Thesis (M.S.)--University of Michigan, 2003. / Includes bibliographical references.

Thesis (Ph. D.)--University of North Texas, Dec., 2008. / Title from title page display. Includes bibliographical references.

Masterarbeit, Univ. Bern, 2004. / Masterarbeit Nachdiplomstudium Management im Gesundheitswesen Medizinische, Rechts- und Wirtschaftswissenschaftliche Fakultät der Universität Bern.

Thesis (doctoral)--Universität, Düsseldorf, 2005. / Includes bibliographical references (p. [387]-423).

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.

abstract: Technology is rapidly evolving, and mental health professionals are increasingly using technology in their clinical work. In reaction to this shift, it is important that research examines the ethical implications of online behaviors. The current study examined the online practices of graduate students in the mental health field and generated prediction models for online client searches and best practices in informed consent and online disclosure. The sample consisted of 316 graduate students in counseling, clinical, and school programs. Of those with clinical experience, a third had utilized the Internet to find information about their client. Progress in the participants' program, as measured by credits completed or in progress, and years of social networking experience were positively related to online client searches. The vast majority (over 80%) of individuals who conducted an online search did not obtain informed consent prior to the search. Curiosity was the most frequent reason given for conducting a client search. Previous professional discussions and belief that information online is private were not significant predictors of obtaining informed consent. The final analysis examined disclosure of client information and found that lower scores on ethical decision-making and years of social networking experience predicted online disclosure. This study is an important step in understanding the implications of the intersection of technology use, ethics, and clinical practice of graduate mental health professionals. / Dissertation/Thesis / M.C. Counseling Psychology 2012

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.

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.

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