Research Ethics Committees: Adaptation to The New European Regulation of Clinical Trials – A Viewpoint From Germany

Research Ethics Committees: Adaptation to The New European Regulation of Clinical Trials – A Viewpoint From Germany

According to Art, 4 of the regulation, the ethical review of the clinical trial has to be performed by an ethics committee (EC), but it is left up to the individual member states to decide whether the EC reviews Part II (informed consent material and quality of the study centers and its staff) only...

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Veröffentlicht in:Clinical therapeutics 2015-08, Vol.37 (8), p.e164-e164
1. Verfasser: Hasford, J
Format: Artikel
Sprache:eng
Schlagworte:
Clinical trials
Committees
Human subjects
Informed consent
Internal Medicine
Medical Education
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Beschreibung
Zusammenfassung:According to Art, 4 of the regulation, the ethical review of the clinical trial has to be performed by an ethics committee (EC), but it is left up to the individual member states to decide whether the EC reviews Part II (informed consent material and quality of the study centers and its staff) only or Part I (trial protocol and risk/benefit assessment), too.
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2015.05.465