Misconduct and Fraud in Clinical Trials: Legal Perspectives

Misconduct and fraud in clinical trials are widespread and case law examples illustrate that no country is spared from the issue. The evaluation of how commonly it occurred is however made difficult because misconduct and fraud have often been underreported. 
 
Initial legal instruments (Nuremberg code, 1947 and Declaration of Helsinki, 1964) provided for ethics and general moral obligations. Since then, international texts are focused on promoting research integrity whereas sanctions, such as penalties or disciplinary measures, are rather left to countries. Therefore, each court must deal with misconduct and fraud according to its own legal procedures, legislation and sanctions, which will be developed during the presentation.
 
Fraud impacts are not limited to these sanctions but it also has indirect effects (withdrawal of funds allocated to the trial, public distrust in research). Thus, even if it may not be possible to completely prevent fraud, some measures might be elaborated to improve detection of fraudulent behaviours.