Consentimiento informado en las prestaciones de salud / Informed consent in health care services / Consentimento informado nas prestações de saúde

Resumen: Por regla general, las prestaciones de salud requieren el consentimiento informado del paciente. Los fundamentos éticos detrás de esta exigencia son la autonomía del paciente para decidir sobre su propio cuerpo y el respeto a su dignidad, que impide instrumentalizarlo. La manera en que el ordenamiento jurídico materializa estos fines es consagrando deberes de información y de consejo, y disciplinando las condiciones bajo las cuales debe prestarse el consentimiento. Jurídicamente, estos deberes delimitan la relación médico-paciente y ayudan a definir hipótesis de responsabilidad civil. En este artículo se revisan las condiciones para la satisfacción de estos deberes, así como los supuestos en que su infracción pueden dar lugar a responsabilidad civil.

Abstract: As a general rule, medical interventions require to be informingly consented by the patient. This requirement is ethically founded in the autonomy of the patient to decide on his own body and the respect for his dignity that prevent to instrumentalise it. The way in which the law materialises those ends is by implementing duties to inform and duties to advise, and regulating the conditions under which the consent must be given. Legally, those duties delimit the relation physician-patient and give guidance to define hypothesis of civil liability. In this article, we revise the conditions for the satisfaction of those duties and the cases in which their breach give rise to civil liability.

Resumo: Por regra general, as prestações de saúde requerem o consentimento informado do paciente. Os fundamentos éticos por trás dessa exigência são a autonomia do paciente para decidir sobre seu próprio corpo e o respeito à sua dignidade, que impede instrumentalizálo. A maneira em que o ordenamento jurídico materializa estes fins é consagrando deveres de informação e de aconselhamento, e disciplinando as condições sob as quais deve prestar-se o consentimento. Juridicamente, estes deveres delimitam a relação médico-paciente e ajudam a definir hipóteses de responsabilidade civil. Neste artigo se revisam as condições para a satisfação destes deveres, assim como os pressupostos em que sua infração podem dar lugar à responsabilidade civil.

El consentimiento informado: su importancia para la investigación retrolectiva y el progreso de la ciencia médica / Informed consent: its importance for retrolective research and medical science progress

Resumen En la investigación retrolectiva, la información necesaria para responder la pregunta de investigación se genera directamente de expedientes clínicos y de otras fuentes clínico-documentales. Este artículo analiza la dispensa del consentimiento informado y el aviso de privacidad cuando la investigación es retrolectiva, de lo cual emergen dos líneas de argumentación: una es el deber del médico de proteger la dignidad, la integridad, el derecho a la autodeterminación, la intimidad del enfermo y la confidencialidad de la información obtenida de él; la otra es la contribución de las investigaciones retrolectivas al control de las enfermedades y a la mejora de la salud de la sociedad. La dispensa del consentimiento o el aviso de privacidad en el expediente clínico es importante para la investigación retrolectiva, pero tiene implicaciones éticas para los investigadores que no cumplan con la racionalidad y responsabilidad personal que tienen ante la sociedad.

Abstract In retrolective research, the information necessary to answer the research question is directly generated from medical records and other clinical-documentary sources. This article analyzes the waiver of informed consent and privacy notice when research is retrolective, from which two lines of argument emerge: one is the physician’s duty to protect patient dignity, integrity, right to self-determination and privacy, as well as the confidentiality of the information obtained from him; the other is retrolective research contribution to the control of diseases and society’s health improvement. Waiver of informed consent or privacy notice documented in the medical record is important for retrolective research, but it has ethical implications for researchers who do not comply with the rationality and personal responsibility they have before society.

COVID-19 and its impact on informed consent: What should health professionals tell their patients or their proxies?

Given the increasing number of ethical and legal issues arising from the impact of the COVID-19 epidemic on informed consent by patients, it is necessary for health professionals to explain to patients how the measures taken to combat the spread of the virus impact on their right to give informed consent. Patients need to be reassured that wherever possible, health professionals are ethically bound to obtain informed consent from patients before they subject them to diagnostic testing and treatment, but at the same time, have to comply with the demands of the law. While the South African Constitution, statutory law and the common law all recognise a person's right to consent before being subjected to treatment or surgical operations, it is necessary to take remedial steps, because of the dangers of spreading the potentially fatal COVID-19 virus, to prevent this. Such steps may involve compelling patients to be screened, tested and treated ­ sometimes without their consent. Guidance is given to healthcare professionals on how they should counsel their patients, and what they should tell patients about the impact of the COVID-19 regulations on healthcare professionals' ethical and legal duties regarding the obtaining of informed consent, as well as on whether, if asked, employers can compel their employees to undergo testing without consent, and what to tell patients about this

Satisfacción de usuarias externas en la atencióngineco-obstétrica, Instituto Hondureño de Seguridad Social, Tegucigalpa, 2016-2017 / Satisfaction of the external users in gyneco-obstetric care, Instituto Hondureño de Seguridad Social, Tegucigalpa, 2016-2017

Antecedentes: El concepto de calidad de atención implica que los pacientes estén informados y compartan la toma de decisiones para su atención. Objetivo: Establecer el nivel de satisfacción en la atención brindada en el Servicio de Ginecología y Obstetricia, Clínica Periférica No.1, Instituto Hondureño de Seguridad Social (IHSS), Tegucigalpa, 2016-2017. Métodos: Se utilizó la Encuesta de Satisfacción de Usuarios del Régimen del Seguro de Atención de Salud Modiicada, creada por el IHSS (Año 2014). Fue aplicada, previo consentimiento informado escrito, por médicos residentes del Posgrado de Ginecología y Obstetricia, Facultad de Ciencias Médicas UNAH. Resultados: Se encuestó un total de 350 pacientes. El grupo de edad más frecuente fue 18-35 años 61.0% (215). Los trámites de admisión fueron percibidos como rápidos por 46.0% (163). El 92.0% (322) y 84.0% (295) de las pacientes expresaron encontrarse satisfechas por la atención brindada por el personal médico y de enfermería, respectivamente. La información brindada acerca de los cuidados después de la consulta médica fue percibida como buena 82.9%, (290), regular 12.3% (43) y mala 4.9% (17). La privacidad brindada en la consulta médica fue percibida como buena 70.3% (246), regular 21.1% (95) y mala 2.6% (9). En cuanto a la comodidad ofrecida durante la consulta médica, fue percibida como buena 82.9%, (290), regular 13.7% (48) y mala 3.4% (12). Discusión: Una proporción importante de las usuarias externas entrevistadas consideró la atención brindada como buena y reirió que le gustaría que se ampliara la oferta de servicios. Es necesario promover la mejora continua de la atención en salud...(AU)

Jurisprudencia sobre transfusión de sangre y consentimiento informado de Testigos de Jehová / The jurisprudence about blood transfusion and informed consent of Jehovah witnesses

The law N° 20.584 established the informed consent. This could suggest that patients have a right to refuse a blood transfusion. However, the dominant jurisprudence in protection claims filed against Jehovah Witnesses who rejected a blood transfusion, reveals that they do not have such a right. There were two exceptions in 2008, where courts acknowledged the patient's autonomy and denied the petition to authorize a blood transfusion. Most cases precede law N° 20.584. However, those cases which were upheld by the courts after the promulgation of the law, although few, follow exactly the same doctrine as before the appearance of this act.

El horizonte de la atención médica en pediatría: ¿qué hacer en el caso de niños que se encuentran en situación de abandono, conflicto, daño o peligro, aunado a una enfermedad grave? / The horizon of medical attention in pediatrics: what to do in the case of children who are in abandonment, conflict, harm or danger situations in combination with a severe disease?

Resumen: Introducción: Las leyes refieren que los menores no tienen la capacidad para dar su consentimiento informado para su propia atención médica; sin embargo, hay condiciones especiales en las que se les permite determinar lo referente a su salud. Cuanto mayores sean las limitaciones de juicio y experiencia en los menores, menos peso se otorga a los valores y objetivos que expresan; cuanto más adversas sean las consecuencias, se deberá exigir un nivel más alto de autoridad para decidir en nombre del menor, dejando al Estado la capacidad de garantizar el bienestar del menor. Caso clínico: Niña de 12 años con diagnóstico de leucemia linfoblástica aguda LI, con antecedentes familiares y sociales precarios; evolución entorpecida por el desapego al tratamiento y sus condiciones insalubres y pobreza extrema. Ambos padres fallecieron al poco tiempo de iniciar su tratamiento, quedando ella al cuidado de su medio hermana mayor de edad. Se exponen la labor y el dilema ético del oncólogo tratante y del personal del Hospital Infantil de México Federico Gómez en la creación de redes de apoyo con el objetivo de priorizar el bienestar de la menor, sin dar lugar al quebrantamiento y la desintegración familiar, consiguiendo exitosamente su recuperación. Conclusiones: El caso fue sometido al Comité de Bioética Hospitalaria. Se formaron redes de apoyo interinstitucionales para intervenir en la dinámica familiar, resolviendo los requerimientos de la menor, y se consiguió con éxito superar la enfermedad.

Abstract: Background: Laws refer that minors do not have the capability to give informed consent for their own medical attention. However, there are special conditions in which they are allowed to decide about their health. The greater the judgement and experience limitations in minors, the less weight is given to the values and objectives they express. Also, the more adverse consequences might be, the higher the level of authority that is demanded to decide on behalf of the minor, thus granting the State the capability to guarantee the well-being of the minor. Case report: 12-year-old female patient with a diagnosis of acute lymphoblastic leukemia, with precarious social and family background; evolution of the disease obstructed by the disregard of the treatment due to her unsanitary and extreme poverty conditions. Both of her parents died soon after the start of the treatment and she was kept under the care of her half-sister of legal age. The work and the ethical dilemma of the pediatrician and the staff of Hospital Infantil de México Federico Gómez are exposed within the building of support networks with the objective of prioritizing the minor's well-being, without allowing family break-up or disintegration, thus succeeding in her recovery. Conclusions: The case was submitted to the Hospital Bioethics Committee. Inter-institutional support networks were built in order to improve dynamics of the family, thus solving the needs of the minor. Despite the misfortune of the situation, the disease was successfully overcome.

Trauma e transfusão sanguínea precoce: o desafiante manejo de hemorragias em Testemunhas de Jeová / Trauma and early blood transfusion: the challenging hemorrhage management in Jehovah's Witnesses

RESUMO O manejo de pacientes que se recusam a receber transfusões de sangue e de seus produtos, como as Testemunhas de Jeová, apresenta-se frequentemente como desafio médico, não só pelo dilema ético, mas porque cria um importante obstáculo ao rápido controle de hemorragias num cenário de trauma. Este artigo explora as razões deste conflito entre o dever de cuidado do médico e o respeito à autonomia do paciente, e desenha um panorama dos entendimentos majoritários do Judiciário sobre o tema. Por fim, conclui-se que a manifestação de vontade do paciente, embora livre, não é suficiente para afastar o médico do seu dever de cuidado. Constatando perigo à vida, o médico deverá proceder a transfusão de sangue, independentemente de consentimento do paciente ou de seus responsáveis.

ABSTRACT The management of patients, such as Jehovah's Witnesses, who refuse to receive blood transfusions, is often a medical challenge, not only because of the ethical dilemma, but also because it creates a major obstacle to rapid hemorrhage control in a setting of trauma. This article explores the reasons for this conflict between the physician's duty of care and the respect for the patient's autonomy, and draws a panorama of the main understandings of the Judiciary on the subject. Finally, it is concluded that the manifestation of the patient's will, although free, is not enough to release the doctor from his (her) duty of care. In case of danger to life, the doctor must carry out a blood transfusion, regardless of the patient's consent or the permission of those responsible for the patient.

¿Sé y puedo? Toma de decisión y consentimiento informado en los trastornos demenciantes: dilemas diagnósticos y jurídicos en Chile / Decision making and consents given by demented patients. Are they valid?

In Chile, more than 180 thousand people (1% of the population) have some form of dementia. The figure should increase to approximately 600,000 (3% of Chileans) by 2050. This disease poses major challenges to the society. One of them is the effective recognition of the autonomy and responsibility of the person living with this condition. This article aims to review the clinical assessment of competence, its agreement with the Chilean legal system and the challenges that the assessment of competence poses in clinical decision-making and the capacity of an individual make decisions, according to the new international obligations subscribed by Chile. It is concluded that inclusion is a pending challenge, reflected among other things, by the non-compliance with binding rules such as Article 12 of the Convention on the Rights of Persons with Disabilities, which affirms that persons with disabilities have the right to be recognized as a person everywhere, before the law.

Tensiones en torno a la inclusión de personas con el diagnóstico de demencia en investigación científica / Tensions around including persons with diagnosis of dementia in scientific research / Tensões sobre a inclusão de pessoas com diagnóstico de demência na investigação científica

Resumen: La demencia -Trastorno Neurocognitivo Mayor- se caracteriza por deterioro cognitivo adquirido y otros síntomas psicológicos y conductuales que impactan en la capacidad de la persona para responder efectivamente a las demandas del ambiente. El número de personas con demencia aumenta de forma consistente en el mundo, volviéndose una prioridad para la salud pública y elevando la urgencia de contar con estrategias para enfrentar su impacto. La investigación científica biomédica, clínica y psicosocial es fundamental en toda estrategia de abordaje de la demencia. Este artículo sintetiza elementos relacionados con la inclusión de personas con demencia en investigación científica desde diferentes perspectivas, incluyendo el impacto del déficit cognitivo y la jurisprudencia local. Entre los dilemas bioéticos vinculados a investigación en demencia se encuentra la evaluación de capacidad de consentimiento. Las leyes 20.120 y 20.584 levantan controversias en el caso de la discapacidad, atingentes a la participación de personas con demencia en investigación científica. El presente manuscrito busca aportar una síntesis de elementos clave para el análisis de la participación de personas con demencia en investigación científica.

Abstract: Dementia -Major Neurocognitive Disorder- features cognitive impairment and other behavioral and psychological symptoms that impact the person's capacity to respond effectively to the environmental demands. The number of persons with dementia is consistently increasing in the world and therefore has become a public health priority that urges the development of strategies to address its impact. Biomedical, clinical and psychosocial scientific research in dementia must be part of any dementia strategy. Dementia research raises bioethical issues and people with dementia are often excluded from research. This article seeks to synthesize relevant elements related to the inclusion of persons with dementia in research from different perspectives, including the impact of cognitive impairment and local jurisprudence. Bioethical dilemmas in dementia research involve, among others, the determination of capacity to consent. Chilean laws 20.120 and 20.084 rise controversies in the case of disability that relate directly to participation of persons with dementia in researching. This manuscript seeks to contribute with a synthesis of key elements for the analysis of the participation of persons with dementia in scientific research.

Resumo: A demência - Transtorno Neurocognitivo Maior - caracteriza-se pela deterioração cognitiva adquirida e outros sintomas psicológicos e comportamentais que impactam sobre a capacidade da pessoa para responder eficazmente às demandas do ambiente. O número de pessoas com demência aumenta consistentemente no mundo, tornando-se uma prioridade para a saúde pública e elevando a urgência de formulação de estratégias para lidar com o seu impacto. A investigação científica biomédica, clínica e psicossocial, é fundamental em toda estratégia de abordagem da demência. Este artigo sintetiza elementos relacionados com a inclusão de pessoas com demência na investigação científica a partir de diferentes perspectivas, incluindo o impacto dos déficits cognitivos e a jurisprudência local. Dentre os dilemas éticos vinculados à investigação em demência se incluem a avaliação da capacidade de consentimento. As leis 20.120 e 20.584 suscitam controvérsias no caso da deficiência, com relação à participação de pessoas com demência em pesquisa científica. O presente artigo visa contribuir com uma síntese de elementos-chave para a análise da participação das pessoas com demência na investigação científica.

Teoría y práctica del consentimiento informado / Theory and practice of informed consent

En el ámbito asistencial, toda persona que consulta posee el derecho al consentimiento informado y, por tanto, el ejercicio actual de la profesión conlleva el deber de respetarlo. Se espera que el profesional brinde información al paciente antes, durante y al finalizar cualquier procedimiento. Los datos revelados, sean verbalmente o por escrito, no deberán omitir el diagnóstico, el pronóstico, el tratamiento indicado, sus beneficios y posibles alternativas, sin dejar de mencionar la probabilidad de eventuales complicaciones. El lenguaje utilizado debe ser adecuado para que el interesado comprenda acabadamente aquello que se le está trasmitiendo y sea capaz de tomar una determinación. Mediante este proceso de información y toma de decisiones, el paciente estará en condiciones de decidir sobre su propia salud...

Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance.

The office of the Drugs Controller General (India) vide order dated 19th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.

Ethical challenges in biobanking: moving the agenda forward in India.

There is no agreement on the typology and definition of biobanks. The present regulations across countries, including India, focus on genomic and genetic databases and DNA and cell line biobanking. It is unclear how the range of the holdings of biological samples in diagnostic and research laboratories fall under these regulatory frameworks. Biobank-related research has become very attractive because of advances in sample storage and data processing, a better understanding of the human genome, and high throughput laboratory assays.

Law on consent and confidentiality in India: A need for clarity.

The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor–patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the ‘Right to Confidentiality’ begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person’s right to medical confidentiality begins.

Estudios acerca del derecho de la salud

Se recogen trabajos que abarcan una amplia variedad de temas jurídicos y de disciplinas afines. Se destacan entre ellos: la salud como un derecho humano; la problemática en torno al ejercicio de la autonomía personal; los determinantes de la salud; el federalismo sanitario; la importancia de la información, prevención y formación en derecho y salud; el régimen jurídico de los medicamentos y el abordaje de temas sobre la salud mental

Brazilian orthodontists and the legal issues involving their professional activity: a legal and behavioral proposal

OBJECTIVE: The aim of this study was to review the use of orthodontic records (OTR's) by Brazilian orthodontists and propose a behavioral approach from a legal point of view, drawing on their interpersonal relationship with their patients. METHODS: A statistical cross-analysis was performed to compare five groups. A sixth group was created comprising the intersection of the responses provided by the five aforementioned groups. RESULTS: The results demonstrate that 42.2% of orthodontists require initial and final records and keep orthodontic records throughout their professional career; 13.9% duplicate the initial records and consider patients as the lawful owners of these documents; 19.5% make use of a medical history questionnaire, to be duly signed by all patients; 5.4% acknowledge that the decision to undergo treatment is ultimately the patient's, and, therefore, an alternative response "not perform the treatment" should be included in the questionnaire; 24% recognize the importance of the Consumer Protection Code (CPC), regard the provision of orthodontic services as an obligation of means; and explain to the patient the risks involved in orthodontic practice. Among the 1,469 orthodontists researched, 0% simultaneously took into account all aspects of this study. CONCLUSION: It was concluded that Brazilian orthodontists adopt a mistaken legal, professional and behavioral attitude, neglecting to build patient's orthodontic record with due care and in accordance with the law, which makes them vulnerable to patient disputes, contentious or otherwise.

OBJETIVO: a proposta desse trabalho foi analisar a prática do prontuário ortodôntico e as atitudes comportamentais sob o ponto de vista jurídico entre os ortodontistas do Brasil, mediante seu relacionamento interpessoal com seus pacientes. MÉTODOS: um questionário composto por 35 perguntas foi enviado para 5.355 ortodontistas. Após a devolução de 27% das correspondências, foi realizado um cruzamento informatizado estatístico em cinco grupos. Um sexto grupo criado foi a intersecção de todas as respostas dos cinco grupos anteriores. RESULTADOS: constatou-se que 42,2% dos ortodontistas solicitam as documentações iniciais ou finais, e guardam o prontuário ortodôntico por toda a carreira profissional; 13,9% duplicam a documentação inicial e consideram que o prontuário ortodôntico pertence ao paciente; 19,5% aplicam questionário de anamnese para todos os pacientes, que é assinado ao final; 5,4% consideram que a decisão pela opção terapêutica é do paciente, incluem a opção "não realizar o tratamento" e afirmam que o contrato é fundamental para o início do tratamento; 24,0% reconhecem a importância do Código de Defesa do Consumidor na profissão, consideram obrigação de meio (obrigação de diligência) os serviços ortodônticos prestados e esclarecem sobre os riscos envolvidos na prática da especialidade; 0% dos ortodontistas realizam simultaneamente todas essas considerações. CONCLUSÃO: o ortodontista brasileiro mantém uma atitude comportamental equivocada, mediante seus pacientes, pois, sob o ponto de vista jurídico-profissional, negligencia a elaboração cautelosa do prontuário dentro dos fundamentos legais conforme o estágio atual da especialidade. Sob o aspecto legal de seu exercício profissional, o ortodontista brasileiro está vulnerável diante questionamentos de seus pacientes, sejam eles litigiosos ou não, justos ou injustos.

La obligación de informar al paciente: Cuestiones sobre el derecho a ser informado / The obligation to inform the patient: Issues on the right to be informed

This article aims to analyze, from a legal perspective, the boundaries of the obligation imposed on health care providers to inform the patient. This requirement originated and was developed as an ethical issue. However, with the newly approved law regulating the rights and duties of patients, the obligation to inform can be viewed from prisms and principles that differ from those governing medical ethics. With this purpose, we will focus on the comparative experience, which will allow us to evaluate the responsibility of health care providers when this duty is breached. We will try to answer the following questions: Which medical information must be informed to the patient? When should the doctor inform the patient? In which form should this information be provided?.

Consentimiento informado / Informed consent

La presente contribución pone énfasis en la importancia del consentimiento informado en la práctica asistencial, sus fundamentos éticos y jurídicos, y al desarrollar la misma remarca aspectos bioéticos y médico-legales conjuntamente con las recientes normas legales que establecen obligaciones a los profesionales y derechos a los pacientes que no deben ignorarse.

In this review we emphasize the importance of the Informed Consent in clinical practice, its ethics and legal fundaments; explaining that we underline bioethic and medico-legal aspects together with the most recent legal regulations establishing obligations of the medical professionals and rights of the patient that can not be ignored.