The first part of this work consisted in a critical document analysis concerning guidelines and regulations in pediatric biomedical research from 1947 until nowadays. Dr Murano is in the final phase of writing a first article on this topic. This paper highlights that there has been a shift from considering children as vulnerable subjects of research, to being protected, to being active participants with their own rights. Such transformation proposes conceptions of children’s autonomy and vulnerability that are profoundly different. Yet, research ethics debates do not generally interrogate philosophical and societal conceptions of childhood, which could help make sense of current sometimes contradictory guidelines and regulations.
The largest part of CareInTrials, however, consisted in conducting fieldwork at the units of Hospital La Paz conducting clinical trials with adolescentes. Before starting this part of the project, we received approval from the Research Ethics Committee of La Paz University Hospital (CEIm, with approval number: PI-4809). Dr Murano then conducted 9 months of ethnographic observations and 23 interviews (of which 9 with minors aged from 12 to 16 years old, 6 accompanying adults and 8 healthcare professionals) in four different trial settings and disciplines: 1) the development of an anti-COVID-19 vaccine, 2) studies on two dermatological diseases, e.g. atopic dermatitis and psoriasis, 2) studies on hemophilia and 3) on the PIK3CA-related overgrowth spectrum. The fieldwork ended in July 2022 and now we are working on the analysis. Some preliminary results highlight the differences of understanding of childhood by different stakeholders (youth, parents, professionals), the focus on trust in others and in science as primary reasons to participate in clinical trials, the absence of reflections on emotions in these settings and the constraints related to current organization of clinical trials practices.
