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...
Main Author: | |
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Format: | Electronic Article |
Language: | English |
Check availability: | HBZ Gateway |
Journals Online & Print: | |
Fernleihe: | Fernleihe für die Fachinformationsdienste |
Published: |
BMJ Publ.
2016
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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
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Online Access: |
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