Module232025

07/05/2025

ETHICS CHALLENGES IN PAEDIATRIC CLINICAL TRIALS My personal top 10 (based on ~600 protocols reviewed 2017-2023)

9. “Aging Out” (no process, incorrect process) 10. Paediatric Assent and Information Sheets (length, complexity)

The Organisation for Professionals in Regulatory Affairs

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Regulation (EU) No 536/2014 of the European Parliament of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and repealing Directive 2001/20/EC 32(3) If during a clinical trial the minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial . Attainment of capacity

Regulation (EU) No 536/2014 Questions & Answers, V6.4, February, 2023 9.4 Question: What is meant by “his or her express informed consent shall be obtained before the subject can continue to participate in the Clinical Trial” (article 32(3) of the Clinical Trials Regulation)? 411. Answer: As soon as a minor participating in a clinical trial reaches the age of legal competence (as defined in national law) his/her participation in the clinical trial has to be terminated unless he/she confirms his/her consent to continue in the study by signing the informed consent form after having been properly informed in agreement with the requirements of the Clinical Trials Regulation.

The Organisation for Professionals in Regulatory Affairs

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