[Research in clinical epidemiology: which rules should be applied?]. 2008

F Claudot, and J Fresson, and H Coudane, and F Guillemin, and B Demoré, and F Alla
Service de médecine légale et de droit de la santé, faculté de médecine, Nancy-Université, France.

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 non-interventional 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 discarded? (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.

UI MeSH Term Description Entries
D005602 France A country in western Europe bordered by the Atlantic Ocean, the English Channel, the Mediterranean Sea, and the countries of Belgium, Germany, Italy, Spain, Switzerland, the principalities of Andorra and Monaco, and by the duchy of Luxembourg. Its capital is Paris. Corsica,Saint Pierre and Miquelon,Miquelon and Saint Pierre,Miquelon and St. Pierre,St. Pierre and Miquelon
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D035843 Biomedical Research Research that involves the application of the natural sciences, especially biology and physiology, to medicine. Medical Research,Experimental Medicine,Investigational Medicine,Investigative Medicine,Research, Biomedical,Research, Medical,Medicine, Experimental,Medicine, Investigational,Medicine, Investigative

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