Conclusion

Fraud has always existed and may occur in any human activity. Fraud in clinical research, whether or not pharmaceutical, poses special ethical problems in view of medical and public health issues. There are no European texts specifically devoted to the control of fraud in basic medical research. For clinical research on drugs the new European Directive on Clinical Trials2 will help to implement the ICH good clinical practice text, in order to protect subjects involved in medical research, as well as to provide high quality, credible data. Fraud itself is not mentioned, but is present in the quality assurance system of the industry with its standard operating procedures, especially in the specific procedure on fraud.

In most European countries, wilful misconduct is not properly handled in the absence of clearly codified regulations; the exceptions are the Nordic countries and UK, which have two different models. The establishment of a European model with a pan-European approach including ad hoc committees for each member state of the European Union, including France, should allow us to arrive at a solution for national institutions and health authorities (for example, Afssaps for France). Nevertheless, prevention is far better than cure, so:

• University courses concerning the appropriate legal and ethical aspects should be included in the training of research workers (physicians, dentists, pharmacists).

• A more precise legislative framework for dealing with fraud should be developed.

• A professional organisation (committee or association) should be set up in each country, taking into account the general legal framework of fraud prevention.

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