Made available in DSpace on 2016-08-10T10:54:11Z (GMT). No. of bitstreams: 1 EURIPEDES RODRIGUES FILHO.pdf: 1862437 bytes, checksum: 9bbde5e059417e2643ece305cfda4d7a (MD5) Previous issue date: 2014-03-12 / The respect due to the human dignity and autonomy requires that all scientific research involving human subjects may only be conducted with due consent of the participant. It could say that for the Ethics Committee (EC), in Brazil, the most important for verifying the adequacy of the ethics of research projects involving human beings is the Informed Consent (IC) .Therefore, as shown by the literature, it is common ground point between most ethics committees of research centers in the world, the need for obtaining informed consent for any research involving human beings. Therefore, those shown by the literature, it is common ground point between ethics committees of most research centers in the world, the need for Obtaining informed consent for any research Involving human beings. Due to the risks related to privacy and confidentiality of data and that such waiver must be requested by the researcher to the CEP, with justification. Aimed to select, interpret, and critically evaluate studies that were focused understanding and readability of the informed consent; identify factors associated with the process of obtaining valid consent factors; identify the inner relationship between the principle of respect for autonomy and informed consent. The methodological procedures were performed in two stages: the first was used an integrative review to check the guiding question of the study, which to question the readability and understanding of informed consent in research involving humans. Included in the sample selected eleven of this review, national and international articles, four of which were in Portuguese (36.36%), one in Spanish (9.09%) and six in English (54.54%). The second was used content analysis to the verification of changes in guidelines for research involving humans in Brazil, referring to the principle of respect for autonomy of the research participant. From the themes "consent and approval", "document / consent" and "consent process", which allow the inference of the changes brought by the new rules on ethics in research involving human beings. The study results suggest that the informed consent should contain simple vocabulary, clarity of language, considering the socioeconomic, educational and cultural participant. Similarly suppose that the four necessary conditions for an autonomous decision are: intentionality, proper knowledge, the absence of external and internal control and authenticity. Concluded that the IC well understood is the key to autonomous decision making and, that authenticity gives the informed consent the essential nature of validity. It was found that the amount of related to informed consent in research involving humans, studies are still very low in the scientific community. Making is therefore a need for greater mobilization of the scientific and academic community for this matter of major interest to society. / O respeito devido à dignidade humana e à autonomia exige que toda pesquisa científica que envolve seres humanos só poderá ser realizada, com o devido consentimento do participante. Pode-se dizer que, para os Comitês de Ética em Pesquisa (CEP), no Brasil, o documento mais importante para a verificação da adequação da eticidade dos projetos de pesquisas que envolvem seres humanos é o Termo de Consentimento Livre e Esclarecido (TCLE). Por conseguinte, como atesta a literatura pertinente, é ponto pacífico entre a maioria dos comitês de ética dos centros de pesquisas do mundo, a necessidade da obtenção do TCLE para qualquer pesquisa que envolva seres humanos. Excetuam-se os casos especiais previstos nas resoluções e declarações nacionais e internacionais, que tratam da impossibilidade de se obter o TCLE de certos participantes, devido aos riscos relacionados à privacidade e à confidencialidade dos dados e, que essa dispensa deve ser solicitada pelo pesquisador ao CEP, com justificativa. Teve como objetivos selecionar, interpretar e avaliar criticamente os estudos que tiveram como enfoque a compreensão e a legibilidade do Termo de Consentimento Livre e Esclarecido (TCLE); verificar os fatores associados ao processo da obtenção do consentimento válido; explicitar a relação interna entre o princípio do respeito à autonomia e o consentimento livre e esclarecido. Os procedimentos metodológicos foram realizados em dois momentos: no primeiro, utilizou-se da revisão integrativa para a verificação da pergunta norteadora do estudo, que problematizou a legibilidade e a compreensão do consentimento livre e esclarecido na pesquisa que envolve seres humanos. Integram a amostra desta revisão onze artigos selecionados, nacionais e internacionais, dos quais foram quatro em Português (36,36%), um em Espanhol (9,09%) e seis em Inglês (54,54%). No segundo, utilizou-se da análise de conteúdo para a verificação das mudanças ocorridas nas normas de pesquisa que envolve seres humanos no Brasil, referente ao princípio do respeito à autonomia do participante da pesquisa, a partir das categorias temáticas consentimento e assentimento , documento / termo de consentimento e processo de consentimento , que permitem a inferência das mudanças trazidas com a nova norma sobre ética em pesquisa envolvendo seres humanos. Os resultados do estudo sugerem que os Termos de Consentimento Livre e Esclarecido devem conter vocabulário simples e clareza da linguagem, considerando o nível socioeconômico, de escolaridade e cultural do participante. Do mesmo modo supõem que as quatro condições necessárias para uma decisão autônoma são: a intencionalidade, o conhecimento adequado, a ausência de controle externo e interno e a autenticidade. Concluiu-se que o TCLE bem compreendido é a chave para a tomada de decisão autônoma e que a autenticidade confere ao consentimento livre e esclarecido o imprescindível caráter de validade. Constatou-se, também, que a quantidade de estudos relacionados ao consentimento livre e esclarecido em pesquisas que envolvem seres humanos ainda é muito reduzida no meio científico. Perfaz-se, portanto, a necessidade de maior mobilização da comunidade científica e acadêmica para esta temática de relevante interesse à sociedade.

O objetivo deste estudo foi o de verificar a adequação do uso do Consentimento Informado em participantes de projetos de pesquisa na área da saúde, através da avaliação integrada de seus componentes de informação e consentimento. Foram realizados três estudos. Os dois primeiros envolveram aspectos da avaliação da capacidade das pessoas e do repasse de informações, sendo preparatórios ao terceiro. A amostra do terceiro estudo foi constituída por 59 participantes de seis projetos de pesquisa. Os dados foram analisados estatisticamente utilizando testes paramétricas, não-paramétricas e Análise de Correspondência. A avaliação do componente de informação incluiu a análise da dificuldade de leitura dos Termos de Consentimento Informado. Dois destes documentos apresentaram estrutura de texto considerada difícil e os outros quatro, estrutura muito difícil, utilizando-se os Índices de Legibilidade. Todos os 59 indivíduos foram considerados capazes de tomarem decisões para participarem de uma pesquisa. A maioria dos participantes afirmou ter recebido explicações prévias (52,8%), ter compreendido as informações (55,9%), não ter recebido resposta às suas dúvidas (76,3%) e achado inacessível o Termo de Consentimento Informado (74,6%). Os participantes não lembraram, seletivamente, dos riscos do projeto. As conclusões foram: que os Termos de Consentimento Informado tinham textos compatíveis com escolaridade mais elevada que a da maioria dos participantes; que os riscos não foram relembrados pela maioria dos participantes; que 44,1% das pessoas convidadas autorizaram a sua participação nos projetos de pesquisa sem terem compreendido o que lhes estava sendo proposto em termos de procedimentos, riscos ou benefícios. / The objective of this dissertation is to examine the adequacy of informed consent instruments used in health research projects involving human subjects, through an integrated analysis of the information and consent components which are part of informed consent. The project was divided into three studies. The first two studies were related to the evaluation of people' s capabilities and of how information was given. These were carried out in preparation for the third study. The sample for this third study was constituted of 59 people who had participated in six different research projects carried out at Hospital de Clínicas de Porto Alegre (HCPA). The data were statistically analyzed using parametric and non-parametric tests, as well as correspondence analysis. The evaluation of the information component included an analysis of the degree of difficulty involved in reading and understanding the six different lnformed Consent Forms analyzed. For that, the Flesch-Kincaid Grade Levei was used. The textual structure of two of these documents was considered difficult, whereas the structure of the remaining four documents was considered very difficult. Ali of the 59 participants were considered capable of deciding whether or not to participate in a research project. The majority of the participants reported that they had received explanations prior to signing the consent form (52.8%), that they had understood the information (55.9%), that they had not received answers to questions raised (76.3% ), and that they were unable to understand the lnformed Consent form (74.6%). The participants did not selectively remember the risks involved in the particular research projects they had participated in. Based on the results, it is possible to conclude that the lnformed Consent Forms had been written for readers with more schooling than most of the participants; that most participants were not able to remember the risks involved in the research projects they had participated in; that 44.1 °/Ó of those invited to participate in a project had consented to do so without understanding what was being proposed in terms of procedures, risks, or benefits.

What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility? In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research. Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.

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

abstract: With new trends in drug development and testing, it must be determined whether the current state of balance of ethos (the moral norm) and regula (the legal framework) can successfully protect patients while keeping the door to scientific innovation open. The rise of the Clinician Investigator (CI) in both academic and private research introduces a challenge to the protection of subjects in the conflicting dual role of physician and scientist. Despite the constant evolution of regulation and ethical standards, questions about the roles' combined effectiveness in relation to this challenge persist. Carl Elliot describes the suicide of a patient-subject enrolled in an industry-funded physician-run anti-psychotic pharmaceutical drug trial in a 2010 Mother Jones article. Elliot provides a personal account of discrepancies seen in the ethical principles of beneficence, respect for subjects and justice. Through analysis of the problems presented in the case as a model for potential dangers in clinical research, the effectiveness of ethics and law in protecting human subjects is examined. While the lag between ethical standard and regulation has historically shown to cause similar issues, the misconception of current regulation and ethical standards may be contributing to the decrease in subject protections. After IRB approval of subject protections in the research protocol, CIs have been shown to downgrade their responsibility to maintaining ethos through the course of the trial. And, despite their experience in patient-centered ethos as a physician, CIs may be inclined to substitute these values for the ethos of a researcher, with the goal to avoid therapeutic misconception. Maintaining personal responsibility for subjects beyond regulatory structure, and promoting the welfare of the subjects in regards to the ethical standard of research investigators, will provide added security for subjects and decrease opportunity for exploitation in future research. / Dissertation/Thesis / M.S. Biology 2012

O objetivo deste estudo foi o de verificar a adequação do uso do Consentimento Informado em participantes de projetos de pesquisa na área da saúde, através da avaliação integrada de seus componentes de informação e consentimento. Foram realizados três estudos. Os dois primeiros envolveram aspectos da avaliação da capacidade das pessoas e do repasse de informações, sendo preparatórios ao terceiro. A amostra do terceiro estudo foi constituída por 59 participantes de seis projetos de pesquisa. Os dados foram analisados estatisticamente utilizando testes paramétricas, não-paramétricas e Análise de Correspondência. A avaliação do componente de informação incluiu a análise da dificuldade de leitura dos Termos de Consentimento Informado. Dois destes documentos apresentaram estrutura de texto considerada difícil e os outros quatro, estrutura muito difícil, utilizando-se os Índices de Legibilidade. Todos os 59 indivíduos foram considerados capazes de tomarem decisões para participarem de uma pesquisa. A maioria dos participantes afirmou ter recebido explicações prévias (52,8%), ter compreendido as informações (55,9%), não ter recebido resposta às suas dúvidas (76,3%) e achado inacessível o Termo de Consentimento Informado (74,6%). Os participantes não lembraram, seletivamente, dos riscos do projeto. As conclusões foram: que os Termos de Consentimento Informado tinham textos compatíveis com escolaridade mais elevada que a da maioria dos participantes; que os riscos não foram relembrados pela maioria dos participantes; que 44,1% das pessoas convidadas autorizaram a sua participação nos projetos de pesquisa sem terem compreendido o que lhes estava sendo proposto em termos de procedimentos, riscos ou benefícios. / The objective of this dissertation is to examine the adequacy of informed consent instruments used in health research projects involving human subjects, through an integrated analysis of the information and consent components which are part of informed consent. The project was divided into three studies. The first two studies were related to the evaluation of people' s capabilities and of how information was given. These were carried out in preparation for the third study. The sample for this third study was constituted of 59 people who had participated in six different research projects carried out at Hospital de Clínicas de Porto Alegre (HCPA). The data were statistically analyzed using parametric and non-parametric tests, as well as correspondence analysis. The evaluation of the information component included an analysis of the degree of difficulty involved in reading and understanding the six different lnformed Consent Forms analyzed. For that, the Flesch-Kincaid Grade Levei was used. The textual structure of two of these documents was considered difficult, whereas the structure of the remaining four documents was considered very difficult. Ali of the 59 participants were considered capable of deciding whether or not to participate in a research project. The majority of the participants reported that they had received explanations prior to signing the consent form (52.8%), that they had understood the information (55.9%), that they had not received answers to questions raised (76.3% ), and that they were unable to understand the lnformed Consent form (74.6%). The participants did not selectively remember the risks involved in the particular research projects they had participated in. Based on the results, it is possible to conclude that the lnformed Consent Forms had been written for readers with more schooling than most of the participants; that most participants were not able to remember the risks involved in the research projects they had participated in; that 44.1 °/Ó of those invited to participate in a project had consented to do so without understanding what was being proposed in terms of procedures, risks, or benefits.

O objetivo deste estudo foi o de verificar a adequação do uso do Consentimento Informado em participantes de projetos de pesquisa na área da saúde, através da avaliação integrada de seus componentes de informação e consentimento. Foram realizados três estudos. Os dois primeiros envolveram aspectos da avaliação da capacidade das pessoas e do repasse de informações, sendo preparatórios ao terceiro. A amostra do terceiro estudo foi constituída por 59 participantes de seis projetos de pesquisa. Os dados foram analisados estatisticamente utilizando testes paramétricas, não-paramétricas e Análise de Correspondência. A avaliação do componente de informação incluiu a análise da dificuldade de leitura dos Termos de Consentimento Informado. Dois destes documentos apresentaram estrutura de texto considerada difícil e os outros quatro, estrutura muito difícil, utilizando-se os Índices de Legibilidade. Todos os 59 indivíduos foram considerados capazes de tomarem decisões para participarem de uma pesquisa. A maioria dos participantes afirmou ter recebido explicações prévias (52,8%), ter compreendido as informações (55,9%), não ter recebido resposta às suas dúvidas (76,3%) e achado inacessível o Termo de Consentimento Informado (74,6%). Os participantes não lembraram, seletivamente, dos riscos do projeto. As conclusões foram: que os Termos de Consentimento Informado tinham textos compatíveis com escolaridade mais elevada que a da maioria dos participantes; que os riscos não foram relembrados pela maioria dos participantes; que 44,1% das pessoas convidadas autorizaram a sua participação nos projetos de pesquisa sem terem compreendido o que lhes estava sendo proposto em termos de procedimentos, riscos ou benefícios. / The objective of this dissertation is to examine the adequacy of informed consent instruments used in health research projects involving human subjects, through an integrated analysis of the information and consent components which are part of informed consent. The project was divided into three studies. The first two studies were related to the evaluation of people' s capabilities and of how information was given. These were carried out in preparation for the third study. The sample for this third study was constituted of 59 people who had participated in six different research projects carried out at Hospital de Clínicas de Porto Alegre (HCPA). The data were statistically analyzed using parametric and non-parametric tests, as well as correspondence analysis. The evaluation of the information component included an analysis of the degree of difficulty involved in reading and understanding the six different lnformed Consent Forms analyzed. For that, the Flesch-Kincaid Grade Levei was used. The textual structure of two of these documents was considered difficult, whereas the structure of the remaining four documents was considered very difficult. Ali of the 59 participants were considered capable of deciding whether or not to participate in a research project. The majority of the participants reported that they had received explanations prior to signing the consent form (52.8%), that they had understood the information (55.9%), that they had not received answers to questions raised (76.3% ), and that they were unable to understand the lnformed Consent form (74.6%). The participants did not selectively remember the risks involved in the particular research projects they had participated in. Based on the results, it is possible to conclude that the lnformed Consent Forms had been written for readers with more schooling than most of the participants; that most participants were not able to remember the risks involved in the research projects they had participated in; that 44.1 °/Ó of those invited to participate in a project had consented to do so without understanding what was being proposed in terms of procedures, risks, or benefits.

Abstract The purpose of the study was to broaden understanding of structural racism by examining the relationships between Indigenous peoples and nation-states in the context of education and how this affects Indigenous lives. This thesis delves into understanding both the theoretical and methodological contributions that more critical analyses can have on: the role of de-colonial approaches to Indigenous health research methodologies so that the most urgent health inequities are addressed through more rigorous and Indigenous specific research processes; and to improve our understanding of the complex interactions that historical and contemporary legacies of residential schools and boarding schools have on the health and well-being of Indigenous populations in Canada and Finland. The research design was a qualitative multiple case study informed by a public health critical race praxis. The study was completed in two phases; consisting of a literature study using content analysis of Indigenous research ethics protocols and policies, in Canada and the Nordic countries; and, three case studies developed from open ended questions from structured interview research comparing discriminatory experiences and its impact on self-perceived health with participants from Six Nations of the Grand River, Canada (n = 25) and the Sámi in Inari, Finland (n = 20); and their family members. The case studies were analyzed using both Western and Indigenous methodologies. Results of Phase one shows how Indigenous resistance to colonial structures within academia in Canada and Finland has resulted in dialogical processes to create an ethical space for working between the differing worldviews of academia and Indigenous communities with the aim to produce ethically valid knowledge. Phase two results shows that regardless of contextual differences of the experiences in Canada and Finland, the main parallel outcomes are similar, i.e. the teachings of shame received in these educational environments. This produces both vulnerabilities and resiliencies and the negative effects of shame require an ongoing healing journey for both individuals and their families and communities at large. Conclusion: For a more in depth understanding of structural racism and its influence on Indigenous health, investigations require methodological choices by both Western and Indigenous methodologies. / Tiivistelmä Tutkimuksen päämääränä on tuottaa tietoa rakenteellisesta syrjinnästä. Tämä tapahtuu tutkimalla alkuperäiskansojen ja kansallisvaltioiden välisiä suhteita koulujärjestelmissä sekä sitä, miten rakenteellinen syrjintä vaikuttaa alkuperäiskansojen jäsenten elämään. Tutkimuksen kriittinen analyysi tuottaa dekoloniaalisia lähestymistapoja terveystutkimuksen menetelmiin, jolloin tärkeimmät terveyserot paljastuvat alkuperäiskansalähtöisten tutkimusprosessien kautta. Tutkimus pyrkii lisäämään ymmärrystä siitä, millaisia väliaikaisia sekä nykypäivään asti ulottuvia vaikutuksia sisäoppilaitoksilla ja kouluasuntoloilla on ollut Kanadan ja Suomen alkuperäiskansojen jäsenten terveyteen ja hyvinvointiin. Väitöskirjan tutkimusasetelma on laadullinen monitapaustutkimus, jossa sovelletaan Critical Health Praxis (PHCR) -menetelmän viitekehystä. Tutkimuksen ensimmäisessä osassa vertaillaan laadullisen sisällönanalyysin avulla Kanadan ja Pohjoismaiden alkuperäiskansojen tutkimuseettisiä käytäntöjä ja menettelytapoja. Toisessa osassa on kolme tapaustutkimusta, jotka perustuvat strukturoidun kyselytutkimuksen avovastausten syrjintäkokemuksiin ja niiden vaikutuksiin itsekoettuun terveyteen Kanadan ensimmäisten kansojen jäsenillä (Six Nations of the Grand River, n = 25) sekä Suomen saamelaisilla (Inarin kunta, n = 20). Tapaustutkimuksissa sovelletaan alkuperäiskansalähtöisiä ja länsimaisia tutkimusmenetelmiä. Tulokset osoittavat, että alkuperäiskansojen vastustus kolonialistisia akateemisia rakenteita kohtaan Suomessa ja Kanadassa on synnyttänyt dialogisia prosesseja, joiden avulla voidaan luoda eettistä tilaa tiede- ja alkuperäiskansayhteisöjen maailmankuvien yhteensovittamiseksi ja eettisesti hyväksyttävän tiedon tuottamiseksi. Toisen vaiheen tulokset osoittavat, että vaikka Kanadan sisäoppilaitosten ja Suomen kouluasuntoloiden yhteiskunnalliset lähtökohdat ja käytännön toteutustavat eroavat toisistaan, lopputulos on samansuuntainen: kouluympäristön aiheuttama häpeä, joka tuottaa sekä haavoittuvuutta että resilienssiä. Kielteisten kokemusten työstäminen vaatii pitkää, parantavaa prosessia, joka koskee niin yksilöitä, perheitä kuin yhteisöjäkin. Johtopäätöksenä todetaan, että tarvitaan sekä länsimaisia että alkuperäiskansalähtöisiä tutkimusmenetelmiä, jos halutaan ymmärtää syvällisesti rakenteellista syrjintää ja sen vaikutuksia alkuperäiskansojen terveyteen ja hyvinvointiin.

Thesis (MPhil (Sociology and Social Anthropology))--University of Stellenbosch, 2010. / Please refer to full text for abstract

Using action research within a critical paradigm framework the author investigated young people’s ability to develop a programme of work that raises awareness of bullying in schools. The research group was made up of six young people, to whom the author and other specialists offered anti-bullying and participatory training techniques. The group eventually designed their own anti-bullying activity programme, which they delivered in creative workshop style sessions to other young people in schools. The author located this research in critical enquiry, engaging the group in a self-reflective process that aimed to be democratic, equitable, liberating and life enhancing. This report is written in the form of a narrative and evaluates the author’s practice as an educative theatre practitioner. Central themes to this research are bullying, power, creative activity and youth participation. Schools, teachers and adults are often described as sucking out the creativity of young people and thus not allowing many of them achieve their full potential. In this context young people are often powerless to deal with some of the difficult issues in their lives such as bullying. The author suggests that peer support is a key strategy to deal with bullying in schools. The author introduces a new concept of peer support called external peer support, which he has evaluated against the current literature. The definition of bullying is explored in depth, as is its relationship to power. The author suggests peer support to be a key strategy in youth participation and ultimately helping youth empowerment.