Research in clinical epidemiology:: Which rules should be applied?

The adaptation of the European directive 2001/20/CE on clinical drug trials was the opportunity for a profound reform of the legislative framework on biomedical research in France. Within the main innovations, the distinction between the three broad research categories was retained: biomedical research, research on standard care, and noninterventional research. These changes have rendered the legislative arsenal of research more complex, and therefore these changes should be reviewed. This article presents how the 2007 French healthcare research regulations can be applied. Briefly, four questions should be asked before research is undertaken: (1) does the study require a specific procedure on a person (intervention or investigation)? (2) Does it use material from the human body that will be preserved or disgarded? (3) Does it require processing personal patient data? (4) Does it include genetic data? Researchers are expecting a simplification of procedures with the new regulations. This objective has been partially met, but a certain number of questions remain unanswered, particularly in the field of epidemiology. (C) 2008 Elsevier Masson SAS. Tous droits reserves.