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: | Drawer...
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| 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: |
Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
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| 520 | |a 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 committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a ‘single decision’ by the Member State concerned. Three possible approaches to the procedures for expressing that ‘single decision’ and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option. | ||
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| SYG | 0 | 0 | |a Europäische Union,Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG,Europäische Union,Verordnung (EU) Nr. 536/2014,Europäische Union,Clinical Trials Regulation,Europäische Union,CTR , Ethikkomitee,Ethikkommission,Ethik-Beirat |