Respect des obligations réglementaires et éthiques des thèses de médecine générale soutenues en 2016 à l’Université de Bordeaux. Évolution avec la Loi Jardé

Abstract : Introduction: the MD thesis, as a scientific study about human person, requires knowledge of regulatory and ethical obligations. Aim: to establish proportion of general practice thesis presented at Bordeaux university in 2016 respecting regulatory and ethical obligations. To estimate the evolution of this proportion if Jardé law and its decrees had been applied. Methods: descriptive restrospective study of general pratice thesis expounded in 2016. Documents have been collected at the university library or from the PhD students. The method part of every thesis had been read to determine the type of study, the population, the regulatory obligations and their compliance. Results: 214 thesis have been expounded in 2016, 152 were quantitatives and 52 qualitatives or joint. A CNIL notification was necessary for 171 thesis, it was only done for 16% of them. Of the 15 theses for which a CPP declaration was required, 13 (87%) have been respected. A CPP notification was necessary for 15 thesis, was done for 87% of them. Only one ANSM notification was necessary and it was done. The academic position of the thesis director significantly increases the respect of the obligations (p=0,0003). If the Jardé law had applied to these works, the number of CPP declaration would have been multiplied by two (7 à 14%), the notification to the ANSM went from 0.5% to 13.6%. The obligations to the CNIL would not have changed. Conclusion: the regulatory obligations were poorly respected for thesis expounded in 2016. The number of requests for agreement, authorization, declaration increases with Jardé Law. A better information for thesis directors and students is needed. A tool available on line will be facilitating.
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Master Thesis
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Camille Le Portz. Respect des obligations réglementaires et éthiques des thèses de médecine générale soutenues en 2016 à l’Université de Bordeaux. Évolution avec la Loi Jardé. Médecine humaine et pathologie. 2018. ⟨dumas-01939873⟩

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