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Making Participation Work: A Grounded Theory Describing Participation in Phase I Drug Trials from the Perspective of the Healthy SubjectOndrusek, Nancy 01 September 2010 (has links)
A qualitative research study was conducted with people who had participated as healthy subjects in phase I drug trials at commercial research facilities, in order to develop a better understanding of their perspective regarding research participation. The participants were recruited using online advertisements posted on the University of Toronto student website (www.my.utoronto.ca) and NOW Magazine online. Thirty-one subjects were interviewed. The audiotaped interviews were transcribed and analyzed using grounded theory methods. A grounded theory was developed that describes the process of participation and the main factors affecting the experience of participation, from the perspective of healthy subjects. The theory, called Making Participation Work, explains how healthy subjects frame participation as an income earning opportunity, and how this framing shapes their behaviour with regard to participation. Participants expressed a range of attitudes about the experience of participation, from very positive to very negative. The main factor affecting the experience is the perceived net burden, which is in turn affected by the degree to which subjects find personal control over their participation. Net burden and finding personal control were both affected by the degree to which subjects felt valued by research staff, and by whether subjects had trust in the research enterprise. Although subjects framed participation as work, the relationship with the study doctors and nurses was viewed as clinical. Most subjects are generally trusting that participation in phase I drug trials is safe. These findings suggest that models of research participation assuming participation motivated by altruism or potential therapeutic benefit cannot accommodate the attitudes and behaviours of healthy subjects in phase I drug trials. New models must be developed which account for the framing of participation as work, while being sensitive to the trust that healthy subjects place in the research enterprise.
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Making Participation Work: A Grounded Theory Describing Participation in Phase I Drug Trials from the Perspective of the Healthy SubjectOndrusek, Nancy 01 September 2010 (has links)
A qualitative research study was conducted with people who had participated as healthy subjects in phase I drug trials at commercial research facilities, in order to develop a better understanding of their perspective regarding research participation. The participants were recruited using online advertisements posted on the University of Toronto student website (www.my.utoronto.ca) and NOW Magazine online. Thirty-one subjects were interviewed. The audiotaped interviews were transcribed and analyzed using grounded theory methods. A grounded theory was developed that describes the process of participation and the main factors affecting the experience of participation, from the perspective of healthy subjects. The theory, called Making Participation Work, explains how healthy subjects frame participation as an income earning opportunity, and how this framing shapes their behaviour with regard to participation. Participants expressed a range of attitudes about the experience of participation, from very positive to very negative. The main factor affecting the experience is the perceived net burden, which is in turn affected by the degree to which subjects find personal control over their participation. Net burden and finding personal control were both affected by the degree to which subjects felt valued by research staff, and by whether subjects had trust in the research enterprise. Although subjects framed participation as work, the relationship with the study doctors and nurses was viewed as clinical. Most subjects are generally trusting that participation in phase I drug trials is safe. These findings suggest that models of research participation assuming participation motivated by altruism or potential therapeutic benefit cannot accommodate the attitudes and behaviours of healthy subjects in phase I drug trials. New models must be developed which account for the framing of participation as work, while being sensitive to the trust that healthy subjects place in the research enterprise.
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Requirements for Education on the Protection of Human Research Subjects: Implications for Educational ResearchersClements, Andrea D., Myrick, P. W. 01 January 2002 (has links)
No description available.
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Requirements for Training in the Ethical Treatment of Human Research Subjects: Implications for Educational ResearchersClements, Andrea D. 01 February 2003 (has links)
No description available.
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Requirements for Training in the Ethical Treatment of Human Research Subjects: Implications for Educational ResearchersClements, Andrea D. 01 November 2002 (has links)
No description available.
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Seleção de pacientes e recrutamento dos sujeitos da pesquisa: implicações éticas e jurídicas no âmbito das Instituições de Ensino Superior públicas - uma visão sob a ótica do Código de Defesa do Consumidor / Patient selection and recruitment of research subjects: ethical and legal implications in the context of the public higher education institutions - a view from the perspective of the Consumer Protection CodeEnio Trujillo 03 June 2016 (has links)
Os sujeitos da pesquisa, em razão de seu estado de vulnerabilidade, reclamam por cuidados éticos e jurídicos. Esta tutela deve anteceder ao status em que o sujeito da pesquisa ainda não está caracterizado como tal, ou seja, quando, como paciente, participa de seleções para integrar experimentos, no caso, promovidos por Instituições de Ensino Superior públicas (IES). No aspecto jurídico, pacientes, sujeitos da pesquisa e comunidade científica foram colocados sob a égide do Código de Defesa do Consumidor a fim de se apurar a tutela desse diploma legal sobre referidas figuras. Em face dessa abordagem ética e jurídica, este estudo teve como objetivo, por meio de uma revista da literatura, desenvolver uma análise crítica sobre a formatação atual utilizada pelas IES pública para recrutamento de sujeitos da pesquisa, através de seus pacientes pré-concebidos; mensurar a importância da formalização de edital pela IES pública nesse contexto de recrutamento. Analisar, ainda, a dicotomia jurídica desenvolvida em torno do Código de Defesa do Consumidor pertinente ao paciente atendido pela IES Pública, por intermédio do SUS e o paciente atendido pela IES privada não submetido ao SUS. Por fim, conferir sob a ótica do Código de Defesa do Consumidor a responsabilidade civil da comunidade científica em decorrência de danos causados ao sujeito da pesquisa. Trata-se de um estudo exploratório e descritivo, com abordagem qualitativa desenvolvida a partir de pesquisas em material existente na literatura nacional e internacional, pertinente à pesquisa envolvendo seres humanos, a sua forma de recrutamento e a responsabilidade civil suscitada em face dos sistemas de saúde público e privado e, não menos, sobre a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. Especificamente, a fundamentação teórica se deu sobre a doutrina da bioética, do biodireito e da ordem jurisdicional, com fomento da legislação brasileira. Foram utilizadas as bases de dados Pubmed, Scielo, Lilacs, Google Acadêmico, Google e Tribunais de Justiça, com a combinação dos seguintes descritores: seleção de pacientes, sujeitos da pesquisa, defesa do consumidor, ética em pesquisa e academia e institutos. Considera-se, ao final, que na IES pública o recrutamento de sujeitos da pesquisa não deve configurar coerção tácita, sendo superlativa a valoração de conceitos éticos intrínsecos à dignidade humana, restando-lhe, ainda a observância de princípios constitucionais referente à administração pública. Nesse âmbito público, a necessidade de edital é requisito formalístico, imperioso para recrutamento de sujeito da pesquisa. Tanto o sistema público de saúde, promovido pela IES pública, como o sistema privado de saúde, promovido pela IES privada, estão sob a tutela do Código de Defesa do Consumidor; ainda devendo ficar sob o pálio deste diploma legal a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. / Human research subjects, due to their vulnerability status, claim to ethical and legal care. This protection must precede the status in which the research subject is not characterized as such, that is when, as a patient, attends selections to integrate experiments in the case, promoted by Public Higher Education Institutions (HEI). In the legal aspect, patients, research subjects and scientific community were placed under the aegis of the Consumer Protection Code in order to establish the tutelage of this statute on those figures. Faced with this ethical and legal approach, this study aimed, through a literature review, develop a critical analysis of the current format used by public HEIs to the recruitment of research subjects, through their predesigned patients; measure the importance of the announcement of the formal public HEIs in this recruitment context. Also, analyze the legal dichotomy developed around the Consumer Protection Code relevant to patients attended by public HEIs, through the Brazilian Public System of Health (BSH) and the patient treated by the private institution not subjected to the BSH. Finally, check, from the perspective of the Consumer Protection Code, the liability of the scientific community due to damages caused to the research subject. This is an exploratory and descriptive study with qualitative approach, developed from research into existing material in national and international literature, relevant to researches involving human beings, their form of recruitment and liability raised in the face of public and private system of health and, not least, on the legal relationship developed between the research subject and the scientific community. Specifically, the theoretical foundation took over the doctrine of bioethics, the bio law and court order, fostering by the Brazilian law. Databases used were Pubmed, Scielo, Lilacs, Google Scholar, Google and Courts of Justice, with the combination of the following descriptors: Patient Selection, Research Subjects, Consumer Advocacy, Ethics, Research and Academies and Institutes. In the end, is considered that in the public HEI, the research subject recruitment should not configure tacit coercion, being superlative the valuation of intrinsic ethical concepts of human dignity, leaving him, yet compliance with constitutional principles relating to public administration. In this public sphere, the need for notice is formalistic requirement imperative for the recruitment of research subjects. Both systems of health, as public promoted by public HEIs, as the private promoted by the private HEIs are under the authority of the Consumer Protection Code; should still be under the canopy of this instrument the legal status developed between the research subject and the scientific community.
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Seleção de pacientes e recrutamento dos sujeitos da pesquisa: implicações éticas e jurídicas no âmbito das Instituições de Ensino Superior públicas - uma visão sob a ótica do Código de Defesa do Consumidor / Patient selection and recruitment of research subjects: ethical and legal implications in the context of the public higher education institutions - a view from the perspective of the Consumer Protection CodeTrujillo, Enio 03 June 2016 (has links)
Os sujeitos da pesquisa, em razão de seu estado de vulnerabilidade, reclamam por cuidados éticos e jurídicos. Esta tutela deve anteceder ao status em que o sujeito da pesquisa ainda não está caracterizado como tal, ou seja, quando, como paciente, participa de seleções para integrar experimentos, no caso, promovidos por Instituições de Ensino Superior públicas (IES). No aspecto jurídico, pacientes, sujeitos da pesquisa e comunidade científica foram colocados sob a égide do Código de Defesa do Consumidor a fim de se apurar a tutela desse diploma legal sobre referidas figuras. Em face dessa abordagem ética e jurídica, este estudo teve como objetivo, por meio de uma revista da literatura, desenvolver uma análise crítica sobre a formatação atual utilizada pelas IES pública para recrutamento de sujeitos da pesquisa, através de seus pacientes pré-concebidos; mensurar a importância da formalização de edital pela IES pública nesse contexto de recrutamento. Analisar, ainda, a dicotomia jurídica desenvolvida em torno do Código de Defesa do Consumidor pertinente ao paciente atendido pela IES Pública, por intermédio do SUS e o paciente atendido pela IES privada não submetido ao SUS. Por fim, conferir sob a ótica do Código de Defesa do Consumidor a responsabilidade civil da comunidade científica em decorrência de danos causados ao sujeito da pesquisa. Trata-se de um estudo exploratório e descritivo, com abordagem qualitativa desenvolvida a partir de pesquisas em material existente na literatura nacional e internacional, pertinente à pesquisa envolvendo seres humanos, a sua forma de recrutamento e a responsabilidade civil suscitada em face dos sistemas de saúde público e privado e, não menos, sobre a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. Especificamente, a fundamentação teórica se deu sobre a doutrina da bioética, do biodireito e da ordem jurisdicional, com fomento da legislação brasileira. Foram utilizadas as bases de dados Pubmed, Scielo, Lilacs, Google Acadêmico, Google e Tribunais de Justiça, com a combinação dos seguintes descritores: seleção de pacientes, sujeitos da pesquisa, defesa do consumidor, ética em pesquisa e academia e institutos. Considera-se, ao final, que na IES pública o recrutamento de sujeitos da pesquisa não deve configurar coerção tácita, sendo superlativa a valoração de conceitos éticos intrínsecos à dignidade humana, restando-lhe, ainda a observância de princípios constitucionais referente à administração pública. Nesse âmbito público, a necessidade de edital é requisito formalístico, imperioso para recrutamento de sujeito da pesquisa. Tanto o sistema público de saúde, promovido pela IES pública, como o sistema privado de saúde, promovido pela IES privada, estão sob a tutela do Código de Defesa do Consumidor; ainda devendo ficar sob o pálio deste diploma legal a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. / Human research subjects, due to their vulnerability status, claim to ethical and legal care. This protection must precede the status in which the research subject is not characterized as such, that is when, as a patient, attends selections to integrate experiments in the case, promoted by Public Higher Education Institutions (HEI). In the legal aspect, patients, research subjects and scientific community were placed under the aegis of the Consumer Protection Code in order to establish the tutelage of this statute on those figures. Faced with this ethical and legal approach, this study aimed, through a literature review, develop a critical analysis of the current format used by public HEIs to the recruitment of research subjects, through their predesigned patients; measure the importance of the announcement of the formal public HEIs in this recruitment context. Also, analyze the legal dichotomy developed around the Consumer Protection Code relevant to patients attended by public HEIs, through the Brazilian Public System of Health (BSH) and the patient treated by the private institution not subjected to the BSH. Finally, check, from the perspective of the Consumer Protection Code, the liability of the scientific community due to damages caused to the research subject. This is an exploratory and descriptive study with qualitative approach, developed from research into existing material in national and international literature, relevant to researches involving human beings, their form of recruitment and liability raised in the face of public and private system of health and, not least, on the legal relationship developed between the research subject and the scientific community. Specifically, the theoretical foundation took over the doctrine of bioethics, the bio law and court order, fostering by the Brazilian law. Databases used were Pubmed, Scielo, Lilacs, Google Scholar, Google and Courts of Justice, with the combination of the following descriptors: Patient Selection, Research Subjects, Consumer Advocacy, Ethics, Research and Academies and Institutes. In the end, is considered that in the public HEI, the research subject recruitment should not configure tacit coercion, being superlative the valuation of intrinsic ethical concepts of human dignity, leaving him, yet compliance with constitutional principles relating to public administration. In this public sphere, the need for notice is formalistic requirement imperative for the recruitment of research subjects. Both systems of health, as public promoted by public HEIs, as the private promoted by the private HEIs are under the authority of the Consumer Protection Code; should still be under the canopy of this instrument the legal status developed between the research subject and the scientific community.
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Mahi whanau (2) : reflecting on the use of consensus cardsort as an effective process for whanau Maori to construct a future narrative. A dissertation submitted in partial fulfilment of the requirements for the degree of Master of Social Practice, Unitec New Zealand /O'Reilly, Denis Christopher. January 2008 (has links)
Thesis (M.SP)--Unitec New Zealand, 2008. / Cardsort is a generic name for any process that uses statements written on cards and has participants sieve, cluster or rank ideas or statements. When the participants themselves create the statements in question this process is consensus cardsort. Includes bibliographical references (leaves 134-145).
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Fornecimento de medicamentos pós-pesquisa / Post-trial access to study medicationsDainesi, Sonia Mansoldo 16 May 2011 (has links)
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.
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Fornecimento de medicamentos pós-pesquisa / Post-trial access to study medicationsSonia Mansoldo Dainesi 16 May 2011 (has links)
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.
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