Introdução: A pesquisa na área farmacológica envolvendo seres humanos é fundamental para a geração de novos conhecimentos, com a finalidade de trazer benefícios na assistência, porém apresenta riscos associados. Conforme o Manual para Boas Práticas em Pesquisa Clínica (GCP), Evento Adverso (EA) é “qualquer ocorrência médica inconveniente, sofrida pelo participante da pesquisa ou sujeito em investigação clínica com fármacos e que não possui, necessariamente, uma relação causal com este tratamento”. Objetivo: Verificar a incidência de Eventos Adversos (EAs) relacionados aos riscos gastroenterológicos mais citados em protocolos de pesquisa farmacológica. Métodos: Trata-se de um estudo de casos incidentes (coorte não-controlada). O fator em estudo foi o conjunto dos eventos adversos gastrintestinais (EA-GI) relatados. Foram avaliados os relatos de eventos adversos comunicados ao Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre no período de janeiro a dezembro de 2010. Nos últimos doze meses foram monitorados 110 diferentes projetos de pesquisa farmacológica com um acumulado de 8179 relatos de eventos adversos avaliados. Resultados: Da amostra de 26 diferentes projetos envolvidos ao longo de 2010 (jan-dez), foram relatados 63 ocorrências de EA-GI. Os EA-GI mais frequentes foram náusea/vômitos com 21 (33,3%) das ocorrências; outras dores abdominais e as não especificadasl com 12 (19%); alteração do hábito intestinal com dez (15,9%) das ocorrências; elevação das enzimas hepáticas com nove (14,3%) e os demais EA-GI com 17, 5%. Estes EA-GI comparativamente aos riscos descritos não estavam adequadamente descritos nos documentos dos protocolos de pesquisa. Conclusão: As presentes conclusões evidenciam a necessidade de uma avaliação criteriosa dos Comitês de Ética em Pesquisa com relação à documentação dos protocolos de pesquisa a serem avaliados e dos relatos de eventos adversos a serem monitorados. O conjunto destas avaliações - prévia e continuada - devem sempre buscar a proteção adequada dos participantes dos projetos de pesquisa. / Background: Human pharmacological research is essential for the generation of new knowledge in order to generate benefits in health care, but risks are associated. According to the Handbook for Good Clinical Practice (GCP), Adverse Event (AE) is "any untoward medical occurrence inconveniences suffered by the participant or subject of research in clinical research with drugs and do not necessarily have a causal relationship with this treatment ". Objective: To determine the incidence of adverse events (AEs) related to the most cited gastroenterological risks in pharmacological research protocols. Methods: An incident cases study (non-controlled cohort) was performed. The factor under study was the set of GI adverse events (AE-GI) reported. We assessed reports of adverse events reported to the Hospital de Clinicas de Porto Alegre Research Ethics Committee from January to December 2010. In the last twelve months have been monitored more than 110 different pharmacological research projects with a cumulative 8,179 adverse event reports evaluated (3). Results: The sample involved 26 different projects in 2010 (Jan-Dec), 63 occurrences were reported as EA-GI. The EA-GI were more frequent nausea / vomiting 21 (33.3%) of cases, abdominal pain with 12 (19%), diarrhea with ten (15.9%) of cases, elevated liver enzymes with nine (14 3%) and other GI with EA-17, 5%. The reports occurred in other associated centers totaling 87.3% and 12.7% at HCPA. Conclusion: These findings highlight the need for a careful evaluation of the Research Ethics Committee specially when documents of research protocols were evaluated and when adverse events reports were monitored. All these evaluations - prior and ongoing - should always seek appropriate protection of participants in research projects.

abstract: For many adolescents, high school is a critical period of self-awareness, peer-influence, and identity construction. During this volatile period, young people explore how to express themselves in ways that range from conformity to non-conformity and transgression. This is particularly true when it comes to young people's understanding and expression of gender identity. For some youth, their personal form(s) of gender expression align neatly with social expectations; for others, it does not. When gender expression does not align with social expectations, students may be vulnerable to bullying or harassment by peers or adults. Often, youth who are policed and regulated by their classmates through bullying (or harassment, depending upon the relevant or implemented policy) are targeted based on their perceived identity, be that racial, ethnic, citizenship, or, most frequently, gender and sexuality. This project advances the need for research done from a critical youth studies perspective (both methodologically and ethically) and provides new insight into the types of language and practices used by youth to express, perform and "do" gender. Utilizing qualitative methodology, including participant observation, focus group and individual interviews, surveys, and the collection and content analysis of school ephemera, this research investigated how high school students navigate gender identity amidst other intersecting identities. This project examined how youth both "do" and "perform" gender in their everyday lives as high school students. Their gender identity is frequently understood amidst other intersecting identities, particularly sexual orientation, religion and race. These youth also pointed to several important influences in how they understand their own gender, and the gender identity of those around them, including media and peer groups. Because this research took place at two charter art schools, the findings also provided a framework for understanding how these two schools, and charter art schools more generally, provide alternative spaces for young people to experiment and play with their identity construction. Findings indicate that youth are forced to navigate and construct their gender identity amidst many conflicting and contradictory ideologies. Schools, media, and peer groups all heavily influence the way young people understand themselves. / Dissertation/Thesis / Ph.D. Justice Studies 2012

Introdução: A pesquisa na área farmacológica envolvendo seres humanos é fundamental para a geração de novos conhecimentos, com a finalidade de trazer benefícios na assistência, porém apresenta riscos associados. Conforme o Manual para Boas Práticas em Pesquisa Clínica (GCP), Evento Adverso (EA) é “qualquer ocorrência médica inconveniente, sofrida pelo participante da pesquisa ou sujeito em investigação clínica com fármacos e que não possui, necessariamente, uma relação causal com este tratamento”. Objetivo: Verificar a incidência de Eventos Adversos (EAs) relacionados aos riscos gastroenterológicos mais citados em protocolos de pesquisa farmacológica. Métodos: Trata-se de um estudo de casos incidentes (coorte não-controlada). O fator em estudo foi o conjunto dos eventos adversos gastrintestinais (EA-GI) relatados. Foram avaliados os relatos de eventos adversos comunicados ao Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre no período de janeiro a dezembro de 2010. Nos últimos doze meses foram monitorados 110 diferentes projetos de pesquisa farmacológica com um acumulado de 8179 relatos de eventos adversos avaliados. Resultados: Da amostra de 26 diferentes projetos envolvidos ao longo de 2010 (jan-dez), foram relatados 63 ocorrências de EA-GI. Os EA-GI mais frequentes foram náusea/vômitos com 21 (33,3%) das ocorrências; outras dores abdominais e as não especificadasl com 12 (19%); alteração do hábito intestinal com dez (15,9%) das ocorrências; elevação das enzimas hepáticas com nove (14,3%) e os demais EA-GI com 17, 5%. Estes EA-GI comparativamente aos riscos descritos não estavam adequadamente descritos nos documentos dos protocolos de pesquisa. Conclusão: As presentes conclusões evidenciam a necessidade de uma avaliação criteriosa dos Comitês de Ética em Pesquisa com relação à documentação dos protocolos de pesquisa a serem avaliados e dos relatos de eventos adversos a serem monitorados. O conjunto destas avaliações - prévia e continuada - devem sempre buscar a proteção adequada dos participantes dos projetos de pesquisa. / Background: Human pharmacological research is essential for the generation of new knowledge in order to generate benefits in health care, but risks are associated. According to the Handbook for Good Clinical Practice (GCP), Adverse Event (AE) is "any untoward medical occurrence inconveniences suffered by the participant or subject of research in clinical research with drugs and do not necessarily have a causal relationship with this treatment ". Objective: To determine the incidence of adverse events (AEs) related to the most cited gastroenterological risks in pharmacological research protocols. Methods: An incident cases study (non-controlled cohort) was performed. The factor under study was the set of GI adverse events (AE-GI) reported. We assessed reports of adverse events reported to the Hospital de Clinicas de Porto Alegre Research Ethics Committee from January to December 2010. In the last twelve months have been monitored more than 110 different pharmacological research projects with a cumulative 8,179 adverse event reports evaluated (3). Results: The sample involved 26 different projects in 2010 (Jan-Dec), 63 occurrences were reported as EA-GI. The EA-GI were more frequent nausea / vomiting 21 (33.3%) of cases, abdominal pain with 12 (19%), diarrhea with ten (15.9%) of cases, elevated liver enzymes with nine (14 3%) and other GI with EA-17, 5%. The reports occurred in other associated centers totaling 87.3% and 12.7% at HCPA. Conclusion: These findings highlight the need for a careful evaluation of the Research Ethics Committee specially when documents of research protocols were evaluated and when adverse events reports were monitored. All these evaluations - prior and ongoing - should always seek appropriate protection of participants in research projects.

Magister Artium - MA / Several studies concur that children from a disadvantaged background are as prepared for formal schooling, compared to their advantaged peers who have access to attend good quality pre-schools. This is particularly true regarding the literature aimed at understanding the challenges that impede school readiness of Foundation Phase learners and the consequences of poor school readiness on learner’s school performance. The overall aim of the study was to explore Foundation Phase teachers’ experiences and perceptions of the challenges that impede school readiness. The research questions for this study probed the challenges that impede the school readiness of Foundation Phase learners of low-to middle-income background; the consequences of poor school readiness on learners’ school performance; the challenges encountered in the classroom by teachers regarding learners with poor school readiness; and the programmes used to assist children with poor scholastic performance. The study was informed by Bronfenbrenner’s Bio-ecological Systems Theory, to understand how the environment shapes the development of a child. The study adopted a qualitative methodological framework with an exploratory research design. The design was suitable since limited literature exists on this topic, thus proving in-depth information of Foundation Phase teachers about the phenomenon under study. Furthermore, a total number of 20 participants were included in this study, and participants were purposively selected. Data was collected by means of semi-structured individual interviews and was thematically analysed.

Indiana University-Purdue University Indianapolis (IUPUI) / Phase I clinical trials (P1Ts) are the first step in testing new medical therapies in humans, and are essential for developing new and innovative therapies for children with cancer. P1Ts are ethically controversial as they are not intended to directly benefit participants, but are particularly controversial for children with cancer who are only able to participate when there is no known curative therapy for their cancer. Benefits of pediatric oncology P1T participation may include improved quality of life (QOL) and hope. Risks may include fostering unrealistic hope, burdening children with additional medical procedures and toxicities, and limiting the opportunity for palliation. The goal of this dissertation was to investigate the P1T participation experience for children with cancer and their parents by: (1) assessing what is currently known about the participation experience, (2) exploring ways to understand and assess treatment burden and QOL during participation, and (3) interviewing parents about the experience of having a child participate in a P1T. Following a review of the literature, two studies were conducted: a longitudinal pilot study of 13 parent and child dyads who enrolled in a pediatric oncology early phase clinical trial at the recruiting institution, and a phenomenological study of 11 parents of children with cancer who participated in pediatric oncology P1Ts. Key findings included a dearth of research on the experiences of children and parents in pediatric oncology P1Ts. Instead, existing research has focused on consent processes. The longitudinal pilot study provided some insight into experiences of children and parents during trial participation, including that there may be time points when parents’ and children’s perceptions of the child’s quality of life substantively differ. Interviews with parents confirmed some of the anticipated benefits and risks of participation in P1Ts, and highlighted parents’ sense of running out of time to find an effective treatment and needing to use time they have with their child well. Specific challenges in conducting this research were participant attrition due to disease progression and the need for multi-site research to obtain an adequate sample.

As part of a preliminary literature review of research concerning the relationship between medical anthropology and bioethics committees, it became clear that Institutional Review Boards, a foundational component of research, had never been evaluated as a population with a characterizable identity. Some examples of contextual critiques and policy analysis with the goal of procedural efficiency were accessible (Gunsalus 2006; Fitzgerald 2009; Lederman 2006; Ozdemir 2009; Sontag 2012), but qualitative data on the local knowledge of IRBs as a population do not exist. A synthesis of theoretical orientations and methodological planning have been integrated to inform these novel research questions to learn more about the ethical decision-making process of an Institutional Review Board within a research university and hospital. Bioethical reasoning grounded in Western morals creates enough opportunity for cognitive dissonance because of the potential misapplication of ethics, but when decision-making authority is deemed objectively scientific, it can cause a power dynamic by being taken as self-evident. Considering these biomedical frameworks, research with human subjects is grounded in morality, making IRBs a relevant site of praxis for philosophical and scientific research. The overall purpose of this project is to identify the ethical values that define Institutional Review Boards as a population, evaluate the moral implications of biomedical governmentality in clinical research, and define common phenomenological understandings of moral praxis within positions of relative power.

Les récents progrès en neuroimagerie ont permis, au cours des dernières années, de faire avancer les connaissances sur les maladies neurologiques et psychiatriques en offrant la possibilité de mieux comprendre l’évolution des maladies neurodégénératives et la nature du comportement, des émotions, de la personnalité, et de la cognition. Plusieurs défis éthiques ont émergés suite à l’utilisation de ces nouvelles technologies d’imagerie cérébrale. La perspective des chercheurs concernant les pratiques d’évaluation des protocoles de recherche en neuroimagerie ainsi que les défis éthiques, sociaux et légaux auxquels font face les chercheurs n'ont pas encore été étudiés, même s’ils constituent des acteurs clés. Nous avons entrepris une étude empirique sur les perspectives des chercheurs quant au processus d'évaluation par les comités d’éthique de la recherche (CÉR) afin d’examiner les enjeux éthiques, légaux et sociaux liés à la pratique de la neuroimagerie au Canada. Pour ce faire, nous avons expédié un questionnaire en ligne et réalisé des entrevues semi-structurées avec des chercheurs en neuroimagerie et des présidents des CÉR. Les entrevues ont été transcrites et analysées à l'aide du logiciel d'analyse qualitative Nvivo. Nos résultats ont mis en lumière plusieurs aspects éthiques légaux et sociaux suscitant une attention particulière afin de remédier aux défis actuels dans la recherche en neuroimagerie ainsi qu’au processus d’évaluation de la recherche par les CÉR. Nos données comportent également des recommandations provenant des chercheurs eux-mêmes afin d'améliorer le processus d'évaluation. Finalement, notre propre expérience avec cette étude multicentrique nous a permis de constater plusieurs des défis mentionnés par les chercheurs. / Over the past years, advances in neuroimaging have allowed for a better understanding of neurologic and psychiatric disorders and yielded insights into behavior, emotion, personality, and cognition as well as allowed for a deeper understanding of neurodegenerative diseases. In light of the uses of these new imaging technologies, several ethical issues have emerged. The perspectives of researchers on current ethics review of neuroimaging protocols and ethical, legal and social issues present in neuroimaging have not been investigated, even though they are key stakeholders. We undertook an empirical study of researcher perspectives regarding the REB review process to examine ethical, legal and social issues associated with the practice of neuroimaging in Canada. We conveyed an online questionnaire survey and conducted semi-structured interviews with neuroimaging researchers and REB chairs. Interviews were transcribed and analyzed using the NVivo qualitative analysis software. Our results put into perspective emerging ethical, social and legal issues which are important challenges to address in the field of neuroimaging as well as practical challenges in the REB process. Our data also contain recommendations, coming from the neuroimagers themselves, in order to improve the evaluation process. Finally, our experience conducting this research has allowed us to confirm the challenges and stakeholders faced by neuroimagers.

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.

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.

Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal.