Bioethical Aspects Research Articles

Enfoque local deliberativo de las controversias bioéticas: una oportunidad para la adecuada implementación de la tamización neonatal

ResumenIntroducción. Las características controversiales de la tamización neonatal influenciadas por consideraciones bioéticas hacen compleja su implementación. Colombia no es ajena a esta situación y las circunstancias locales complican el panorama. Objetivo. Determinar cómo se abordan en el contexto local las controversias bioéticas en torno a la tamización neonatal como fundamento de las deliberaciones sobre el deber ser de esta actividad en Colombia.Materiales y métodos. Se aplicó una encuesta en el marco de un estudio interpretativo con dos componentes de análisis, uno descriptivo y otro deliberativo, en torno a los valores expuestos por funcionarios del Instituto Nacional de Salud. Resultados. La oferta obligatoria de la tamización por parte de la nación, independientemente del costo de oportunidad y el consentimiento para el uso de sus resultados y de las muestras residuales en la investigación, no suscitaron controversias, pero sí el tipo de información y la autorización para hacer la tamización. Los funcionarios con mayor experiencia expresaron su preferencia por una tamización obligatoria (17,7 Vs. 11,79 años en promedio; p=0,007). Sorpresivamente, a pesar del riesgo de discriminación, teniendo como fin el neonato, hubo acuerdo en entregar toda la información a padres e historia clínica. Otro aspecto controversial fue la identificación de los pacientes en el seguimiento, frente a lo cual los funcionarios de mayor experiencia en aspectos bioéticos prefirieron el uso de códigos (4,5 Vs. 1,26 años en promedio; p=0,009). En este contexto, estrategias como el disentimiento informado, el asesoramiento especializado o los programas de salud pública que aprecien la diversidad permitirían rescatar valores, incluso aquellos aparentemente opuestos.Conclusión. La aproximación local al deber ser de la tamización neonatal desde una perspectiva bioética deliberativa permitió ajustar una propuesta para su implementación.

Human anatomy education and management of anatomic specimens during and after COVID-19 pandemic: Ethical, legal and biosafety aspects

COVID-19 is an infection caused by the SARS-CoV-2 virus, initially identified in the city of Wuhan, China, in December 2019. Since then, the virus has spread to the continents, causing a major pandemic. The impacts of this pandemic on the education of human anatomy interfere in at least two aspects: (1) receiving and managing anatomical specimens in anatomy laboratories and (2) adaptations for classes on remote virtual teaching. Therefore, this study reviewed and discussed the legal and bioethical aspects, considering the scenario of a South American Country, aiming to stimulate the debate on these two relevant themes in the international community. Because of the COVID-19 pandemic and the impossibility of mass testing, anatomists and other workers in the field must deal with the risk of receiving bodies infected with SARS-CoV-2. In this situation, additional care measures in biosafety practices are essential to protect the staff. Such measures are: the bodies must be preserved by the perfusion of formaldehyde or other fixative solutions; embalming must be performed in ventilated rooms with a good air exhaust system; to avoid excessive manipulation of bodies and procedures such as pulmonary insufflation or craniotomy; and proper use of personal protective equipment, including lab coat, gloves and masks. As for exposure of body images in online classes, this review showed that there are no legal impediments to this end. However, anatomists must adopt measures aimed at protecting the memory of the deceased, such as using secure digital platforms with restricted access; family authorization/consent and student awareness.

Protection of Human Rights in the Context of Fight against Gene Doping

This article examines issues related to the protection of human rights in the context of the fight against the use of gene doping. The fact of using gene therapy in relation to a person already includes a significant range of potential ethical problems, including probable health risks, the degree of awareness of the patient’s consent to perform certain manipulations, as well as the long-term consequences for a person’s life, and, which is equally important, for future generations. At the same time, the problems of the use of gene doping in relation to athletes significantly aggravates and complicates the process of building regulatory approaches. The article notes the particular susceptibility of the athlete's right to health care in the context of the problem of gene doping. The paper studies the features of the implementation and protection of the human right to protect health and the right to privacy, including legislation aspect of biomedicine and bioethics, as well as taking into account the difficulties associated with the identification of the use of gene doping. Conclusions regarding possible areas for improving legal regulation in this area, among which, strengthening or detailing the legal regulation of the provision of high-tech medical care, properly informing athletes, coaches and other sports professionals about the possible risks of applying genetic engineering methods to humans, proper regulation of testing procedures, toughening criminal liability and expansion of the subject matter of such crimes are formulated.

Bioethical Aspects of Human Geneticization

Human geneticization, discussed in the following text, is usually associated with the bio-medical practices aimed at human improvement, with the use of genetic enhancement, also understood as genetic improvement or genetic correction. Despite the wide range of benefits claimed by scientists (including biotechnologists and geneticists), these practices undoubtedly generate a number of ethical and legal problems. They concern, among other things, the legitimacy of conducting research in the field of biotechnology or genetics, including reprogenetics, its possible direction, projections related to the development of the research, as well as the methods and means used to control the aforementioned research, or even the problem of both the legislative and moral validity of its further practical implementation. This can be seen, for example, in the ongoing discussion on the geneticization of human life, and in the broader context of its progressive biomedicalization. In view of the considerable breadth and complexity of the issue of geneticization, this text focuses primarily on a closer examination of the possibilities that genetic enhancements, supported by the potential which genetic engineering might bring, followed by due consideration of selected bio-ethical dilemmas that may arise from the application of such enhancements.

La fecundación «post mortem» en España

Los continuos avances científicos, junto con los avances sociales, han provocado la necesidad de una regulación de las técnicas de reproducción asistida. Una de las técnicas en la que más vacíos legales se pueden encontrar en ella, es la fecundación post mortem. En este trabajo, se hará un análisis de los aspectos jurídicos y bioéticos enfocados a los límites. El fin del trabajo es ofrecer una vista general sobre la situación legal y jurídica de la técnica al lector, al mismo tiempo que se mencionarán posibles soluciones a los conflictos en el marco legal y ético.

Bioethical Aspects of Improving the Production of Rabies Immunoglobulin in Russia

The main objective of the present research was to review the studies that look into ways of improving production of anti-rabies immunoglobulin in terms of bioethical principles: ensuring patients’ right to receive quality pharmaceutical care, and compliance with the 3R principles. At the same time, compliance with bioethical principles should contribute to the improvement of production technology and the product quality, which is especially important for antirabies immunoglobulin due to the existing high demand for it. The paper analyses the current trends in avoidance of animal use in the production of rabies immunoglobulin. It summarises the main methods of production of serum products for post-exposure prophylaxis of rabies. The example of heterologous rabies immunoglobulin is used to substantiate the need to improve quality control of drugs by following the 3R principles. The paper highlights the potential use of cell cultures for determination of rabies immunoglobulin specific activity. The authors formulated the objectives that include development and use of pyrogen detection methods which do not involve animal use and are consistent with the current pharmacopoeial standards. They assessed the possibility and feasibility of removing Abnormal Toxicity Test for heterologous rabies immunoglobulin in accordance with the current international trends. The formulated objectives imply optimisation of production of heterologous rabies immunoglobulin in Russia in order to improve the quality of antirabies measures. The objectives include higher production volumes to ensure the availability of the product to patients, reduction of the product reactogenicity by using cell-culture technologies for obtaining rabies antigen, as well as development and implementation of in vitro test methods for product quality control in terms of Specific activity, Pyrogenicity, and Abnormal toxicity

Tecnologías disruptivas como alternativa a la obtención de órganos y tejidos artificiales

El artículo tiene como objetivo exponer el panorama acerca de las tecnologías disruptivas relacionadas con la medicina regenerativa, que plantean una solución a la obtención de órganos y tejidos artificiales que, en la actualidad con los métodos existentes como los trasplantes y xenotrasplantes, han demostrado ser poco efectivos para solventar una problemática de salud pública mundial. En este sentido, se abordan tecnologías como: ingeniería de tejidos, ingeniería genética, nanomedicina y nanotecnología, que buscan sustituir o mejorar los métodos actuales. Estas tecnologías disruptivas plantean aspectos bioéticos que deben ser vistos desde otra perspectiva, donde la manipulación de la materia a escala atómica y molecular abren un sinnúmero de posibilidades en pro mejorar la calidad de vida del hombre, e incluso prolongar la misma, por lo que se adopta el concepto de nanobioética, que toma los principios de la bioética contemporánea, proyectándolos a escalas nanométricas, buscando analizar las implicaciones positivas y negativas de la vida en estas dimensiones. En conclusión, se espera que el paciente tenga opciones a la hora de requerir un órgano o tejido en un futuro no muy lejano, donde las tecnologías disruptivas están allanando el camino para ello.

Is Transhumanism a New Face of Bioethics?

The paper deals with a possible interdependence between bioethics and transhumanism. It seems that nowadays transhumanism is a separate discipline and we can say at most about bioethical aspects of that. However, a more in-depth investigation reveals that transhumanism is a rival of the contemporary bioethics and tends to take control over it. So, this paper tried to prove that this is not a necessity. There are still vital differences between bioethics and transhumanism and they justify keeping the former separate. The main difference concerns the object of investigation: bioethics is about ethical enquiry of the existing, bodily human being, whereas transhumanism is directed toward a future creature called posthuman. Thus, although there are attempts within transhumanism to replace bioethics, they are still two separate fields of investigation and hence the former is not a new and fully-fledged face of the latter.

Ответственность науки и общество: может ли биоэтика повлиять на медицинскую практику?

Статья основана на материалах интервью с профессором Милдред Соломон, президентом одной из старейших и крупнейших независимых исследовательских организаций в области биоэтики в США — Центра Гастингс. Цель данного материала не только в том, чтобы пояснить, что такое биоэтика (этому посвящено много книг и публикаций). В большей степени статья нацелена на анализ того, как биоэтика может: 1) влиять на науку и, используя социологические исследования, вносить изменения в клиническую практику, формируя новые нормы общения, а также в политику в сфере общественного здравоохранения; 2) воздействовать на национальное и международное законодательство в области здравоохранения; 3) способствовать созданию междисциплинарных команд, независимых площадок гражданской активности; 4) посредством гражданской активности ученых формировать глобальную сеть образовательных и научно-исследовательских центров по всему миру, ориентированных на исследование национальных аспектов биоэтики и практики медицины, организации научных обменов и проектов, которые призваны создать этику глобального здравоохранения. Также статья рассматривает, что такое Центр Гастингс, как устроена работа независимого исследовательского проекта и каков его вклад в развитие биоэтики в условиях эпидемии. Этот аспект демонстрируется на примере аналитических материалов ученых, а также гражданской инициативы около 1400 биоэтиков и работников здравоохранения США, адресованной федеральному Правительству с рекомендациями о корректировке государственных противоэпидемических мер. Благодарность. Работа выполнена в рамках проекта РНФ № 18-78-10018 «Проблемы биоэтики в историческом контексте и социокультурной динамике общества».

Clinical research protocol to evaluate the effectiveness and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic.

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)

Bioética e residência em Medicina da Família e Comunidade

A Residência Médica (RM) é considerada o padrão-ouro em termos da especialização médica no país. A bioética integra o rol de disciplinas obrigatórias para a formação em nível de RM, merecendo destaque pela (i) crescente complexidade do trabalho em saúde e (ii) incipiente abordagem dos problemas éticos na formação dos profissionais da saúde. Com base nestas considerações, foi desenhada a primeira “Oficina de Formação em Bioética e Atenção Primária à Saúde”, para o Programa de Residência em Medicina de Família e Comunidade do Município do Rio de Janeiro (PRMFC-SMS-RJ), com o objetivo de fomentar o debate sobre os aspectos bioéticos da prática profissional na Atenção Primária à Saúde/Estratégia Saúde da Família (APS/ESF). O escopo do presente artigo é relatar a experiência e contribuir para as discussões sobre a necessária abordagem dos conflitos éticos para a excelência do cuidado em saúde na APS/ESF.

Caminho do diálogo II: ampliando a experiência bioética para o ensino médio

Resumo A inserção da bioética na educação básica e a bioética ambiental são duas vertentes em ascensão. Na confluência dessas duas áreas, desponta ação promovida pela Organização das Nações Unidas denominada “Objetivos do desenvolvimento sustentável”, cuja agenda propõe 17 objetivos a serem cumpridos até 2030 para o equilíbrio das dimensões econômica, social e ambiental do desenvolvimento. Neste escopo foi realizada a atividade “Caminho do diálogo II”, que apresentou estudantes de ensino médio à reflexão sobre bioética e aos objetivos do desenvolvimento sustentável. Este artigo relata a experiência dessa intervenção e discute a bioética no contexto da educação, sem a intenção de trabalhar formalmente conceitos de bioética, mas de introduzir a perspectiva bioética pelo diálogo interdisciplinar de forma a identificar vulnerabilidades e debater soluções em meio ambiente, desenvolvimento e sustentabilidade. Aprovação CEP-PUCPR 2.672.382

Proibição de doação sanguínea por pessoas homoafetivas: estudo bioético

Resumo Este estudo teve o objetivo de identificar e discutir aspectos bioéticos que envolvem a proibição de doação sanguínea por pessoas homoafetivas. Trata-se de revisão integrativa da literatura, com abordagem crítico-reflexiva de artigos disponíveis na Biblioteca Virtual em Saúde e publicados entre 2013 e 2018. Foram selecionados sete estudos que contemplaram a temática, a partir dos quais surgiram quatro categorias: “inaptidão para doação de sangue”; “só homossexuais praticam sexo anal?”; “saúde pública ou heterossexismo na saúde?”; e “considerações da bioética principialista para doação sanguínea de pessoas homoafetivas”, remetendo aos quatro pilares da teoria principialista. A bioética promove reflexões sociais, direciona linhas de pensamento ou questionamento e cria novos espaços para discussão do assunto. Os dilemas envolvidos nessa abordagem dizem respeito à negação dos quatro pilares bioéticos aos sujeitos homoafetivos, induzindo maleficência a esse grupo vulnerável e aos receptores do tecido sanguíneo.

Antropología del envejecimiento: el respeto a la autonomía del mayor

En el presente artículo abordamos el tema del cuidado al mayor desde la antropología filosófica. Mediante un enfoque fenomenológico, aportaremos claves para mejorar la práctica del cuidado subrayando los aspectos bioéticos implicados en la misma. A medida que la persona va perdiendo autonomía e independencia, debido a las incapacidades propias del deterioro, aparecen situaciones de manipulación por parte de familiares, profesionales e instituciones. Por último, mostraremos cómo la bioética narrativa, puede sensibilizar a profesionales y familiares preparando unas relaciones de cuidado más empáticas y respetando los límites bioéticos que protegen la situación de especial vulnerabilidad de la persona mayor.

Burnout syndrome in surgeons, surgery residents, and medical students: Prevalence and associated factors

The aim of the study was to determine the burnout syndrome’s prevalence in surgeons, surgery residents and medical students in a private institution using the Maslach Burnout Inventory and to analyze associated factors related to the presence of this syndrome. Materials and methods: Once approved by the Ethics and Research Committee from our Institution, the Maslach Burnout Inventory was used to identify the presence of burnout syndrome in a sample of 72 physicians at the surgery service. The diagnosis of burnout syndrome was defined as the association of a high level of emotional exhaustion and depersonalization with a low level of professional achievement. Its prevalence was determined and an analysis of demographic factors and bioethical training was performed. The relationship of these factors was examined concerning the syndrome’s presence or absence, using Fisher’s exact test, Chi-square, and Mann–Whitney U-test. Finally, a logistic univariate and multivariate regression analysis applied. Results: A 65% (Confidence interval 95% 54-76) burnout syndrome global prevalence was found. The prevalence found in medical students was 67%, in surgery residents 76%, and in surgeons 45.5%. Statistical significance was found between the absence of the syndrome and bioethics training (p = 0.000), presence of burnout syndrome, age (higher risk in young people, p = 0.020), and working hours per week (higher risk in subjects with higher workload p = 0.034). No statistical relationship was observed between the burnout syndrome and the gender or the medical position. Conclusions: High burnout syndrome prevalence was found in the medical population from the department of surgery at our institution. This study suggests that the proper knowledge of bioethical aspects in the practice of medicine is a cardinal element that protects against the development of burnout syndrome. The present study points toward an appropriate bioethics training as a preventive factor

Bioethical aspects of criminal law regulation of necrophilia in the Republic of Croatia

Necrophilia is one of the most taboo segments of the psychopathological, but also of the legal, categories, whereat issues of acts against the (deceased) human body and its desecration, but also the phenomena of life and death per se, are coming to the fore. This paper seeks to contribute to the evaluation of certain problematic legal and (bio)ethical segments related to necrophilia, primarily by using a case law method, a formal-logical legal method, as well as the method of linguistic interpretation of law, as argumentative aids for the analysis of the criminal law regulation of necrophilia. Also, a bioethical sensibility will be implemented in the aforementioned discourse - the intentional subject attribute of integrative bioethics49, for the purpose of orientation and emphasis of the responsibility towards a person's life as the fundamental deontological paradigm of certain law procedures.

Bioethical Aspects of Rehabilitation Clinical Practice: A Comparative Study between Opinions of Staff and Patients in Acute and ChronicStage Departments

Bioethical Aspects of Rehabilitation Clinical Practice: A Comparative Study between Opinions of Staff and Patients in Acute and ChronicStage Departments

Eugenics between Darwin’s Εra and the Holocaust

Heredity and reproduction have always been matters of concern. Eugenics is a story that began well before the Holocaust, but the Holocaust completely changed the way eugenics was perceived at that time. What began with Galton (1883) as a scientific movement aimed at the improvement of the human race based on the theories and principles of heredity and statistics became by the beginning of the 20th century an international movement that sought to engineer human supremacy. Eugenic ideas, however, trace back to ancient Greek aristocratic ideas exemplified in Plato’s Republic, which played an important role in shaping modern eugenic social practices and government policies. Both positive (prevention and encouragement of the propagation of the fit, namely without hereditary afflictions, i.e. socially acceptable) and negative (institutionalization, sterilization, euthanasia) eugenics focused on the encouragement of healthy and discouragement of unhealthy reproduction. All these practices were often based on existing prejudices about race and disability. In this article, we will focus on the rise of eugenics, starting with the publication of Origin of Species to the Holocaust. This examination will be multidisciplinary, utilizing genetics, legal history and bioethical aspects. Through this examination, we will discuss how provisional understandings of genetics influenced eugenics-based legislation. We will also discuss the rise of biopolitics, the change of medical ethos and stance towards negative eugenics policies, and the possible power of bioethical principles to prevent such phenomena.

Bioethical aspects of the new eugenics

With the advances in biotechnology and in the Human Genome Mapping Project, the ability to manipulate the DNA and perform gene therapy has increased and raised some concerns. The new eugenic theory is one of them. The concept of eugenics first appeared in the late nineteenth century1, as a theory of the improvement of the human race. It nearly disappeared after World War II2 but is now returning with new theories and ethical debates. The purpose of this study is to present some considerations regarding contemporary and widespread technological advances in assisted reproduction. We bring attention to the relations between assisted reproduction and a possible new eugenic policy, stressing the relevance of the matter and discussing some of the implied ethical issues. We do not intend to conduct a comprehensive study on the subject, but to provide some considerations that may contribute to further debate. A literature review was conducted focused on the ethical, bioethical and legal aspects of eugenics. In addition, some media coverage on the current use of the above-mentioned technologies was also consulted.

Edición genómica en línea germinal: dilemas éticos

La edición genómica en células germinales es una técnica de ingeniería genética en la que el ADN es insertado, eliminado o reemplazado en el genoma de los gametos o células precursoras. En noviembre de 2018, el investigador chino He Jiankui, anunciaba junto con sus colegas la "creación" de los primeros bebés genéticamente modificados del mundo a través del sistema CRISPR-Cas9, las gemelas Lulu y Nana. Estas declaraciones generaron diferentes reacciones en la comunidad científica, así como preguntas sobre los dilemas bioéticos que envuelven este tipo de procedimientos.
 El objetivo del presente artículo es analizar los consensos nacionales e internacionales relacionados con los aspectos bioéticos en la investigación de edición genómica en humanos.