Aspects législatifs et éthiques de la recherche biomédicale en Tunisie
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La recherche biomédicale en Tunisie est régie par un cadre législatif et éthique destiné à protéger les participants humains et à promouvoir la rigueur scientifique. Le principal texte de référence est le décret n 2014-3657 du 3 octobre 2014, modifiant et complétant le décret n 90-1401 du 3 septembre 1990, fixant les modalités de l'expérimentation médicale ou scientifique des médicaments destinés à la médecine humaine qui établit les règles encadrant les essais cliniques et les études biomédicales. Ce cadre impose des exigences rigoureuses, notamment en matière de la participation du volontaire sain, le consentement éclairé, de protection des données personnelles, et de supervision par des Comités de Protection des Personnes (CPP).Toutefois, des insuffisances législatives subsistent, notamment dans le contexte du COVID-19. Le cadre juridique peine à suivre les évolutions rapides des technologies biomédicales, comme les thérapies géniques et les études sur les mégadonnées. La protection des données personnelles, bien qu'encadrée par la loi, reste insuffisante face aux standards internationaux.
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