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)

El consentimiento informado en el menor maduro: comprensión y capacidad de decisión / The informed consent in the mature minor: Understanding and decision-making capacity

Introducción: El consentimiento informado del menor es un requerimiento fundamental de la investigación pediátrica. Actualmente existe una desarmonización en cuanto a la edad del menor maduro para consentir y no se dispone de herramientas sistemáticas para evaluar la competencia en la capacidad de decisión. El objetivo de este trabajo es analizar la situación ética y legal del consentimiento en menores, así como los estudios que utilizan un instrumento objetivo de evaluación en el menor maduro.Material y métodos: Revisión bibliográfica de artículos científicos en PubMed, Embase y Literatura gris, publicados con palabras clave «informed consent minors», sin restricción de fecha hasta marzo 2019. Se revisaron los abstracts y una selección de los artículos completos siguiendo un protocolo de identificación, cribado, elegibilidad e inclusión.Resultados: De los 260 registros identificados, se excluyeron 139. Tras categorizar los 121 artículos resultantes, finalmente se seleccionaron 13 siguiendo los criterios de elegibilidad, incluyéndose 7 artículos sobre normativa ética y legal internacional, y 6 sobre evaluación de comprensión y capacidad de decisión. En 4 estudios se ha utilizado la entrevista semiestructurada McCarthur Competency Assessment Tool for Clinical Research (MacCAT-CR), en diferentes rangos de edad (6-21 años), niños sanos y con alguna patología.Conclusiones: La entrevista semiestructurada McCarthur adaptada a adolescentes podría ser una herramienta adecuada con medidas psicométricas robustas para la valoración de competencia para el consentimiento informado de menores entre 9 y 12 años. La regulación del consentimiento informado en investigación pediátrica debería ser receptiva a estas evidencias. (AU)

Introduction: The informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor.Material and methods: Systematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion.Results: Of the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6-21 years) in healthy and sick children.Conclusions: The semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence. (AU)

Adolescent Consent for Human Papillomavirus Vaccine: Ethical, Legal, and Practical Considerations.

We address ethical, legal, and practical issues related to adolescent self-consent for human papillomavirus (HPV) vaccination. HPV vaccination coverage continues to lag well behind the national goal of 80% series completion. Structural and behavioral interventions have improved vaccination rates, but attitudinal, behavioral, and access barriers remain. A potential approach for increasing access and improving vaccination coverage would be to permit adolescents to consent to HPV vaccination for themselves. We argue that adolescent self-consent is ethical, but that there are legal hurdles to be overcome in many states. In jurisdictions where self-consent is legal, there can still be barriers due to lack of awareness of the policy among healthcare providers and adolescents. Other barriers to implementation of self-consent include resistance from antivaccine and parent rights activists, reluctance of providers to agree to vaccinate even when self-consent is legally supported, and threats to confidentiality. Confidentiality can be undermined when an adolescent's self-consented HPV vaccination appears in an explanation of benefits communication sent to a parent or if a parent accesses an adolescent's vaccination record via state immunization information systems. In the context of the COVID-19 pandemic, which has led to a substantial drop in HPV vaccination, there may be even more reason to consider self-consent. The atmosphere of uncertainty and distrust surrounding future COVID-19 vaccines underscores the need for any vaccine policy change to be pursued with clear communication and consistent with ethical principles.

[Patient care, right to information and consent for minors in situations of parental conflict. Clinical guidelines in the context of Spanish legislation]. / Atención a menores con progenitores en conflicto en materia de información y consentimiento relativos a la salud de los hijos. Protocolo asistencial en el contexto de la legislación vigente.

Among the main social and legislative changes as regards family matters that have taken place in Spain in the last few years, are included: (i) the gradual increase in legal disputes between parents, and (ii) the introduction of Law 26/2015 on Child Protection, which modified Law 41/2002 on the Freedom of the Patient. These searched for a balance between the rights of minors and the powers of the parents, particularly when the former had not reached 16 years or had sufficient maturity or, having reached it, the decision puts their life or health at severe risk. Likewise, it has led to a jurisprudence that determines that, for any minor, there are particularly sensitive, "special" or "important" health care actions, such as psychotherapy or surgical treatments, which require, with exceptions, the consent of both parents for it to be carried out. All this, however, subject to the discretion of the doctor responsible, who must always look after the best interests of the minor. For this reason, healthcare for minors, occasionally, lead to complex conflicts as regards information and consent by the parents, particularly when they do not agree. A review is presented on the current legislative framework and the main legal concepts that regulate the healthcare of minors as regards information and consent relative to health, as well a healthcare protocol for the care of minors in situations of conflict between parents, developed in the Gregorio Marañón Hospital of Madrid, and endorsed by the Official Medical Collegiate of Madrid.

Problemas de información a los padres y tutores en la asistencia a urgencias en menores de 14 a 17 años por consumo de sustancias psicoactivas / Issues with information given to parents and guardians on medical care in the emergency department relating to minors aged from 14 to 17 years due to psychoactive substance

INTRODUCCIÓN: El cumplimiento de los deberes de la patria potestad exige a los padres y/o tutores estar informados de aquellos aspectos relevantes relacionados con la salud del menor. La legislación actual reconoce la autonomía a partir de los 16 años o menores emancipados. En este trabajo se analiza la información que reciben los padres o tutores legales de los menores mayores de 14 años que acuden a un servicio de urgencias hospitalario general de tercer nivel por intoxicación aguda por alcohol y otras drogas de abuso incluidos medicamentos como las benzodiacepinas si se consumen con fines recreativos. MATERIAL Y MÉTODOS: Se revisaron las historias clínicas de los menores atendidos en el servicio de urgencias de un hospital de tercer nivel durante los años 2016 y 2017 para conocer la información referida a los padres y se entrevistó a los médicos y enfermeros de dicho servicio para conocer la información que daban a los padres/tutores. RESULTADOS: En las historias clínicas en las que se citaba que el menor iba acompañado por amigos (11,5%), 5 de ellas (9,6%) no especificaban si se había realizado el aviso a padres/tutores. De las 26 historias clínicas (50%) en las que no había especificación del acompañamiento, en 22 (42,3%) tampoco existía especificación del aviso. Mientras que 28 de los 35 encuestados (80%) afirma avisar siempre que el menor no hubiera ido acompañado por sus padres o tutores. CONCLUSIONES: Se pone de manifiesto la existencia de una falta de información de tipo asistencial relativa al aviso a padres/tutores, así como una discrepancia entre los datos proporcionados por los médicos y enfermeros y los obtenidos en las historias clínicas

BACKGROUND: In accordance with parental legal duties, parents and guardians should be informed about health issues relevant to child health. Current Spanish legislation acknowledges autonomy from 16 years or emancipated minors. This study analyses the information given to the parents or legal guardians of minors over 14 years of age attending a tertiary-level general hospital emergency department on psychoactive substance intoxication (alcohol, cannabis, benzodiazepines). MATERIAL AND METHODS: The medical records of minors treated in the emergency department of a tertiary-level hospital, between 2016 and 2017, were reviewed. A survey of medical and nursing professionals from the emergency services was also conducted. RESULTS: Of the medical records that mentioned that the minor attended the emergency department with friends (11.5%), 5 (9.6%) did not specify if the parents or guardians were called. Of the 26 medical records (50%) in which there was no mention of whether if the minor attended alone or accompanied, 22 (42.3%) made no mention of informing parents. The study data show that 28 of the 35 respondents (80%) always notified if the minor had not been accompanied to the emergency department by a parent or guardian. CONCLUSIONS: There is lack of information relating to informing parents/guardians, as well as a discrepancy between the data provided by health professionals and the medical reports analysed

When Does A Minor's Legal Competence To Make Health Care Decisions Matter?

In this article, I examine the role of minors' competence for medical decision-making in modern American law. The doctrine of parental consent remains the default legal and bioethical framework for health care decisions on behalf of children, complemented by a complex array of exceptions. Some of those exceptions vest decisional authority in the minors themselves. Yet, in American law, judgments of minors' competence do not typically trigger shifts in decision-making authority from adults to minors. Rather, minors' decisional capacity becomes relevant only after legislatures or courts determine that the default of parental discretion does not achieve important policy goals or protect implicated constitutional rights in a particular health care context and that those goals can best be achieved or rights best protected by authorizing capable minors to choose for themselves. It is at that point that psychological and neuroscientific evidence plays an important role in informing the legal inquiry as to whether minors whose health is at issue are legally competent to decide.

Ethical Issues Raised by the Media Portrayal of Adolescent Transplant Refusals.

Cases of adolescents in organ failure who refuse solid organ transplant are not common, but several have been discussed in the media in the United States and the United Kingdom. Using the framework developed by Buchanan and Brock for surrogate decision-making, I examine what role the adolescent should morally play when deciding about therapy for life-threatening conditions. I argue that the greater the efficacy of treatment, the less voice the adolescent (and the parent) should have. I then consider how refusals of highly effective transplant cases are similar to and different from refusals of other lifesaving therapies (eg, chemotherapy for leukemia), which is more commonly discussed in the media and medical literature. I examine whether organ scarcity and the need for lifelong immunosuppression justify differences in whether the state intervenes when an adolescent and his or her parents refuse a transplant. I argue that the state, as parens patriae, has an obligation to provide the social supports needed for a successful transplant and follow-up treatment plan, although family refusals may be permissible when the transplant is experimental or of low efficacy because of comorbidities or other factors. I conclude by discussing the need to limit media coverage of pediatric treatment refusals.

Informed consent approaches for clinical trial participation of infants with minor parents in sub-Saharan Africa: A systematic review.

BACKGROUND: Regulations are vague regarding the appropriate decision-maker and authority to consent for children of minor parents participating in clinical trials. In countries with high rates of underage mothers, such as in sub-Saharan Africa, this lack of guidance may affect the rights of potential paediatric participants already bearing increased vulnerability. It can also influence the recruitment and generalizability of the research. We provide evidence and discuss informed consent management in such cases to inform best practice. MATERIALS AND METHODS: We searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar for articles published up to March 2019. In total, 4382 articles were screened, of which 16 met our inclusion criteria. Studies addressing informed consent in clinical trials involving children with minor parents in sub-Saharan Africa were included. We performed descriptive and qualitative framework analyses. The review was registered in PROSPERO: CRD42018074220. RESULTS: Various informed consent approaches were reported. Articles supporting individual consent by minor parents based on emancipation or "mature minor" status lacked evidence in the context of research. National laws on medical care guided consent instead. When no laws or guidance existed an interpretation of the local decision-making culture, including community engagement and collaboration with local ethics committees, defined the informed consent approach. CONCLUSIONS: The review emphasises that the implementation of informed consent for children with minor parents may be variable and hampered by absent or ambiguous clinical trial regulations, as well as divergent local realities. It may further be influenced by the research area and study-specific risks. Clear guidance is required to help address these challenges proactively in clinical trial planning. We provided a set of questions to be considered in the development of an ethically acceptable informed consent approach and proposed information that should be integrated into international clinical trial guidelines.

Transsexuality: Legal and ethical challenges.

Sex-change procedures, better described as gender-change procedures, involve preparing patients psychologically and surgically for gender transition to treat their gender dysphoria. Physical treatment might include hysterectomy for female to male transition, and post-castration fashioning of an artificial vagina for male to female transition. Conservative opposition to accommodating and recognizing such procedures remains in some countries, and where treated, transgender individuals might face social hostility and oppression. However, human rights laws increasingly provide for transgender non-discrimination and government re-issue of official documents such as birth certificates and social insurance cards in the changed gender. A UK legal decision required a transgendered male who retained his ovaries and uterus to be registered as mother on the birth certificate of the child he bore. Most challenging are decisions on adolescents' requests for gender transition, especially over parents' objections. Laws increasingly recognize that legal minors with sufficiently evolved intellectual and emotional capacity can make decisions for themselves.

Is consent causing confusion for clinicians? A survey of child and adolescent Mental health professional's confidence in using Parental Consent, Gillick Competence and the Mental Capacity Act.

All professionals engaged in clinical work should be competent to assess consent for the interventions they provide. This study assesses CAMHS clinicians confidence and knowledge in the various forms of consent and the number of minors admitted to mental health units in England under parental consent alone.An online questionnaire using vignettes of possible scenarios was sent to child and adolescent mental health practitioners in Tees Esk and Wear Valleys Trust. A freedom of information request was used to determine the number of young people admitted through parental consent.Thirteen of the 20 trusts contacted had no knowledge of the number of young people admitted under parental consent. A total of 93 participants completed the survey. Out of six vignettes, there were two where the majority of responses were discordant with current legal advice. Both of these vignettes considered the use of parental consent for admission to a mental health unit.This study provides further evidence to indicate that the current consent processes in CAMHS causes confusion for clinicians. There continues to be very few safeguards for children admitted under parental consent, with most trusts in England and Wales having no centralised knowledge of whether this is occurring and the numbers involved if it is.

Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations.

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is "too immature" and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings' validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.

Reflecting on 'Hannah's Choice': Using the Ethics of Care to Justify Child Participation in End of Life Decision-Making.

It has been ten years since the case of Hannah Jones-the 12-year-old girl who was permitted to refuse a potentially life-saving heart transplant. In the past decade, there has been some progress within law and policy in respect of children's participatory rights (UNCRC-Article 12), and a greater understanding of family-centred decision-making. However, the courts still largely maintain their traditional reluctance to find children Gillick competent to refuse medical treatment. In this article, I revisit Hannah's case through the narrative account provided by Hannah and her mother, to ascertain what lessons can be learnt. I use an Ethics of Care framework specially developed for children in mid-childhood, such as Hannah, to argue for more a creative and holistic approach to child decision-making in healthcare. I conclude that using traditional paradigms is untenable in the context of palliative care and at the end of life, and that the law should be able to accommodate greater, and even determinative, participation of children who are facing their own deaths.

The Medico-Legal 'Making' of 'The Transgender Child'.

Thirty years ago, the transgender child would have made no sense to the general public, nor to young people. Today, children and adolescents declare themselves transgender, the National Health Service diagnoses 'gender dysphoria', and laws and policy are developed which uphold young people's 'choice' to transition and to authorize stages at which medical intervention is permissible and desirable. The figure of the 'transgender child' presumed by medicine and law is not a naturally occurring category of person external to medical diagnosis and legal protection. Medicine and law construct the 'transgender child' rather than that the 'transgender child' exists independently of medico-legal discourse. The ethical issue of whether the child and young person can 'consent' to social and medical transition goes beyond legal assessment of whether a person under16 years has the mental capacity to consent, understand to what s/he is consenting, and can express independent wishes. It shifts to examination of the recent making of 'the transgender child' through the complex of power/knowledge/ethics of medicine and the law of which the child can have no knowledge but within which its own desires are both constrained and incited.