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.
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 initiative to promote the development of their sense of utility, moral capacity, and sense of belonging to something. It is important to analyze this from a specific sociocultural context, such as the Colombian context, from its representations in the physician or researcher’s perception or meanings regarding the minor’s moral development since several influential practices are produced. These are specifically physician–patient relationships that depend on the respect or violation of the minor’s rights within the framework of the principles of bioethics.
Investigations that describe the dilemmas faced by researchers and doctors associated with obtaining informed consent from mature minors, to which they are obliged by law, do not emphasize or report the (imaginary) meanings regarding the minor’s autonomy and responsibility.
Research in this field has shown that it has not been easy to clearly and precisely determine when humans begin to be autonomous subjects and legally responsible for their actions. In this aspect, authors such as Gutiérrez et al. state that consent is a process by which children are provided basic information about an investigation provided they demonstrate “… the ability to express preferences and understand the nature and purpose of the research techniques.”
In this order of ideas, Freeman states that children’s rights are very important, and therefore, they must be treated equally and even as autonomous beings, with the child’s “best interests” in mind, which may be gained through the means of consent. Thus, developing a child’s autonomy is as important as developing that of any other person, regardless of what stage of development they are in. Conversely, Sayoux and Frometa state that research related to children’s autonomy is limited to a historical and philosophical description of the need to consider the parents in decision-making, beginning with informed consent, wherein the child is a secondary subject who is not considered capable of decision-making. The family plays an important role in the interaction of complex networks in the parent–child relationship, which is reflected in the child’s dependence and vulnerability and their decision-making capability.
However, studies such as those conducted by Manson (2015) and Tucker F (2016) refer to the need to implement a transitional paternalism where it is not the child’s competence that is evoked but their flexibility, which leads to the normative power to morally structure the child to take responsibility for their decisions to an admissible extent. More specifically, C&R should prefer the fair methods, which give greater respect to the child’s decisions, rather than the symmetrical alternative of whether to consent.[6,7]
C&R should be aware that childhood is a stage in which the child develops a basic dependence on others; therefore, transitional paternalism appeals to an individual’s obligations to help others self-govern.[7,8] Likewise, López states that C&R should recognize minors as moral subjects only in their particular and unique evaluative aspects and very slightly from a normative and universal outset. In other words, they should recognize them as subjects with a universal right but not beyond the developmental stage that they have reached.
Elements of dominance emerge as influential practices from the way C&R perceive children’s autonomy or their moral development; these are manifested in the physician–patient relationship during the process of obtaining informed consent. Accordingly, Sánchez Vázquez proposed a classification system that illustrates the type of physician–patient power relationships that emerges from an applied ethics perspective. This could explain the dynamics of informed consent, including paternal-moral, normative-legal and differential type relationships. Influential relationships respond to different logics when addressing the ethical problem surrounding the figure of the child; for example, the paternal-moral relationship conceives the child as only a “social being,” which is the object of care. The normative-legal relationship introduces the universal dimension brought about by the human rights phenomenon, in which the child is already treated as a dignified being with full rights. Finally, the differential relationship considers the child’s particular and unique perspective, highlighting the constant alternation of each child between autonomy and subjective vulnerability.
In summary, the different types of physician–patient relationships help us reflect on a child’s autonomy and formulate moral structuring guidelines (educative) for each type of patient. It should be mentioned that current guidelines do not clearly describe when to request a child’s consent for research, especially when they show a capacity for understanding. Several studies describe the minimum requirements of health personnel when children are placed in their care. Their needs should be considered when they are needed to provide consent without coercion, and they need to be called by their name, among other things that define the axiological, teleological, and deontological elements,[12,13] which contributes to the child’s moral strengthening. Thus, autonomy interpreted as the child’s moral maturity could depend on how they assume their self-care practices and even recognize the importance of accepting their participation in an investigation. These elements could lead to the C&R treating the child as a moral subject worthy of respect, with agency or self-government capacity,[7,8,15] which is demonstrated by their self-care practices. Conversely, according to an analysis of practices adapted to international standards for research in children, it also helps to examine the possible dilemmas and tensions raised regarding a child’s autonomous capacity, which are constantly evolving from a particular social and historical context.[2,5,9,13] In many countries, these rules state the responsibility of assessing a child or adolescent’s (minor’s) autonomy in decision-making, wherein each case is unique and particular, thereby achieving consent regulation.
Informed consent merges influential practices of a deliberative or submissive type. Thus, as Powell and Buchanan expressed: “It is a complex construct where particular values and beliefs influence the way of conducting research’ and thus perceiving the ‘other’.” Undoubtedly, it is imperative to understand that beyond the principles of beneficence, justice, and respect as normative elements, the sociocultural aspects of children and their families must be considered; otherwise, it may lead to an extreme paternalistic relationship.[4,7,14]
Clearly, children, who are a vulnerable population, require representation by their legal guardians regardless of the C&R’s perception of the child’s moral development, which is neither under discussion nor is considered a problem or ethical dilemma. The problem lies in acknowledging the “other,” that is, the child as a moral subject, which confirms the guardian’s decision owing to the understanding and moral structuring that they have received from clinicians or researchers through an educative process to which the family substantially contributes.[7,17] Consequently, informed consent does not end when the child leaves the practice or agrees to participate in an investigation; conversely, it is strengthened when the child practices self-care, establishing their best interest in improving or contributing to scientific knowledge above the needs characteristic of their age.[11,13,18]
A limited number of studies have identified the practices of researchers and clinicians regarding children’s participation in research and their consent for treatment.[12,13,18] Most studies have only provided a description of the individual abilities of children and adolescents (minors) and have not mentioned anything about the meaning of autonomy and influential practices that emerge from C&R to recognize the child’s autonomy during the process of obtaining informed consent.[7,17] However, they prove that the ethical challenges regarding biomedical research in children and adolescents (minors) are not simple when considering the moral capacity to make decisions, which could promote a relationship of extreme paternalism.
Opel et al. believe that the participation of children in biomedical research is justified because they contribute to improving treatments and diagnostic methods and are important for establishing guidelines for the control and management of pediatric diseases because such research cannot be conducted in adults. In this sense, informed consent could be obtained more for administrative reasons than for reasons owing to moral duty. López mentions that C&R should consider the evaluation of the child’s moral development based on the articles of the United Nations Children’s Fund, which address the participation of children in research.[9,21,22] Article 12 states that “Children who can establish their own opinions should have the right to express them and have them taken into account.” Article 13 states that “Children are free to not participate and should not be pressured.” Therefore, “participation is a right, not an obligation.” Ultimately, the child’s decision is a subjective fact for C&R, and therefore, it should be interpreted according to the framework of bioethical principles, in which the principle of beneficence prevails over the principle of autonomy without prior evaluation. This statement indicates that the conception of beneficence could be considered to be paternalistic.[23,24]
The child’s moral development should not be considered to be a limitation but a variation in the exercise of obtaining consent, while taking into account the child’s reasoning and common sense expressed in a language adapted to their cognitive development. The child’s will to volunteer must be free but with the joint support of their guardian, C&R, family, and environment (heteronomy).[7,10,17,25] According to Kottow (2007), “the ethical concept of informed consent depends on the abolition of all unjustified medical paternalism.” Therefore, the aim of this study was to describe the influential practices that exist between C&R and children with chronic diseases during the process of obtaining informed consent expressed in the physician–patient relationship.