Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

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.

Datos en tiempos de pandemia: la urgencia de un nuevo pacto. Reflexiones desde América Latina y el Caribe / Data in times of pandemic: The urgency of a new covenant. Reflections from Latin America and the Caribbean / Dades en temps de pandemia: la urgencia d'un nou pacte. Reflexions des d'Amèrica Llatina I Carib

Los avances de las Tecnologías de la Información y la Comunicación (TIC) permiten acceder en tiempo real a una cantidad ingente de datos, a través de los cuales es posible conocer el comportamiento de hechos sociales. En este escenario, la actual pandemia por SARS-CoV-2 ha permitido, bajo cuestionables criterios de inmediatez y urgencia, circular información que genera realidad e impacta en la toma de decisiones; y, además, ha favorecido la apropiación del dato, exponiendo a las personas a violaciones de sus derechos fundamentales. Ambos asuntos son sensibles para América Latina y el Caribe, región que hoy se presenta no sólo como el epicentro de la pandemia sino también de las desigualdades. La contribución que desde la reflexión y deliberación bioética puede realizarse en esta materia, adquiere especial relevancia con vistas a generar un nuevo pacto para el tratamiento de los datos

Advances in Information and Communication Technologies (ICT) provide real-time access to a vast amount of data, through which it is possible to know the behavior of social facts. In this scenario, the current SARS-CoV-2 pandemic has allowed, under questionable criteria of immediacy and urgency, to circulate information that generates reality and impacts on decision-making; and has also favored the appropriation of the data, exposing people to violations of their fundamental rights. Both issues are sensitive to Latin America and the Caribbean, a region that today is presented itself not only as the epicenter of the pandemic but also of inequalities. The contribution that bioethical reflection and deliberation can make in this matter, acquires special relevance with a view to generating a new covenant for the treatment of data

Els avenços de les Tecnologies de la Informació I la Comunicació (TIC) permeten accedir en temps real a una quantitat ingent de dades, a través dels quals és possible conèixer el comportament de fets socials. En aquest escenari, l'actual pandèmia per SARS-CoV-2 ha permès, sota qüestionables criteris d'immediatesa I urgència, circular informació que genera realitat I impacta en la presa de decisions; i, a més, ha afavorit l'apropiació de la dada, exposant a les persones a violacions dels seus drets fonamentals. Tots dos assumptes són sensibles per a Amèrica Llatina I el Carib, regió que avui es presenta no només com l'epicentre de la pandèmia sinó també de les desigualtats. La contribució que des de la reflexió I deliberació bioètica pot realitzarse en aquesta matèria, adquireix especial rellevància amb vistes a generar un nou pacte per al tractament de les dades

Tuberculosis en América Latina y el Caribe: reflexiones desde la bioética / Tuberculosis in Latin America and the Caribbean: Reflections from Bioethics / Tuberculose na América Latina e no Caribe: reflexões da bioética

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.

[Between Huxley and Orwell: Big Data and Health]. / Entre Huxley y Orwell: Big Data y salud.

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.

[Humanization: A Conceptual and Attitudinal Problem]. / Humanizar la medicina: un desafío conceptual y actitudinal.

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.

Comitês de ética assistencial: dos grandes dilemas aos novos desafios / Health care ethics committees: from great dilemmas to new challenges

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.

Bioética y derecho a decidir sobreel propio cuerpo, sus extensiones, productos y derivados: el discutible caso de las células HeLa / Bioethics and the right to decide over your own body, their extensions, products and derivatives: the controversial HeLa cells case

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.

[Ethical considerations regarding the communication of diagnosis of prodromal Alzheimer's disease]. / Consideraciones éticas de la comunicación diagnóstica en la enfermedad de Alzheimer prodrómica.

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.

Consideraciones éticas de la comunicación diagnóstica en la enfermedad de Alzheimer prodrómica / [Ethical considerations regarding the communication of diagnosis of prodromal Alzheimer’s disease].

Population aging has increased age-related diseases such as dementia, Alzheimer’s 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.

Consideraciones éticas de la comunicación diagnóstica en la enfermedad de Alzheimer prodrómica. / [Ethical considerations regarding the communication of diagnosis of prodromal Alzheimers disease].

Population aging has increased age-related diseases such as dementia, Alzheimers 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.

Implicancias éticas, legales y sociales del manejo de información sensible en materia de investigación genética

Objetivos: Identificar en la legislación argentina en materia de investigación en seres humanos, las cuestiones atinentes a la protección de información sensible (datos genéticos) que involucre a sujetos primarios de investigación así como a sujetos secundarios y compararlas. Indagar si los/as investigadores/as , que desarrollan protocolos relativos a genética humana en la República Argentina conocen y aplican los Documentos (nacionales e internacionales) existentes en materia de investigación en seres humanos. Describir los criterios utilizados por los/as investigadores/as para resguardar la confidencialidad de los datos obtenidos durante el desarrollo de protocolos de investigación en el campo de la genética humana. Elaborar recomendaciones éticas, legales y sociales con el objeto de realizar una propuesta Legislativa en materia de Datos Genéticos, la cual debiera articularse con otra normativa tan necesaria como ésta y orientada a regular los biobancos y las muestras para investigación

A phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, temozolomide, interleukin 2, and IFN-alpha 2B in patients with metastatic melanoma.

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.

New agents and future directions in biotherapy.

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.

Análisis bioético del esfuerzo terapéutico en pacientes críticos / Bioetic analysis of therapeutics efforts in critical patients

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.