Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

Published by European Commission (EC)

Clinical TrialsEthics CommitteeNeonateMinorAdolescentConsentAssent 

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

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