Professional and academic profile of the Brazilian research ethics committees.

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.

Components of intersectoral partnerships and positive health outcomes in highly vulnerable areas in São Paulo/Brazil: a mixed methods study / Elementos constitutivos das parcerias intersetoriais e resultados positivos de saúde em áreas de alta vulnerabilidade social em São Paulo/Brasil: um estudo misto

Introduction: Studying highly vulnerable areas is challenging, but it can support intersectoral actions to tackle the social inequalities prevalent therein.Objective: This research explores the relationship between the central constituents of intersectoral collaborations and the positive results of intersectoral actions in areas of high social vulnerability in São Paulo, Brazil. It also analyzes the perception of professionals in basic health units (BHU) regarding the results related to those actions.Methods: This study employed methodological triangulation and the mixed method sequential explanatory strategy. First, we applied an online form validated by face and content for BHU managers. Then, we used the SPSS Statistics software to perform nonparametric tests. Statistical significance was set at p < 0.05, and 95% confidence intervals and phi coefficients were calculated. After identifying the units that carried out intersectoral actions with different partners, we conducted focus groups in four of them with 26 health professionals until saturation. Finally, we integrated quantitative and qualitative data.Results: The bivariate analysis showed that the creation of healthy habits and environmental improvements were associated with the central components of intersectoral partnerships. The content analysis presented steps to elaborate the actions and arrive at the results from the central elements. Integration of the results explained how the results related to the actions were elaborated, considering the central elements of the collaborative processes.Conclusions: Partners negotiate with patients or communities to adhere to the care provided through the collaborative process. However, they recognized that they needed to evaluate the proposed actions regularly.

Introdução: Estudar áreas de alta vulnerabilidade é desafiador, mas pode subsidiar ações intersetoriais para o enfrentamento das desigualdades sociais prevalentes nestas.Objetivo: Esta pesquisa explora a relação entre os constituintes centrais das colaborações intersetoriais e os resultados positivos das ações intersetoriais em áreas de alta vulnerabilidade social em São Paulo, Brasil. Também analisa a percepção dos profissionais das Unidades Básicas de Saúde sobre os resultados relacionados a essas ações.Método: Aplicamos uma triangulação de métodos. A estratégia explicativa sequencial de método misto foi utilizada seguindo os seguintes passos: Primeiramente, aplicamos um formulário online validado por face e conteúdo para gestores de UBS, e 60,7% dos gestores responderam. Utilizou-se o software SPSS Statistic para realizar o teste não paramétrico. Valores de p <= 0,05 foram considerados estatisticamente significantes. O intervalo de confiança de 95% e o coeficiente Phi também foram calculados. Após identificar as Unidades que realizavam ações intersetoriais com diferentes parceiros, realizamos grupos focais em quatro delas com a participação de 26 profissionais de saúde até a saturação. Por fim, integramos os dados quantitativos e qualitativos.Resultados: A análise bivariada mostrou que a criação de hábitos saudáveis e melhorias ambientais estiveram associadas aos elementos centrais que constituem as parcerias intersetoriais com significância estatística (p <= 5). A análise de conteúdo apresentou os passos para elaborar as ações e chegar aos resultados a partir dos elementos centrais. Ao integrar os resultados, respondemos como foram elaborados os resultados relacionados às ações, considerando os elementos centrais dos processos colaborativos.Conclusão: Os parceiros intersetoriais negociam com os pacientes ou comunidades a adesão aos cuidados sugeridos pelo processo colaborativo. No entanto, reconhecem que precisam avaliar regularmente as ações propostas.

Ethical and legal analysis of scientific research on corpses in Brazil / Análisis ético y legal de la investigación científica con cadáveres en Brasil / Análise ética e jurídica da pesquisa científica sobre cadáveres no Brasil

Abstract Currently there is an increasing interest in publications on the use of corpses for research in Brazil and worldwide. Scientific evidence reveal that these studies have little ethical and regulatory control. In Brazil, the regulation of this subject is scarce and scattered among laws and sublegal normative acts, hindering the knowledge of ethical and legal practices adopted by researchers. This article analyzes the laws and norms for scientific research on corpses in Brazil through a corpus that underlies this type of research. From the 1940-2012 period, we found seven documents of the Brazilian legislation that gather information for ethical and clear research. Finally, we present guidelines and a protocol to be followed by researchers for the development of ethical and legal studies with corpses in Brazil.

Resumen En Brasil y en todo el mundo se observa actualmente un interés creciente por las publicaciones sobre el uso de cadáveres para la investigación. Sin embargo, evidencias científicas revelan que estos estudios tienen poco control ético y regulatorio. En Brasil, la normalización del tema es escasa y dispersa entre leyes y actos jurídicos sublegales, lo que dificulta el conocimiento de las prácticas éticas entre los investigadores. El presente artículo analiza leyes y normas para la investigación científica sobre cadáveres en Brasil utilizando el corpus documental que sustenta este tipo de estudios. Se encontraron siete documentos de la legislación, publicados entre 1940 y 2012, que recopilan información para una investigación ética y clara. Con base en el análisis de estos textos, se presentan pautas y protocolos que deben seguir los investigadores en estudios éticos y legales con cuerpos humanos en Brasil.

Resumo Atualmente há crescente interesse em publicações sobre o uso de cadáveres para pesquisa no Brasil e no mundo. Evidências científicas revelam que esses estudos têm pouco controle ético e regulatório. No Brasil, a normalização do assunto é escassa e dispersa entre leis e atos jurídicos sublegais, o que dificulta o conhecimento das práticas éticas dos pesquisadores. Este artigo analisa leis e normas de pesquisa científica sobre cadáveres no Brasil utilizando corpus documental subjacente a esse tipo de estudo. Entre 1940 e 2012, foram encontrados sete documentos na legislação brasileira que reuniam informações para pesquisas éticas e claras. Por fim, são apresentados diretrizes e protocolos que devem ser seguidos por pesquisadores em estudos éticos e legais com corpos humanos no Brasil.

A aprovação da Resolução CNS nº 510/2016 é um avanço para a ciência brasileira / The approval of Resolution CNS no. 510/2016 is a progress for Brazilian science

Resumo A Resolução nº 510/2016 do Conselho Nacional de Saúde determina diretrizes éticas específicas para as ciências humanas e sociais (CHS) e é resultado de anos de trabalho de pessoas e instituições que há muito apontavam a inadequação de uma única orientação de cunho biomédico para pesquisas em diferentes áreas. Discutem-se aqui as principais diferenças entre a pesquisa em CHS e a pesquisa biomédica. A disputa pelo poder de definir o que é ciência caracteriza o campo científico, no qual não cabe a interferência do sistema de Comitês de Ética em Pesquisa/Comissão Nacional de Ética em Pesquisa, cuja missão é a proteção do participante de pesquisa. Comentam-se seis mudanças que a Resolução nº 510/2016 traz. Observa-se que as normas brasileiras sobre ética em pesquisa ainda são restritas. No âmbito internacional, vários códigos de ética são mais abrangentes. A Noruega dispõe de diretrizes específicas para as ciências sociais, humanas, jurídicas e teológicas, que contemplam o valor e a função social da pesquisa; os interesses da sociedade; a necessidade da liberdade para investigar; o papel e os interesses dos gestores acadêmicos; os princípios e os interesses dentro das comunidades científicas, inclusive em suas relações com os estudantes; a responsabilidade das agências de financiamento; as consequências dos resultados das pesquisas; e a popularização da ciência.

Abstract The Brazilian National Health Council's Resolution no. 510/2016 states the specific ethical procedures for social science and humanities (SSH) research. It is the result of many people's work who, for a long time, have been arguing the inadequacy of one single strictly biomedical set of guidelines supposed to be applied in all areas. The main differences between SSH research and biomedical research are discussed in this article. The fight for the power to state what science is characterizes the scientific field, in which the interference of the Research Ethics Board/Brazilian Commission on Research Ethics system is not adequate, because the mission of this system is to protect research participants. We discuss six changes brought by Resolution no. 510/2016. Brazilian guidelines on research ethics are prominently narrow. At the international level, many research codes are broader. Norway has specific guidelines for research in Social Science, Humanities, Law and Theology, which include the discussion on research's social value and function; society's interests; the need for academic freedom to conduct research considering ethical procedures; the role and interests of academic managers; principles and interests within academic communities, including their relationship with students; funding agents' responsibility; researches' results consequences; and science popularization.

A equidade racial e a educação das relações étnico-raciais nos cursos de Saúde / La equidad racial y la educación de las relaciones étnico-raciales en los cursos de Salud / Racial equity and education of ethnic-racial relations in Health Care courses

Este artigo discute a prática da implantação da Política Nacional de Saúde Integral para a População Negra por parte dos gestores da educação dos profissionais de Saúde, problematizando a presença da temática "equidade racial em Saúde" no cotidiano das instituições de ensino superior (IESs). Esta pesquisa, composta por entrevistas em profundidade com 12 coordenadores de cursos da área da Saúde de três universidades do Estado de São Paulo, identificou que o novo marco normativo teve efeito positivo no que tange à recepção do tema nas grades curriculares observadas, mas que os coordenadores, no entanto, ainda demonstram desconhecimento ou discordância em relação à sua necessidade.(AU)

Este artículo discute la práctica de la implantación de la Política Nacional de Salud Integral para la Población Negra por parte de los gestores de la educación de los profesionales de Salud, problematizando la presencia del tema "equidad racial en Salud" en el cotidiano de las instituciones de enseñanza superior (IESs). Esta investigación, compuesta por entrevistas en profundidad con 12 coordinadores de cursos del área de la Salud de tres universidades del Estado de São Paulo, Brasil, identificó que el nuevo marco normativo tuvo efecto positivo en lo que se refiere a la recepción del tema en los cuadros curriculares observados, pero que los coordinadores, no obstante, todavía demuestran desconocimiento o discordancia en relación a su necesidad.(AU)

This article discusses the current implementation of the National Policy of Comprehensive Health for the Black Population, by the managers of health professionals' education, with the aim of proposing enhanced presence of the subject "racial equity in Health" in the day to day of higher education institutions (HEI). This research work contains in-depth interviews with 12 different coordinators of Healthcare courses from three universities in the State of São Paulo, Brazil and it has identified that the aforementioned normative frameworks have positively influenced the inclusion of such matters in the observed syllabuses. Nonetheless, those coordinators, in turn, still seem to show lack of knowledge or even disagreement with the mentioned policy.(AU)

Biobanking and Privacy Law in Brazil.

This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, the conclusion summarizes the information in the article and its contribution to the study of the biobanking ethical challenges, especially the protection of privacy. It is highlighted that biobanking regulatory harmonization among countries is necessary, since it increases scientific possibilities that can come from broader cooperation among biobanks and several research centers on the national and international levels.

Research ethics in the dynamic of scientific field: challenges in the building of guidelines for social sciences and humanities.

The development of guidelines on research ethics for social science and humanities (SSH) takes place in the scientific field, marked by disputes aimed at the establishment of hegemonic scientific standard. In Brazil, the National Health Council is responsible for approving these guidelines, which involve certain specificities. Based on the authors' experience in the SSH Working Group of the National Commission on Research Ethics (GT CHS / CONEP), this article presents the process of development of guidelines for SSH, and some its challenges: the distance between the statutory guarantee and the effective execution of guidelines; the biomedical hegemony and the marginal position of the SSH in the CEP / CONEP system; the inadequacy of the current resolution facing the research features in CHS; the use of the concept of risk in guidelines aimed at SSH in the health area. Some interfaces and tensions in the debate between scientific merit and ethical evaluation are also discussed. The analysis highlights important impasses and difficulties regarding inter-paradigmatic dialogue in health research, considered the characteristics of the different traditions, the CONEP's heavily relying on the positivist perspective and the defense of that paradigm hegemony.

Ethics, collective health, qualitative health research and social justice.

The scientific field is characterized by the disputes about the delimitation of the field problems, methods and theories that can be considered scientific. The recognition that it is not neutral, that a researcher is a moral subject, and its practices are moral ones, entail that moral reflections, that is, ethics, should be a core process of every researcher. Therefore ethics is not a heteronomous issue, and cannot be reduced to guidelines. In the first part of this article we examine the need to develop an open approach to the construction of guidelines in a plural scientific field that must take into account diverse paradigms, which implies different values. The Brazilian process of writing guidelines on research ethics for social science and humanities in the context of the Ministry of Health will be discussed as an example. In the second part we expand the analysis of research ethics posing a perspective that integrates qualitative research, social justice and discipline trends. In the final considerations we explore the possibility that research ethics is better discussed taking into account the ontology, epistemology and political values rather than one specific methodological approach or from a dichotomic perspective between biomedicine versus social science and humanities.

Ethics, collective health, qualitative health research and social justice / Ética, Saúde Coletiva, pesquisa qualitativa em saúde e justiça social

AbstractThe scientific field is characterized by the disputes about the delimitation of the field problems, methods and theories that can be considered scientific. The recognition that it is not neutral, that a researcher is a moral subject, and its practices are moral ones, entail that moral reflections, that is, ethics, should be a core process of every researcher. Therefore ethics is not a heteronomous issue, and cannot be reduced to guidelines. In the first part of this article we examine the need to develop an open approach to the construction of guidelines in a plural scientific field that must take into account diverse paradigms, which implies different values. The Brazilian process of writing guidelines on research ethics for social science and humanities in the context of the Ministry of Health will be discussed as an example. In the second part we expand the analysis of research ethics posing a perspective that integrates qualitative research, social justice and discipline trends. In the final considerations we explore the possibility that research ethics is better discussed taking into account the ontology, epistemology and political values rather than one specific methodological approach or from a dichotomic perspective between biomedicine versus social science and humanities.

ResumoO campo científico é caracterizado por disputas sobre a delimitação do campo dos problemas, métodos e teorias que podem ser considerados científicos. O reconhecimento de que o campo científico não é neutro, que o pesquisador é um sujeito moral, e que suas práticas são morais, obriga à reflexão moral, ética, que é central para todo investigador. Portanto ética não é uma questão heterônoma e não pode ser reduzida às diretrizes. Na primeira parte deste artigo examinamos a necessidade de se desenvolver uma abordagem inclusiva para a construção de diretrizes num campo científico plural, que deve considerar os diversos paradigmas, que implicam em diferentes valores. O processo brasileiro de elaboração de diretrizes éticas para pesquisas em ciências humanas e sociais no contexto do Ministério da Saúde será discutido como exemplo. Na segunda parte ampliamos a análise sobre ética nas investigações, propondo uma perspectiva que integra pesquisa qualitativa, justiça social e tendências disciplinares. Nas considerações finais, exploramos a possibilidade de que ética em pesquisa é melhor discutida considerando a ontologia, a epistemologia e os valores políticos ao invés de uma abordagem metodológica específica ou a partir de uma perspectiva dicotômica como biomedicina e ciências humanas e sociais.

Ética em pesquisa na dinâmica do campo científico: desafios na construção de diretrizes para ciências humanas e sociais / Research ethics in the dynamic of scientific field: challenges in the building of guidelines for social sciences and humanities

ResumoA elaboração de diretrizes para a apreciação ética de pesquisas em ciências humanas e sociais (CHS) se efetiva no campo científico, espaço marcado por disputas voltadas ao estabelecimento do padrão hegemônico de cientificidade. No Brasil, cabe ao Conselho Nacional de Saúde aprovar essas diretrizes, o que envolve certas especificidades. Com base na vivência das autoras no Grupo de Trabalho CHS da Comissão Nacional de Ética em Pesquisa (GT CHS/CONEP), este manuscrito apresenta o processo de elaboração de uma resolução para CHS e alguns dos seus desafios: a distância entre a garantia legal e a efetivação de diretrizes; a hegemonia biomédica e a posição marginal das CHS no Sistema CEP/CONEP; a inadequação da atual resolução ante as características da pesquisa em CHS; e o emprego do conceito de risco, em diretrizes voltadas a CHS no espaço da saúde. Discutem-se ainda interfaces e tensões no debate entre mérito científico e avaliação ética. A análise evidencia importantes impasses e dificuldades concernentes ao diálogo interparadigmático na pesquisa em saúde, consideradas as características das distintas tradições, a ancoragem da CONEP na perspectiva positivista e a defesa da hegemonia dessa tradição.

AbstractThe development of guidelines on research ethics for social science and humanities (SSH) takes place in the scientific field, marked by disputes aimed at the establishment of hegemonic scientific standard. In Brazil, the National Health Council is responsible for approving these guidelines, which involve certain specificities. Based on the authors' experience in the SSH Working Group of the National Commission on Research Ethics (GT CHS / CONEP), this article presents the process of development of guidelines for SSH, and some its challenges: the distance between the statutory guarantee and the effective execution of guidelines; the biomedical hegemony and the marginal position of the SSH in the CEP / CONEP system; the inadequacy of the current resolution facing the research features in CHS; the use of the concept of risk in guidelines aimed at SSH in the health area. Some interfaces and tensions in the debate between scientific merit and ethical evaluation are also discussed. The analysis highlights important impasses and difficulties regarding inter-paradigmatic dialogue in health research, considered the characteristics of the different traditions, the CONEP's heavily relying on the positivist perspective and the defense of that paradigm hegemony.

[Reflexivity as the ethos of qualitative research]. / Reflexividade como éthos da pesquisa qualitativa.

This paper seeks to promote reflection on ethics in anthropological and qualitative research and emphasize the comprehensive, relational and reflective character of this process, as well as the advantages and problems that arise from different logic and often conflicting interests between researchers and their interlocutors. The text is divided into four parts and addresses the ethical: (a) significance of these approaches; (b) behavior of the researcher in the field; (c) analysis of the empirical material; and (d) considerations in the preparation of results of anthropological and qualitative studies, using some classic examples from the international literature. The paper concludes by reflecting on the distinction between the requirements of the Ethics Committee and the Ethics of research itself. It must be clear that the comprehensive sense of ethics which includes the responsibility of the researcher cannot be condensed in the instruments required for the judgment of projects because the following elements are involved in the development of research, namely the social significance of the work, the institutional relations with fund providers, how to treat staff and research students in academic work and commitments with the scientific community.

Reflexividade como éthos da pesquisa qualitativa / Reflexivity as the ethos of qualitative research

Este ensaio, cuja finalidade é subsidiar a reflexão sobre a ética em pesquisa antropológica e qualitativa, busca ressaltar o caráter compreensivo, relacional e reflexivo desse processo, assim como as vantagens e os problemas que advêm das lógicas diferentes e, muitas vezes, dos interesses conflitantes entre o pesquisador e seus interlocutores. O texto se divide em quatro partes e contempla: (a) o sentido ético dessas formas de abordagem; (b) o comportamento ético do pesquisador no campo; (c) a ética na análise do material empírico; (d) cuidados éticos na elaboração dos resultados de estudos antropológicos e qualitativos, valendo-se de alguns exemplos clássicos da literatura internacional. O texto conclui refletindo sobre a distinção entre as exigências dos Comitês de Ética e a Ética da pesquisa propriamente dita: é preciso ter claro que o sentido abrangente da ética que inclui a responsabilidade do pesquisador não pode ser condensado nos instrumentos exigidos para julgamento dos projetos porque estão em jogo, além do desenvolvimento da pesquisa, o sentido social do trabalho, as relações institucionais com os financiadores, a forma de tratar a equipe de pesquisa, os estudantes nela incluídos e os compromissos com a comunidade científica.

This paper seeks to promote reflection on ethics in anthropological and qualitative research and emphasize the comprehensive, relational and reflective character of this process, as well as the advantages and problems that arise from different logic and often conflicting interests between researchers and their interlocutors. The text is divided into four parts and addresses the ethical: (a) significance of these approaches; (b) behavior of the researcher in the field; (c) analysis of the empirical material; and (d) considerations in the preparation of results of anthropological and qualitative studies, using some classic examples from the international literature. The paper concludes by reflecting on the distinction between the requirements of the Ethics Committee and the Ethics of research itself. It must be clear that the comprehensive sense of ethics which includes the responsibility of the researcher cannot be condensed in the instruments required for the judgment of projects because the following elements are involved in the development of research, namely the social significance of the work, the institutional relations with fund providers, how to treat staff and research students in academic work and commitments with the scientific community.

O desafio de revisar aspectos éticos das pesquisas em ciências sociais e humanas: a necessidade de diretrizes específicas / The challenge of reviewing ethical aspects of social and human research: the need for specific guidelines

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.

Masculinidades e prevenção do HIV / Masculinities and HIV prevention

Este artigo discute concepções de masculinidade e sua influência na vulnerabilidade ao HIV. Os homens participantes deste estudo consideram como característica masculina ser um bom provedor financeiro, sexual e afetivo. A sexualidade masculina é considerada intensa e requerente de satisfação imediata. Segundo esse paradigma, um homem deve ter uma resposta sexual imediata e estar sempre pronto para uma mulher que se coloque disponível. A decisão do número de filhos cabe à mulher, assim como a contracepção. Ser homem é não ser homossexual ­ entendido como aquele que é o passivo na relação sexual. O uso da camisinha é inconcebível numa relação estável, e as razões que motivam o uso são apenas a curiosidade e a necessidade de evitar uma gravidez. Nenhum dos participantes afirmou ter utilizado a camisinha para prevenir DST/Aids. Os homens que usam camisinha em todas as relações sexuais assumiram para si a responsabilidade de evitar uma gravidez, o que poderia resultar em pagar pensão. Assim, apresenta-se como uma boa opção associar prevenção das DST/Aids e anticoncepção. Os dados analisados reforçam a necessidade de se considerarem as concepções sobre masculinidade existentes na sociedade para o desenvolvimento de ações eficazes destinadas à saúde dos homens.

The need for adequate ethical guidelines for qualitative health research.

This paper discusses adequacy as to the application of Brazilian guidelines, Resolution 196/96(1) and complementaries to qualitative health researches, considering that these are based on non-positivistic paradigms. Frequently, decisions about the research are made together with the studied community. There is a concern with justice and social change. And, since subjectivity can be considered their privileged instrument, such researchers seek a balance between objectivity and subjectivity, discussing how to overcome the researcher's view. We have studied the application and the concept of research found in international and in the Brazilian guidelines. We have noticed that they adopt a positivist conception of research, which establishes 1) the hypothesis test, 2) that all procedures are previously defined by the researcher; 3) neutrality of the researcher and of the knowledge produced. We will present some characteristics of qualitative research; the ethical implications in the way as qualitative research is conceived in non-positivist paradigms and a brief history of these guidelines. Our conclusion: it is inadequate to analyze qualitative researches using these documents, and we suggest the design of specific guidelines for them.

[Synthesis of the reflections of the meeting on ethics in qualitative health research, Guarujá, São Paulo State]. / Síntese das reflexões da reunião sobre ética em pesquisa qualitativa em Saúde, Guarujá, SP.

This article presents a synthesis of the report collectively elaborated in the meeting on Ethics in Qualitative Health Research, which took place in Guarujá, São Paulo State, from August 28 to 30, in 2006. The meeting was organized by the Ethical Committee of the Municipal Health Office of São Paulo, supported by the Special Programme for Research and Training in Tropical Diseases (TDR), sponsored by UNICEF/UNDP/World Bank/WHO and stressed the need to review the Brazilian guidelines for the analysis of the ethical aspects of qualitative health research.