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Conducting suicide research in Australia in relation to the operation of themes Research Ethics CommitteesMacgill, Jennifer January 2008 (has links)
This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy
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Conducting suicide research in Australia in relation to the operation of themes Research Ethics CommitteesMacgill, Jennifer . University of Ballarat. January 2008 (has links)
This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy
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The work of Phase I ethics committees : expert and lay membershipHumphreys, Stephen John January 2013 (has links)
Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity. IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced. Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised. Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process. Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered. The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.
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"We were in one place and the Ethics Committee in another" : trainee clinical psychologists' experiences of research ethics processesBrindley, Robert January 2012 (has links)
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.
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O sistema de avaliação da ética em pesquisa no Brasil: estudo dos conhecimentos e práticas de lideranças de Comitês de Ética em Pesquisa / Research ethics evaluation system in Brazil: knowledge and practices of leaders of research ethics institutional review boards.Freitas, Corina Bontempo Duca de 23 February 2007 (has links)
O objetivo do estudo foi construir o perfil dos indicados pelos Comitês de Ética em Pesquisa - CEPs - para membros da Comissão Nacional de Ética em Pesquisa - CONEP, líderes no sistema de controle da ética em pesquisa no Brasil, quanto à representação de grupos sociais, formação e experiência profissional e experiência e conhecimento em ética na pesquisa. Enquanto informantes-chave, buscou-se conhecer práticas correntes no sistema, e compreensão da regulamentação. Foram aplicados questionários, via correio ou via eletrônica, aos 188 componentes da lista de 2003, obtendo-se 94 respostas válidas, que representaram 80% dos CEPs. O questionário constou de 4 partes - a parte I, de caracterização pessoal, mostrou proporção semelhante de gênero, alta qualificação acadêmica, participação em cursos de pequena duração sobre ética em pesquisa/ bioética, e sensibilidade social. Dos respondentes, 50% tinham cargos de gestão na instituição, 18% deles ligados diretamente à pesquisa, apenas 4% eram representantes de usuários, 90% participaram de pesquisas nos últimos 10 anos, sendo um terço em pesquisa clínica. A parte II correspondeu a uma auto-avaliação de sua participação como membros de CEPs, que mostrou satisfação com a relevância do trabalho, valorização de qualidades como responsabilidade, compromisso, habilidade para trabalho em equipe, sendo que 89% e 85% consideraram-se preparados e competentes respectivamente, apesar de percepção variada da representatividade e compreensão política de sua atuação. Identificaram-se áreas de maior dificuldade na análise de projetos, e encontros, seminários e discussão de casos como formas preferenciais de preparação. A parte III identificou as percepções sobre o funcionamento do sistema de avaliação ética das pesquisas no Brasil, evidenciando a utilização das diretrizes e normas do CNS na análise dos projetos. A mais efetiva participação dos representantes de usuários e o monitoramento das pesquisas são dificuldades freqüentes. Sugestões de melhoria do sistema referiram a abordagem dos projetos da área de ciências humanas, pré-requisitos e preparação para membros de CEPs, integração e melhoria da comunicação entre CEPs e com a Comissão Nacional. A parte IV foram estudos de casos, que evidenciaram convergência de posicionamentos na grande maioria das situações apresentadas. Conclui-se que o reconhecimento da liderança desses indicados nos CEPs institucionais tem reflexos da cultura institucional, mais comumente universidades, e que a indicação de membros reconhecidos pelos seus pares, pode conformar um perfil favorável à atuação na Comissão Nacional. / The objective of the study was to analyze the profile of the persons indicated by the research ethics institutional review boards to become members of the National Commission of Research Ethics (Comissão Nacional de Ética em Pesquisa/CONEP), considered as leaders in the research ethics evaluation system in Brazil, as to their social group representation, professional experience, experience in research ethics, views about current practices in the system and relations to formal regulations. Questionnaires were sent by mail and electronically to the 188 members of IRBs indicated as candidates in 2003 for nomination as member of CONEP, with 94 answers, representing 80% of the IRB universe at that time. The questionnaire was composed of 4 parts, with part 1 dedicated to personal characterization. The results indicated equal gender proportions, high academic qualification, and frequent participation in short courses about research and bioethics. About 50% occupied institutional positions, 18% directly related to research, and only 4% were representatives of the patients. About 90% had involvement with research in the last 10 years, a third with clinical research. Part II was dedicated to their self-evaluation as members of IRBs, revealing feelings of satisfaction and gratification with their work, and valorization of attributes such as responsibility, compromise, team work capabilities, and 89% and 85% considered themselves prepared and competent for their functions, although with differing perceptions regarding representation and political understandings about their work. Some areas present more difficulties in the analysis of the projects and meetings, seminars and case discussions were mentioned as preferential mechanisms for development. Part III identified perceptions about the functioning of the national research ethics evaluation system, and the utilization of official regulations in project analysis. A more effective participation of the patient representatives and the monitoring of projects are major problems. Areas of necessary investment: how to deal with social sciences research projects, pre-requisites and preparation of IRB members and improved communication of IRBs with each other and the National Commission. Part IV consisted of case studies dedicated to frequent ethical dilemmas in research and the majority had convergent positions as to how to deal with them. The profile of these members as leaders in their IRBs reflects also very strong institutional cultures.
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Gruppennützige Forschung an Kindern und Jugendlichen / Ihre ethische und rechtliche Zulässigkeit unter besonderer Berücksichtigung der Bewertung von Vorsitzenden deutscher Ethikkommissionen / Non-therapeutic research in minors / Its ethical and legal legitimacy with special regard to the attitude of chair-persons of German Research Ethics CommitteesRadenbach, Katrin 09 January 2007 (has links)
No description available.
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O sistema de avaliação da ética em pesquisa no Brasil: estudo dos conhecimentos e práticas de lideranças de Comitês de Ética em Pesquisa / Research ethics evaluation system in Brazil: knowledge and practices of leaders of research ethics institutional review boards.Corina Bontempo Duca de Freitas 23 February 2007 (has links)
O objetivo do estudo foi construir o perfil dos indicados pelos Comitês de Ética em Pesquisa - CEPs - para membros da Comissão Nacional de Ética em Pesquisa - CONEP, líderes no sistema de controle da ética em pesquisa no Brasil, quanto à representação de grupos sociais, formação e experiência profissional e experiência e conhecimento em ética na pesquisa. Enquanto informantes-chave, buscou-se conhecer práticas correntes no sistema, e compreensão da regulamentação. Foram aplicados questionários, via correio ou via eletrônica, aos 188 componentes da lista de 2003, obtendo-se 94 respostas válidas, que representaram 80% dos CEPs. O questionário constou de 4 partes - a parte I, de caracterização pessoal, mostrou proporção semelhante de gênero, alta qualificação acadêmica, participação em cursos de pequena duração sobre ética em pesquisa/ bioética, e sensibilidade social. Dos respondentes, 50% tinham cargos de gestão na instituição, 18% deles ligados diretamente à pesquisa, apenas 4% eram representantes de usuários, 90% participaram de pesquisas nos últimos 10 anos, sendo um terço em pesquisa clínica. A parte II correspondeu a uma auto-avaliação de sua participação como membros de CEPs, que mostrou satisfação com a relevância do trabalho, valorização de qualidades como responsabilidade, compromisso, habilidade para trabalho em equipe, sendo que 89% e 85% consideraram-se preparados e competentes respectivamente, apesar de percepção variada da representatividade e compreensão política de sua atuação. Identificaram-se áreas de maior dificuldade na análise de projetos, e encontros, seminários e discussão de casos como formas preferenciais de preparação. A parte III identificou as percepções sobre o funcionamento do sistema de avaliação ética das pesquisas no Brasil, evidenciando a utilização das diretrizes e normas do CNS na análise dos projetos. A mais efetiva participação dos representantes de usuários e o monitoramento das pesquisas são dificuldades freqüentes. Sugestões de melhoria do sistema referiram a abordagem dos projetos da área de ciências humanas, pré-requisitos e preparação para membros de CEPs, integração e melhoria da comunicação entre CEPs e com a Comissão Nacional. A parte IV foram estudos de casos, que evidenciaram convergência de posicionamentos na grande maioria das situações apresentadas. Conclui-se que o reconhecimento da liderança desses indicados nos CEPs institucionais tem reflexos da cultura institucional, mais comumente universidades, e que a indicação de membros reconhecidos pelos seus pares, pode conformar um perfil favorável à atuação na Comissão Nacional. / The objective of the study was to analyze the profile of the persons indicated by the research ethics institutional review boards to become members of the National Commission of Research Ethics (Comissão Nacional de Ética em Pesquisa/CONEP), considered as leaders in the research ethics evaluation system in Brazil, as to their social group representation, professional experience, experience in research ethics, views about current practices in the system and relations to formal regulations. Questionnaires were sent by mail and electronically to the 188 members of IRBs indicated as candidates in 2003 for nomination as member of CONEP, with 94 answers, representing 80% of the IRB universe at that time. The questionnaire was composed of 4 parts, with part 1 dedicated to personal characterization. The results indicated equal gender proportions, high academic qualification, and frequent participation in short courses about research and bioethics. About 50% occupied institutional positions, 18% directly related to research, and only 4% were representatives of the patients. About 90% had involvement with research in the last 10 years, a third with clinical research. Part II was dedicated to their self-evaluation as members of IRBs, revealing feelings of satisfaction and gratification with their work, and valorization of attributes such as responsibility, compromise, team work capabilities, and 89% and 85% considered themselves prepared and competent for their functions, although with differing perceptions regarding representation and political understandings about their work. Some areas present more difficulties in the analysis of the projects and meetings, seminars and case discussions were mentioned as preferential mechanisms for development. Part III identified perceptions about the functioning of the national research ethics evaluation system, and the utilization of official regulations in project analysis. A more effective participation of the patient representatives and the monitoring of projects are major problems. Areas of necessary investment: how to deal with social sciences research projects, pre-requisites and preparation of IRB members and improved communication of IRBs with each other and the National Commission. Part IV consisted of case studies dedicated to frequent ethical dilemmas in research and the majority had convergent positions as to how to deal with them. The profile of these members as leaders in their IRBs reflects also very strong institutional cultures.
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