RESUMO
RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.
SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.
Assuntos
Humanos , Comitês de Ética em Pesquisa , COVID-19 , Experimentação Humana/legislação & jurisprudência , Experimentação Humana/ética , Chile , Direitos do Paciente , Pesquisa Biomédica/legislação & jurisprudência , Pesquisa Biomédica/ética , Sujeitos da Pesquisa/legislação & jurisprudência , PandemiasAssuntos
Pesquisa Biomédica/legislação & jurisprudência , Demência , Doenças Neurodegenerativas , Política Pública , Sujeitos da Pesquisa/legislação & jurisprudência , Chile , Ética em Pesquisa , Humanos , Autonomia Pessoal , Consentimento do Representante Legal/legislação & jurisprudência , Populações VulneráveisRESUMO
Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.
La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.
Assuntos
Temas Bioéticos/legislação & jurisprudência , Ética em Pesquisa , Regulamentação Governamental , Sujeitos da Pesquisa/legislação & jurisprudência , Colômbia , HumanosRESUMO
Resumen La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.
Abstract Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.
Assuntos
Humanos , Temas Bioéticos/legislação & jurisprudência , Regulamentação Governamental , Ética em Pesquisa , Sujeitos da Pesquisa/legislação & jurisprudência , ColômbiaRESUMO
Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country.
Assuntos
Educação de Pós-Graduação/ética , Educação de Pós-Graduação/legislação & jurisprudência , Ética em Pesquisa , Fidelidade a Diretrizes , Sujeitos da Pesquisa/legislação & jurisprudência , Brasil , Humanos , Ciências Sociais/ética , Universidades/éticaAssuntos
Pesquisa Biomédica/normas , Sujeitos da Pesquisa/legislação & jurisprudência , Doadores de Tecidos , Obtenção de Tecidos e Órgãos , Temas Bioéticos , Função Retardada do Enxerto/prevenção & controle , Humanos , Hipotermia Induzida/ética , Consentimento Livre e Esclarecido/ética , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , Defesa do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Obtenção de Tecidos e Órgãos/ética , Estados Unidos , United States Health Resources and Services AdministrationRESUMO
The purpose of this paper was to describe the need to protect the rights of human subjects participating in nursing research, and procedures for doing so. The path taken to the task at hand was to approach the topic by discussing the philosophical underpinnings of human subject protection and describing the approach for doing this in all cases where humans are used as research subjects. These underpinnings include specific ethical principles of respect for persons, beneficence, and justice, and the procedures used in the U.S. for protecting the rights of human subjects. Once the process was clarified, the considerations necessary to protect the special groups referred to as ''vulnerable'' are discussed. Given the author's access to U.S. documents and the fact that U.S. government agencies took early steps to formalize rules and regulations for the protection of human subjects, vulnerable or otherwise, the experience of the United States was selected for presentation. It is recognized that there are now relevant international documents that are exceedingly helpful, and also, that various countries may have their own guidelines for investigators to follow. In such cases researchers can engage in comparative analysis between their own guidance and the processes described here, and decide their path accordingly.
Assuntos
Ética em Pesquisa , Direitos Humanos/legislação & jurisprudência , Pesquisa em Enfermagem/ética , Populações Vulneráveis/legislação & jurisprudência , Humanos , Sujeitos da Pesquisa/legislação & jurisprudência , Estados UnidosRESUMO
This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system.
Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Programas Nacionais de Saúde/legislação & jurisprudência , Direitos do Paciente/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência , Brasil , Indústria Farmacêutica/ética , Guias como Assunto , Acessibilidade aos Serviços de Saúde/ética , Humanos , Cooperação Internacional , Programas Nacionais de Saúde/ética , Direitos do Paciente/ética , Responsabilidade SocialRESUMO
The informed consent is a process in which a person agrees to participate in a research, knowing the risks, benefits, problems or consequences that may arise during developing it. The aim of this study is to collect the characteristics of the informed consent process (ICP) so its understanding and compliance allow an ethical dialog, thoughtful and responsible exercise for the researcher. We present the results of an extensive review of the ICP elements from its components to their legal and ethical foundation, including the myths and realities that exist about the format of informed consent as a legal protection. The informed consent is not an established format that researchers reproduce in their research, but its praxis is a daily task in the research with human subjects as critical, deliberative, and committed communication between two moral agents: the researcher and the researched one.
Assuntos
Ética em Pesquisa , Experimentação Humana/ética , Consentimento Livre e Esclarecido , Confidencialidade , Europa (Continente) , Declaração de Helsinki , Experimentação Humana/legislação & jurisprudência , Experimentação Humana/normas , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Agências Internacionais , Autonomia Pessoal , Sujeitos da Pesquisa/legislação & jurisprudência , Sujeitos da Pesquisa/psicologia , EspanhaAssuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Países em Desenvolvimento , Experimentação Humana/legislação & jurisprudência , Pesquisadores/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência , Populações Vulneráveis , Argentina , Ensaios Clínicos como Assunto/ética , Ética em Pesquisa , Experimentação Humana/ética , Humanos , Autonomia Pessoal , Pesquisadores/ética , Justiça SocialRESUMO
This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze - as an example - the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries.
Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Países Desenvolvidos , Países em Desenvolvimento , Ética em Pesquisa , Regulamentação Governamental , Experimentação Humana/ética , Internacionalidade , Pesquisa Biomédica/normas , Pesquisa Biomédica/tendências , Comportamento Cooperativo , Comitês de Ética em Pesquisa , Europa (Continente) , Governo Federal , Órgãos Governamentais , Guias como Assunto , Declaração de Helsinki , Humanos , Japão , Sujeitos da Pesquisa/legislação & jurisprudência , Estados Unidos , United States Food and Drug Administration , Universidades , Venezuela , Organização Mundial da SaúdeAssuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos , Experimentação Humana/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência , Criança , Experimentação Humana/ética , Humanos , Consentimento dos Pais/ética , Consentimento dos Pais/legislação & jurisprudência , Estados UnidosRESUMO
Achieving proper balance between the social good that comes from performing research that involves children and offering the appropriate level of protection to children who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with human participants. This is especially true of research that involves children and other vulnerable groups. The welfare of children participating in research depends on knowledgeable, caring, and responsible investigators who place the well-being of the research participant above all other aspects of the research project. The purpose of this article is to provide a brief overview of the history of research involving children, to provide a basis for understanding the context within which the current federal regulations were written, and to provide an overview of the regulatory requirements that relate to research involving children. Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants.
Assuntos
Ética em Pesquisa , Pediatria/ética , Criança , Comitês de Ética em Pesquisa/legislação & jurisprudência , Ética em Pesquisa/história , Honorários e Preços , Declaração de Helsinki , História do Século XX , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa/economia , Sujeitos da Pesquisa/legislação & jurisprudência , Medição de Risco , Estados UnidosRESUMO
This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.