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1.
Hastings Cent Rep ; 54(3): 57-58, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38842870

RESUMO

What ethically justifies the provision of invasive and irreversible treatments to minors? In this commentary, I examine this question in response to Moti Gorin's article "What Is the Aim of Pediatric 'Gender-Affirming' Care?," which critiques autonomy-based arguments for justification of gender-affirming care in minors. Minors generally lack sufficient autonomy to make significant medical decisions or major life decisions. For this reason, parents are generally their decision-makers, working with medical professionals to choose treatments that serve the best interests of the minor. Medical care in minors is justified by beneficence, not autonomy, and this should be no different for gender-affirming care. This severely undermines autonomy-based arguments for provision of gender-affirming care to minors. Given the lack of conclusive evidence for benefit, the nature of the treatment, and the fact that gender dysphoria in minors resolves spontaneously in most cases, there is presently insufficient justification for provision of such care to minors.


Assuntos
Disforia de Gênero , Menores de Idade , Autonomia Pessoal , Humanos , Disforia de Gênero/terapia , Pessoas Transgênero , Adolescente , Criança , Feminino , Tomada de Decisões/ética , Masculino , Consentimento Informado por Menores/ética , Assistência à Saúde Afirmativa de Gênero
2.
J Law Med Ethics ; 52(1): 62-64, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38818597

RESUMO

Policies allowing some minors to consent to receive recommended vaccines are ethically defensible. However, a policy change at the federal level expanding minor consent for vaccinations nationwide risks triggering a political backlash. Such a move may be perceived as infringing on the rights of parents to make decisions about their children's health care. In the current post-COVID environment of heightened anti-vaccination activism, changes to minor consent laws may be unadvisable, and policy makers should proceed with caution.


Assuntos
Vacinação , Adolescente , Criança , Humanos , Movimento contra Vacinação , COVID-19/prevenção & controle , Política de Saúde/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Informado por Menores/legislação & jurisprudência , Consentimento Informado por Menores/ética , Menores de Idade/legislação & jurisprudência , Política , Estados Unidos , Vacinação/ética , Vacinação/legislação & jurisprudência
3.
J Law Med Ethics ; 52(1): 52-61, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38818609

RESUMO

This paper challenges historically preconceived notions surrounding a minor's ability to make medical decisions, arguing that federal health law should be reformed to allow minors with capacity as young as age 12 to consent to their own Centers for Diseases Control and Prevention (CDC)-approved COVID-19 vaccinations. This proposal aligns with and expands upon current exceptions to limitations on adolescent decision-making. This analysis reviews the historic and current anti-vaccination sentiment, examines legal precedence and rationale, outlines supporting ethical arguments regarding adolescent decision-making, and offers rebuttals to anticipated ethical counterarguments.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Consentimento Informado por Menores , Humanos , Adolescente , Estados Unidos , Criança , COVID-19/prevenção & controle , Consentimento Informado por Menores/legislação & jurisprudência , Consentimento Informado por Menores/ética , Vacinação/legislação & jurisprudência , Vacinação/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Menores de Idade/legislação & jurisprudência , Centers for Disease Control and Prevention, U.S. , SARS-CoV-2 , Tomada de Decisões
4.
Rev. esp. anestesiol. reanim ; 71(1): 28-33, Ene. 2024.
Artigo em Espanhol | IBECS | ID: ibc-230172

RESUMO

Desde hace años se realizan consultas y seguimiento de pacientes de forma no presencial. Durante la pandemia de COVID-19 diferentes sociedades han recomendado potenciar las consultas telemáticas. La consulta preanestésica no presencial es un acto médico que debe incluir los objetivos básicos de evaluación, preparación, información y obtención del consentimiento. Se debe disponer de medios y tiempo para realizarla. Al comienzo de la consulta debe identificarse el médico y el o los progenitores. La consulta preoperatoria no presencial es especialmente útil en niños ASA I y II que van a someterse a cirugías de bajo riesgo, a una reintervención o a procedimientos diagnósticos. Aquellos pacientes que requieran una exploración física, más allá de la posible de manera telemática, deberán citarse en la consulta presencial. El personal de enfermería puede participar de forma activa en este proceso siempre y cuando el anestesiólogo supervise todo el proceso, tome todas las decisiones sobre el procedimiento y sea el responsable de la información que se da a los padres y al niño, aclarando personalmente cualquier duda. El anestesiólogo debe informar del procedimiento, sus riesgos, incluidos los personalizados, y alternativas. Se registrará en la historia clínica que se ha informado, cuándo y a quién. EL anestesiólogo firmará el Consentimiento Informado haciendo figurar la fecha que da la información y los padres deberán firmarlo antes de la intervención.(AU)


Medical consult and follow-up of patients have been carried out remotely for years. During the COVID-19 pandemic, different societies have recommended promoting online consultations. The remote pre-anesthetic consultation is a medical act that must include the basic objectives of evaluation, preparation, information and obtaining consent. You must have the resources and time to do it. At the beginning of the consultation, the doctor and the parent(s) must be identified. Non-face-to-face preoperative consultation is especially useful in ASA I and II children evaluated for low-risk surgeries, reintervention, or diagnostic procedures. Those patients who require a physical examination, beyond that possible electronically, should make an appointment in the face-to-face consultation. The nursing staff can actively participate in this process as long as the anesthesiologist supervises the entire process, makes all decisions about the procedure and is responsible for the information given to the parents and the child, personally clarifying any doubts. The anesthesiologist must inform about the procedure, its risks, including personalized ones, and alternatives. It will be recorded in the medical history the information given, when and to whom. The anesthesiologist will sign the Informed Consent stating the date that the information is given, and the parents must sign it before the intervention.(AU)


Assuntos
Humanos , Masculino , Feminino , Criança , Telemedicina , Medicação Pré-Anestésica , Consulta Remota , Segurança do Paciente , Anestesiologia/tendências , Consentimento Informado por Menores
6.
Arch. pediatr. Urug ; 94(2): e602, 2023.
Artigo em Espanhol | LILACS, UY-BNMED, BNUY | ID: biblio-1520100

RESUMO

El artículo aborda un tema particularmente sensible para la investigación científica como lo son los estudios que involucran directamente a niños y niñas. El valor social y la relevancia científica de la investigación en este campo es indudable, sin embargo, su justificación requiere especial detenimiento en las condiciones para el ejercicio de sus derechos antes, durante y después del proceso de investigación. La naturalización de su denominación como "población vulnerable" y el ejercicio de su autonomía relativa, son dos dimensiones principales aquí. El artículo navega por preguntas que no se resuelven aquí precisamente, ¿qué garantías para el proceso efectivo de asentimiento informado?, ¿cómo acompañar en la toma de decisiones sin sustituir al niño y la niña? Sin embargo, sí avanza en la instalación de dilemas y aspectos conceptuales y reflexivos sustantivos en la práctica científica.


The article deals with a particularly sensitive topic for scientific research, such as research studies that directly involve boys and girls. The social value and scientific relevance of research in this field is unquestionable; however, its justification requires special care regarding the conditions of children's rights before, during and after the research process. The naturalization of their denomination as a "vulnerable population" and the exercise of their relative autonomy are the two main dimensions of this study. This paper explores questions that are not answered in it precisely: what guarantees informed consent during the effective process? How to accompany the decision making process without replacing the boy and the girl? However, the study makes progress regarding the setting of substantive conceptual and reflective dilemmas and aspects in scientific practice.


O artigo trata de um tema particularmente sensível para a pesquisa científica, os estudos que envolvem diretamente meninos e meninas. O valor social e a relevância científica da pesquisa neste campo é inquestionável, porém, sua justificativa requer cuidados especiais nas condições de exercício dos direitos da criancas, durante e após o processo de pesquisa. A naturalização de sua denominação como "população vulnerável" e o exercício de sua autonomia relativa são as duas dimensões principais deste paper. O artigo explora por questões que não são aqui resolvidas de forma precisa: quais sao as garantias para o processo efetivo de assentimento informado? Como acompanhar o proceso da tomada de decisões sem substituir o menino e a menina? No entanto, realizamos um avanço na instalação de dilemas e aspectos conceituais e reflexivos substantivos na prática científica.


Assuntos
Humanos , Criança , Ética em Pesquisa , Consentimento Informado por Menores/ética
7.
Rev. derecho genoma hum ; (57): 75-116, July-December 2022.
Artigo em Espanhol | IBECS | ID: ibc-219444

RESUMO

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)


Assuntos
Humanos , Consentimento Informado por Menores/legislação & jurisprudência , Consentimento Livre e Esclarecido/legislação & jurisprudência , Preparações Farmacêuticas/administração & dosagem , Legislação de Medicamentos , Responsabilidade pela Informação/legislação & jurisprudência
9.
Invest. educ. enferm ; 40(2): 95-106, 15 de junio 2022. tab
Artigo em Inglês | LILACS, BDENF - Enfermagem, COLNAL | ID: biblio-1379479

RESUMO

Objective. To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. Methods. This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. Results. Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. Conclusion. The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.


Objetivo. describir la importancia del Formulario de Consentimiento Informado para los niños y adolescentes invitados a participar en un estudio clínico aleatorizado y sus principales reacciones a su explicación. Métodos. se trata de una investigación exploratoria descriptiva con abordaje cualitativo, realizada con 17 niños y adolescentes, quienes fueron invitados a participar de un estudio clínico en el área de oncología en un hospital ubicado en Río de Janeiro (Brasil). A los datos se les realizó análisis temático. Resultados. Luego de la interpretación de los datos, se generaron 2 unidades temáticas: la firma del formulario de consentimiento y la comprensión del estudio. Los niños y adolescentes entendieron las etapas del estudio contenidas en la firma del Término de Asentimiento y se interesaron, haciendo preguntas para aclarar sus dudas sobre la investigación. Conclusión. El consentimiento informado era importante para que los participantes entendieran la investigación y tuvieran autonomía sobre su participación. Al potenciar el protagonismo de los niños y adolescentes en el proceso de investigación, recomendamos que debe fomentarse su uso en los estudios con población pediátrica.


Objetivo. Descrever a importância do Termo de Assentimento para crianças e adolescentes convidados a participar de um estudo clínico e suas principais reações quanto à explicação do mesmo. Métodos. Trata-se de uma pesquisa do tipo descritiva exploratória com abordagem qualitativa, realizada com 17 crianças e adolescentes, que foram convidados a participar de um estudo clínico na área da oncologia em um hospital localizado no Rio de Janeiro (Brasil). Os dados foram analisados empregando-se a análise temática. Resultados. Após a interpretação dos dados, foram geradas 2 unidades temáticas: a assinatura do termo de assentimento em que os participantes se sentiram protagonistas frente a possibilidade de expressarem a concordância ou não em participar da pesquisa, e a compreensão sobre o estudo quando elas mostraram que entenderam as etapas do estudo fazendo perguntas pertinentes para esclarecer suas dúvidas. As crianças e adolescentes compreenderam as etapas do estudo que constavam no Termo de Assentimento e tiveram interesse, fazendo perguntas para esclarecer suas dúvidas com relação à pesquisa. Conclusão. O termo de assentimento foi importante para os participantes compreenderem sobre a pesquisa e para terem autonomia sobre sua participação. Por potencializar o protagonismo de crianças e adolescentes no processo de pesquisar conclui-se que seu uso em estudos que envolvem a população pediátrica deve ser incentivado.


Assuntos
Humanos , Criança , Adolescente , Criança , Adolescente , Comitês de Ética em Pesquisa , Termos de Consentimento , Consentimento Informado por Menores
10.
Arq. ciências saúde UNIPAR ; 26(1): 95-99, Jan-Abr. 2022.
Artigo em Português | LILACS | ID: biblio-1362688

RESUMO

Objetivo: relatar a experiência na construção e aplicabilidade de um termo de assentimento livre esclarecido em uma pesquisa com crianças pré-escolares e escolares hospitalizadas para tratamento oncológico. Material e método: trata-se de um relato de experiência sobre a construção e aplicabilidade de um Termo de Assentimento Livre e Esclarecido lúdico para realização de um estudo sobre perfil nutricional e educação alimentar e nutricional de crianças em tratamento oncológico de um hospital público infantil em Santa Catarina-Brasil. Resultados: a construção e aplicabilidade do Termo de Assentimento Livre Esclarecido permitiu melhor compreensão da criança anterior à realização da pesquisa referente às etapas e fases da coleta dos dados do estudo, assim como os riscos e benefícios do mesmo. Foi possível à criança esclarecer suas dúvidas e participar ativamente do estudo. Foram convidadas para participar do estudo 13 crianças de ambos os sexos entre 5 ­ 12 anos de idade que estavam internadas no ambulatório de oncologia. Considerações Finais: adoção do Termo de Assentimento Livre Esclarecido Lúdico construído mostrou-se efetivo ao alcance do objetivo de sua utilização no contexto ético em pesquisa e avançou no sentido de despertar sobre potencialidade para além da pesquisa e, também, como recurso fundamental para o assentimento das crianças em situações específicas no processo de adoecimento e internação, possibilitando o exercício de direito e compreensão do que está sendo realizado durante seu tratamento.


Objective: report the experience in the construction and applicability of an informed term of consent in a survey of children hospitalized for cancer treatment. Material and method: experience report on the construction and applicability of a free and informed term of consent for conducting a study on the nutritional profile and food and nutrition education of children and adolescents undergoing cancer treatment at a public hospital in Santa Catarina, Brazil. Results: the construction and applicability of the informed term of consent allowed a better understanding of the child prior to conducting the research regarding the steps and phases of data collection, as well as its risks and benefits. It was possible for the child to clarify their doubts and actively participate in the study. Thirteen children of both sexes, aged between 5 - 12 years, hospitalized and in the oncology outpatient clinic, were invited to participate. Final considerations: adoption of the playful free and informed term of consent proved to be effective in reaching the objective of its use in the ethical research context and it has advanced in the sense of raising awareness of the potentiality beyond research, and also as a fundamental resource for the consent of children in specific situations in the illness and hospitalization process, enabling them to exercise their rights and understand what is happening during their treatment.


Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Criança , Criança Institucionalizada/educação , Ética em Pesquisa/educação , Nutrição da Criança , Consentimento Informado por Menores , Oncologia , Jogos e Brinquedos/psicologia , Educação Alimentar e Nutricional , Hospitalização
11.
Cuad. bioét ; 33(107): 1-11, enero abril, 2022.
Artigo em Espanhol | IBECS | ID: ibc-203237

RESUMO

En la práctica médica pediátrica, se presenta el caso de menores de 18 años con disforia de género o con discordancia de género, caracterizadas por una incongruencia entre el sexo biológico y el género sentido. De esta manera, se ofrece la posibilidad médica y jurídica de iniciar un tratamiento de afirmación de género en niños y adolescentes. Aunque el tratamiento indicado para lograr dicho objetivo ha sido avalado por algunas asociaciones científicas, también ha sido objeto de serios cuestionamientos por la posible irreversibilidad de los procedimientos que se realizan en el cuerpo del menor. Por este motivo, si bien la leyle reconoce cierta autonomía al menor para tomar la decisión de iniciar un tratamiento de afirmación de género, la falta de madurez para entender y asumir la información que se le brinda podría llegar a cuestionar la validez del consentimiento informado.


In pediatric medical practice, there is the case of children and young persons under 18 with gender dysphoria or gender discordance, characterized by an incongruity between biological sex and gender identity. In this way, the medical and juridical possibility of gender affirmation treatment is offered to minors. Although this treatment has been endorsed by some scientific associations, it has also been the subject of serious questioning due to the possible irreversibility of the procedures performed on the minor’s body. For this reason, although the law recognizes some autonomy to the minor to make the decision to initiate a gender affirmation treatment, the lack of maturity to understand and assume the information that isprovided could affect the validity of the informed consent


Assuntos
Humanos , Adolescente , Ciências da Saúde , Disforia de Gênero , Consentimento Informado por Menores , Identidade de Gênero , Menores de Idade , Saúde da Criança , Pediatria , Bioética , Terapêutica
13.
Pediatrics ; 149(1)2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34972226

RESUMO

Most sexually active youth in the United States do not believe that they are at risk for contracting HIV and have never been tested. Creating safe environments that promote confidentiality and respect, obtaining an accurate sexual and reproductive health assessment, and providing nonstigmatizing risk counseling are key components of any youth encounters. Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients. In light of persistently high numbers of people living with HIV in the United States and documented missed opportunities for HIV testing, the Centers for Disease Control and Prevention and the US Preventive Services Task Force recommend universal and routine HIV screening among US populations, including youth. Recent advances in HIV diagnostics, treatment, and prevention help support this recommendation. This clinical report reviews epidemiological data and recommends that routine HIV screening be offered to all youth 15 years or older, at least once, in health care settings. After initial screening, youth at increased risk, including those who are sexually active, should be rescreened at least annually, and potentially as frequently as every 3 to 6 months if at high risk (male youth reporting male sexual contact, active injection drug users, transgender youth; youth having sexual partners who are HIV-infected, of both genders, or injection drug users; youth exchanging sex for drugs or money; or youth who have had a diagnosis of or have requested testing for other sexually transmitted infections). Youth at substantial risk for HIV acquisition should be routinely offered HIV preexposure prophylaxis, and HIV postexposure prophylaxis is also indicated after high-risk exposures. This clinical report also addresses consent, confidentiality, and coverage issues that pediatricians face in promoting routine HIV testing and HIV prophylaxis for their patients.


Assuntos
Aconselhamento/métodos , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Teste de HIV , Pediatras , Papel do Médico , Profilaxia Pré-Exposição , Adolescente , Confidencialidade , Humanos , Consentimento Informado por Menores , Cobertura do Seguro , Educação de Pacientes como Assunto , Comportamento de Redução do Risco , Comportamento Sexual , Adulto Jovem
14.
Pediatrics ; 148(6)2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34850191

RESUMO

BACKGROUND: According to international transgender care guidelines, an important prerequisite for puberty suppression (PS) is transgender adolescents' competence to give informed consent (IC). In society, there is doubt whether transgender adolescents are capable of this, which in some countries has even led to limited access to this intervention. Therefore, this study examined transgender adolescents' medical decision-making competence (MDC) to give IC for starting PS in a structured, replicable way. Additionally, potential associated variables on MDC, such as age, intelligence, sex, psychological functioning, were investigated. METHODS: A cross-sectional semistructured interview study with 74 transgender adolescents (aged 10-18 years; 16 birth-assigned boys, 58 birth-assigned girls) within two Dutch specialized gender-identity clinics was performed. To assess MDC, judgements based on the reference standard (clinical assessment) and the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), a validated semistructured interview, were used. RESULTS: Of the transgender adolescents, 93.2% (reference standard judgements; 69 of 74) and 89.2% (MacCAT-T judgements; 66 of 74) were assessed competent to consent. Intermethod agreement was 87.8% (65 of 74). Interrater agreements of the reference standard and MacCAT-T-based judgements were 89.2% (198 of 222) and 86.5% (192 of 222), respectively. IQ and sex were both significantly related to MacCAT-T total score, whereas age, level of emotional and behavioral challenges, and diagnostic trajectories duration were not. CONCLUSIONS: By using the MacCAT-T and clinicians' assessments, 93.2% and 89.2%, respectively, of the transgender adolescents in this study were assessed competent to consent for starting PS.


Assuntos
Tomada de Decisão Clínica/métodos , Consentimento Informado por Menores/psicologia , Competência Mental/psicologia , Puberdade , Pessoas Transgênero/psicologia , Adolescente , Comportamento do Adolescente , Fatores Etários , Criança , Comportamento Infantil , Estudos Transversais , Feminino , Humanos , Consentimento Informado por Menores/estatística & dados numéricos , Inteligência , Julgamento , Masculino , Países Baixos , Padrões de Referência , Pessoas Transgênero/estatística & dados numéricos
15.
An. pediatr. (2003. Ed. impr.) ; 95(6): 413-422, Dic. 2021. tab
Artigo em Espanhol | IBECS | ID: ibc-208364

RESUMO

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)


Assuntos
Humanos , Criança , Consentimento Informado por Menores/ética , Consentimento Informado por Menores/legislação & jurisprudência , Tomada de Decisões , Publicações Científicas e Técnicas
16.
Bull Cancer ; 108(10): 893-894, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34229855

RESUMO

A successful Hematopoietic stem cell transplantation (HSCT) is often the only hope of survival for children suffering from a range of potentially life-threatening hematological malignancies. The financial, ethical, and emotional problems faced by the matched sibling donor and their recipient siblings during the HSCT are extremely complex and challenging. Herein, the authors have attempted to pen down these in the configuration of a poem.


Assuntos
Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/ética , Poesia como Assunto , Temas Bioéticos , Criança , Comissão de Ética , Transplante de Células-Tronco Hematopoéticas/economia , Humanos , Índia , Consentimento Informado por Menores , Irmãos , Doadores de Tecidos/psicologia
18.
J Pediatr ; 231: 24-30, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33484694

RESUMO

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.


Assuntos
Consentimento Informado por Menores/ética , Consentimento Informado por Menores/legislação & jurisprudência , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus , Adolescente , Fatores Etários , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Humanos , Competência Mental/legislação & jurisprudência , Competência Mental/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Estados Unidos
19.
Pediatrics ; 147(3)2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33334920

RESUMO

It is widely agreed that an effective response to the coronavirus disease 2019 pandemic needs to include a vaccine that is safe and effective for minors. However, many current vaccine trials have no plans for when to enroll minors. Others have recently proposed enrolling minors as young as 12 years old. This lack of a systematic approach raises 2 concerns. Waiting too long to enroll minors could unjustly deny minors and their families the benefits of a vaccine and has the potential to delay an effective response to the pandemic by a year or longer. At the same time, enrolling minors too soon runs the risk of exposing them to excessive risks. With these concerns in mind, in the present article, we propose recommendations for when and how to enroll minors in vaccine trials for the coronavirus disease 2019.


Assuntos
Vacinas contra COVID-19 , Ensaios Clínicos como Assunto/normas , Voluntários Saudáveis , Menores de Idade , Adolescente , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Criança , Ensaios Clínicos como Assunto/ética , Participação da Comunidade , Comitês de Ética em Pesquisa , Humanos , Consentimento Informado por Menores , Pandemias/prevenção & controle , SARS-CoV-2
20.
J Pediatr Adolesc Gynecol ; 34(2): 190-195, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33333259

RESUMO

STUDY OBJECTIVE: In this study we evaluated published studies about foster care to: (1) determine the types of data used; (2) describe the degree to which a sexual/reproductive health topic was addressed; and (3) describe the consent process. DESIGN: Analysis of published literature. SETTING: PubMed was searched using "foster care" for English articles published between January 1, 2017 and September 4, 2019. PARTICIPANTS: None. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Articles were coded into 4 data source categories: primary, secondary, peripheral, or perspective data. Articles with a primary data source were coded for participant ages: only 9 years old and younger, 10- to 17-year-olds (minor adolescents), and only 18 years old and older. Articles using a secondary data source were coded for the source of the data registry. All articles were coded for presence of a sexual/reproductive health outcome. The primary data articles that included minor adolescents were coded for the study topic and consent process. RESULTS: Of the 176 articles about foster care, 72/176 (41%) used primary data, 53/176 (30%) used secondary data, and 51/176 (29%) used peripheral/perspective data. Forty-eight of the primary data articles included minor adolescents. Secondary data sources included few national research surveys. Sexual/reproductive health outcomes were measured in 17 articles, 4 of which used primary data. The consent process for minor adolescents varied and had no consistent pattern across studies. CONCLUSION: Research on best practices for consent processes and use of registries could be developed to increase research on sexual/reproductive health outcomes among adolescents in foster care.


Assuntos
Criança Acolhida/estatística & dados numéricos , Consentimento Informado por Menores/estatística & dados numéricos , Saúde Reprodutiva , Sujeitos da Pesquisa/estatística & dados numéricos , Saúde Sexual , Adolescente , Criança , Feminino , Humanos , Masculino
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