Ley Trans, liberum arbitrium / Transgender law, liberum arbitrium

La nueva ley sobre la igualdad de las personas trans y la garantía de derechos de las personas LGTBI (Ley 4/2023, de 28 de febrero) ha sido una ley discutida y criticada por algunos grupos de profesionales de la medicina que atienden a la población infantil. Las críticas desde el ámbito médico y pediátrico se pueden hacer siempre ante cualquier ley que consideremos que afecta a los derechos sanitarios de los menores. Lo que sucede es que algunas de esas críticas son sobre aspectos que no se recogen en la ley. En el siguiente artículo analizaremos lo que dice la ley, lo que dicen algunas asociaciones de profesionales y lo que dice la legislación sobre los derechos sanitarios del menor, con el fin de contribuir al debate de esos controvertidos aspectos de la ley (AU)

The new law on the equality of trans people and the guarantee of rights of LGTBI people (Law 4/2023, February 28th) has been discussed by some groups of medical professionals that have shown their disagreement.In relation to any law, criticism can be made from the medical or pediatric field; whenever it affects the rights of minors. However, criticisms, if they exist, should be made about what the law says, not about other aspects.In the following article we will analyze what the law says, what some professional associations say and what the legislation says about the health rights of minors, in order to contribute to the debate on these controversial aspects of the law. (AU)

Evaluación de la madurez del menor en el ámbito sanitario: la perspectiva de padres y pediatras / Assessment of the maturity of the minor in the health field: the perspective of parents and pediatricians

Introducción: el modelo de respeto a la autonomía y de participación progresiva en el contexto pediátrico requiere que el pediatra que atiende al paciente menor sea capaz de evaluar y decidir si este presenta suficiente madurez y es competente para tomar una decisión sanitaria, o en qué grado participa en la misma. El objetivo es determinar la correlación entre la valoración de la madurez del menor realizada por parte de pediatras y de padres de forma subjetiva, con la realizada mediante una prueba objetiva, la Escala de Valoración de la Madurez de Lleida, MadurTest. Material y métodos: estudio prospectivo, observacional y transversal; 199 adolescentes de entre 12 y 16 años, con patología aguda y crónica. Se evaluó la madurez de los pacientes con la escala MadurTest, y los pediatras y los padres valoraron la madurez del menor con preguntas de la escala Likert para madurez. Resultados: la media de la puntuación de MadurTest fue de 6,39, presentando las niñas un nivel de madurez superior a los niños en la mayoría de las franjas de edad. La valoración de madurez por parte de los pediatras fue de 3,18 de media y por parte de los padres de 3,18. No se observa correlación entre la puntuación obtenida en el MadurTest con la valoración por parte de los profesionales ni por parte de los padres. No obstante, se observa una correlación entre las valoraciones efectuadas por los padres y los profesionales (r = 0,73; p <0,00001). Conclusiones: la madurez de los menores valorada de forma subjetiva por pediatras y padres no se correlaciona con la madurez evaluada de forma objetiva mediante el test MadurTest (AU)

Introduction: the model of respect for autonomy and progressive participation in the pediatric context requires that attending pediatricians be able to assess minor maturity, and decide the degree of participation. The objective of this study is to determine the correlation between the assessment made subjectively by paediatricians and parents, with the maturity of the minor carried out by means of an objective test, the Lleida Maturity Assessment Scale, MadurTest.Material and methods: prospective, observational and cross-sectional study. 199 adolescents between 12 and 16 years old, affected by acute and chronic pathology. The maturity of the patients was evaluated with the MadurTest scale and pediatricians and parents assessed the maturity of the minor in the form of the Likert maturity scale.Results: the mean of the MadurTest score is 6.39, girls present a higher level of maturity than boys in most age groups. The maturity assessment by pediatricians is 3.18 on average and by parents 3.18. No correlation is observed between the score obtained with the MadurTest and the assessment by professionals or by parents. However, a correlation is observed between the assessments made by parents and professionals (r = 0.73, p <0.00001)Conclusions: the maturity of minors assessed subjectively by paediatricians and parents does not correlate with the maturity assessed objectively using the MadurTest. (AU)

Problemática de los medicamentos empleados fuera de la ficha técnica (uso off-label): Análisis de sus exigencias, con especial consideración a la obligación de información y consentimiento informado / Problems of off-label use of drugs: Analysis of the requirements, with special consideration to the obligation of information and informed consent

El médico siempre debe perseguir el mayor beneficio para su paciente, intentando provocar el mínimo perjuicio a la hora de prescribirle un fármaco. Ante dicha tesitura, cuando no existe una alternativa terapéutica autorizada, es relativamente frecuente administrar medicamentos fuera de la ficha técnica (off-label) en ciertas especialidades. Bajo tales premisas, el objeto de este trabajo es analizar los requisitos legales, la forma de articular la obligación de información y el consentimiento informado del paciente, situación esta última especialmente compleja en el caso de la emisión por parte del menor de edad. (AU)

When prescribing a medication, a physician makes a benefit-risk evaluation based on the drug’s potential benefits outweighing the potential risks. Faced with this situation, when there is no authorized therapeutic alternative, it is relatively common to administer drugs off-label in certain specialties. The aim of this paper is to analyze the legal requirements, the way to articulate the obligation of information and the informed consent of the patient, a particularly complex situation in the case of minors. (AU)

The ethics of informed consent and shared decision-making in pediatric surgery.

Informed consent is a required feature in the practice of pediatric surgery. Surgeons cannot practice the trade without it and most of us learned to do it as part of our "apprenticeship" in surgical training. We were bystanders when the senior resident or attending spoke to the patient and family and we were silent witnesses to the signing of the document called a "consent." Intentional instruction about informed consent is rudimentary in most residencies. By the time we become surgical fellows, it is assumed that we have the requisite skill set to perform this "task" so we can get on with what we like to do best; operating. For many, it is viewed as a perfunctory step which, if done properly, will comply with hospital policies, might someday be exhibited during medical litigation, and ultimately it will occupy a tiny bit of memory in the hospital EMR system. However, this "thing" called the informed consent is much more than an item on a pre-op check list. The re-branding of the term "informed consent" into "shared decision-making" underscores the "re-evolution" that has occurred in thought and practice from the act of obtaining an individual's permission for treatment toward the process leading up to that act.1 It reflects some of our most important ethical values in healthcare and is still the source of scholarly inquiry and controversy. In this paper, the terms "informed consent" and "shared decision-making" will be used interchangeably but the intention is focused on the process of how physicians and their patients make choices together. If you have not thought about this topic recently, I encourage you to take a moment and explore some of the interesting and challenging questions which are still unanswered. Although the ethical principles underlying informed consent are shared by adult and pediatric medicine, there are many aspects which are unique to the medical care of children. This article highlights some of those challenges and controversies illustrated by two case studies and viewed through the lens of bioethics.

Teoria da maturidade progressiva do menor aplicada no direito à saúde / Minor progressive maturity theory applied in the right to health

O presente artigo analisou os limites do poder familiar nos casos envolvendo recusa de tratamento médico por adolescentes. A partir dos dispositivos constitucionais e infraconstitucionais, pretendeu-se fazer uma releitura da autonomia do adolescente e, em virtude do fenômeno da mundialização dos juízes, reforçar no Direito brasileiro alguns fundamentos oriundos de precedente inglês que deu origem à teoria do menor maduro. Concluiu-se com a análise dos fundamentos e dos requisitos para a recusa de tratamento médico por adolescentes no direito brasileiro.

This article analyzed the limits of family power in cases involving refusal of medical treatment by adolescents. Based on the constitutional principles and infraconstitutional provisions, it was intended to re-read the adolescent autonomy and, due to the phenomenon of the globalization of judges, to reinforce in Brazilian law some fundamentals derived from an English precedent that gave rise to the theory of the mature minor. It was concluded with the analysis of the fundamentals and requirements for the refusal of medical treatment by adolescents in Brazilian law.

Design and Validation of an Instrument To Measure a Minor's Maturity When Faced with Health Decisions.

Decision-making capacity in children and adolescents in healthcare requires thorough assessment: the minor's maturity, understanding of the decision, risk of the situation and contextual factors needs to be explored. The intention was to design and validate a test-the Maturtest-to assess the maturity of minors in decision-making processes in healthcare. A reasoning test on moral conflicts for adolescents was designed to infer the degree of maturity of minors applied to decision-making regarding their own health. The test was completed by a sample of 441 adolescents aged from twelve to sixteen, with a corresponding analysis of their psychometric skills to measure feasibility, viability, reliability, validity, and sensitivity to change. Psychometric test results showed viability, reliability, validity, and sensitivity to change. High correlation (correlation index = 0.74) between the test score and the reference method were notable. A high stability was obtained with an intraclass correlation coefficient (r = 0.77). The average response time of the test was twenty-three minutes. This test measures the moral maturity of adolescents. It is presented as an objective, useful, valid, reliable tool, easy to fill out, edit and apply in a healthcare context. It helps to assess the maturity of minors faced with a decision.

Significados de autonomía durante la toma del asentimiento informado al menor con enfermedad autoinmune percibidos por los clínicos e investigadores / Meanings of autonomy during the taking of informed consent to the minor with autoimmune disease perceived by clinicians and researchers / Significados de autonomia durante a obtenção do consentimento informado para o menor com doença autoimune percebida por clinico e pesquisadores

El presente artículo presenta un análisis sobre los significados que tienen los clínicos e investigadores, con respecto a la autonomía del menor maduro con enfermedad autoinmune; los cuales podrían llevar a diferentes prácticas de poder durante el momento de la toma del asentimiento informado. Teniendo presente la doctrina del menor maduro, es deber de los clínicos e investigadores contribuir al desarrollo moral o la autonomía del menor desde la misma reflexión de sus prácticas de poder. El objetivo del presente artículo es describir los significados o percepciones de los clínicos e investigadores, al momento del asentimiento informado, en relación con la autonomía o desarrollo moral del menor con enfermedad autoinmune, que surgen de sus experiencias, conocimientos y concepciones previas sobre el menor. La metodología utilizada fue de naturaleza cualitativa con enfoque subjetivista e interpretativista y alcance transversal. Se aplicaron entrevistas semiestructuradas a 21 personas, investigadores y clínicos, que atienden niños con enfermedades autoinmunes, cuyos datos fueron analizados por medio del programa Atlas Ti. 8.0. Como conclusión, el asentimiento informado es un proceso de modelo ético de comunicación asertiva, que busca la estructuración moral del menor más allá de lo percibido por el clínico o investigador. Además, los clínicos e investigadores consideran que estructurar al menor es percibirlo como un sujeto autónomo, lo cual es posible cuando presenta adherencia al tratamiento y cuidado responsable, independientemente del apoyo del tutor.

This article presents an analysis on the meanings that clinicians and researchers, have regarding the autonomy of the mature minor with autoimmune disease, which could lead to different power practices during the moment of taking the informed consent, keeping in mind the doctrine of the minor mature, it is the duty of the clinicians and researchers to contribute to the moral development or the autonomy of the minor from the same reflection of his practices of power. The objective was to describe the meanings or perceptions of clinicians and researchers, at the time of informed consent, in relation to the autonomy or moral development of the child with autoimmune disease, which arise from their experiences, knowledge and previous conceptions about the child. The methodology used was of a qualitative nature with a subjectivist and interpretative approach and a transversal scope. Semistructured interviews were applied to 21 people, researchers and clinicians, who attend children with autoimmune diseases, whose data were analyzed through the Atlas Ti program. 8.0. In conclusion, the informed consent is a process of assertive communication ethical model that seeks the moral structuring of the child beyond what is perceived by the clinician or researcher, in addition the clinicians and researchers consider that to structure the minor is to perceive him as an autonomous subject; which is possible when it shows adherence to treatment and responsible care independently of the tutor's support.

Este artigo apresenta uma análise sobre os significados que clínicos e pesquisadores têm em relação à autonomia do menor maduro com doença autoimune, o que poderia levar a diferentes práticas de poder durante o momento de obtenção do consentimento informado, tendo em vista a doutrina da menor maturidade, É dever dos clínicos e pesquisadores contribuir para o desenvolvimento moral ou a autonomia do menor a partir do mesmo reflexo de suas práticas de poder. O objetivo foi descrever os significados ou percepções de clínicos e pesquisadores, no momento do consentimento informado, em relação à autonomia ou desenvolvimento moral da criança com doença autoimune, que decorrem de suas experiências, conhecimentos e concepções prévias sobre a criança. A metodologia utilizada foi de natureza qualitativa, com uma abordagem subjetivista e interpretativa e um escopo transversal. Entrevistas semiestruturadas foram aplicadas a 21 pessoas, pesquisadores e clínicos, que atendem crianças com doenças autoimunes, cujos dados foram analisados por meio do programa Atlas Ti. 8,0 Em conclusão, o Termo de Consentimento Livre e Esclarecido é um processo de comunicação assertiva, modelo ético que busca a estruturação moral da criança além do percebido pelo clínico ou pesquisador, além dos clínicos e pesquisadores considerarem que estruturar o menor é percebê-lo como um sujeito autônomo; o que é possível quando mostra aderência ao tratamento e cuidados responsáveis independentemente do suporte do tutor.

Transitional paternalism: how shared normative powers give rise to the asymmetry of adolescent consent and refusal.

In many jurisdictions, adolescents acquire the right to consent to treatment; but in some cases their refusals - e.g. of life-saving treatment - may not be respected. This asymmetry of adolescent consent and refusal seems puzzling, even incoherent. The aim here is to offer an original explanation, and a justification, of this asymmetry. Rather than trying to explain the asymmetry in terms of a variable standard of competence - where the adolescent is competent to consent to, but not refuse, certain interventions - the account offered here focuses more closely on the normative power to render actions permissible. Where normative powers are shared they can readily give rise to an asymmetry between consent and refusal. We then turn to why it is justifiable that normative powers be shared in adolescence. Transitional paternalism holds that the acquisition of normative powers by competent adolescents should not be an instant one, achieved in a single step, but that there should be a transitional period where paternalistic protection is rolled back, but not entirely withdrawn until a later date. Transitional paternalism could be implemented without generating the asymmetry between consent and refusal but, it is argued, the asymmetric version of transitional paternalism is to be preferred insofar as it offers a greater respect for the adolescent's decisions than the symmetrical alternative.

The mature minor: some critical psychological reflections on the empirical bases.

Moral and legal notions engaged in clinical ethics should not only possess analytic clarity but a sound basis in empirical findings. The latter condition brings into question the expansion of the mature minor exception. The mature minor exception in the healthcare law of the United States has served to enable those under the legal age to consent to medical treatment. Although originally developed primarily for minors in emergency or quasi-emergency need for health care, it was expanded especially from the 1970s in order to cover unemancipated minors older than 14 years. This expansion initially appeared plausible, given psychological data that showed the intellectual capacity of minors over 14 to recognize the causal connection between their choices and the consequences of their choices. However, subsequent psychological studies have shown that minors generally fail to have realistic affective and evaluative appreciations of the consequences of their decisions, because they tend to over-emphasize short-term benefits and underestimate long-term risks. Also, unlike most decisionmakers over 21, the decisions of minors are more often marked by the lack of adequate impulse control, all of which is reflected in the far higher involvement of adolescents in acts of violence, intentional injury, and serious automobile accidents. These effects are more evident in circumstances that elicit elevated affective responses. The advent of brain imaging has allowed the actual visualization of qualitative differences between how minors versus persons over the age of 21 generally assess risks and benefits and make decisions. In the case of most under the age of 21, subcortical systems fail adequately to be checked by the prefrontal systems that are involved in adult executive decisions. The neuroanatomical and psychological model developed by Casey, Jones, and Summerville offers an empirical insight into the qualitative differences in the neuroanatomical and neuropsychological bases of adolescent versus adult decision making. These and other data, as well as developing law bearing on the culpability of juvenile criminal offenders, argue for critically re-evaluating the expansion of the mature minor exception with regard to medical decision making, as well as in support of a rebuttable presumption in favor of treating minors as immature decisionmakers. The clinical ethics of adolescent medical decision making will need foundationally to be reconsidered.

Maturing the minor, marginalizing the family: on the social construction of the mature minor.

The doctrine of the mature minor began as an emergency exception to the rule of parental consent. Over time, the doctrine crept into cases that were non-emergent. In this essay, we show how the doctrine also developed in the context of the latter part of the 20th century, at the same time that the sexual revolution, the pill, and sexual liberation came to be seen as important symbols of female liberation--liberation that required that female minors be granted the status of a mature minor. To do so moves sexual morality out of the domain of the family, where it had always been situated, and into the domain of the state. We also show how a phenomenological account of the care of the body in the family conforms to the latest in neuroscientific understandings of adolescent brain development. The family attenuates the dependency of adolescents and provides an important social contextualization for the care of the body, including the inculcation of sexual mores in adolescence. We conclude that the drive to push sexual decision making as a matter of state concern further undermines the foundations of the moral meanings of sex and sexuality.

Ignoring the data and endangering children: why the mature minor standard for medical decision making must be abandoned.

In Roper v. Simmons (2005) the United States Supreme Court announced a paradigm shift in jurisprudence. Drawing specifically on mounting scientific evidence that adolescents are qualitatively different from adults in their decision-making capacities, the Supreme Court recognized that adolescents are not adults in all but age. The Court concluded that the overwhelming weight of the psychological and neurophysiological data regarding brain maturation supports the conclusion that adolescents are qualitatively different types of agents than adult persons. The Supreme Court further solidified its position regarding adolescents as less than fully mature and responsible decisionmakers in Graham v. Florida (2010) and Miller v. Alabama (2012). In each case, the Court concluded that the scientific evidence does not support the conclusion that children under 18 years of age possess adult capacities for personal agency, rationality, and mature choice. This study explores the implications of the Supreme Court decisions in Roper v. Simmons, Graham v. Florida, and Miller v. Alabama for the "mature minor" standard for medical decision making. It argues that the Supreme Court's holdings in Roper, Graham, and Miller require no less than a radical reassessment of how healthcare institutions, courts of law, and public policy are obliged to regard minors as medical decisionmakers. The "mature minor" standard for medical decision making must be abandoned.

Parents, adolescents, and consent for research participation.

Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

Lectura clínica de una sentencia judicial: el derecho a la vida y su aplicación en la toma de decisiones clínicas / Clinical interpretation of a court ruling: the right to life and its application in clinical decision making

En el año 2009 se conoce el caso de un niño afectado de leucemia aguda linfoblástica. Es tratado con buen resultado y se obtiene la remisión completa, pero más tarde aparece una recidiva. Los padres no otorgan su consentimiento para el tratamiento, generando un conflicto que llega al mundo judicial y da lugar a dos fallos de gran interés para los profesionales de la salud. Por una parte se señala qué signfica en la práctica clínica el derecho a la vida. Por otra, se desarrolla el proceso de toma de decisiones sobre los menores con base en la teoría del menor maduro, un hito jurispridencial en Chile. Con el propósito de contribuir a esclarecer el significado de la sentencia de la Corte de Apelaciones de Valdivia, se expone su contenido en términos clínicos y se concluye con las aportaciones más significativas.

In 2009, the case of a child affected by acute lymphoblastic leukemia took place. He is treated with good results resulting in complete remission, but relapse occurred later. The parents did not consent to the new treatment, creating a conflict that reaches the legal world and leads to two court rulings of great interest to health professionals. One explained the meaning of the right to life in the clinical practice, and the other dealt with the decision-making process regarding minors based on the theory of the mature minor doctrine, a jurisprudential milestone in Chile. In order to help clarify the meaning of the ruling of the Corte de Apelaciones of Valdivia, its content is presented in clinical terms and ended with the most significant contributions.