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The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

RESUMO

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.

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It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1st January 2020 to 20th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

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In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.

Resumen: En la última década, el Paraguay ha presentado avances en el desarrollo de la investigación relacionada con la salud con seres humanos. Sin embargo, existe una obligación estatal de asegurar que las investigaciones sean realizadas éticamente: protegiendo la dignidad, los derechos y el bienestar de los participantes, la integridad científica y la adherencia a pautas éticas locales e internacionales. Los comités de ética de la investigación institucionales constituyen la instancia o recurso principal para garantizar la mencionada obligación. Ante lo expuesto y el contexto carente de adecuada regulación en el cual actualmente se desarrollan las investigaciones en el país, en el presente artículo defenderemos el imperativo ético de establecer un sistema de acreditación de los comités de ética de la investigación. Para ello, expondremos y justificaremos su necesidad y buscaremos responder algunas objeciones relativas al imperativo ético defendido, como, por ejemplo, el valor per se de la acreditación de los comités de ética en investigación en la protección de los participantes, la inversión de tiempo y burocracia que implican los procesos de acreditación y el marco regulatorio incipiente para las investigaciones en seres humanos en el Paraguay. Finalmente, propondremos el fortalecimiento de la gobernanza de la ética de la investigación en el país, como medio principal para establecer, implementar y supervisar un sistema de acreditación de los comités de ética de la investigación. Palabras clave: comité de ética en investigación; acreditación de los comités de ética de la investigación; investigación relacionada con la salud con seres humanos; protección de los sujetos de estudio en las investigaciones; pautas éticas internacionales; gobernanza de la ética de la investigación. Resum: A l'última dècada, el Paraguai ha presentat avenços en el desenvolupament de la recerca relacionada amb la salut amb éssers humans. Tot i això, hi ha una obligació estatal d'assegurar que les investigacions siguin realitzades èticament: protegint la dignitat, els drets i el benestar dels participants, la integritat científica i l'adherència a pautes ètiques locals i internacionals. Els comitès d'ètica de la investigació institucionals constitueixen la instància o el recurs principal per garantir l'obligació esmentada. Davant del que s'ha exposat i el context sense regulació adequada en el qual actualment es desenvolupen les investigacions al país, en aquest article defensarem l'imperatiu ètic d'establir un sistema d'acreditació dels comitès d'ètica de la investigació. Per això, exposarem i justificarem la seva necessitat i buscarem respondre algunes objeccions relatives a l'imperatiu ètic defensat, com, per exemple, el valor perseguit de l'acreditació dels comitès d'ètica en recerca en la protecció dels participants, la inversió de temps i burocràcia que impliquen els processos d'acreditació i el marc regulador incipient per a les investigacions en éssers humans al Paraguai. Finalment, proposarem l'enfortiment de la governança de l'ètica de la investigació al país com a mitjà principal per establir, implementar i supervisar un sistema d'acreditació dels comitès d'ètica de la investigació. Paraules clau: comitè d'ètica en investigació; acreditació dels comitès d'ètica de la investigació; investigació relacionada amb la salut amb éssers humans; protecció dels subjectes d'estudi a les investigacions; pautes ètiques internacionals; governança de l'ètica de la investigació.

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BACKGROUND: Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC's Chairs to compose their membership. METHODS: All 779 Brazilian RECs' chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. RESULTS: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. CONCLUSION: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC's specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

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Abstract: Objective: To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. Materials and methods: The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). Results: Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. Conclusions: Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research.

Resumen: Objetivo: Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos: Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados: Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones: Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación.

RESUMO

Propósito/Contexto. En este artículo expondremos los diferentes tipos de comités de bioética y realizaremos un recorrido por su historia para luego adentrarnos en el rol de enfermería dentro de estos espacios. Metodología/Enfoque. Los comités de bioética son organismos que abordan aspectos dilemáticos de orden moral que se presentan en las ciencias de la salud, las ciencias biológicas y las políticas de salud innovadoras. Si bien la conformación debería ser multidisciplinar, con el objetivo de tener un enfoque amplio frente a las situaciones que se presentan, en la práctica no siempre sucede esto. Nos enfocaremos en analizar cómo es la experiencia de estos profesionales dentro de los comités y cuáles son las barreras que se encuentran al querer formar parte de estos equipos. Resultados/Hallazgos. Entre los hallazgos se encuentran las dificultades para la participación de los enfermeros en los comités por falta de tiempo, reconocimiento y apoyo institucional, de los compañeros y de los superiores, falta de formación específica y confusión entre problemas éticos y legales. También se encontró dispersión en la legislación argentina sobre el tema. Discusión/Conclusiones/Contribuciones. Es necesario ganar un mayor reconocimiento y apoyo por parte de las instituciones y de los colegas y superiores para que la participación de los profesionales en enfermería pueda ser efectiva.

Purpose/Context. This article presents different types of bioethics committees, looks through their history, and delves into the role of nursing in these settings. Methodology/Approach. Bioethics committees deal with moral dilemmas arising in health sciences, biological sciences, and innovative health policies. While their structure should be multidisciplinary for a broad approach to emerging situations, it does not always happen in practice. We will focus on analyzing what nurses' experience is like within committees and the barriers they face when joining these teams. Results/Findings. We found difficulties in the participation of nurses in committees due to a lack of time, recognition, and support by institutions, colleagues, and superiors, no specific training, and confusion between ethical and legal issues. A dispersion was also detected in Argentine legislation on the subject. Discussion/Conclusions/Contributions. Greater recognition and support from institutions, colleagues, and superiors is necessary for the participation of nursing professionals to be effective.

Objetivo/contexto. Neste artigo exporemos os diferentes tipos de comitês de bioética e realizaremos um percurso por sua história para logo adentrar-nos no rol de enfermagem dentro destes espaços. Metodologia/Abordagem. Os comitês de bioética são organismos que abordam aspectos dilemáticos de ordem moral que se apresentam nas ciências da saúde, nas ciências biológicas e nas políticas de saúde inovadoras. Embora a conformação deveria ser multidisciplinar, com o objetivo de ter uma abordagem ampla diante das situações que se apresentam, na prática nem sempre isso acontece. Vamos nos concentrar em analisar como é a experiência destes profissionais dentro dos comitês e quais são as barreiras diante das que se encontram ao querer fazer parte destas equipes. Resultados/Descobertas. Entre as descobertas encontram-se as dificuldades para a participação dos enfermeiros nos comitês por falta de tempo, reconhecimento e apoio institucional, dos companheiros e dos superiores, falta de formação específica e confusão entre problemas éticos e legais. Também encontrou se dispersão na legislação argentina sobre o tema. Discussão/Conclusões/Contribuições. É necessário ganhar um maior reconhecimento e apoio por parte das instituições e dos colegas e superiores para que a participação dos profissionais de enfermagem possa ser efetiva.

RESUMO

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.

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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.

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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.

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Resumo: Considerando a importância do trabalho desenvolvido pelos Comitês de Ética em Pesquisa (CEPs) e sua implicação com a própria história da formação da bioética, o objetivo deste artigo é analisar as fontes de informação sobre os Comitês de Ética em Pesquisa envolvendo seres humanos presentes na Scientific Eletronic Library Online (SciELO), a fim de mapear os principais aspectos do campo nesta área. Trata-se de pesquisa exploratória descritiva com técnica de análise de revisão sistemática para coleta de dados. Foram recuperados 137 resumos, dos quais foram analisados 41. Pela análise dos dados, verifica-se que há uma intensificação nas publicações sobre este tema a partir de 2010, não apresentando uma clara concentração num periódico específico. A maior parte dos estudos é de cunho teórico e varia entre análises exploratórias de orientação descritiva sobre o papel dos CEPs e críticas sobre a forma em que estes elaboram seus pareceres. Observa-se uma intensificação do debate em relação à análise das pesquisas sociais. Nesse sentido, quatro questões nos parecem marcantes: (a) a ingerência promovida pelos CEPs em relação ao método das pesquisas; (b) a questão da análise ética das pesquisas oriundas das ciências humanas não pode ser vista como uma relação de inclusão ou exclusão; (c) a burocratização dos CEPs; e (d) a questão em relação à necessidade de acreditação dos CEPs.

Abstract: Considering the importance of the work developed by the Research Ethics Committees (REC) and their involvement with the history of bioethics training itself, the objective of this article is to analyze the sources of information on the Research Ethics Committees that involve human beings present in the Scientific Electronic Library Online (SciELO), in order to map the main aspects of the field in this area. This is a descriptive exploratory investigation with systematic review analysis technique for data collection. 137 abstracts were retrieved, of which 41 were analyzed. By analyzing the data, it is verified that there is an increase in the publications on this subject as of 2010, not presenting a clear concentration in a specific newspaper. A large part of the studies is theoretical and varies between exploratory analysis of descriptive guidance on the role of the RES and criticisms on how they prepare their opinions. There is an intensification of the debate regarding the analysis of social research. In this sense, four points seem important to us: (a) the interference promoted by the CIS in relation to the research method; (b) the ethical analysis of the investigations of the human sciences cannot be seen as a relation of inclusion or exclusion; (c) the bureaucratization (burocratização) of the RES; and (d) the need for accreditation of the RES.

Resumen: Considerando la importancia del trabajo desarrollado por los Comités de Ética en Investigación (CEI) y su implicación con la propia historia de la formación de la bioética, el objetivo de este artículo es analizar las fuentes de información sobre los Comités de Ética en Investigación que involucran seres humanos presentes en el Scientific Eletronic Library Online (SciELO), con el fin de mapear los principales aspectos del campo en esta área. Se trata de una investigación exploratoria descriptiva con técnica de análisis de revisión sistemática para la recolección de datos. Fueron recuperados 137 resúmenes, de los cuales se analizaron 41. Por el análisis de los datos, se verifica que hay una intensificación en las publicaciones sobre este tema a partir de 2010, no presentando una clara concentración en un periódico específico. Gran parte de los estudios es de carácter teórico y varía entre análisis exploratorios de orientación descriptiva sobre el papel de los CEI y críticas sobre la forma como estos elaboran sus pareceres. Se observa una intensificación del debate en relación al análisis de las investigaciones sociales. En este sentido, cuatro puntos nos parecen importantes: (a) la injerencia promovida por los CEI con relación al método de las investigaciones; (b) el análisis ético de las investigaciones oriundas de las ciencias humanas no puede ser visto como una relación de inclusión o exclusión; (c) la burocratização de los CEI; y (d) la necesidad de acreditación de los CEI.

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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.

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En este artículo se describen algunas de las dificultades presentadas cuando se postulan, para su evaluación y aval de parte del comité de ética, proyectos de investigación de áreas del conocimiento con lenguajes y lógicas que se alejan de la investigación clínica. Se presentan dos casos, cuyos objetos de conocimiento tienen epistemologías disímiles a los que usualmente se deliberan en estas instancias. El primero trata de una instalación de arte que permitió el estudio del vínculo afectivo entre seres humanos y ratones de laboratorio. Se analizan las solicitudes puntuales de parte del comité de ética y las respuestas emitidas por la artista para obtener su aprobación. El segundo consiste en la introducción de la planta invasora Tá m ar i x spp en el ecosistema ribereño de los Estados Unidos, convirtiéndose en el sitio de anidamiento del ave atrapamoscas Empidonax trailii extimus en peligro de extinción. Este fenómeno suscitó cuestiones éticas desafiantes para los restauradores ecológicos en su búsqueda por el significado de lo natural. Se concluye que los comités de ética podrían acoger la perspectiva de los conocimientos situados de Donna Haraway y la teoría del actor-red de Bruno Latour, que sugieren que, en el afán de alcanzar una universalidad, la ciencia ha tendido a buscar una estandarización reduccionista de la diversidad de significados.

This article describes some of the difficulties when a research project pertaining to knowledge areas with languages and logics that are distant from clinical research is submitted to an ethics committee for its evaluation and approval. Two cases, with different knowledge object epistemologies to the ones usually deliberated in those instances are presented. The first case deals with an art installation that allowed the study of the link of affection between human beings and lab mice. The ethics committee's punctual requests and the answers given by the artist are analyzed in order to get its approval. The second case describes the introduction of the invasive species plant Tamarix spp in the riparian ecosystem of the United States, becoming the nesting site of an endangered flycatcher bird Empidonax trailii extimus. This phenomenon prompted challenging ethics issues for the ecological restorationists in their search for the meaning of the natural. The authors conclude ethics committees should welcome Donna Haraway's situated knowledges perspective and Bruno Latour's actor-network theory suggesting that in the pursue of reaching a universality, science has tended to standardize diverse meanings in a reductionist way.

Este artigo descreve algumas das dificuldades apresentadas quando elas são postuladas, para avaliação e aprovação por parte do comitê de ética, projetos de pesquisa nas áreas de conhecimento com linguagens e lógicas que se desviam da pesquisa clínica. Apresentamos dois casos, cujos objetos de conhecimento têm diferentes epistemologias que são geralmente discutidas nestes casos. A primeira é uma instalação de arte que permitiu o estudo sobre o vínculo emocional entre os seres humanos e ratos. Analisa solicitações de parte específica do Comitê de ética e as respostas emitidas pelo artista para aprovação. A segunda é a introdução da planta invasora Tamarix spp no ecossistema costeiro dos Estados Unidos, tornando-se o lugar da nidificação da ave papa-moscas Empidonax trailii extimus em perigo de extinção. Este fenômeno suscitou questões éticas desafiadoras para os restauradores de ecossistemas em sua busca pelo significado do natural. Conclui-se que os comitês de ética poderiam adoptar a perspectiva de conhecimento situado de Donna Haraway e a teoria ator-rede de Bruno Latour, que sugerem que, no esforço para atingir a universalidade, a ciência tem tendido a procurar uma padronização reducionista da diversidade do significados.

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Los errores históricos en investigación médica llevaron al mundo a la creación de los comités de ética en investigación en salud (CEI), organizaciones pluri y multidisciplinarias conformadas por profesionales de variadas competencias, especialidades y formas de pensamiento, cuya función es evaluar proyectos de investigación y su ejecución, con independencia para garantizar la protección de los participantes e integridad científica. El presente artículo realiza una reflexión sobre la independencia de los comités, que se fundamenta en las categorías independencia, libertad y autonomía, en los principios bioéticos de Beauchamp y Childress, de Maliandi y Thüer aplicados a los CEI y publicaciones que han tratado el tema. Sobre la independencia de los comités, se concluye su importancia, la cual está relacionada con los miembros de los CEI, investigadores, financiadores, entes reguladores, e instituciones a las que pertenecen los CEI ­educativas, de salud o centros de investigación públicos y privados­, con metas asociadas a investigaciones, publicaciones y contratos para evaluación de proyectos. Si bien es cierto que hay compromiso institucional de respaldo a la independencia de los CEI, es necesario revisar cómo funciona en la realidad, cómo se relaciona con dilemas bioéticos, cómo se articula con los principios de respeto a la autonomía­individualidad, justicia­universalidad, no maleficencia­conservación y beneficencia­realización con la ética convergente y cuál es el concepto de expertos que han investigado sobre el particular. Conclusión: En la actualidad no es posible garantizar la independencia de los CEI, para lo que se deben definir medidas y estrategias adicionales que la fortalezcan.

The historical errors in medical research led the world to create research ethics committees in Health (REC), pluri and multidisciplinary organizations conformed by professionals with variate skills, specializations and forms of thinking, oriented to evaluate research projects and follow-up its develop, with independence, focused to guarantee subject's protection and the safety, and scientific integrity. This article reflects about committee's independence, supported on categories independence, freedom and autonomy, Beauchamp and Childress's bioethics principles, Maliandi and Thüer, applied to REC and related publications. Regarding the independence of the committees, it's important, and its related to REC members, researchers, sponsors, regulatory entities, and institutions to which the REC belong ­educational, health organizations and governmental and private research centers­, with goals associated with research, publications and contracts to project's assessments. While it is true there is institutional commitment to support the REC's independence, its necessary review how it really works, how its relate to bioethics dilemmas, how it's articulated with the principles of respect for the autonomy-individuality, justice-universality, non-maleficence-conservation and, beneficence-realization with the convergent ethics and the concept of experts who have researched about the subject. Conclusion: At present, it is not possible to guarantee the REC's independence, for these reasons, should be defined as additional measures and strategies to strengthen its independence.

Os erros históricos na pesquisa médica forçaram o mundo a criar Comitês de Ética em Pesquisa em Saúde (CEP), que são organizações multidisciplinares conformado por profissionais de variadas habilidades, especialidades e modos de pensar, cuja função é avaliar projetos de pesquisa, e sua execução, independentemente, para garantir a proteção dos participantes e a integridade científica. Este artigo reflete sobre a independência dos comitês, com base nas categorias independência, liberdade e autonomia nos princípios bioéticos de Beauchamp e Childress, de Maliandi e Thüer, aplicados ao CEP e publicações que abordaram o tema. Quanto à independência dos comitês, conclui-se a sua importância, relacionada aos membros do CEP, pesquisadores, financiadores, entidades reguladoras e instituições pertencentes ao CEP ­ centros de pesquisa educacionais, de saúde ou públicos e privados ­, com metas associadas pesquisas, publicações e contratos para avaliação de projetos. Embora seja verdade que existe um compromisso institucional real de apoiar a independência do CEP, é necessário rever a forma como funciona na realidade, no que se refere aos dilemas bioéticos, articulados com os princípios do respeito à autonomia-individualidade, justiça-universalidade, não-maleficência - conservação e beneficência-realização com convergência ética e com o conceito de especialistas que investigaram o assunto. Conclusão: Atualmente não é possível garantir a independência do CEP, para o qual devem ser definidas medidas e estratégias adicionais para fortalecer a independência das CEP.

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Objective: To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Methods: Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. Results: CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). Conclusions: We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013).

Objetivo: Evaluar algunas variables sobre la calidad metodológica y ética de los ensayos clínicos publicados en 10 revistas de medicina de familia. Métodos: Estudio descriptivo de calidad sobre 10 revistas de medicina de familia incluyendo ensayos clínicos en humanos publicados entre 2010 y 2013. Obtuvimos 141 ensayos clínicos y fueron excluidos 2447. Resultados: Ensayos clínicos controlados paralelos en el 92,9% (intervalo de confianza del 95% [IC 95%]: 92.0-93.9). Aleatorización enmascarada en el 72.3% (IC 95%: 71.7-73.1), descentralizada en el 51.8% (IC 95%: 51.4-52…4) y utilizando como control un tratamiento activo el 82.2% (IC 95%: 81.5-83.1). Consentimiento informado escrito en el 48.9% (IC 95%: 48.5-49.5) y no fue retirado en el 56.0% (IC 95%: 55.5-56.7). En 134 ensayos clínicos se contó con la aprobación por un comité ético de investigación clínica (CEIC), y en 117 no hubo conflicto de intereses. Se obtuvo un κ medio de 0,96 (IC 95%: 0.93-0.99). Conclusiones: Observamos, tras considerar las normas CONSORT, un aumento en algunas variables de calidad, como la aleatorización enmascarada (19.6%) y la aprobación por un CEIC (75%), en los ensayos clínicos publicados en 10 revistas de medicina de familia (2010-2013).

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Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting (done with speed and efficiency) ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees (RECs), and developed a template for expediting review of research protocols in epidemic and emergency conditions.

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As diretrizes brasileiras sobre ética em pesquisas com seres humanos são um conjunto de 11 resoluções do Conselho Nacional de Saúde (CNS). A Resolução nº 196/96 era a mais antiga até 13 de junho de 2013, quando a Resolução 466/12 entrou em vigência, ambas se dirigem a pesquisas em qualquer área do conhecimento. Pesquisadores das ciências sociais e humanas têm encontrado dificuldade na aprovação das suas pesquisas pelo sistema formado pelos Comitês de Ética em Pesquisa (CEP) e pela Comissão Nacional de Ética em Pesquisa (CONEP), ainda que esses projetos não tenham problemas éticos. O cerne da questão está em que a Resolução nº 196/96 considera apenas a pesquisa biomédica e não dialoga com outras tradições de pesquisa. Entretanto, como seu âmbito de abrangência inclui todas as pesquisas com seres humanos, esse sistema a adota por referência e coloca questões inadequadas, que demonstram desconhecimento das metodologias qualitativas, muito utilizadas nas ciências sociais e humanas. Considerando que a Resolução 466/12 mantém a mesma lógica da Resolução 196/96, este texto discute as raízes históricas da Resolução nº 196/96, apresenta algumas dificuldades que esses pesquisadores vêm enfrentando com o sistema CEP-CONEP e aponta as inadequações da definição de pesquisa e dos procedimentos que as diretrizes brasileiras estabelecem para a revisão ética das pesquisas qualitativas em saúde. A Resolução 466/12 coloca possibilidade de uma resolução específica para ciências sociais e humanas que, se acompanhada de capacitação permanente dos membros do Sistema CEP/CONEP, pode melhorar essa situação.

The Brazilian guidelines on ethics in human research are made up of 11 resolutions of the National Health Council (CNS). The Resolution 196/96 was the oldest one until June 2013, when the Resolution 466/12 was enforced, and was applied to human research in all areas. Researchers from social and human sciences are facing difficulties to have their projects approved by the system made up of the Committees on Ethics in Research (CEP) and the National Commission on Ethics in Research (CONEP), even when these projects have no ethical problems. The key question is that the Resolution 196/96, and Resolution 466/12, considers only the biomedical research and does not dialogue with other research traditions. However, because its scope is all human research, this system based on this resolution asks inadequate questions, that show the lack of knowledge about qualitative research - which is very popular among social and human research. Considering that Resolution 466/12 kept the same logic of Resolution 196/96, this paper discusses the historical roots of Resolution 196/96, presents some difficulties that researchers have been facing with CONEP-CEPs system and points out the inadequacy of the research definition and the procedures established by the Brazilian guidelines to the ethical revision of qualitative research. Specific guidelines for social sciences and humanities are necessary, as well as the permanent qualification of the CEP and CONEP members. Although the Resolution 466/12, enforced in June 13, 2013, does not move in this direction, it opens the possibility to have specific resolution to socials and human sciences that, if in addition to permanent capacity building of members of the system CEP/CONEP, can improve this situation.

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INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students' research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. CONCLUSION: Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol.

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INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5 percent concerned research with new drugs, vaccines and diagnostic tests, 48.5 percent consisted of undergraduate students' research projects, 68.9 percent of the research had no sponsorship, and 97.5 percent were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2 percent), lack of information about the protocol at the informed consent form (25.8 percent), as well as doubts regarding methodological and statistical issues of the protocol (77.1 percent). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. CONCLUSION: Among the ...

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