Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent

Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent

In principle, persons wishing to participate in a clinical trial must give informed consent in advance after comprehensive information has been provided. Under certain conditions, it is possible to deviate from this requirement in the European Union (EU) in order to enable the participation of so-ca...

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Bibliographic Details
Main Authors: Schweim, Janna K., Nonnemacher, Michael, Jöckel, Karl-Heinz
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2021-03-01
Series:GMS German Medical Science
Subjects:
clinical trial
informed consent
vulnerable person
patient incapable of giving informed consent
legal representative
Online Access:http://www.egms.de/static/en/journals/gms/2021-19/000290.shtml

Internet

http://www.egms.de/static/en/journals/gms/2021-19/000290.shtml

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