What is the role of ethics committees after Regulation (EU) 536/2014?

EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a ‘single decision’. This raises the problem of identifying: (1) the facility designated to express this ‘single decision’ and (2) the role of ethics commit...

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Bibliographic Details
Main Author: Petrini, Carlo (Author)
Format: Electronic Article
Language:English
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Published: BMJ Publ. 2016
In: Journal of medical ethics
Year: 2016, Volume: 42, Issue: 3, Pages: 186-188
Standardized Subjects / Keyword chains:B Europäische Union, Verfasserschaft1, Verordnung über klinische Prüfungen mit Humanarzneimitteln / Ethics committee
Online Access: Volltext (JSTOR)
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