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      DEVELOPING A RESEARCH ETHICS COMMITTEE: THE CASE OF MANAUS HEALTH SYSTEM Translated title: DESENVOLVIMENTO DE UM COMITÊ DE ÉTICA DA INVESTIGAÇÃO: O CASO DO SISTEMA DA SAÚDE DE MANAUS Translated title: DESARROLLANDO UN COMITÉ DE ÉTICA DE INVESTIGACIÓN: EL CASO DEL SISTEMA DE SALUD DE MANAUS

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          Abstract

          The growing complexity of biomedical investigation with human beings generates many conflicts regarding ethical values that add up to the difficulty of fulfilling all the requirements imposed by the legislation on bioethics. Manaus Health City Office (MHCO), in North Brazil, had already had a long time exchange program with local universities which was not managed by a specific sector, so research projects were authorized without further analysis of feasibility, relevance, or a follow-up of its actions within the local health system. In 2008, MHCO created the Research Ethics Commission (RECO). So, is MHCO a field for research? We ought to say yes inasmuch as from the local health system stem subjects and services completely characterizing the health and the city itself. From 2008 to 2011, the number of submitted projects intended to be implemented inside the health establishments was 282, concerning undergraduate and graduate papers. MHCO represents an action of the local government in monitoring research activity in the local health system and, at the same time, catches the attention of public employees as researchers of their own environment of work. This action helps to identify internal problems and shows the impression Manaus society has in relation to the health system.

          Translated abstract

          A crescente complexidade da pesquisa biomédica com seres humanos gera muitos conflitos éticos que contribuem para a dificuldade de satisfazer todas as exigências impostas pela legislação sobre bioética. A Secretaria Municipal de Saúde de Manaus, na região norte do Brasil, já tinha um intercâmbio com universidades locais que não eram geridos por qualquer sector específico, para que os projectos de investigação foram autorizados sem análise de viabilidade ou de relevância e de quaisquer acções de acompanhamento no âmbito do sistema de saúde local. Em 2008, a Secretaria criou o Comitê de ética da pesquisa. E ben, ¿constitui o Secretariado um campo de pesquisa? Deve ser dito que sí, por causa do sistema de saúde local partem assuntos e serviços que caracterizam completamente para a saúde e para a cidade. Entre 2008 e 2011, o número total de projetos apresentados para o trabalho em estabelecimentos de saúde foi 282, do trabalho de graduação e pós-graduação. A Secretaria representa a ação do governo local para monitorar as atividades de pesquisa no sistema de saúde local e, ao mesmo tempo, atrai a atenção dos funcionários públicos, como os pesquisadores em seu próprio ambiente de trabalho. Esta ação ajuda a identificar problemas internamente e revela a maneira em que a sociedade de Manaus vê o sistema de saúde.

          Translated abstract

          La creciente complejidad de la investigación biomédica con seres humanos genera muchos conflictos éticos que se suman a la dificultad de cumplir con todos los requisitos impuestos por una legislación en bioética. La Secretaría Municipal de Salud de Manaus (MHCO, en inglés), en el la Región Norte de Brasil, ya tenía un intercambio con universidades locales que no era gestionado por ningún sector en específico, por lo que los proyectos de investigación se autorizaban sin análisis de viabilidad o relevancia y sin ningún seguimiento de acciones dentro del sistema de salud local. En 2008, la MHCO creó la Co-misión de Ética de la Investigación (RECO, en inglés). Entonces, ¿constituye la MHCO un campo para la investigación? Hay que decir que sí en el sentido de que, del sistema local de salud, parten temas y servicios que caracterizan por completo a la salud y a la ciudad en sí. Entre 2008 y 2011, el total de proyectos presentados para trabajar dentro de los establecimientos de salud asciende a 282, relacionados con trabajos de pregrado y postgrado. La MHCO representa una acción del gobierno local para supervisar las actividades de investigación en el sistema local de salud y, al mismo tiempo, atrae la atención de los empleados públicos como investigadores de su propio entorno laboral. Dicha acción contribuye a identificar problemas a nivel interno y revela la forma en que la sociedad de Manaus ve al sistema de salud. Articulo de reflexión.

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          Mapping African ethical review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa.

          Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa.
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            Nossa História

            (2012)
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              Ethics in Clinical Research: The Indian Perspective

              Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rlb
                Revista Latinoamericana de Bioética
                rev.latinoam.bioet.
                Universidad Militar Nueva Granada (Bogotá )
                1657-4702
                June 2013
                : 13
                : 1
                : 64-73
                Affiliations
                [1 ] Manaus Health City Office (Secretaria Municipal de Saúde de Manaus Brazil
                [2 ] Research Ethics Commission
                Article
                S1657-47022013000100006
                cb2f0e9f-b7aa-406d-bc57-e509940d5387

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Colombia

                Self URI (journal page): http://www.scielo.org.co/scielo.php?script=sci_serial&pid=1657-4702&lng=en
                Categories
                MEDICAL ETHICS

                General medicine
                Bioethics,Government,Human Research,Ethics Committee,Healthcare,Bioética,governo,pesquisa em seres humanos,Comitê de Ética,assistência à saúde,Gobierno,Investigación en humanos,Comités de Ética,Asistencia Sanitaria

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