Le Cadre Numérique Complet de l'Université de Jendouba pour la Gestion de l'Éthique de la Recherche : Un Système Intégré avec Vérification en Temps Réel, Audits Surprises et Accès Public via Codes QR et DOI
DOI :
https://doi.org/10.62438/tunismed.v103i11.5812Mots-clés :
Authentification, protocoles, essais cliniques, conformité , systèmes de surveillance , cybersécurité , données électroniques, santé publique, gouvernance de la recherche , transparenceRésumé
L'Université de Jendouba met en œuvre un cadre numérique novateur pour transformer la gestion des approbations des comités d'éthique de la recherche (CER), avec un déploiement progressif commencé le 13 juin 2025, s'attaquant aux enjeux mondiaux pressants en matière d'intégrité et de transparence de la recherche. Construit sur des normes internationales comme la Déclaration d'Helsinki et les Bonnes Pratiques Cliniques (BPC), ce système utilise des outils avancés tels que les codes QR et les Identificateurs d'Objets Numériques (DOI) pour permettre une vérification en temps réel et un accès public aux protocoles approuvés. Essentiellement, le système étend sa surveillance au-delà des approbations du CER, en surveillant l'ensemble du processus de recherche pour garantir la conformité éthique, de la soumission initiale du protocole jusqu'à la publication finale des résultats.
Ce cadre répond à des défis critiques, notamment la falsification des approbations du CER, la manipulation des données et les modifications non divulguées des protocoles de recherche. Il comprend des vérifications automatisées de conformité, des évaluations des protocoles basées sur les risques et un suivi en temps réel des activités de recherche pour s'assurer que les études respectent leurs plans approuvés. De plus, des audits surprises et des mécanismes de surveillance continue sont en place pour détecter et prévenir les pratiques contraires à l'éthique à chaque étape du processus de recherche.
Premier système de ce type en Afrique du Nord, cette plateforme s'aligne sur les directives éthiques de recherche tant locales qu'internationales, favorisant la collaboration et la standardisation entre les disciplines. Elle intègre également la technologie blockchain et se connecte aux bases de données éthiques mondiales pour améliorer la transparence et la confiance dans les résultats de recherche.
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