Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

This paper discusses the importance of return of clinical trial data to patients in the context of the FACILITATE project that aims to develop a participant-centric approach for the systematic return of individual clinical trial data. It reflects on the need for an ethical framework to support the r...

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Bibliographic Details
Published in:Frontiers in medicine 2024-07, Vol.11, p.1408600
Main Authors: Staunton, Ciara, Blom, Johanna M C, Mascalzoni, Deborah
Format: Article
Language:English
Subjects:
clinical trials
decision-making
health data-sharing
informed consent
Medicine
return of clinical trial data
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Summary:This paper discusses the importance of return of clinical trial data to patients in the context of the FACILITATE project that aims to develop a participant-centric approach for the systematic return of individual clinical trial data. It reflects on the need for an ethical framework to support the return of clinical trial data. The discussion revolves around the developing FACILITATE ethical framework, specifically focusing on the ethical principles that form the foundation of the framework and guidance on how to implement those principles into practice.
ISSN:2296-858X
2296-858X
DOI:10.3389/fmed.2024.1408600