ABSTRACT
The ethical problems in vaccine research have grown in frequency and magnitude in last decades, due to the dominant place of the pharmaceutical industry in the development of such studies. Traditional issues of security and efficacy have been aggravated by the conflicts of interests introduced by commercial competition in a global market worth billions of dollars. We present here a few examples in which the professional integrity of researchers, the moral responsibility of sponsors, and the public regulation and control by national States are put into question. The consequences of these changes represent serious threats to the rights of people included in these studies as well as disputable progress for public health.
Subject(s)
Biomedical Research/ethics , Drug Industry/ethics , Public Health/ethics , Vaccines , Argentina , Conflict of Interest , Humans , International CooperationABSTRACT
Los problemas éticos de las investigaciones sobre vacunas han crecido en las últimas décadas en frecuencia y magnitud debido a la posición dominante de la industria farmacéutica en el desarrollo de esos estudios. Las tradicionales cuestiones de seguridad y eficacia se han visto agravadas por el conflicto de intereses introducido por la competencia comercial en un mercado a escala global de miles de millones de dólares. La integridad profesional de los investigadores, la responsabilidad moral de los patrocinadores, y la regulación y control por parte de los Estados nacionales, se muestra cuestionada en varios ejemplos. Los resultados de estos cambios son las amenazas a la protección de los derechos de las personas incluidas en estas investigaciones y el discutible progreso que resulta para la salud pública.
The ethical problems in vaccine research have grown in frequency and magnitude in last decades, due to the dominant place of the pharmaceutical industry in the development of such studies. Traditional issues of security and efficacy have been aggravated by the conflicts of interests introduced by commercial competition in a global market worth billions of dollars. We present here a few examples in which the professional integrity of researchers, the moral responsibility of sponsors, and the public regulation and control by national States are put into question. The consequences of these changes represent serious threats to the rights of people included in these studies as well as disputable progress for public health.
Subject(s)
Animals , Male , Mice , Benzamides/administration & dosage , Enzyme Inhibitors/administration & dosage , Poly(ADP-ribose) Polymerases/immunology , Stress, Psychological/enzymology , Stress, Psychological/immunology , Analysis of Variance , Antibody Formation/drug effects , Corticosterone/blood , Dose-Response Relationship, Drug , Habituation, Psychophysiologic/physiology , Hemocyanins/immunology , Poly(ADP-ribose) Polymerases/drug effects , Random Allocation , Restraint, Physical/physiology , Stress, Psychological/bloodABSTRACT
Los problemas éticos de las investigaciones sobre vacunas han crecido en las últimas décadas en frecuencia y magnitud debido a la posición dominante de la industria farmacéutica en el desarrollo de esos estudios. Las tradicionales cuestiones de seguridad y eficacia se han visto agravadas por el conflicto de intereses introducido por la competencia comercial en un mercado a escala global de miles de millones de dólares. La integridad profesional de los investigadores, la responsabilidad moral de los patrocinadores, y la regulación y control por parte de los Estados nacionales, se muestra cuestionada en varios ejemplos. Los resultados de estos cambios son las amenazas a la protección de los derechos de las personas incluidas en estas investigaciones y el discutible progreso que resulta para la salud pública.(AU)
The ethical problems in vaccine research have grown in frequency and magnitude in last decades, due to the dominant place of the pharmaceutical industry in the development of such studies. Traditional issues of security and efficacy have been aggravated by the conflicts of interests introduced by commercial competition in a global market worth billions of dollars. We present here a few examples in which the professional integrity of researchers, the moral responsibility of sponsors, and the public regulation and control by national States are put into question. The consequences of these changes represent serious threats to the rights of people included in these studies as well as disputable progress for public health.(AU)
Subject(s)
Animals , Male , Mice , Benzamides/administration & dosage , Enzyme Inhibitors/administration & dosage , Poly(ADP-ribose) Polymerases/immunology , Stress, Psychological/enzymology , Stress, Psychological/immunology , Analysis of Variance , Antibody Formation/drug effects , Corticosterone/blood , Dose-Response Relationship, Drug , Habituation, Psychophysiologic/physiology , Hemocyanins/immunology , Mice, Inbred C57BL , Poly(ADP-ribose) Polymerases/drug effects , Random Allocation , Restraint, Physical/physiology , Stress, Psychological/bloodABSTRACT
The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.
Subject(s)
Biomedical Research/ethics , Ethics, Research , Government Regulation , Human Experimentation/ethics , Bioethics , Biomedical Research/legislation & jurisprudence , Ethics Committees, Research , Europe , Humans , Latin America , Research Subjects/legislation & jurisprudenceABSTRACT
Introducción: Este trabajo considera el alcance crítico y normativo que la bioética y los derechos humanos tienen en el campo específi co de la psiquiatría. Método: Se analizan de modo general la Declaración Universal sobre Bioética y Derechos Humanos, la perspectiva de la Declaración de Madrid, los Principios para la protección de los enfermos mentales y el mejoramiento de la atención de la salud mental, la Declaración de Hawai y la Declaración sobre los Derechos y Salvaguardas Legales de los Enfermos Mentales, entre otras normativas. Conclusión: para avanzar desde la teoría a la práctica en bioética y derechos humanos en psiquiatría es necesario tener en cuenta seis valores: la salud, el bienestar, la integridad, la libertad, la vida y la identidad tanto personal como comunitaria.
Introduction: This paper considers the critical and normative scope that bioethics and human rights have in the specifi c fi eld of psychiatry. Method: The Universal Declaration on Bioethics and Human Rights, the Declaration of Madrid, the Principles for the protection of the mentally ill and the improvement of mental health services, the Declaration of Hawaii and the Declaration of Rights and Legal Safeguards of the Mentally Ill are analyzed in a general way. Conclusion: In order to move from theory to practice in bioethics and human rights in psychiatry, six values must be taken into account: Health, Welfare, Integrity, Liberty, Life, and Identity of both the person and the community.
ABSTRACT
El artículo establece las diferencias entre ética médica y bioética y plantea los alcances de esta última. Propone tres objetivos de la enseñanza de la bioética a residentes de psiquiatría: transmitir conocimientos sobre los problemas éticos más frecuentes, desarrollar habilidades para su solución y modificar las actitudes tradicionales de la comunidad médica. Además, sugiere cuáles serían los contenidos básicos de un programa y discute las habilidades y actitudes que deberían resultar de tal enseñanza. Finalmente presenta algunos de los problemas de su implementación a tres niveles: ministerios de salud, dirección de hospitales y departamentos de docencia e investigación...
This paper describes different between medical ethics and bioethics with its spectrum. It purposes three main goals for education of psychiatry residents: knowledge about the most frequent ethical problems, development of skills to resolve them, while modifying traditional attitudes of the medical community. The basic contents of a program and resulting skills and acttitudes are suggested. Difficulties of program implementation in three different levels are discussed: health agencies, direction of hospitals and educacional and research departments...
Subject(s)
Bioethics/education , Ethics, Medical , PsychiatryABSTRACT
In The Clouds by Aristophanes, Strepsiades brings his son before Socrates so that he could learn Philosophy for he has heard that this science teaches how to overcome the most difficult causes with reasons. And Strepsiades wants his son to learn the art of failing to pay debts. Regarding medical education in our time, Edmund Pellegrino has noted that the educational philosophy of medical schools determines what a "good" physician is. Thus, teaching bioethics to future health professionals makes us face old problems now: What teaching method to choose among all the possible various ones? What should teaching aim at? Which will be our educational philosophy? Therefore I shall introduce here the epistemological basis of our Bioethics teaching program in Argentina and its implementing strategies in the undergraduate curriculum and the post-graduate level.
Subject(s)
Bioethics , Curriculum , Education, Medical , Interdisciplinary Communication , Interprofessional Relations , Medicine , Argentina , Humanism , Humanities , Humans , Philosophy , ScienceABSTRACT
El autor examina los puntos de aproximación entre los sistemas locales de salud (SILOS) y la bioética en tres áreas fundamentales: estructural o institucional, metodológica o justificativa, y regulativa o normativa. Se comparan, así, la descentralización del sistema de salud planteada por los SILOS con el descentramiento del poder en los comités de ética multidisciplinarios; la estrategia de participación social con el movimiento estadounidense de decisiones comunitarias sobre la salud, y los conceptos básicos de la atención primaria de salud con el principio de justicia. Las teorías de Pellegrino y Thomasma sobre las bases filosóficas de la práctica médica consolidan el marco de análisis comparativo. Se concluye proponiendo una conjunción SILOS-bioética en la cual esta disciplina puede servir de fundamento para impartir eticidad a la planificación participativa y a las decisiones comunitarias
Subject(s)
Local Health Systems , Bioethics , Health Systems , Politics , Primary Health Care , Community Participation , Latin America , Caribbean RegionABSTRACT
El autor examina los puntos de aproximación entre los sistemas locales de salud (SILOS) y la bioética en tres áreas fundamentales: estructural o institucional, metodológica o justificativa, y regulativa o normativa. Se comparan, así, la descentralización del sistema de salud planteada por los SILOS con el descentramiento del poder en los comités de ética multidisciplinarios; la estrategia de participación social con el movimiento estadounidense de decisiones comunitarias sobre la salud, y los conceptos básicos de la atención primaria de salud con el principio de justicia. Las teorías de Pellegrino y Thomasma sobre las bases filosóficas de la práctica médica consolidan el marco de análisis comparativo. Se concluye proponiendo una conjunción SILOS-bioética en la cual esta disciplina puede servir de fundamento para impartir eticidad a la planificación participativa y a las decisiones comunitarias
