Moral structuring of children during the process of obtaining informed consent in clinical and research settings

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RESEARCH ARTICLE

Open Access

Moral structuring of children during the process of obtaining informed consent in clinical and research settings Anderson Díaz-Pérez1,2* , Elkin Navarro Quiroz3

and Dilia Esther Aparicio Marenco2

Abstract Background: Informed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent. Methods: This was a cross-sectional, qualitative study via a subjective and interpretivist approach. The study was performed by conducting semi-structured interviews of 21 clinicians and researchers. Data analysis was performed using the SPSS version 21® and Atlas Ti version 7.0® programs. Results: The deliberative and paternalistic models were influential practices in the physician–patient relationship. In the deliberative model, the child is expected to have a moral awareness of their care. The paternalistic model determined that submission was a way of structuring the child because he or she is considered to be a subject of extreme care. Conclusions: The differentiated objectification [educational] process recognizes the internal and external elements of the child. Informed consent proved to be an appropriate means for strengthening moral and structuring the child. Keywords: Autonomy, Paternalism, Doctor–patient relationship, Consent, Informed consent in minors, Capacity, Children, Understanding, Moral, Practices, Pediatrics, Clinical, Investigator, Biomedical

Background Informed consent is the communication process wherein the child (boy, girl, or adolescent) is informed of aspects related to their illness or the importance of their participation in a study. In countries such as Colombia and Spain, clinicians and researchers (C&R) are legally required to inform and obtain a child’s consent unless they have been proven to be mentally incapable of providing it. * Correspondence: [email protected] 1 Department of Social and Human Sciences, Simón Bolívar University, Barranquilla, Colombia 2 Corporación Universitaria Rafael Núñez, Faculty Of Health sciences, Cartagena de Indias, Colombia Full list of author information is available at the end of the article

This investigation sought to identify the dynamics involved when requesting informed consent because it aims to understand the tensions that may occur between the researcher or clinician and the mature child with autoimmunity and their family, since it is the latter who directly provide their approval by means of the so-called informed consent, by substitution or by representation. Studies such as the one proposed by Royo, Prado, and Maíllo (2012) indicate that in order for the physician or researcher to consider that the moral elements have been achieved in the minor, there must be an i