Care in Clinical Trials involving Youth. Exploring Vulnerability through Empirical Philosophy in a Clinical Trials Unit.

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Given the tragic legacy of unscrupulous research conducted on human subjects during the 20th century, ethics debates and regulations have taken a precautionary approach that gives pivotal attention to individual autonomy and protection of vulnerable subjects. While this approach has led to a much-needed increase of awareness about the importance of respecting human dignity and human rights in biomedical research and clinical trials, it risks causing two unintended consequences: 1) it might overshadow positive understandings of clinical trials; 2) it might limit participation of adolescents and young adults. CareInTrials therefore takes a bottom-up approach to research ethics and focuses on the experiences and narratives of youth participating in clinical trials. It is an empirical philosophy study. On the one hand, it conducts ethnographic observations and interviews with participants, their parents/legal representatives and researchers in a leading European Clinical Trials Unit. On the other hand, it does a philosophical analysis, which focuses on lived embodied experiences and the situated existential dimension of youth. For scientific rigor, a secondment in a Research Unit dedicated to philosophy and history of science is part of the action. This research ultimately aims to provide new insights and recommendations for more nuanced and tailored regulations on clinical trials, which acknowledge both youth’s demand for autonomy and their condition of vulnerability. Given the intersectoral and international cooperation involved, this action represents a unique opportunity for the researcher to gain experience and visibility to be spent in future academic and health-related employments, while contributing to societal strive for youth’s inclusion and empowerment.