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

Description du projet

Focus sur les sujets humains

Les essais cliniques font partie intégrante de la recherche médicale. L’utilisation de sujets humains est également primordiale. Beaucoup de choses ont changé depuis les années 1900, lorsqu’il n’y avait aucune réglementation concernant l’utilisation éthique de sujets humains en recherche. Toutefois, l’approche de précaution d’aujourd’hui risque également de provoquer des conséquences indésirables: elle pourrait éclipser la compréhension positive des essais cliniques et limiter la participation des adolescents et des jeunes adultes. Dans ce contexte, le projet CareInTrials, financé par l’UE, étudiera l’éthique et se focalisera sur les expériences des jeunes participants aux essais cliniques. Les résultats fourniront de nouvelles données et nourriront des recommandations pour des réglementations plus nuancées et plus personnalisées en matière d’essais cliniques, qui tiennent à la fois compte des exigences des jeunes et de leur statut vulnérable.

Objectif

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.