Guidelines on Informed Consent (Clinical Trials Regulation)

Published in Regulatory Frameworks by


Every scientific research has impacts on the people involved and on society as a whole, which is why it is crucial to have a clear mapping and reflection on the ethical criteria adopted during the conduct of research. This requirement is even more stringent when the research concerns the health sector and involves the participation of people in studies aimed at developing new medicinal products and treatments.

For this reason, the European Commission pushed forward a Regulation with the final aim of fostering harmonisation throughout the European health research sector and minimising the divergence in the approach of the different State Members. This Clinical Trials Regulation (CTR) was finally approved on 16 June 2014, but it only became applicable on 31 January 2022.

CyberEthics Lab. has developed Guidelines for obtaining the Informed Consent in a clinical trial, according to CTR.


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