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1.
In. Roitman, Adriel Jonas. Ética en investigación: Nuevos desafíos, ¿viejos dilemas?. Ciudad de Buenos Aires, Gobierno de la Ciudad de Buenos Aires. Ministerio de Salud. Dirección General de Docencia, Investigación y Desarrollo Profesional, jun. 2023. p.15-17.
Monography in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1437702

ABSTRACT

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.


Subject(s)
Ethics Committees, Research/organization & administration , Ethics Committees, Research/statistics & numerical data , Health Services Research/organization & administration , Hospitals, Pediatric/trends , COVID-19
2.
In. Roitman, Adriel Jonas. Ética en investigación: Nuevos desafíos, ¿viejos dilemas?. Ciudad de Buenos Aires, Gobierno de la Ciudad de Buenos Aires. Ministerio de Salud. Dirección General de Docencia, Investigación y Desarrollo Profesional, jun. 2023. p.18-20.
Monography in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1438006

ABSTRACT

Exposición sobre posibles dilemas éticos ante la pandemia Covid-19 desde los comité de ética en investigación, en relación a la validación de resultados y distribución de diferentes vacunas, y a los criterios objetivos en la toma de decisiones con respecto a las conductas médicas aprobadas y permitidas durante la pandemia; de modo tal de crear un protocolo especial para la utilización de las futuras generaciones en contextos similares.


Subject(s)
Ethics Committees, Research/organization & administration , Ethics Committees, Research/trends , Ethics, Research , COVID-19 Vaccines/pharmacology , COVID-19/immunology , Clinical Protocols
3.
In. Roitman, Adriel Jonas. Ética en investigación: Nuevos desafíos, ¿viejos dilemas?. Ciudad de Buenos Aires, Gobierno de la Ciudad de Buenos Aires. Ministerio de Salud. Dirección General de Docencia, Investigación y Desarrollo Profesional, jun. 2023. p.21-24.
Monography in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1438022

ABSTRACT

Se presenta brevemente la evaluación ética de los protocolos presentados durante la pandemia de Covid-19 al Comité Provincial de Bioética de Santa Fe, organismo que regula las investigaciones con seres humanos en esta provincia, articulando esta tarea con los 24 comités de ética acreditados a nivel provincial. Se describen especialmente dos protocolos que fueron observados y en uno de los casos rechazado por el Comité en base a aspectos éticos.


Subject(s)
Clinical Protocols , Ethics Committees, Research/organization & administration , Ethics Committees, Research/trends , COVID-19 Vaccines , COVID-19/immunology , Hydroxychloroquine/therapeutic use
4.
Rev. invest. clín ; 71(5): 297-305, Sep.-Oct. 2019. tab, graf
Article in English | LILACS | ID: biblio-1289699

ABSTRACT

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.


Subject(s)
Humans , Clinical Trials as Topic/methods , Ethics Committees, Research/organization & administration , Drug Industry/economics , Research Support as Topic/economics , Clinical Trials as Topic/economics , Clinical Trials as Topic/ethics , Informed Consent
5.
Gac. méd. Méx ; 155(4): 406-409, jul.-ago. 2019.
Article in Spanish | LILACS | ID: biblio-1286525

ABSTRACT

Resumen La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.


Abstract Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.


Subject(s)
Humans , Ethics Committees, Research/organization & administration , Biomedical Research/ethics , Ethics, Research
6.
Rev. invest. clín ; 71(3): 149-156, May.-Jun. 2019. tab, graf
Article in English | LILACS | ID: biblio-1289682

ABSTRACT

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.


Subject(s)
Humans , Research Design , Ethics Committees, Research/organization & administration , Observational Studies as Topic/ethics , Research Personnel/organization & administration , Registries/ethics , Interviews as Topic/methods , Retrospective Studies , Informed Consent/ethics
7.
Buenos Aires; Ministerio de Salud del Gobierno de la Ciudad Autónoma de Buenos Aires. Dirección General de Docencia, Investigación y Desarrollo Profesional,; 2019. 52 p. ilus.
Monography in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1452300

ABSTRACT

El 25 de octubre de 2018 se realizó el Segundo Encuentro de Comités de Ética en Investigación 2018 "Salud Pública, Innovaciones en Investigación y Perspectivas Éticas", en la sede del Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires. Los objetivos propuestos fueron coordinar acciones para la conformación de redes de conocimiento en investigación traslacional en un marco ético, brindar una actualización en aspectos éticos de nuevos diseños en investigación, traslacional, gestión de datos y muestras biológicas en salud y proponer un espacio de encuentro y diálogo entre los diferentes actores ligados a la investigación en salud. (AU)


Subject(s)
Ethics Committees, Research/organization & administration , Ethics Committees, Research/trends , Ethics Committees, Research/ethics , Ethics, Research , Public Health Systems Research/trends
8.
Buenos Aires; Gobierno de la Ciudad de Buenos Aires. Ministerio de Salud. Dirección General de Docencia, Investigación, y Desarrollo Profesional; 2018. 37 p. ilus.
Monography in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1452185

ABSTRACT

El 9 de mayo de 2018 se realizó el Primer Encuentro de Comités de Ética en Investigación 2018 "Vínculos entre la Comunidad y la Investigación en y para la Salud", en la sede central del Ministerio de Salud de la Ciudad de Buenos Aires. Los objetivos propuestos fueron los de visibilizar problemáticas asociadas al rol del representante de la comunidad en el Comité de Ética en Investigación, identificando barreras y oportunidades para el desempeño de sus funciones; generar un espacio de encuentro entre diferentes actores ligados a la salud de la comunidad y los Comités de Ética en Investigación, para fortalecer el conocimiento interinstitucional y el trabajo mancomunado; y exponer las nuevas pautas CIOMS con énfasis en el rol de representantes de la comunidad en los CEIs. (AU)


Subject(s)
Community Participation/methods , Community Participation/trends , Ethics Committees, Research/organization & administration , Ethics Committees, Research/trends , Ethics Committees, Research/ethics , Ethics, Research , Knowledge Management for Health Research , Public Health
9.
Buenos Aires; s.n; 2018. 28 p.
Non-conventional in Spanish | LILACS, InstitutionalDB, BINACIS, UNISALUD | ID: biblio-1452413

ABSTRACT

Encuentro de investigación realizado en la sede del Ministerio de Salud de la Ciudad de Buenos Aires, basado en tres ejes principales: Políticas públicas de investigación: oportunidades para avanzar en la construcción de una red de conocimiento para la salud; Estrategias para consolidar la gestión del conocimiento en salud en el ámbito público; y Acreditación y supervisión de comités de ética en investigación públicos y privados: oportunidades para el fortalecimiento de la formación en investigación


Subject(s)
Ethics Committees, Research/organization & administration , Ethics Committees, Research/trends , Knowledge Management for Health Research , Public Health Systems Research/instrumentation , Public Health Systems Research/trends , Information Services/trends
10.
Salud colect ; 11(2): 247-260, abr.-jun. 2015. tab
Article in Spanish | LILACS | ID: lil-752675

ABSTRACT

En función de los escasos estudios publicados sobre los comités de ética en investigación (CEI) de Argentina, este trabajo tiene como objetivo describir la estructura y funcionamiento de los CEI de instituciones de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires. Con ese fin, se realizó un estudio descriptivo, cuali-cuantitativo, a partir de la aplicación de una encuesta entre marzo y julio de 2012. La muestra quedó conformada por 46 CEI. El 40% de sus miembros eran médicos y la distribución por sexo y edad se adecuaba a la normativa. Se encontraron falencias en la cantidad de metodólogos, representantes de la comunidad, abogados y miembros externos a las instituciones, falta de personal administrativo y de lugar fijo para las reuniones, presupuestos escasos para gastos y poco entrenamiento en ética de la investigación. Algunos de los encuestados reportaron problemas de relación con la institución y los investigadores, y con el tiempo disponible para realizar la tarea.


Given the few existing studies on research ethics committees (RECs) in Argentina, this paper aims to describe the structure and functioning of institutional RECs in the Autonomous City of Buenos Aires and Greater Buenos Aires. A descriptive, qualitative and quantitative research study was carried out using a survey conducted between March and July 2012. The sample was made up of 46 RECs. Forty percent of committee members were doctors and the age and sex distribution met standards. Inadequate numbers of methodologists, community representatives, lawyers and members external to the institution were identified, as well as shortcomings regarding administrative staff, fixed locations for meetings, budgets adequate to expenditures and training in research ethics. Some of those surveyed reported problems in their relationship with the institution and with researchers, in addition to difficulties regarding the time available to perform tasks.


Subject(s)
Ethics Committees, Research/organization & administration , Argentina , Surveys and Questionnaires , Cities , Ethics Committees, Research/statistics & numerical data , Qualitative Research
11.
Journal of Korean Academy of Nursing ; : 315-322, 2015.
Article in Korean | WPRIM | ID: wpr-120098

ABSTRACT

PURPOSE: This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. METHODS: General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. RESULTS: The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. CONCLUSION: Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.


Subject(s)
Humans , Ethics Committees, Research/organization & administration , Guidelines as Topic , Nursing Research/ethics
13.
Belo Horizonte; s.n; 2013. 87 p. graf, ilus, tab.
Thesis in Portuguese | LILACS, BDENF | ID: lil-713483

ABSTRACT

INTRODUÇÃO: De acordo com a Resolução 196/96 do Conselho Nacional de Saúde brasileiro, Comitês de Ética em Pesquisa (CEP) visam a segurança e proteção de sujeitos de pesquisa. Devem ter condições mínimas para o funcionamento descritas em resoluções brasileiras e complementares, entretanto há carência de informações sobre os perfis destes órgãos no cenário brasileiro para que se busquem meios de aperfeiçoá-los. OBJETIVO: Analisar a organização e funcionamento dos comitês do município de Belo Horizonte(BH). Foram considerados somente os CEP cadastrados no Sistema Nacional de Ética em Pesquisa com situação regular junto à Comissão Nacional de Ética em Pesquisa. METODOLOGIA: Estudo seccional e descritivo, realizado com coordenadores de 23 CEP no município de BH em 2012. Questões relacionadas à infraestrutura, composição, processo de instalação e funcionamento dos CEP foram coletadas por meio de um questionário. Os resultados foram analisados através de estatística descritiva. RESULTADOS: Quanto à infraestrutura, 78,3% dos CEP possuem espaço físico e computador exclusivo e 100% têm acesso à internet. Em relação à composição, são constituídos na grande maioria por médicos, 100% possuem membros da comunidade no colegiado e 52,2% ofereceram algum curso sobre ética e bioética. Foram fundados entre 1996 e 2006, 100% possui regimento interno e ata de reuniões e 52,2% dos entrevistados relataram que os CEPs que coordenam precisam de algum pessoal de apoio. DISCUSSÃO: A maioria dos colegiados têm se dedicado para cumprir o seu papel, apresentando características que são adequadas às resoluções brasileiras. Entretanto, nenhum comitê está isento de aperfeiçoamento. A maioria dos pontos passíveis de melhorias estão relacionados ao apoio institucional. CONCLUSÃO: A organização e funcionamento dos CEP de BH possuem pontos de aperfeiçoamento importantes para a realização de sua função com qualidade. Faz-se necessário a realização de trabalhos que perpassam...


INTRODUCTION: According to Resolution 196/96 of the Brazilian National Health Council, an Institutional Review Board (IRB) has the aim of protect research subjects thus keeping their safety. For its operation as described in the Brazilian resolutions and complementary, minimum pre-establish requirements must be archived. However there is scarcity of information about the profiles of these organs in the Brazilian scenario whose knowledge is essential to their improvement. OBJECTIVE: Analyze the organization and functioning of IRBs of the city of Belo Horizonte. Were considered only the IRBs registered in the National System of Research in Ethics, and with regular status in the National Research in Ethics Council. METHODS: Sectional and descriptive study, conducted with coordinators / deputy coordinators of 23 IRBs in the city of Belo Horizonte in the year 2012. Issues related to infrastructure, composition, process of installation and operation of the IRBs were investigated through a questionnaire. The results were analyzed using descriptive statistics. RESULTS: All the IRBs evaluated were founded between 1996 and 2006, 100% has bylaws and minutes of meetings and 52.2% of the interviewed reported needing some support staff. The vast majority of the member is composed of medical doctors, 100% have community members in the collegiate and 52.2% offered a course on ethics and bioethics; and 78.3% of the IRBs have their own physical space and an exclusive computer, with internet access. .DISCUSSION: Most boards have dedicated themselves to play their role, showing characteristics that are in agreement to the Brazilian resolutions. However, no IRB is exempt improvements, mostly related to the institutional support. CONCLUSION: The organization and operation of the IRBs of the city of Belo Horizonte have important points of improvement in order to perform its function with excellence. Beyond the analysis of the facts, works that have direct impact in the work done...


Subject(s)
Humans , Bioethics , Ethics Committees, Research/organization & administration , Brazil , Surveys and Questionnaires
14.
Rev. argent. salud publica ; 3(11): 6-10, jun 2012. tab
Article in Spanish | LILACS | ID: lil-665101

ABSTRACT

La revisión ética de un protocolo de investigación es un requisito regulador. En Argentina, no se tiene información acerca de cuántos comités de ética en investigación(CEI) existen ni de cómo funcionan. OBJETIVO: Relevar los CEI que actúan en instituciones de la Ciudad Autónoma de Buenos Aires y el conurbano bonaerense, a fin de conocer su funcionamiento y las dificultades que conlleva el monitoreo en campo de los estudios aprobados. MÉTODOS: Se realizó una encuesta semiestructurada a los 38 CEI que accedieron a participar. Los resultados se expresaron en porcentajes para las variables categóricas y en mediana y rango intercuartílico (RIC) 25-75 para las continuas. RESULTADOS: El 65,8% de los CEI tienen al menos 10 años de funcionamiento. El 47,4% de ellos están conformados por 10 o más miembros, en su mayoría médicos. La mayoría de las instituciones no remunera a sus miembros, y ninguna los exime de sus tareas habituales por asistir a las reuniones. El 37,1% de las instituciones suspendió al menos un protocolo por aspectos de seguridad. El 65% de los CEI afirmó tener dificultades para realizar el seguimiento de los protocolos de investigación después de su aprobación. CONCLUSIONES: Existen falencias en cuanto a la composición de los CEI. Por ejemplo, se detectaron demasiados miembros médicos y pocos representantes de la comunidad, metodólogos, etc. También hay dificultades por falta de tiempo, recursos y reconocimiento por parte de los investigadores y de las instituciones en las que se encuentran insertos los CEI. Como consecuencia, en la mayoría de los casos resulta dificultoso el seguimiento en campo de los estudios aprobados


The ethical evaluation of research protocols is a regulatory requirement. In Argentina, there is no information about how many institutional review boards (IRB) exist or how they work. OBJECTIVE:To survey IRB of the Autonomous City of Buenos Aires and its metropolitan area, in order to know how they function and which difficulties arise during the field monitoring of approved studies. METHODS: A semi-structured survey was conducted to the 38 IRB that agreed on participating in the study. Values were expressed as percentages for categorical variables, as median and interquartile range 25-75 for continuous ones. RESULTS: 65.8% of the IRB started working at least 10 years ago. 47.4% consists of 10 or more members, most of them physicians. Most institutions do not remunerate IRB members, which are not exempted in any case from their normal duties to attend meetings. 37.1% of the institutions stopped at least one protocol for security aspects. 65% of IRB had difficulties to track research protocols after approval. CONCLUSIONS:The composition of the IRBs is inadequate. For example, too many members are physicians and not enough of themare community representatives, methodologists, etc. There are also problems related to lack of time, resources and consideration by researchers and institutions. There fore, the field monitoring of approved studies turns to be difficultin most of the cases


Subject(s)
Humans , Bioethics/history , Ethics Committees, Research/organization & administration , Ethics, Research , History of Medicine , Research Policy Evaluation , Data Collection/statistics & numerical data , Surveys and Questionnaires
15.
Rev. peru. med. exp. salud publica ; 27(4): 621-628, dic. 2010.
Article in Spanish | LILACS, LIPECS | ID: lil-573944

ABSTRACT

Se realizó una revisión de los procesos de constitución y funciones de instancias nacionales de la ética de la investigación en salud en países de Latinoamérica y Europa, que se caracterizan por su relación con la legislación y estructuras gubernamentales del ámbito de la salud, pero, sobre todo, por estar vinculados en casi la totalidad de casos con el funcionamiento de los Comités de Ética en Investigación. Sobre la base de dicha revisión se efectúa un balance primicial y perspectivas de la conformación de una Comisión Nacional de Ética de la Investigación en Salud en el Perú.


We performed a review of the constitution processes and functions of national commissions on health research ethics in Latin America and Europe countries, which are characterized by its relation with the legislation and governmental structures in health sector, but, especially, in almost totality of cases for being linked by the functioning of the Research Ethics Committees. On the basis of this review there are realized an initial balance sheet and perspectives of the conformation of a National Commission on Health Research Ethics in Peru.


Subject(s)
Biomedical Research , Ethics Committees, Research/legislation & jurisprudence , Ethics Committees, Research/organization & administration , Peru
17.
Femina ; 37(11)nov. 2009. tab
Article in Portuguese | LILACS | ID: lil-545662

ABSTRACT

O coordenador de estudos clínicos (CEC) é a pessoa responsável pelogerenciamento desse tipo de estudo. Poucos trabalhos científicos têm trazido dados a respeito do papel doCEC nas diferentes especialidades médicas. Este estudo tem como objetivo revisar a literatura e identificar a suafunção. Entre 1997 e 2008, identificaram-se 76 publicações sobre pesquisa clínica envolvendo CEC. Apenas16 referiam-se especificamente às atividades desse profissional. Foram descritos 19 tipos de habilidades, 25subcategorias e 128 diferentes funções de um CEC. Entre elas destacam-se: habilidades clínicas, psicossociais, decomunicação e organizacional e a responsabilidade pelo processo do termo de consentimento livre e esclarecido.Em alguns locais, o CEC escreve protocolos de pesquisas e faz avaliações estatísticas. Para esse trabalho, muitasvezes, há necessidade de disponibilidade em horário integral. A literatura disponível sobre as funções do CEC équase totalmente estrangeira e reduzida. No Brasil, a Sociedade Brasileira de Pesquisa Clínica é responsável porquase todas as publicações existentes. Todavia, muito do que se lê em publicações estrangeiras acerca do papeldo coordenador não corresponde à realidade brasileira.


The Study Coordinator (SC) is the person who is responsible for themanagement of clinical studies. Few scientific studies have shown data about the role of the SC in variousmedical specialties. This article aims to search for and identify the scientific literature regarding the role of theSC. Between 1977 and 2008, 76 publications on clinical research involving SC were identified. Only 13 werespecifically related to the functions of a SC. The activities described included 19 types of skills, 25 subcategoriesand 128 different functions of a SC. Among them, it is possible to mention: clinical, psychosocial, communicativeand organizational skills, as well as the responsibility for the whole process of the informed consent. In someplaces, the SC writes protocols of research and makes statistical evaluations. In order to accomplish this job, theSC often has to be available in full time. The literature that brings information on the role of the SC is almostcompletely foreign and in small number. In Brazil, the Brazilian Society of Clinical Research is responsible foralmost all the existing publication. However, much of what one reads in foreign publications about the role ofthe SC does not correspond to the Brazilian reality.


Subject(s)
Male , Female , Clinical Competence , Ethics Committees, Research/organization & administration , Clinical Trials as Topic/ethics , Organization and Administration , Biomedical Research/organization & administration , Biomedical Research/trends , Research Personnel/organization & administration , Clinical Protocols/standards
19.
Brasília; Ministério da Saúde; 4 ed., rev; 2007. 138 p. (Série A. Normas e Manuais Técnicos (Série CNS Cadernos Técnicos)).
Monography in Portuguese | LILACS, ColecionaSUS, CNS-BR | ID: biblio-1129152

ABSTRACT

Nos últimos anos, mudou significativamente o perfil das pesquisas relacionadas com o campo biomédico no Brasil. Investigações com células-tronco, engenharia genética, novas tecnologias reprodutivas e outros temas relacionados ao acelerado desenvolvimento científico e tecnológico passaram a fazer parte do cotidiano das instituições públicas e privadas que trabalham com o assunto. Inicialmente restritas aos círculos científicos, tais investigações estão hoje agendadas pela mídia e são debatidas por toda sociedade, o que era impensável há alguns anos. As discussões alcançam o Governo, o Legislativo, o Judiciário e a própria população, que, em última análise, é quem recebe os impactos (e os benefícios...) de todo esse vertiginoso processo. Exemplo disso foi a recente polêmica relacionada com a Lei de Biossegurança, que autorizou as pesquisas com células-tronco embrionárias no País. Diferentes setores da sociedade vieram a público manifestar-se favoravelmente ou contra a proposta, com variados argumentos técnico-científicos, éticos, religiosos, etc. O Conselho Nacional de Saúde (CNS) assumiu, há quase duas décadas, a responsabilidade de debater os aspectos éticos relacionados com as pesquisas que envolvem seres humanos. Ao acompanhar essa delicada evolução e ao regulamentar os projetos em desenvolvimento, o CNS tem por objetivo, além de evitar abusos e proteger os sujeitos das pesquisas, contribuir para o desenvolvimento seguro de investigações que possam realmente beneficiar a sociedade brasileira. Desde 1996, o País conta com a Resolução n.º 196/96 do CNS que regulamenta o funcionamento do setor. Por essa Resolução, toda pesquisa em andamento no País e que envolve seres humanos deve necessariamente ser submetida à apreciação de Comitês de Ética em Pesquisa (CEPs), especialmente credenciados, sob a coordenação superior da Comissão Nacional de Ética em Pesquisa (Conep). Esta, além de controlar o sistema nacional avaliador das investigações, analisa casos especiais e tem a responsabilidade crítica de estar constantemente atualizada com relação aos protocolos e às agendas internacionais nesse campo. Dessa forma, o CNS, com o apoio de toda uma complexa estrutura de suporte composta pela Conep e pelos Comitês locais, cumpre sua meta prioritária de assegurar que toda pesquisa com seres humanos no Brasil seja desenvolvida de forma ética e segura, protegendo a integridade e os direitos de cidadãos dos voluntários.


Subject(s)
Humans , Ethics Committees, Research/organization & administration , Ethics, Research , Manuals and Guidelines for Research Management , Ethics Committees, Research/standards , Health Councils/standards , Human Experimentation/standards , Human Experimentation/ethics
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