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

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

In the 20th century, ethics debates and guidelines on children’s participation in clinical trials and biomedical research have shifted from the need to protect them from research to the need to protect them through research. The initial precautionary approach that gave pivotal attention to individual autonomy and appealed for protection of vulnerable subjects, has been gradually turned into an approach centered on the need for foundational data to achieve evidence-based pediatric medicine. These debates focus on “what’s right to do” for minors, but do not generally consider their perspectives nor discuss critical understandings of childhood. Given the increasing literature in bioethics that values the combination of empirical and philosophical methods, CareInTrials suggests a shift in focus for research ethics discussions in pediatrics: it centers on decision making in clinical trials and in participants’ narratives and perspectives. CareInTrials is an empirical philosophy study, which makes use of qualitative methods to provide a philosophical reading of the experiences of youth participating in clinical trials. It pursues three main objectives: 1) it analyzes how international ethical guidelines and regulations have problematized the ethical issues at stake with minors’ participation in research over the years; 2) it observes the daily interactions and communications related to adolescents’ (aged 12-17 y.o.) participation in clinical trials, 3) it explores the meaning making of adolescents (12-17 y.o.) participating in clinical trials, their parents and healthcare professionals. To meet these objectives, three main methods were used: 1) a document analysis of research ethics guidelines and regulations involving human subjects from 1947 until today; 2) a 9 months ethnographic observation study at La Paz University Hospital; 3) 23 semi-structured interviews with different actors involved in clinical trials (namely, adolescents aged 12-17 years old currently enrolled in clinical trials, their accompanying adults and healthcare workers). The material thus collected was analyzed through a philosophical analysis that engages with critical understandings of childhood in human and social sciences, the lived experience, and the existential dimension in medicine. A secondment at the “Science, Philosophy and History” (SPHERE) Research Unit (CNRS - University of Paris) was part of the action. CareInTrials provided insights to current ethical debates and recommendations on pediatric clinical trials and more broadly for pediatric health research and innovation. The philosophical analysis of the experiences and narratives of different actors involved allowed to: 1) highlight the changing perspectives on childhood in biomedical research, 2) provide in-depth accounts of real life situations that show the complexity and nuances that theoretical changes bring to practice, 3) highlight some ethical aspects that could be improved.

Data: CORDIS, © European Union