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

Project description

A closer look at human subjects

Clinical trials are a vital part of medical research. The use of human subjects is also important. Much has changed since the 1900s when there were no regulations regarding the ethical use of human subjects in research. However, today’s precautionary approach also risks causing unintended consequences: it might overshadow positive understandings of clinical trials and could limit the participation of adolescents and young adults. In this context, the EU-funded CareInTrials project will research ethics and focus on the experiences of youth participating in clinical trials. The findings will provide new insights and inform recommendations for more nuanced and tailored regulations on clinical trials that acknowledge both youth’s demand for autonomy and their condition of vulnerability.

Objective

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.

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MSCA-IF - Marie Skłodowska-Curie Individual Fellowships (IF)

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Call for proposal

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(opens in new window) H2020-MSCA-IF-2019

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Coordinator

FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSIATRIO LA PAZ
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 160 932,48
Address
PASEO DE LA CASTELLANA 261
28046 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Other
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 160 932,48
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