whilst all countries have legislation on fraud, this has never prevented its occurrence. In clinical research on medicines, good clinical practice procedures are the only "official" texts that cover this problem and, once fraud is suspected or proved, no sanction is specified except a few lines in the French law on biomedical research, and the civil and criminal codes. Within companies, the standard operating procedures, based upon good clinical practice and drafted by the interested parties with the support of quality assurance and audit department, serve as a basis for prevention. Nevertheless, they are generally written for monitoring outside activities, and few companies have systematic procedures for detecting internal fraud. Similarly, investigators and public bodies generally have no procedures available to monitor fraud, with the exception of INSERM, which now has its own good research practice.

Fraud can be prevented in part by education and also by telling the proposed investigators during prestudy investigator meetings that the study will be monitored during regular periodic visits either by sponsor audit or by official inspection.

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