A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica. / Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

The diploma thesis is divided into a theoretical and a practical part. The first part describes the current state of the issue of informed consent in a general context and related topics. To obtain the data, I used the qualitative research, the method of questioning, and the data collection technique of a semi-structures interview. The research sample group consisted of 11 patients and two doctors. The objective of the thesis was to identify and describe the differences between the theory and the practice of informed consent in the hospital, and to find out whether there has been any shift in the mistakes and errors associated with informed consent as stated by Haškovcová (2007). The research results have shown that the interviewed patients are not familiar with the concept of informed consent. The knowledge of the informed consent concept was more accurate by doctors as presumed. On the issue of viewed benefits of informed consent, it is clear from respondents? answers that informed consent is viewed primarily as doctors? legal protection against any complaints or lawsuits made by the patients in the performance of their profession by making the patient familiar with any complications that may occur during the performance. This benefit is perceived by both patients and doctors. Doctors see its benefit also as the protection of patients. Another benefit viewed by doctors is the written informed consent form. Six of the interviewed patients stated that informed consent was submitted to them to sign by the nurse/male nurse without proper instructions. Furthermore, doctors? answers show that the timing of instructions depends on the nature of the surgery, whether it is planned or acute. However, some patients said that they were not even instructed with the sufficient time after giving informed consent even when related to a planned procedure. The most stated form was the combination of written and oral instructions, so the patient was first instructed orally and then he was also handed a detailed description of the particular procedure in the written form. There was no uniformity about the question of the amount of submitted information among the interviewed patients as well as doctors ? some of them prefer just basic information, some of them want to know all the information. One of the interviewed doctors favored just the adequate informed consent and saw the detailed informed consent as problematic, another doctor preferred introduction of all the details, although in the written form, mainly because of legal protection. In terms of quality of the provided information, it is clear from the statements of the patients that two most important facts for them are that the performance is in their benefit and the duration of hospitalization. All patients have agreed on the fact that it is very good that they are informed about the procedure which will be performed on them. However, they were not united regarding the issue of participation in the decision ? two patients stated that not even the properly informed patient should participate in the decision about their treatment. Only one doctor expressed his stance to the patient?s participation in the decision stating that he tries to persuade his patients that his proposed solution is the optimal. The standard for the patients is to ask questions when they are concerned about something or interested in it. However, the statements showed that they do not always get the answer they are satisfied with. When the patients stated that they do not ask their doctors about anything, their reasons were enough information, lack of staff and a feeling of unwillingness on the part of doctors. If the patients did not receive enough information from the medical staff, they looked for it in other sources of information. This thesis points to the broader psychosocial context of informed consent, so its results may help during the training of staff in the assisting professions.

abstract: Sexual assault at colleges and universities in the United States is a significant health and human rights issue that impacts somewhere between one-in-four and one-in-five students. Despite the alarmingly high burden, overall rates of disclosing to crisis, health, and victim services, and reporting to schools and law enforcement remain low. In order to buffer students from associated short- and long-term harm, and help them reestablish safety and pursue justice, empirically-supported, innovative, and trauma-informed secondary prevention strategies are needed. To address this pressing issue, the current study used a trauma-informed, feminist community research approach to develop and design a prototype of an internet-based decision aid specifically tailored to assist students at Arizona State University who experience sexual assault with making informed choices about reporting and seeking care, advocacy, and support on and off campus. Results from preliminary alpha testing of the tool showed that: 1. It is feasible to adapt decision aids for use with the target population, and 2. While aspects of the tool can be improved during the next phases of redrafting and redesign, members of the target population find it to be acceptable, comprehensible, and usable. / Dissertation/Thesis / Doctoral Dissertation Global Health 2018

Analisa a loucura no mundo atual como uma categoria em mudança, considerando a possibilidade do trabalho se tornar o eixo estruturante para a \"pessoa psicótica\" através do desenvolvimento de estratégias identitárias de transição realizada em oficinas de orientação profissional. Os sujeitos são 17 usuários de duas instituições de saúde mental da Rede Pública do Estado de São Paulo, caracterizados como \"pessoas psicóticas\". Passam por uma entrevista grupal de triagem para levantar seu histórico e expectativas profissionais; participam de uma oficina de orientação profissional, na qual é realizada a proposta de intervenção, advinda da experiência profissional do pesquisador e da literatura especializada; e realizam uma entrevista de saída para avaliação do processo. Os dados coletados indicam que a orientação profissional para \"pessoas psicóticas\" pode se constituir num espaço intermediário que visa gerar o resgate gradativo da autonomia sobre si, a operacionalização para a elaboração de projetos e o desenvolvimento de estratégias identitárias de construção de projetos, primeiramente pela construção de projetos ocupacionais de transição para depois consolidar a criação e recriação constantes de projetos profissionais no mundo do trabalho. Conclui que a \"pessoa psicótica\", vivendo num mundo em transição, pode criar lugares diferenciados para si através da desconstrução do conceito de \"louco\" utilizando o trabalho como suporte, ao mesmo tempo em que encontra extrema dificuldade em realizar essa tarefa / Investigates the madness at the current world as a class in changing considering the possibility of work becomes the structural axis for the \"psychotic persons\" by the transition identity strategies development that take place in vocational guidance workshops. The subjects are 17 patients from two mental health public institutions in the state of São Paulo specified as \"psychotic persons\". Administers a group selection interview to investigate their wishes related to work and their life story; a vocational guidance workshop in which a new practice is arisen, derived from the specialized bibliography and the researcher professional experience; and a final group interview to evaluate the group process. The data gathered indicates that a vocational guidance for \"psychotic persons\" could be an intermediate place that aims to make possible the gradual self recovery, the instrumentation for the working up of a project and the identity strategies development of construction of projects, in the first place by the production of transition occupational projects and then by the constant rebuilding of professional projects in the work world. Findings demonstrate that the \"psychotic persons\" currently living at world that is in a transition should create special places for themselves changing the \"mad\" concept by the work transformed in a support for them, at the same time that they find an extreme difficulty to do this task

This thesis is investigating in how current buying and purchasing decisions within retail interior are made and how they possibly could be changed or affected with sensory engagement, to promote social sustainability by promoting individual knowledge and sense making in B2B (business to business) context.  The background for this thesis sprung from many sources but is mainly based on the last couple of decades’ societal changes in both digital developments, contributing to more separated consumer behaviour but also in the economical shift from a production area to a consumption age. Which both have fostered a, social and common confidence in the visual sense.  Purchasers are today in 2017, are despite last year’s recent sustainability focus within, b2b, still controlled by business factors such as generating profit and increase market share. For this reason and due to a supportive technical development urging on screen information, much of previous instinctive material and production knowledge have gone missing since the faith in the mere visual still dominate the human perception and information intake.  Business reliance on economical components has proven to not support the individual knowledge generation nor engage with entailing learning. In a series of interviews and LAB experiments this thesis explored the concept of lost material knowledge and developed a conceptual design tool for conversation and learning. Reaching out to rookies as well as advanced constructors of retail interior creating a bridge of tactile experiences to discuss and explore in B2B.  By creating a common tool, effacing the focus on the visual, this thesis argues for the importance of bringing back the information and richness of tactile engagement in order to support and foster the individual learning process and break the chain of lost knowledge.  A hypothesis that this essay is arguing for is that a reintroduction of importance at the individual level can make employees, within B2B, feel more involved and important in its development. In the long run, a continuation and development of this type of methods could change and question existing business strategies and promote the possibilities for social soft values to enter the B2B world.

Orientador: Cléa Adas Saliba Garbin / Banca: Renato Moreira Arcieri / Banca: Eduardo Daruge Junior / Resumo: O trabalho executado pelos profissionais auxiliares da odontologia constitui uma ferramenta diferenciada para se obter um aumento de produtividade, principalmente no que se refere ao serviço público de saúde. Para o cirurgião-dentista alcançar a produtividade máxima, os auxiliares precisam ter conhecimento de suas funções segundo as legislações vigentes. Esses conhecimentos abrangem a parte técnica e as posturas éticas desses profissionais, buscando uma humanização dos serviços na odontologia e a promoção dos direitos dos pacientes. Sendo assim, o consentimento informado e o sigilo profissional devem ser respeitados na prática odontológica, não apenas como uma doutrina legal, mas como um direito moral dos pacientes e que gera obrigações morais para os Cirurgiões- Dentistas e pessoal auxiliar. O objetivo foi avaliar o conhecimento dos Técnicos em Saúde Bucal (TSB) e Auxiliar de Saúde Bucal (ASB) quanto à realização de suas funções regulamentadas pela Lei Nº 11.889, de 24 de dezembro de 2008, assim como a formação destes e capacitação recebida antes de exercerem suas funções no sistema publico de saúde; avaliar também o conhecimento destes em relação aos conceitos bioéticos, no que diz respeito ao consentimento informado e sigilo profissional, aprendidos durante os cursos de formação ou prática profissional dentro do sistema público de saúde. A população alvo do presente estudo foram os TSB e ASB (N=76) que atuam no sistema público de 5 municípios da área de abrangência do DRS II-SP. A coleta dos dados foi realizada através de questionários semiestruturados e auto-administrados, com questões abertas e fechadas. A taxa resposta foi de 90,79% (n= 69). Os resultados mostraram que a maioria dos profissionais conhece parte de suas funções (56%). Quase metade dos profissionais tem curso de formação (47,8%). Quanto às ... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: The work made by dental auxiliaries is a different tool to obtain an increase of productivity, principally about public health service. It's necessary that auxiliaries have knowledge about their role according current Law, and so, dental surgeon get the maximum productivity. This knowledge involves techniques and ethical postures of them, aiming humanization on dental services and promotion of patient's rights. So, informed consent and professional secrecy should be respected on dental practice, not only like a legal doctrine, but like a moral right of patients and that cause moral duties for dental surgeons and dental auxiliaries. The aim of this study was to evaluate the knowledge of hygienists (TSB) and dental auxiliaries (ASB) about performance of their roles regulated by Law number 11.889, December 24th, 2008, evaluate the formation of them and capacitating received before they had executed their roles on Public Health System; to evaluate the knowledge of them about bioethical means, in relation to informed consent and professional secrecy, learned during courses of formation or professional practice into public health system. The target population of this study were TSB and ASB (N=76) that work on public health system from 5 cities belong to DRS II-SP. Data collection was performed through semi-structured questionnaire and self-applied, with opened and closed questions. The answer rate was 90,79% (n=69). The results showed that the majority of professionals know part of their roles (56%). Near half of them has formation course (47,8%). About received information during current course, 80% affirmed had received all information that are necessary for their formation, however, 84% affirmed feel necessity of actualization of their knowledge to develop their works. 58% of researched professionals said that they didn't receive capacitating after ... (Complete abstract click electronic access below) / Mestre

INTRODUÇÃO: A obtenção de órgãos para pesquisa é essencial para o estudo da neurobiologia da doença mental. Na comunidade científica internacional há uma demanda crescente para a disponibilização de tecido cerebral humano para estudos sobre a neurobiologia das doenças neuropsiquiátricas, com grande interesse no uso desses tecidos para a investigação dos processos biológicos básicos associados às doenças mentais. No cenário atual, entretanto, biobancos de tecido cerebral dedicados às doenças psiquiátricas são extremamente escassos. OBJETIVO: Descrever a frequência de doação de tecido cerebral para pesquisa por familiares de pessoas que cometeram suicídio MÉTODO: Foram incluídas solicitações para doação de encéfalo a familiares de indivíduos que cometeram suicídio com idade entre 18 a 60 anos cuja necropsia foi realizada entre março de 2014 e fevereiro de 2016. Foram excluídos casos com lesões no tecido cerebral devido a trauma na hora da morte. RESULTADOS: Tivemos acesso a 56 casos de suicídio. Destes, 24 estavam dentre os critérios de exclusão do projeto. Foram excluídos do estudo 11 casos por falta de responsáveis para assinar o Termo de Consentimento Livre e Esclarecido (TCLE). Finalmente, dos 21 remanescentes, 9 responsáveis autorizaram a doação de tecido cerebral, em sete casos de fragmento de córtex e dois do encéfalo. CONCLUSÕES: As doações de tecido cerebral para pesquisa são indispensáveis para a elucidação de causas biológicas, e há uma escassez de material biológico disponível para a investigação do sistema nervoso central em doenças neuropsiquiátricas. Neste estudo demostra-se que a doação para pesquisa em nosso meio é possível, com uma proporção de consentimento similar àquela relatada em doenças neurodegenerativas. / INTRODUCTION: Obtaining organs for research is essential to study the neurobiology of mental illness. The international scientific community there is a growing demand for the availability of human brain tissue for studies of the neurobiology of neuropsychiatric diseases, with great interest in the use of these tissues for investigation of basic biological processes associated with mental illness. In the current scenario, however, brain tissue biobanks dedicated to psychiatric disorders are extremely scarce. OBJECTIVES: To describe the frequency of brain tissue donation for research purposes by families of individuals that committed suicide. METHODS: All the requests for brain tissue donation for a brain biorepository made to the families of individuals aged 18-60 years that committed suicide between March 2014 and February 2016 were included. Cases presenting with brain damage due to acute trauma were excluded. RESULTS: Fifty-six suicide cases were reported. 24 fulfilled the exclusion criteria; 11 were excluded because no next of kin was found to sign the informed consent. Finally, of the 21 remaining cases, brain tissue donation was authorized in 9 - – 7 fragments of brain tissue and 2 the entire organ. CONCLUSIONS: The donation of brain tissue for research is essential for the elucidation of the neurobiology of neuropsychiatric illness. In the present study, we report the feasibility of brain tissue donation for research purposes. Moreover, that the rates of this sort of donation is similar to the rates reported for neurodegenerative diseases.

Este trabalho compara as duas gravações realizadas pelo pianista András Schiff em 1984 e 2011, respectivamente, do Cravo Bem-Temperado de J. S. Bach, e discute as entrevistas concedidas pelo pianista à imprensa especializada, nas quais ele expõe sua abordagem com relação à interpretação da música de J. S. Bach. O objetivo do trabalho é corroborar a hipótese de que o pianista adota, na sua gravação mais recente, uma abordagem mais próxima ao estilo de performance da música barroca denominado estilo retórico, conforme proposto por Haynes (2007) e Golomb (2004; 2008). Conclui-se, através da análise das gravações e das entrevistas supracitadas, que Schiff adota princípios do estilo retórico na sua execução, além de reconhecer implicitamente, nas suas entrevistas, a relevância dos princípios retóricos para a execução da música de Bach. Também são discutidos os argumentos do pianista a favor do uso do piano como instrumento apropriado para a execução da música de Bach e da rejeição do uso do pedal de sustentação deste instrumento, e a relação de Schiff com o movimento da Performance Historicamente Informada. / This paper compares the two recordings made by the pianist András Schiff in 1984 and 2011, respectively, of the First Book of The Well-Tempered Clavier by J. S. Bach, and discusses the interviews granted by the pianist to the specialized press where he exposes his approach to the interpretation of Bach's music. The paper aims to support the hypothesis that the pianist adopts in his latest recording an approach called Rhetorical Style by Haynes (2007) and Golomb (2004; 2008) which, according to the authors, is closer to the Baroque Music performance style. By analyzing the aforementioned recordings and interviews, it is concluded that Schiff adopts principles of the Rhetorical Style in his performance, and also implicitly acknowledges in his interviews the relevance of rhetorical principles for the execution of Bach's music. Also discussed are the pianist's arguments in favor of using the piano as an appropriate instrument for the execution of Bach's music and against the use of the instrument' sustain pedal, in addition to Schiff's relationship with the Historically Informed Performance movement.

abstract: ABSTRACT Whole genome sequencing (WGS) and whole exome sequencing (WES) are two comprehensive genomic tests which use next-generation sequencing technology to sequence most of the 3.2 billion base pairs in a human genome (WGS) or many of the estimated 22,000 protein-coding genes in the genome (WES). The promises offered from WGS/WES are: to identify suspected yet unidentified genetic diseases, to characterize the genomic mutations in a tumor to identify targeted therapeutic agents and, to predict future diseases with the hope of promoting disease prevention strategies and/or offering early treatment. Promises notwithstanding, sequencing a human genome presents several interrelated challenges: how to adequately analyze, interpret, store, reanalyze and apply an unprecedented amount of genomic data (with uncertain clinical utility) to patient care? In addition, genomic data has the potential to become integral for improving the medical care of an individual and their family, years after a genome is sequenced. Current informed consent protocols do not adequately address the unique challenges and complexities inherent to the process of WGS/WES. This dissertation constructs a novel informed consent process for individuals considering WGS/WES, capable of fulfilling both legal and ethical requirements of medical consent while addressing the intricacies of WGS/WES, ultimately resulting in a more effective consenting experience. To better understand components of an effective consenting experience, the first part of this dissertation traces the historical origin of the informed consent process to identify the motivations, rationales and institutional commitments that sustain our current consenting protocols for genetic testing. After understanding the underlying commitments that shape our current informed consent protocols, I discuss the effectiveness of the informed consent process from an ethical and legal standpoint. I illustrate how WGS/WES introduces new complexities to the informed consent process and assess whether informed consent protocols proposed for WGS/WES address these complexities. The last section of this dissertation describes a novel informed consent process for WGS/WES, constructed from the original ethical intent of informed consent, analysis of existing informed consent protocols, and my own observations as a genetic counselor for what constitutes an effective consenting experience. / Dissertation/Thesis / Ph.D. Biology 2013

Este trabalho compara as duas gravações realizadas pelo pianista András Schiff em 1984 e 2011, respectivamente, do Cravo Bem-Temperado de J. S. Bach, e discute as entrevistas concedidas pelo pianista à imprensa especializada, nas quais ele expõe sua abordagem com relação à interpretação da música de J. S. Bach. O objetivo do trabalho é corroborar a hipótese de que o pianista adota, na sua gravação mais recente, uma abordagem mais próxima ao estilo de performance da música barroca denominado estilo retórico, conforme proposto por Haynes (2007) e Golomb (2004; 2008). Conclui-se, através da análise das gravações e das entrevistas supracitadas, que Schiff adota princípios do estilo retórico na sua execução, além de reconhecer implicitamente, nas suas entrevistas, a relevância dos princípios retóricos para a execução da música de Bach. Também são discutidos os argumentos do pianista a favor do uso do piano como instrumento apropriado para a execução da música de Bach e da rejeição do uso do pedal de sustentação deste instrumento, e a relação de Schiff com o movimento da Performance Historicamente Informada. / This paper compares the two recordings made by the pianist András Schiff in 1984 and 2011, respectively, of the First Book of The Well-Tempered Clavier by J. S. Bach, and discusses the interviews granted by the pianist to the specialized press where he exposes his approach to the interpretation of Bach's music. The paper aims to support the hypothesis that the pianist adopts in his latest recording an approach called Rhetorical Style by Haynes (2007) and Golomb (2004; 2008) which, according to the authors, is closer to the Baroque Music performance style. By analyzing the aforementioned recordings and interviews, it is concluded that Schiff adopts principles of the Rhetorical Style in his performance, and also implicitly acknowledges in his interviews the relevance of rhetorical principles for the execution of Bach's music. Also discussed are the pianist's arguments in favor of using the piano as an appropriate instrument for the execution of Bach's music and against the use of the instrument' sustain pedal, in addition to Schiff's relationship with the Historically Informed Performance movement.