Aim: Whilst there is a wide range of research that explores ethics guidance and committee perspectives of research ethics processes, there is a lack of research into trainee experiences. The aim of this study was to explore Trainee Clinical Psychologists experience of the research ethics process and provide a platform to those voices. It was hoped that this research may be able to create a deeper understanding of applicants’ experiences, in which both positive and negative experiences of the application process can be shared and explored. This understanding could then potentially support ethics committees, training courses and applicants to work together and thus improve the application process and resulting research at a national level within the context of Clinical Psychology training. Method: This study adopted a qualitative approach in conducting semi-structured interviews with three Trainee and three Newly Qualified Clinical Psychologists who had applied for ethical approval for their Doctoral thesis. Interpretative Phenomenological Analysis (IPA) was used in an attempt to illuminate the lived experience of applying for research ethical approval. Results: From the analytic procedure, three main themes emerged regarding the experience of research ethics processes from participants’ accounts: The emotional intensity and personal impact of the ethics process; Responses to and ways of managing the ethics process; and Challenges within the ethics process. Implications: This study highlights the importance of recognising the impact of the relationships between Trainee Clinical Psychologists, Clinical Psychology training courses and Research Ethics Committees upon trainees’ journey through the research ethics process. A ‘them and us’ dynamic is being maintained by misunderstandings about each other’s roles, uncertainty and stereotyping, amongst other factors. Potential ways to change this dynamic and improve the research ethics process during clinical Psychology Training has been explored.

A precaução com riscos e prejuízos na utilização de instrumentos de pesquisa interacionais, tais como questionários e entrevistas, ainda é muito pequena, visto que, a maioria dos pesquisadores entende que riscos são possibilidades de danos ou agressões ao corpo físico, esquecendo-se que a presença de riscos de ordem moral, emocional ou espiritual pode ocasionar aos participantes da pesquisa prejuízos e, até mesmo, danos a sua saúde mental. Segundo o princípio da não-maleficência proposto por Beauchamp e Childress, o pesquisador tem a obrigação de não infligir danos ou males intencionalmente. Dentro desta perspectiva, uma análise acurada de tais instrumentos de pesquisa deve ser feita, avaliando-se a relação riscos/benefícios. Deve-se também se considerar as precauções quando da inclusão de indivíduos pertencentes a grupos vulneráveis, já que os mesmos apresentam uma maior predisposição a sofrer danos. Estes só poderão ser incluídos na pesquisa se a sua participação for essencial à hipótese que está sendo testada. Um levantamento realizado com protocolos de pesquisa encaminhados a um Comitê de Ética em Pesquisa (CEP), verificou que uma grande parte dos pesquisadores (14; 15,2%) descreveram os riscos de suas pesquisas com questionário ou entrevista, como inexistentes, devido ao fato de se tratar ?apenas de questionamentos?. Contudo, tais instrumentos podem ser tão evasivos e repletos de riscos quanto às experimentações que envolvem o corpo físico. Deste modo, chama-se a atenção para o fato de que a falta de uma análise crítica e uma descrição dos riscos pelo pesquisador pode acarretar a ausência de medidas a serem utilizadas para evitá-los ou minimizá-los, e, até mesmo, a previsão de uma assistência especializada, caso venham a ocorrer. Palavras chave: bioética; ética em pesquisa; risco; redução do dano; método; coleta de dados. / Precaution with risks and damages in the use of interactive research instruments, such as questionnaires and interviews, is still very small, since a majority of researchers understand that risks are possibilities of damage or aggression to the physical body and forget that the presence of moral, emotional or spiritual risks can cause damage to research participants and even damages to their mental health.. According to the nonmaleficence principle proposed by Beauchamp & Childress, researchers are obliged not to cause any intentional harm or damage. Thus, a comprehensive analysis of such instruments of research must be made, evaluating the relation between its risks and benefits. Additional precaution must be considered if vulnerable individuals are to be included in the research, since they are more predisposed to suffer damage. Such individuals could only be included in the research if their participation is essential to the hypothesis that is being tested. A survey carried out using protocols of research that were directed to a Committee of Ethics in Research (CER) verified that a great part of researchers (14; 15.2%) that used questionnaires or interviews in their works hadn?t described any risks in this practice, and if so they were considered ?only questionings\". However, such instruments can be as invasive and full of risks as the experiments involving the physical body. For this reason, we think it?s important to focus on the fact that the lack of a critical analysis and description of the risks by the researcher can cause the absence of measures necessary to prevent them or to minimize them, and, even the forecast of a specialized assistance, in case they occur.

The globalized postmodern world is marked by sharp contrasts arising notably in respect of people s dignity indifferent of the places they inhabit. A continuous increase in the level of requirements aiming at protecting participants in the conduct of research in all fields of knowledge involving human beings is symptomatic, especially in democratic societies. From this viewpoint, research ethics is conceived as a new field of knowledge linking different insights. The objective of this study was to study the concepts of professor researchers in the field of social sciences and humanities at Federal University of Santa Maria (UFSM) on research ethics. The research consisted of an exploratory study with quantitative approach, using a questionnaire in order to obtain the quantitative descriptive survey of opinions of researchers about ethical issues in social sciences and humanities. Our research covered a total of 143 faculty researchers working in 13 different graduating programs at the Center of Social Sciences and Humanities (CCSH) area, involving variables related to the following constructs: Profile of the researchers; Conception regarding Ethics on Human Research; Conception on the need for approval of the Ethics and Research Committee (CEP) in CCSH area; Interest and ease in seeking information regarding Research Ethics. A return rate of 32.5% was obtained in-between results, and a predominance of researchers who do not show a clear conception regarding the ethics in this type of research was observed. It was also evident that most of the participants understood that the submission of projects to the CEP is optional in the field of social sciences and humanities. We have also observed that a significant portion of respondents have never had any interest in seeking information on research ethics, implying that the conception of the subject among researchers is limited; yielding thus a gap that may require hard work to promote, provoke and foment discussion on ethical issues. This discussion may contribute to an effective raising of awareness taking advantage of ethical principles in research involving humans in this area. / No mundo pós-moderno globalizado, marcado por profundos contrastes decorrentes notadamente do grau de respeito à dignidade das pessoas, nos diferentes espaços os quais habitam, é sintomática, especialmente nas sociedades democráticas, uma contínua elevação do grau de exigências voltadas à proteção dos participantes na condução das pesquisas em todas as áreas do conhecimento que envolva seres humanos. Sob este olhar, a ética em pesquisa é concebida como um novo campo do conhecimento interligando diferente saberes. Neste contexto o presente estudo teve como objetivo principal, estudar a concepção dos docentes pesquisadores da área das Ciências Sociais e Humanas da UFSM sobre ética em pesquisa. Constou de uma pesquisa exploratória, com enfoque quantitativo, utilizando-se de um questionário para o levantamento descritivo quantitativo de opiniões de pesquisadores sobre os aspectos éticos na área das ciências sociais e humanas. Abrangeria um total de 143 docentes pesquisadores, os quais atuam nos 13 programas de Pós-Graduação da área do CCSH, envolvendo variáveis relacionadas aos seguintes construtos: Perfil dos pesquisadores; Concepção sobre Ética em Pesquisa com Seres Humanos; Concepção sobre a necessidade de aprovação do CEP na área do CCSH; Interesse e facilidade na busca de informações sobre Ética em Pesquisa. Obteve-se um índice de retorno de 32,5 %, entre os resultados obtidos, destaca-se um predomínio de pesquisadores, que não demonstram uma clara concepção em relação à ética em pesquisa. Evidenciou-se também, que a maioria dos participantes entende que a submissão ao CEP é opcional para os projetos da área das ciências sociais e humanas. Percebe-se ainda, que uma parcela significativa dos respondentes nunca teve interesse em buscar informações sobre ética em pesquisa, dando a entender que a concepção sobre o tema, entre os pesquisadores da área é limitada, originando desta forma, uma lacuna que exigirá um árduo trabalho no sentido de divulgar, provocar e fomentar discussões sobre as questões éticas, o que certamente irá contribuir para uma efetiva conscientização e instrumentalização dos preceitos éticos nas pesquisas que envolvem seres humanos nesta área.

Made available in DSpace on 2014-12-17T15:51:32Z (GMT). No. of bitstreams: 1 FlaviaLSM_DISSERT.pdf: 1575036 bytes, checksum: bd9a6689fff5ecc9afddc0317d8fc5d8 (MD5) Previous issue date: 2012-08-24 / Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior / This study analyzed the perception of ethics on the part of students of Post-graduation in Tourism, to develop their academic research. It is characterized as exploratory-descriptive, being considered quantitative with some elements analyzed qualitatively. Data were collected through an electronic questionnaire, originated in google docs and sent via e-mail to 54 students in three graduate programs in Tourism: The Tourism Master of the Federal University of Rio Grande do Norte (UFRN), the Master in Tourism and Hospitality of the University of Vale do Itajai (UNIVALI) and Master of Tourism at the University of Caxias do Sul (UCS), resulting in 22 responses. The study presents a profile of the dissertation research of post-graduate students, their perception about research ethics, as well as the difficulties encountered in the research process. Notes that research of dissertation are geared mostly for the historical and cultural aspects of tourism and the choice of topics for the essays came in first place, due to the influence of the guiding lines of research and, secondly, due to social relevance. The methods used in post-graduate research are descriptive, the literature and exploratory. It also notes that most students graduate in tourism (81%) attaches great importance to ethics in carrying out their dissertation research, students claim that ethics brings credibility and seriousness to research. Furthermore, it was realized that they have no knowledge about the practice of misconduct by researchers in the field of Tourism. Demonstrate that the major ethical challenge encountered by students is in relationship with the research subject, what happens during data collection. It also notes that none of the respondents sent any project to be evaluated by an Ethics Committee (CEP), moreover, most do not know the resolution 196/96, which has the main guidelines on research ethics at national level. Concludes that the students post-graduate in tourism have little knowledge about the standards and guidelines on research ethics. They demonstrate ignore the benefits of research ethics in regarding the protection and preservation of the participant, as well as the benefits it generates for society / O presente estudo consiste na an?lise da percep??o da ?tica por parte dos discentes de p?s-gradua??o em Turismo, no desenvolvimento de suas pesquisas acad?micas. Caracteriza-se como explorat?rio-descritivo, sendo considerado quantitativo com alguns elementos analisados de forma qualitativa. Os dados foram coletados atrav?s de um question?rio eletr?nico, originado no google docs e enviado via e-mail para 54 alunos de tr?s Programas de p?s-gradua??o em Turismo: o Mestrado em Turismo da Universidade Federal do Rio Grande do Norte (UFRN); o Mestrado em Turismo e Hotelaria da Universidade do Vale do Itaja? (UNIVALI); e o Mestrado em Turismo da Universidade de Caxias do Sul (UCS), obtendo-se 22 respostas. O estudo apresenta o perfil das pesquisas de disserta??o dos alunos de p?s-gradua??o, a percep??o dos mesmos sobre a ?tica em pesquisa, bem como as dificuldades enfrentadas no processo de pesquisa. Observa que as pesquisas de disserta??o est?o voltadas, em sua maioria, para os aspectos hist?rico-culturais do turismo e a escolha dos temas das disserta??es se deu em primeiro lugar, devido ? influ?ncia das linhas de pesquisa dos orientadores e, em segundo lugar, devido ? relev?ncia social. Os m?todos mais utilizados nas pesquisas de p?s-gradua??o s?o o descritivo, o bibliogr?fico e o explorat?rio. Observa ainda que a maior parte dos alunos de p?s-gradua??o em turismo (81%) atribui grande valor ? ?tica na realiza??o das suas pesquisas de disserta??o, os alunos afirmam que a ?tica traz credibilidade e seriedade ?s pesquisas. Al?m disso, percebeu-se que os mesmos n?o t?m conhecimento sobre a pr?tica de condutas impr?prias de pesquisadores na ?rea do Turismo. Demonstra que o principal desafio ?tico encontrado pelos alunos est? no relacionamento com o sujeito da pesquisa, que acontece na fase de coleta de dados. Constata ainda que nenhum dos entrevistados enviou qualquer projeto para ser avaliado por um Comit? de ?tica em Pesquisa (CEP), ademais, a maioria n?o conhece a Resolu??o 196/96, que possui as principais orienta??es sobre ?tica em pesquisa a n?vel nacional. Conclui que os discentes de p?s-gradua??o em turismo possuem pouco conhecimento quanto ?s normas e orienta??es sobre ?tica em pesquisa. Os mesmos demonstram desconhecer os benef?cios que a ?tica em pesquisa traz com rela??o ? prote??o e preserva??o do participante, bem como quanto aos benef?cios que gera ? sociedade

Le but de cette recherche ethnographique, menée au Pérou à partir de 2008, est de restituer les pratiques, les discours moraux et les multiples stratégies qui sous-tendent l’appropriation des vestiges et des pièces archéologiques par plusieurs acteurs. Cette question est abordée à travers le prisme particulier du trafic d’art et des pratiques considérées comme illicites. Une ethnographie itinérante (Marcus, 1995) et une méthodologie basée sur la biographie des objets (Kopytoff, 1986) permettent dereconstruire le circuit de céramiques, de la production (la fouille clandestine) à laconsommation (l’achat) en passant par leur échange, don et contrefaçon. De trésors à biens culturels, d’artefacts à curiosités, le parcours de ces objets met au jour à la fois la multiplicité de leurs usages socio-politiques et l’évolution des instances delégitimation qui les concernent.La thèse s’intéresse plus particulièrement au département de Lambayeque, situé sur la côte nord, connu pour les remarquables découvertes archéologiques (civilisation Mochica) qui y ont eu lieu au cours des dernières décennies. Elle démontre que, loin d’être les fruits d’un consensus, la patrimonialisation et la mise en tourisme, en tantque ressources économiques et symboliques, peuvent exacerber les conflits, en créantdes dynamiques d’inclusion et exclusion. De fait, l’opposition historique entre conservateurs et destructeurs du patrimoine renforce encore davantage l’asymétrie entre professionnels et communautés porteuses, en termes de savoir et de pouvoir. De plus, le manque de filiation des habitants avec les ancêtres (et donc l’absence de continuité et d’ « authenticité »), jugé par les institutions comme en lien avec une attitude destructive et purement marchande, a entravé une réelle participation de la communauté dans la patrimonialisation. Pour en être reconnus en tant qu’acteurs légitimes, et non comme simples bénéficiaires, ils sont ainsi contraints de reformuler leurs régimes de valeur et de renégocier leurs logiques d’appartenance. / The aim of this ethnographic research, carried out in Peru as of 2008, is to map the practices, moral discourses and multiple strategies which underlie the appropriation of relics and archaeological objects by different actors. This topic is analysed through the prism of art trafficking and practices considered to be illicit. A multi-sited ethnography (Marcus 1995) and a methodology based in the biography of objects (Kopytoff, 1986) allows to reconstruct the circuit of ceramics, from production (clandestine digging) to consumption (purchase), through various forms of exchange, gift and counterfeit. From treasures to cultural goods, from artefacts to oddities, the itinerary of these objects sheds light on the multiplicity of their socio-political uses and the evolution of legitimation authorities concerned by them. The thesis focuses more specifically on the region of Lambayeque, on the northern Peruvian coast, which has been characterised by extraordinary archaeological discoveries (Mochica civilisation) over the last few decades. It shows that, far from being the product of consensus, the heritage making and touristic development, as an economic and symbolical resource, can exacerbate conflicts, creating dynamics of inclusion and exclusion. In fact, the historical opposition between heritage conservationists and destroyers reinforces the asymmetry between professionals and bearer communities, in terms of knowledge and power. Moreover, a destructive attitude and commercial interest in relics, considered as the sign of a lack of filiation and therefore of continuity and « authenticity », hinders inhabitants’ participation. In order to be recognized as legitimate actors, and not as simple beneficiaries of heritage making they are obliged to reformulate their value regimes and renegotiate their logics of belonging.

The presented work is an empirical study offering an insight into the providing of addictology care in the everyday practice. In a selected Organization, I ethnographically examine how the good addictology practice is done and what, according to the participants, makes it good. That means how the Organization comes to what is good and what is not, when and in which situation is it good. Through analyses of Organization's everyday life taking place in various facilities helping people at risk of dependents and their loved ones, through documents analyses and through the way the Organization presents itself, I offer proved a support for the good practice. These are the organization's spirit, that is cultivated from the long-term care for the organization's culture and also an awareness of the constant formation of one's own path towards good and even better care. However, neither the path nor the spirit has the same face and final form. Although it stands on solid foundations, which are the organizational values (respect, openness, responsibility, relationship and cooperation) and is based on a long history and traditions, it is shaped by what every day brings to the Organization. Despite its functional support, the Organization is not free from mistakes, errors. However, it seeks to ensure that its...

Against the background of a dilemma experienced by researchers during a genomics study at an established biomedical research centre in Kenya, the broad aims of this thesis are to develop appropriate responses to important ethical questions on sharing information on a common and serious genetic condition, sickle cell disorder, and assess the responsibilities of researchers in this regard. Using an empirical approach to normative reflection across two phases of qualitative research, I explore the nature of important moral concerns related to sharing sickle cell disease information from researchers’ and community members’ points of view; and develop a bottom-up normative analysis around the questions generated. This analysis interweaves community experiences, processes of community reasoning and ex situ normative reflection; placing community views and values centrally while referencing these to wider ethical debates, commentaries and guidelines in the literature. Two main outputs of this thesis are to provide recommendations for information sharing on SCD findings in the genomics study in Kilifi; and to propose a set of key issues to consider for this type of information in other studies and geographic settings. I conclude that researchers have a strong responsibility to share SCD information on affected children with families as a form of ancillary service (validating tests, counselling and care); but less responsibility to actively share carrier information. Concurrent responsibilities are working collaboratively with the Ministry of Health/District General Hospital to plan and implement services for SCD; ensuring counselling services support family stability as far as reasonably possible; and to build forms of community engagement and informed consent that counter risks of diagnostic interpretations of research.

This work is focused on ethics education for pupils of older school age. The first part is theoretical, the basic definitions are presented here. Older school age is described from a view of evolutionary psychology and also changes typical for this age are mentioned. The work deals with the position of the ethics education for older school age in the curricula of the Czech Republic and it presents different views on this topic. The practical part concerns the research of the ethics education for older school age in district of Tábor. The final section provides commentary of the results of the research survey among teachers of the ethics education for older school age and it analyses the obtainech infomation.

A tendência de globalização dos ensaios clínicos, observada nos últimos anos, trouxe à tona questões antes não discutidas como a continuidade do tratamento com os medicamentos em investigação, após a conclusão da pesquisa. A inclusão de países em desenvolvimento nesses estudos traz consigo a preocupação com a vulnerabilidade dos participantes da pesquisa. No Brasil, há cerca de cinco anos, os Comitês de Ética em Pesquisa, CEP, e, particularmente, a Comissão Nacional de Ética em Pesquisa, CONEP, passaram a solicitar a manutenção do fornecimento do(s) medicamento(s) do estudo após sua finalização. Embora baseada nos principais documentos éticos que norteiam a pesquisa clínica, essa solicitação apresenta dificuldades práticas para implantação, principalmente no caso de doenças crônicas. O objetivo deste trabalho foi identificar as questões envolvidas na continuidade do fornecimento de medicamentos após a conclusão de ensaio clínico e analisar a perspectiva de atores que compõem o cenário da pesquisa clínica nacional. Questionários e respectivos Termos de Consentimento Livre e Esclarecidos, TCLE, foram enviados por correioeletrônico, entre outubro de 2009 e janeiro de 2010, a membros de CEPs (todos os CEPs credenciados pela CONEP naquela data), pesquisadores (em duas áreas terapêuticas, HIV/AIDS e Diabetes mellitus) e patrocinadores. Aos pesquisadores foi solicitado que aplicassem o questionário a seus pacientes de pesquisa. A taxa de resposta dos CEPs foi de 20,7% (124 responderam, de 599 questionários enviados), 20% para os pesquisadores (58 de 290) e 45,3% para os patrocinadores (24 de 53). Cinquenta e quatro pacientes convidados por seus médicos responderam. Com relação à informação contida no TCLE, o item menos informado é relativo a como obter o medicamento após o estudo, para todos os grupos pesquisados. Com relação à motivação dos pacientes ao participar de uma pesquisa, 96,2% dos pacientes responderam como \"muito importante\", na decisão, a busca de melhores cuidados médicos e atenção à própria saúde, e 94,2% o fato de colaborar para o desenvolvimento da ciência (altruísmo). Entretanto, os demais grupos entrevistados não pensam da mesma forma: para eles, a maior motivação dos pacientes, ao participar de pesquisas clínicas, é a busca de melhores cuidados médicos e atenção à sua saúde, seguido da busca pelo acesso a alternativas de tratamento para sua doença. Ao serem perguntados sobre quem deveria receber o medicamento em investigação após o estudo, os pacientes responderam que todas as pessoas deveriam receber o medicamento após o estudo (60,4%); entre os pesquisadores, a maior parte (43,1%) respondeu que o medicamento deveria ser fornecido às pessoas participantes do estudo e 39,7% deles responderam que o medicamento deveria ser fornecido às pessoas que se beneficiariam do medicamento em estudo. Já os representantes de CEP concordaram com os pacientes que todas as pessoas deveriam receber o medicamento, mas em proporção bem menor (35,3%). Os patrocinadores opinaram que o medicamento do estudo deveria ser fornecido aos participantes da pesquisa que dele se beneficiariam (50%). Houve consenso entre os grupos em que, havendo a continuidade do tratamento, este deveria ser fornecido pelo patrocinador e de forma gratuita. Ao responder a questão relativa a quanto tempo deveria o medicamento ser fornecido, pesquisadores e patrocinadores consideraram que o medicamento deveria ser fornecido até estar disponível na rede pública, enquanto que os membros de CEP, opinaram que isso deveria acontecer durante o período que o paciente fosse beneficiado. Os pacientes responderam que o benefício deveria ser mantido pela vida toda. Devido às várias limitações deste estudo (representatividade da amostra, população restrita a usuários da Internet), seus resultados podem não ser generalizados, mas podem contribuir para a discussão do tema, ao analisar os pontos de vista de vários atores do cenário da pesquisa clínica nacional. / The recent trend of globalization of clinical trials, observed in the last years, raised some non-previously discussed issues, such as the continuity of treatment after the conclusion of the study. The inclusion of developing countries in these trials brings together the concern with the participants\' vulnerability. In Brazil, about 5 years ago, the Ethics Committees (EC) and the National Commission of Ethics in Research (so called CONEP) started requiring the access to study medication after the trial ends. Even being based on the main documents related to ethics and research, some practical issues make this requirement difficult to implement, mainly in the arena of chronic diseases. The goal of this research was to identify the questions related to continuing the supply of the investigational medicine and analyze the perspective of all stakeholders involved in clinical research. Questionnaires and informed consents were sent through e-mail, between Oct 2009 and Jan 2010, to EC members (all ECs mentioned at CONEP site at that moment), clinical investigators (in two therapeutical areas, HIV/AIDS and Diabetes) and sponsors. We also asked the clinical investigators to submit the questionnaire (in paper) to their patients who already participated in clinical research. The response rate in each group was: 20.7% in EC members\' group (599 questionnaires sent, 124 replied), 20% in clinical investigators\' group (58 of 290) and 45.3% in sponsors\' group (24 of 53). Fifty four patients answered the questionnaire through their doctors. Regarding to the information displaced in the informed consent, the item less informed, according to all groups, was related to how to obtain the study medication after the conclusion of the trial. Concerning the motivation of patients which made them accept to participate in a clinical trial, 96.2% of patients answered as \"very important\" to obtain better health care and attention and 94.2% mentioned also as \"very important\" the possibility to collaborate with the progress of the science (altruism). However, among the other groups, the responses were different: for them, the major motivation for the patients would be to have access to better health care and attention (similar to patients) and search for access to treatment alternatives for their diseases. When asked to whom should be given the study medication after the trial, the patients answered that all patients should receive it (60.4%); for the clinical investigators, 43.1% believe that the medication should be given to the participants of the study and 39.7% to the subjects who participated and benefited from the study treatment. The EC members agreed (but to a lesser degree, 35.3%) with the patients that all individuals with the disease should receive the medication after the trial. For 50% of the sponsors, the study medication should be assured to the participants who had benefit from the treatment. In the case of need of access extension after the trial, a consensus could be observed among all groups, concerning to whom should provide the medication (the sponsor) and how (completely free). One question addressed the issue of how long the treatment should be assured after the trial: clinical investigators and sponsors replied that the medication should be kept until be available in the public health sector; the EC members thought it should be furnished while the patient keeps the benefit. The patients answered that the benefit should be assured for all life. Due to the several limitations of this research (such as the sample representativeness, population restrict to internet users), their results can\'t be generalized; however, the data can contribute to the discussion of this very complex topic through analyzing the views of the several stakeholders of the scenario of clinical research in Brazil.

A tendência de globalização dos ensaios clínicos, observada nos últimos anos, trouxe à tona questões antes não discutidas como a continuidade do tratamento com os medicamentos em investigação, após a conclusão da pesquisa. A inclusão de países em desenvolvimento nesses estudos traz consigo a preocupação com a vulnerabilidade dos participantes da pesquisa. No Brasil, há cerca de cinco anos, os Comitês de Ética em Pesquisa, CEP, e, particularmente, a Comissão Nacional de Ética em Pesquisa, CONEP, passaram a solicitar a manutenção do fornecimento do(s) medicamento(s) do estudo após sua finalização. Embora baseada nos principais documentos éticos que norteiam a pesquisa clínica, essa solicitação apresenta dificuldades práticas para implantação, principalmente no caso de doenças crônicas. O objetivo deste trabalho foi identificar as questões envolvidas na continuidade do fornecimento de medicamentos após a conclusão de ensaio clínico e analisar a perspectiva de atores que compõem o cenário da pesquisa clínica nacional. Questionários e respectivos Termos de Consentimento Livre e Esclarecidos, TCLE, foram enviados por correioeletrônico, entre outubro de 2009 e janeiro de 2010, a membros de CEPs (todos os CEPs credenciados pela CONEP naquela data), pesquisadores (em duas áreas terapêuticas, HIV/AIDS e Diabetes mellitus) e patrocinadores. Aos pesquisadores foi solicitado que aplicassem o questionário a seus pacientes de pesquisa. A taxa de resposta dos CEPs foi de 20,7% (124 responderam, de 599 questionários enviados), 20% para os pesquisadores (58 de 290) e 45,3% para os patrocinadores (24 de 53). Cinquenta e quatro pacientes convidados por seus médicos responderam. Com relação à informação contida no TCLE, o item menos informado é relativo a como obter o medicamento após o estudo, para todos os grupos pesquisados. Com relação à motivação dos pacientes ao participar de uma pesquisa, 96,2% dos pacientes responderam como \"muito importante\", na decisão, a busca de melhores cuidados médicos e atenção à própria saúde, e 94,2% o fato de colaborar para o desenvolvimento da ciência (altruísmo). Entretanto, os demais grupos entrevistados não pensam da mesma forma: para eles, a maior motivação dos pacientes, ao participar de pesquisas clínicas, é a busca de melhores cuidados médicos e atenção à sua saúde, seguido da busca pelo acesso a alternativas de tratamento para sua doença. Ao serem perguntados sobre quem deveria receber o medicamento em investigação após o estudo, os pacientes responderam que todas as pessoas deveriam receber o medicamento após o estudo (60,4%); entre os pesquisadores, a maior parte (43,1%) respondeu que o medicamento deveria ser fornecido às pessoas participantes do estudo e 39,7% deles responderam que o medicamento deveria ser fornecido às pessoas que se beneficiariam do medicamento em estudo. Já os representantes de CEP concordaram com os pacientes que todas as pessoas deveriam receber o medicamento, mas em proporção bem menor (35,3%). Os patrocinadores opinaram que o medicamento do estudo deveria ser fornecido aos participantes da pesquisa que dele se beneficiariam (50%). Houve consenso entre os grupos em que, havendo a continuidade do tratamento, este deveria ser fornecido pelo patrocinador e de forma gratuita. Ao responder a questão relativa a quanto tempo deveria o medicamento ser fornecido, pesquisadores e patrocinadores consideraram que o medicamento deveria ser fornecido até estar disponível na rede pública, enquanto que os membros de CEP, opinaram que isso deveria acontecer durante o período que o paciente fosse beneficiado. Os pacientes responderam que o benefício deveria ser mantido pela vida toda. Devido às várias limitações deste estudo (representatividade da amostra, população restrita a usuários da Internet), seus resultados podem não ser generalizados, mas podem contribuir para a discussão do tema, ao analisar os pontos de vista de vários atores do cenário da pesquisa clínica nacional. / The recent trend of globalization of clinical trials, observed in the last years, raised some non-previously discussed issues, such as the continuity of treatment after the conclusion of the study. The inclusion of developing countries in these trials brings together the concern with the participants\' vulnerability. In Brazil, about 5 years ago, the Ethics Committees (EC) and the National Commission of Ethics in Research (so called CONEP) started requiring the access to study medication after the trial ends. Even being based on the main documents related to ethics and research, some practical issues make this requirement difficult to implement, mainly in the arena of chronic diseases. The goal of this research was to identify the questions related to continuing the supply of the investigational medicine and analyze the perspective of all stakeholders involved in clinical research. Questionnaires and informed consents were sent through e-mail, between Oct 2009 and Jan 2010, to EC members (all ECs mentioned at CONEP site at that moment), clinical investigators (in two therapeutical areas, HIV/AIDS and Diabetes) and sponsors. We also asked the clinical investigators to submit the questionnaire (in paper) to their patients who already participated in clinical research. The response rate in each group was: 20.7% in EC members\' group (599 questionnaires sent, 124 replied), 20% in clinical investigators\' group (58 of 290) and 45.3% in sponsors\' group (24 of 53). Fifty four patients answered the questionnaire through their doctors. Regarding to the information displaced in the informed consent, the item less informed, according to all groups, was related to how to obtain the study medication after the conclusion of the trial. Concerning the motivation of patients which made them accept to participate in a clinical trial, 96.2% of patients answered as \"very important\" to obtain better health care and attention and 94.2% mentioned also as \"very important\" the possibility to collaborate with the progress of the science (altruism). However, among the other groups, the responses were different: for them, the major motivation for the patients would be to have access to better health care and attention (similar to patients) and search for access to treatment alternatives for their diseases. When asked to whom should be given the study medication after the trial, the patients answered that all patients should receive it (60.4%); for the clinical investigators, 43.1% believe that the medication should be given to the participants of the study and 39.7% to the subjects who participated and benefited from the study treatment. The EC members agreed (but to a lesser degree, 35.3%) with the patients that all individuals with the disease should receive the medication after the trial. For 50% of the sponsors, the study medication should be assured to the participants who had benefit from the treatment. In the case of need of access extension after the trial, a consensus could be observed among all groups, concerning to whom should provide the medication (the sponsor) and how (completely free). One question addressed the issue of how long the treatment should be assured after the trial: clinical investigators and sponsors replied that the medication should be kept until be available in the public health sector; the EC members thought it should be furnished while the patient keeps the benefit. The patients answered that the benefit should be assured for all life. Due to the several limitations of this research (such as the sample representativeness, population restrict to internet users), their results can\'t be generalized; however, the data can contribute to the discussion of this very complex topic through analyzing the views of the several stakeholders of the scenario of clinical research in Brazil.