RESUMO
Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.
Assuntos
Comitês de Ética em Pesquisa/organização & administração , Comitês de Ética em Pesquisa/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/organização & administração , Hospitais Pediátricos/tendências , COVID-19RESUMO
RESUMEN La protección de datos personales en los sistemas de salud requiere de medidas y procedimientos especiales para asegurar que la privacidad de la información no sea vulnerada. Los avances en la tecnología digital y el acceso a la transmisión en tiempo real de datos personales, familiares, clínicos y de laboratorio de los pacientes y/o sujetos de estudio, puede comprometer la protección de esta información. La privacidad de los datos personales en salud en tiempos de pandemia ha significado un reto mayor, es por ello que se presenta esta contribución especial que tiene por objetivo, identificar los resguardos éticos y normativos en materia de protección de datos, para garantizar el pleno respeto de los derechos de privacidad de las personas y la confidencialidad de sus datos, bajo el contexto de la atención en salud, sobre todo en condiciones de crisis sanitaria; como la vivida durante la pandemia de SARS-CoV-2. Se propone además una armonización legislativa en América Latina, sobre la privacidad y la protección de datos personales.
ABSTRACT The protection of personal data in health systems requires special measures and procedures to ensure that the privacy of the information is not violated. Advances in digital technology and access to real-time transmission of personal, family, clinical, and laboratory data of patients and/or study subjects may compromise the protection of this information. The privacy of personal data in health in times of pandemic has meant a greater challenge, that is why this unique contribution is presented, whose objective is to identify the ethical and regulatory safeguards in terms of data protection to guarantee full respect for the privacy rights of people and the confidentiality of their data, under the context of health care, especially in conditions of health crisis, such as the one experienced during the SARS-CoV-2 pandemic. It also proposes a legislative harmonization in Latin America, on privacy and protection of personal data.
RESUMO
The protection of personal data in health systems requires special measures and procedures to ensure that the privacy of the information is not violated. Advances in digital technology and access to real-time transmission of personal, family, clinical, and laboratory data of patients and/or study subjects may compromise the protection of this information. The privacy of personal data in health in times of pandemic has meant a greater challenge, that is why this unique contribution is presented, whose objective is to identify the ethical and regulatory safeguards in terms of data protection to guarantee full respect for the privacy rights of people and the confidentiality of their data, under the context of health care, especially in conditions of health crisis, such as the one experienced during the SARS-CoV-2 pandemic. It also proposes a legislative harmonization in Latin America, on privacy and protection of personal data.
RESUMO
Resumen El objetivo de este artículo es analizar las condiciones de acceso a servicios de salud de las personas con tuberculosis en América Latina y el Caribe (ALC), reflexionando desde la bioética sobre los aspectos de salud pública implicados. Se realizó una revisión documental del contexto de la tuberculosis en ALC con base en datos epidemiológicos. Los resultados se analizaron a partir de su relación con los determinantes sociales de la salud, los principios éticos que pautan la práctica médica y la responsabilidad social de los actores de salud. La tuberculosis es un problema de salud pública acuciante en la región, debido a su impacto familiar, comunitario, social, económico y sanitario, que afecta principalmente a personas y poblaciones vulneradas. En ALC la tuberculosis constituye un serio problema ético y de salud pública que causa un significativo número de muertes, discapacidad e incremento de la pobreza. La comprensión de su responsabilidad social por parte de los actores de salud es imperativa para cumplir con el derecho a servicios de salud de calidad, que aseguren un diagnóstico oportuno y un tratamiento completo de la enfermedad, y que guarden los principios de justicia, no discriminación y dignidad de los/las enfermos/as, para lo cual es importante que las estrategias nacionales de control de la tuberculosis incluyan cambios en los determinantes sociales de la enfermedad, así como el respeto de la etnia, cultura, lengua e identidad de los pacientes.
Abstract The objective of this article is to analyze the conditions of access to health services by people with tuberculosis in Latin America and the Caribbean (LAC), reflecting on the public health aspects involved from a bioethical perspective. A literature review of the context of tuberculosis in LAC based on epidemiological data was performed. The results were analyzed from its relationship with the social determinants of health and the ethical principles that guide medical practice. Tuberculosis is a pressing public health problem in the region because of its family, social, economic and health impact. It mainly affects vulnerable individuals and populations. Health services violate ethical principles. Tuberculosis is a serious ethics and public health problem in the region that causes death, disability and increased poverty. It is imperative to ensure the right to health services and to understand the individual and public health consequences of non-adherence to treatment. It is important that national tuberculosis control strategies include principles of dignity and non-discrimination of the sick, changes in the social determinants of the disease, and respect for the ethnicity, language culture and identity of patients.
Resumo O objetivo deste artigo é analisar as condições de acesso aos serviços de saúde para pessoas com tuberculose na América Latina e no Caribe (ALC), refletindo a partir da bioética sobre os aspectos de saúde pública envolvidos. Uma revisão documental do contexto da tuberculose na ALC foi realizada com base em dados epidemiológicos. Os resultados foram analisados com base em sua relação com os determinantes sociais da saúde, os princípios éticos que norteiam a prática médica e a responsabilidade social dos atores da saúde. A tuberculose é um problema urgente de saúde pública na região, devido ao seu impacto familiar, comunitário, social, econômico e sanitário, que afeta principalmente pessoas e populações vulneráveis. Na ALC, a tuberculose é um grave problema ético e de saúde pública que causa um número significativo de mortes, deficiências e aumento da pobreza. É imperativo que os agentes de saúde compreendam a sua responsabilidade social para que, dessa forma, seja possível garantir o direito a serviços de saúde de qualidade, que assegurem o diagnóstico oportuno e o tratamento completo da doença, e que defendam os princípios de justiça, não-discriminação e a dignidade dos/das pacientes, para a qual é importante que as estratégias nacionais de controle da tuberculose incluam mudanças nos determinantes sociais da doença, bem como o respeito à etnia, cultura, língua e identidade dos pacientes.
Assuntos
Humanos , Tuberculose , Bioética , Determinantes Sociais da Saúde , Acessibilidade aos Serviços de Saúde , América LatinaRESUMO
When in 1966 the United Nations stated in its International Covenant on Civil and Political Rights, the ideal of a free human being with respect to his privacy through the prohibition of arbitrary interference in his private life, it was not possible to imagine the impact of global unlimited connectivity, autonomy of new information technologies, the development of huge interconnected databases, the independent and unrestricted circulation of data, which have led to ethical and legal questions arising from this to treat personal and health data.
RESUMO
The exercise of medicine has changed since its beginnings up to the present day. Technological advances and changes in the management of the health service caused a distance between the patient and the doctor. On the other hand, professionals prefer to not have their own patients, but rather to strictly adhere to the diagnosis or treatment (specialists) without involving or committing themselves. A fragmentation of the attention that does not benefit the patient can thus be observed. The humanization in medical attention is characterized by a group of practices that are orientated at achieving better attention and greater care. The humanization process of the endeavor contributes so that this is welcomed by the other party, to improve the relationship, the patients safety and to prevent medical errors.
RESUMO
Los avances científico-tecnológicos revolucionaron la historia de la medicina. En este artículo, procuramos realizar un breve análisis de los principales dilemas éticos que han surgido como consecuencia del desarrollo tecnológico a partir de la mitad del siglo XX, y procuramos focalizar en el estudio acerca de cómo han abordado estas cuestiones los primeros comités de bioética del mundo. Empeza por la Comisión de Seattle hasta considerar las propuestas sobre la autonomía del paciente, se destaca la creciente toma de conciencia sobre los nuevos escenarios en que se desarrolla la relación médico-paciente, la cual paulatinamente ha dejado de ser diádica para dar cabida a la participación de diversos actores.
Os avanços científicos e tecnológicos revolucionaram a história da medicina. Neste trabalho, propomos fazer uma breve análise dos principais dilemas éticos que surgiram como resultado do desenvolvimento tecnológico desde meados do século XX e nos concentramos em um estudo de como os primeiros comitês de bioética no mundo tinham abordado estas questões. Começando com a Comissão de Seattle até considerar as propostas sobre a autonomia do paciente, chamamos a atenção para a crescente conscientização de médicos e pacientes sobre novos cenários em que a relação médico-paciente se desenvolve, tendo em conta que já não é uma relação diádica, mas tem sido estendida para permitir a participação de novos atores.
Scientific and technological advances have revolutionized the history of medicine. In this article, we aim to provide a brief analysis of the major ethical dilemmas that have emerged since the middle of the twentieth century as a result of technological developments, and analyze the way in which the first bioethics committees approached these issues. Beginning with the Seattle Committee and continuing to consider proposals regarding patient autonomy, we highlight the growing awareness of doctors and patients of new scenarios in which the patient-doctor relationship is no longer dyadic but has expanded to allow the participation of other actors.
Assuntos
Humanos , Masculino , Feminino , Bioética , Tomada de Decisões , Atenção à Saúde , Comitês de Ética Clínica , História da Medicina , Autonomia Pessoal , Desenvolvimento Tecnológico , Conscientização , Relações Médico-PacienteRESUMO
Los avances científico-tecnológicos revolucionaron la historia de la medicina. En este artículo, procuramos realizar un breve análisis de los principales dilemas éticos que han surgido como consecuencia del desarrollo tecnológico a partir de la mitad del siglo XX, y procuramos focalizar en el estudio acerca de cómo han abordado estas cuestiones los primeros comités de bioética del mundo. Empeza por la Comisión de Seattle hasta considerar las propuestas sobre la autonomía del paciente, se destaca la creciente toma de conciencia sobre los nuevos escenarios en que se desarrolla la relación médico-paciente, la cual paulatinamente ha dejado de ser diádica para dar cabida a la participación de diversos actores.(AU)
Os avanços científicos e tecnológicos revolucionaram a história da medicina. Neste trabalho, propomos fazer uma breve análise dos principais dilemas éticos que surgiram como resultado do desenvolvimento tecnológico desde meados do século XX e nos concentramos em um estudo de como os primeiros comitês de bioética no mundo tinham abordado estas questões. Começando com a Comissão de Seattle até considerar as propostas sobre a autonomia do paciente, chamamos a atenção para a crescente conscientização de médicos e pacientes sobre novos cenários em que a relação médico-paciente se desenvolve, tendo em conta que já não é uma relação diádica, mas tem sido estendida para permitir a participação de novos atores.(AU)
Scientific and technological advances have revolutionized the history of medicine. In this article, we aim to provide a brief analysis of the major ethical dilemmas that have emerged since the middle of the twentieth century as a result of technological developments, and analyze the way in which the first bioethics committees approached these issues. Beginning with the Seattle Committee and continuing to consider proposals regarding patient autonomy, we highlight the growing awareness of doctors and patients of new scenarios in which the patient-doctor relationship is no longer dyadic but has expanded to allow the participation of other actors.(AU)
Assuntos
Ciência, Tecnologia e Sociedade , Pesquisa Biomédica , Comitês de Ética em Pesquisa , BioéticaRESUMO
Resumen: la investigación con células de origen humano y animal fue incorporada en la ciencia hace más de un siglo y su uso, tan cotidiano, no había merecido cuestionamiento alguno acerca de sus implicaciones éticas, legales y sociales por parte de la comunidad científica pues se asumía que era inocuo e impersonal. La información genética evidencia comportamientos biológicos individuales o colectivos de sus grupos familiares o generaciones, situación que puede transgredir la confidencialidady el derecho a la privacidad de las personas y sus familias. El caso de la investigación con células HeLa constituye un modelo de interpretación del ethos científico que requiere ser abordado desde un enfoque interdisciplinario, con una perspectiva de derechos humanos y bajo una redefinición de los conceptos legales, sociales y éticos del cuerpo humano, la salud, la enfermedad y la vida, a fin de garantizar la efectiva protección de los derechos personales fundamentales.
Abstract: the use of human and animal cells in research was incorporated into scientific processes more than one century ago, and due its daily use it had not aroused any questioning about their ethical, legal, and social implications by the same researchers because its use was considered as innocuous and impersonal. The genetic information realizes the biological behavior of people individuallyand collective of their familiar groups and generations, situation that can transgress the confidentiality, privacy, and the right to privacy of individuals and their families. HeLa cell research constitutes a model of interpretation of the scientific community against the personal and familiar rights that must be studied from an interdisciplinary approach, from an human rights perspective and with a redefinition of legal, social and ethical concepts of human body, health, disease and life, to ensure the effective protection of fundamental personal rights.
Assuntos
Humanos , Temas Bioéticos , Direitos Humanos , Direitos do Paciente , PesquisaRESUMO
Population aging has increased age-related diseases such as dementia, Alzheimer's disease (AD) being the most common in older adults (50%-60%). It is one of the most feared conditions for its irreversible and incurable, by its chronicity and it consists of a long process of depersonalization. The clinical diagnosis is mainly based on DSM-IV and NINCDS-ADRDA. Definitive diagnosis is post-mortem, as it requires histopathological confirmation. However, there have been new diagnostic criteria based EA biomarkers, which can be done in life, anticipating the course of several years before dementia. Thus, physicians are increasingly exposed to AD patients in early stages, having to face the dilemma of communicating the diagnosis to a patient with cognitive failures and disease awareness, with the implications that generates about him and his family. The objectives of this paper will analyze the ethical problem of communication of clinical diagnosis of AD in prodromal stages (pre-dementia) in our country, based on the analysis of ethical principles (autonomy and non maleficence) involved in decision making.
Assuntos
Doença de Alzheimer , Sintomas Prodrômicos , Revelação da Verdade/ética , Doença de Alzheimer/diagnóstico , HumanosRESUMO
La ficha clínica reviste vital importancia en tanto repositorio de la información del paciente al reunir datos tanto personales como sensibles, gozando estos últimos de un estatuto especial. Desde la perspectiva de los Derechos Humanos, el resguardo de la información sensible del titular de la ficha clínica se relaciona con la protección del derecho a la intimidad, a la vida privada y a la imagen, entre otros. Se analizan aquí el manejo de la información obrante en la ficha clínica en algunos países latinoamericanos, el interés económico que representan los datos sensibles para la formación de bases de datos, el uso de la ficha clínica para fines académicos y para fines propios de la salud pública y la administración sanitaria. Finalmente, se relevan propósitos y compromisos de respeto a la dignidad del ser humano, en este caso contenidos en la Declaración Universal de Bioética y Derechos Humanos de UNESCO.(AU)
Medical Records are of vital importance as they collect the patient information, gathering personal and sensitive data, giving a very special protection to the last one. From Human Rights scope, protecting a persons sensitive data which could be found in her medical records is in direct relation to the protection of the right to privacy, the right to a private life and the right to ones image, among others. In this paper, we try to analyze how the information contained in medical records is used, especially in Latin American countries, the economic value that is assigned to sensitive data in order to build database, as well as the use of medical records for academic purposes and for public health and sanitary management issues. Finally, we will analyze the purposes and compromises regarding respect for human dignity, which are expressed in UNESCOs Universal Declaration on Bioethics and Human Rights.(AU)
O registro médico é de vital importância enquanto contém a informação do paciente ao reunir tanto os dados pessoais quanto sensíveis, tendo os últimos um estatuto especial. Desde a perspectiva dos Direitos Humanos, a proteção da informação sensível do titular do registro médico está relacionada com a proteção do direito á intimidade, á vida privada e á imagem, entre outros. Neste artigo será analisada a gestão da informação que está contida no registro médico, com preferência nos países latino-americanos, o interesse econômico que representam os dados sensíveis para a formação de bancos de dados, assim que o uso do registro médico com fins acadêmicos e para fins próprios da saúde pública e da administração sanitária. Finalmente, serão analisados os propósitos e compromissos de respeito á dignidade do ser humano, neste caso aqueles contidos na Declaração Universal de Bioética e Direitos Humanos da UNESCO.(AU)
Assuntos
Bioética , Ética Médica , Confidencialidade , Direitos Humanos , Direitos do Paciente , Prontuários Médicos , PrivacidadeRESUMO
Population aging has increased age-related diseases such as dementia, Alzheimers disease (AD) being the most common in older adults (50
). It is one of the most feared conditions for its irreversible and incurable, by its chronicity and it consists of a long process of depersonalization. The clinical diagnosis is mainly based on DSM-IV and NINCDS-ADRDA. Definitive diagnosis is post-mortem, as it requires histopathological confirmation. However, there have been new diagnostic criteria based EA biomarkers, which can be done in life, anticipating the course of several years before dementia. Thus, physicians are increasingly exposed to AD patients in early stages, having to face the dilemma of communicating the diagnosis to a patient with cognitive failures and disease awareness, with the implications that generates about him and his family. The objectives of this paper will analyze the ethical problem of communication of clinical diagnosis of AD in prodromal stages (pre-dementia) in our country, based on the analysis of ethical principles (autonomy and non maleficence) involved in decision making.
Assuntos
Doença de Alzheimer , Revelação da Verdade/ética , Sintomas Prodrômicos , Doença de Alzheimer/diagnóstico , HumanosRESUMO
PURPOSE: In an effort to reduce the frequency of central nervous system (CNS) progression in patients with metastatic melanoma with ongoing systemic response to biochemotherapy, we modified our standard concurrent biochemotherapy regimen by replacing dacarbazine (DTIC) with oral temozolomide. EXPERIMENTAL DESIGN: Patients received cisplatin, vinblastine, and temozolomide (20 mg/m(2) cisplatin and 1.2 mg/m(2) vinblastine i.v., days 1-4; 150 mg/m(2) p.o. temozolomide, days 1-4) concurrent with interleukin 2 (9 MIU/m(2)/day) by continuous i.v. infusion on days 1-4 and IFN-alpha (5 MU/m(2)/day) on days 1-5, 8, 10, and 12. Prophylactic antibiotics and a maximum of four cycles were administered. Routine granulocyte-colony stimulating factor and aggressive antiemetics were also provided. Tumor staging included torso computed tomography scans and brain magnetic resonance imaging pretreatment, after cycle 4 and then every 3 months for 2 years. Torso computed tomography scans were also performed after cycle 2. RESULTS: A total of 147 treatment cycles were administered to 48 patients. No patients had received prior chemotherapy or interleukin 2; however, 19 (40%) had received prior adjuvant IFN-alpha. Significant toxicities included 2 deaths from cardiac events (pericarditis al tamponade and posttreatment myocardial infarction with associated ventricular arrhythmia) and 3 gastrointestinal serious adverse events (pancreatitis, appendicitis, and upper GI bleed). No other nonhematological grade 4 toxicities were observed. Tumor responses were seen in 22 of 47 evaluable patients (relative risk, 47%) with 7 complete responses (15%). Response durations ranged from 1 to 29+ months with 1 currently ongoing. Median survival was 7.5 months. The CNS was the initial site of progression in 2 responding patients. An additional 6 responding patients developed CNS progression within 3 months of systemic progression. Initial CNS progression was significantly less frequent what was seen with the prior DTIC-based biochemotherapy regimen (2 of 22 versus 12 of 19; P = 0.001). CONCLUSION: This regimen appears to be active and reasonably well tolerated in patients with metastatic melanoma. Although the substitution of temozolomide for DTIC reduced the incidence of initial CNS progression, this effect did not appear to result in an improved overall outcome.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Encefálicas/tratamento farmacológico , Dacarbazina/análogos & derivados , Melanoma/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Encefálicas/patologia , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Dacarbazina/administração & dosagem , Dacarbazina/efeitos adversos , Intervalo Livre de Doença , Feminino , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Infusões Intravenosas , Interferon alfa-2 , Interferon-alfa/administração & dosagem , Interferon-alfa/efeitos adversos , Interleucina-2/administração & dosagem , Interleucina-2/efeitos adversos , Masculino , Melanoma/secundário , Pessoa de Meia-Idade , Projetos Piloto , Proteínas Recombinantes , Temozolomida , Resultado do Tratamento , Vimblastina/administração & dosagem , Vimblastina/efeitos adversosRESUMO
Many new biotherapy agents to treat cancer are being studied as single agents and in combination with conventional cancer therapy, such as chemotherapy. These agents include the monoclonal antibodies, rituximab, trastuzumab, alemtuzumab, and IMC-C225. Radioimmunotherapy, a type of biotherapy that combines a radioactive isotope with a monoclonal antibody, also is being studied and has shown promise in the treatment of lymphoma. A tyrosine kinase inhibitor, STI 571, has been approved recently by the U.S. Food and Drug Administration. Several vaccines as cancer treatment are currently under investigation. Other biotherapy agents being investigated include angiogenesis inhibitors, such as endostatin, antivascular endothelial cell growth factor, and thalidomide, an agent that inhibits the formation of blood vessels that supply tumors.
Assuntos
Antineoplásicos/uso terapêutico , Produtos Biológicos/uso terapêutico , Neoplasias/terapia , Radioimunoterapia/métodos , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Anticorpos Monoclonais Murinos , Produtos Biológicos/farmacologia , Drogas em Investigação/uso terapêutico , Feminino , Previsões , Humanos , Masculino , Neoplasias/diagnóstico , Rituximab , Sensibilidade e Especificidade , Talidomida/uso terapêutico , Trastuzumab , Resultado do TratamentoRESUMO
El Siglo XX se caracteriza por el desarrollo vertiginoso de la Medicina, la Genética, la Biología y la Química Farmacéutica y por tanto de sus aplicaciones en el campo de la resolución de enfermedades. Aparecen posteriormente la Antropología y la Sociología aplicadas intentando describir y/o explicar el proceso de salud-enfermedad-atención como partes de un sistema complejo y no como instancias disociadas e inconexas. Particularmente la Medicina, como consecuencia de los múltiples desarrollos científico-tecnológicos, ha progresado en forma acelerada a partir de 1945. Tales avances han sido acompañados por la implantación de técnicas sofisticadas, algunas de ellas cruentas, mortificantes, intrusivas, frecuentemente muy costosas y de alta complejidad. El veloz incremento de la disponibilidad tecnológica y su innegable expansión han instalado una discusión acerca de la tendencia cada vez mayor a proveer de tratamientos más onerosos a una cantidad más escasa de personas que padecen determinadas enfermedades, en las cuales tan sólo es posible prolongar artificialmente la agonía. Dicha discusión debería fundamentarse desde la perspectiva de la Salud Pública. Dado que los beneficios "curativos" resultan comparativamente muy onerosos en relación a su efectividad, generalmente los análisis utilitaristas cuestionan a estos "milagros de la medicina" por ser de carácter marginal y difíciles de sostener conforme una distribución "justa" de los recursos. Creemos importante indagar respecto de los criterios subyacentes en una Unidad de Terapia Intensiva, UTI, para optar cuando es necesario por: a- prescribir tratamientos que avalan a la medicina como el "arte de curar" y por ende conservan indefinidamente "la vida"; b- limitar la aplicación de medidas terapéuticas respetando la calidad de vida y el derecho a morir con dignidad en pacientes cuyo deceso es inminente.