The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

BackgroundThe lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be i...

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Bibliographic Details
Main Authors: Annalisa Landi, Yanis Mimouni, Viviana Giannuzzi, Franz Schaefer, Annagrazia Altavilla, Spencer Gibson, Daria Julkowska
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-04-01
Series:Frontiers in Medicine
Subjects:
informed consent
rare diseases
research
ethics review
registries
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2024.1384026/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2024.1384026/full

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