Gaps in the ethical governance of pharmaceutical clinical trials in Europe

Gaps in the ethical governance of pharmaceutical clinical trials in Europe

The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key defici...

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Bibliographic Details
Main Authors: Rosemarie D. L. C. Bernabe, Shereen A. Dawkins-Cox, Christine C. Gispen-de Wied
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Medicine
Subjects:
ethical governance
clinical trials
research ethics committees
GCP inspections
end-to-end ethics
clinical trial oversight
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2024.1507021/full
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