Thesis (MPhil)--University of Stellenbosch, 2002. / ENGLISH ABSTRACT: The implementation of eugenic policies reached its peak during the zo" century when thousands of people with intellectual disabilities and other "undesirable qualities" were involuntary sterilized. Although most of the eugenic policies have been removed, countries such as South Africa, still make legally provision for the involuntary sterilization of people with intellectual disabilities. Torbjërn Tannsjë (1998) used the "argument from autonomy" to argue that involuntary sterilization practices are wrong because it involves compulsion. According to him, society should never interfere with people's reproductive choices and people should never be required to qualify for the right to have children. The aim of this assignment was to systematically assess the "argument from autonomy" as far as the policy of involuntary sterilization of people with intellectual disabilities is concerned. To this end, the concept of autonomy and the principle of respect for autonomy are discussed and applied to the intellectually disabled. It is argued that autonomy and respect for autonomy are useful concepts to apply to some people with intellectual disabilities. These individuals should not be automatically assumed to be incompetent, but their competence needs to be determined on an individual level, with reference to the complexity of the decision to be made. Special effort is needed from health care professionals to obtain (where possible) informed consent from people with intellectual disabilities. The application of the principle of respect for autonomy to matters of reproduction leads to the conclusion that people with severe to profound levels of disability, are unable to provide informed consent for sexual intercourse. Therefore some form of paternalistic protection is needed for these individuals. People with mild to moderate intellectual disabilities who are however competent to consent to sexual intercourse should never be prohibited from procreation by means of involuntary sterilization. State interference in matters of reproduction should be limited to interventions where (i) children are seriously harmed by parents and (ii) to protect those who are incompetent to consent to sexual interactions with others. Apart from these exceptions, the intellectually disabled is entitled to the same procreative rights as all other citizens. / AFRIKAANSE OPSOMMING: Die implementering van eugenetiese beleid het gedurende die 20 ste eeu 'n hoogtepunt bereik met die onwillekeurige sterilisering van duisende persone met intellektuele gestremdhede en ander "ongewensde kwaliteite". Alhoewel meeste van die eugenetiese wetgewing verwyder is, maak lande soos Suid-Afrika steeds wetlik voorsiening vir die onwillekeurige sterilisasie van persone met intellektuele gestremdhede. Torbjërn Tannsjo (1998) maak gebruik van die "outonomie argument" om te argumenteer dat onwillekeurige sterilisasie praktyke onaanvaarbaar is omdat dit dwang bevat. Hy voer aan dat die samelewing nooit in die reproduktiewe keuses van mense behoort in te meng nie en dat dit nooit vir mense nodig moet wees om vir ouerskap te kwalifiseer nie. Die doel van hierdie werkstuk was om sistematies die "outonomie argument" te analiseer ten opsigte van die beleid van die onwillekeurige sterilisasie van persone met intellektuele gestremdhede. Met hierdie doel voor oë word die konsep outonomie en die beginsel van respek vir outonomie bespreek en toegepas op die intellektueel gestremde persoon. Daar word aangevoer dat outonomie en respek vir outonomie nuttige beginsels is om in ag te neem in kwessies rakende intellektueel gestremdes. Hierdie individue moet nie outomaties as onbevoeg beskou word nie, maar hul bevoegdheid moet eerder op 'n individuele basis beoordeel word, inaggeneem die kompleksiteit van die besluit wat geneem moet word. Voorts word daar van gesondheidsorgpersoneel verwag om moeite te doen met die verkryging van oorwoê toestemming (waar moontlik) by persone met intellektuele gestremdhede. Die toepassing van die beginsel van respek vir outonomie op aspekte rakende reproduksie, lei tot die gevolgtrekking dat persone met ernstige intellektuele gestremdhede nie in staat is om toestemming tot seksuele omgang te verleen nie. Dus, is 'n vorm van paternalistiese beskerming in hierdie gevalle aangedui. Persone met intellektuele gestremdhede wat egter wel bevoeg is om toestemming tot seksuele omgang te verleen, moet nooit weerhou word van voortplanting deur middel van onwillekeurige sterilisering nie. Inmenging deur die staat in kwessies rakende reproduksie moet beperk word tot intervensies waar (i) kinders ernstige skade berokken word en (ii) die beskerming van persone wat onbevoeg is om toestemming tot seksuele interaksies met ander te verleen, benodig word. Afgesien hiervan, is die intellektuele gestremde persoon geregtig op dieselfde reproduktiewe regte as alle ander landsburgers.

Thesis (MPhil)--University of Stellenbosch, 2005. / ENGLISH ABSTRACT: Paarl, in the Western Cape, has been identified as one of the 15 national sites where antiretroviral treatment (ARVs) would be made available to people living with HIV/AIDS. Paarl Hospice initiated a support group for people to deal with this disease in 2003. Since February 2004 Paarl Hospice has been recruiting people from the surrounding informal settlements for ARVs. By means of participant observation I explored how HIV/AIDS-related disclosure experiences unfolded in places, spaces and events associated with the support group in the context of factors enabling and preventing people from accessing Hospice House. I did this by considering the insights drawn from an anthropological approach. I found the meanings of disclosure in the majority of studies to be limited and restricted. Available studies approached disclosure in a top-down fashion by regarding the definition of disclosure as the announcement of HIV-positivity at the time of diagnosis only. These studies have not considered social differences relating to disclosure neither did they focus on the actual process of disclosure. By means of a constructivist approach to grounded theory I seek to broaden the definition of disclosure to account for the range of ways in which disclosure practices take place. I found that disclosure could not be separated from the situational context in which it occurs and that it can only be understood in relation to the circumstances and relationships in which it takes place. In this study, disclosure was an ongoing process, situated somewhere between active, public announcement of an HIV-status and complete secrecy and somewhere between voluntary and involuntary revealing of the disease. / AFRIKAANSE OPSOMMING: Paarl in die Wes-Kaap is geïdentifiseer as een van die 15 nasionale areas waar antiretrovirale medikasie beskikbaar gestel sou word aan mense wat leef met MIV/VIGS. Paarl Hospice het gedurende 2003 ʼn ondersteuningsgroep geїnisieer om aan MIV/VIGS aandag te gee. Sedert Februarie 2004 is Paarl Hospice in die proses om mense te werf uit die omliggende informele behuisingsgebiede vir antiretrovirale behandeling. Met behulp van antropologiese insigte en deelnemende waarneming kon ek nagaan hoe verskillende maniere van MIV/VIGS-verwante bekendmaking ontvou in plekke, ruimtes en gebeurtenisse wat verband hou met die ondersteuningsgroep. MIV/VIGSverwante bekendmaking is ondersoek te midde van inhiberende en fasiliterende faktore wat mense verhoed of aanhelp om Paarl Hospice te besoek. Ek het bevind dat die definisie van bekendmaking in die meeste navorsing gebrekkig is. Beskikbare navorsing het bekendmaking volgens ‘n bo-na-onder-wyse benader as die openbare bekendmaking van ‘n MIV-status na afloop van diagnose alleenlik. Met behulp van ‘n konstruktiewe benadering van die begronde teorie het ek gepoog om die definisie van bekendmaking uit te bou om sodoende die verskeidenheid maniere waarop bekendmaking plaasvind te akkommodeer. Ek het vasgestel dat bekendmaking onlosmaakbaar deel is van die situasionele konteks waarin dit plaasvind en dat dit slegs begryp kan word in verband tot die verhoudings en omstandighede waarin dit plaasvind. In hierdie studie was bekendmaking ʼn voortdurende proses, gesitueer tussen aktiewe openbare bekendmaking en volledige geheimhouding van ʼn MIVstatus, asook tussen volkome vrywillige en onvrywillige bekendmaking van ʼn MIVstatus.

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de maîtrise en droit option Droit et Biotechnologies". Ce mémoire a été accepté à l'unanimité et classé parmi les 15% des mémoires de la discipline. / La recherche biomédicale réalisée en situation d'urgence traduit la confrontation entre différents principes conducteurs éthiques. Le respect de l'autonomie de la personne, illustré à travers l'obtention du consentement libre et éclairé du sujet pressenti, peut sembler un concept vide de sens dans le cas des malades présentant une condition médicale critique. Pour ces patients en proie à une crise médicale, et donc vulnérables, une protection individuelle accrue s'impose. Une surprotection irait, toutefois, à la fois à l'encontre du principe de justice distributive et du principe de bienfaisance, impliquant de ne pas exclure totalement un groupe de sujets des expectatives élevées de bénéfices d'une recherche correctement balisée. Ce texte a pour objectif de cerner quel est le fondement - éthique - des textes législatifs, réglementaires et normatifs qui permettent l'enrôlement de ces malades atteints de pathologies foudroyantes dans des protocoles de recherche, alors même qu'aucun consentement, qu'il soit autonome ou substitué, n'a été donné. Inspirée du modèle de réflexion éthique pluraliste, l'auteur pose comme hypothèse que c'est le principe de justice distributive qui sous-tend la politique éthique de tels textes, puisque contribuant au développement des avancées thérapeutiques en urgence et à la nécessité d'augmenter l'efficacité des traitements disponibles. Ce texte cherche finalement à définir une démarche d'approbation des protocoles de recherche qui seront réalisés en situation d'urgence. / Biomedical research performed under emergency conditions highlights the conflict between competing ethical principles. The respect for the autonomy of the person, illustrated by the need to obtain a subject's informed consent, can seem an empty concept in the case of a patient presenting severe medical conditions. For those patients in a midst of a medical crisis, and therefore vulnerable, particular protection is necessary. An overprotection would, however, contravene both the principles of distributive justice and of beneficence, principles that hold that an entire group of subjects ought not to be excluded from the expectations of the benefits of properly controlled research. The object of this text is to discem the ethical foundation of the legislative, regulatory and normative texts that permit those stricken with devasting diseases to participate in research projects without consent having been granted. Based on the pluralist ethical model, the author asserts as a hypothesis that it is the principle of distributive justice which supports the ethical policies underlying such texts, since contributing to the development of therapeutic advances in emergencies and to the necessity of increasing the effectiveness of available treatments. This text attempts ultimately to establish procedures to be followed in obtaining approval in research projects in the case of an emergency.

Cette thèse propose de documenter les dynamiques sociales dans un espace géographique en milieu rural sénégalais — l’aire de Toudinga — où des recherches principalement démographiques et médicales sont menées depuis 1964 dans le cadre des activités de l’IRD (Institut de recherche pour le développement), anciennement Orstom (Office de la recherche scientifique dans les territoires d’outre-Mer). Cette étude se situe au croisement de l’anthropologie de la santé, de l’ethnologie africaniste et de la sociologie des sciences et des organisations. Cette intersection permet d’aborder de multiples aspects socio-culturels relatifs au fonctionnement et aux enjeux de la recherche médicale en Afrique sub-saharienne. Ce travail traite en premier lieu du fonctionnement social de l’aire de Toudinga et présente une analyse des représentations de la recherche scientifique et des interactions entre les professionnels de la recherche et les habitants de la région. Il met également en évidence l’influence des facteurs historiques, identitaires et institutionnels sur la construction locale de l’éthique. Cette étude aborde également des thèmes plus généraux relatifs à l’anthropologie de la recherche médicale tels que l’influence du contexte social sur le recueil du consentement (rapports sociaux de sexe, de classe d’âge, don / contre-don), l’impact de la recherche médicale sur l’offre de soins locale ou encore l’analyse des facteurs sociaux expliquant la crédibilisation des rumeurs de vol de sang / This thesis documents the social dynamics that occur in a rural context in Senegal — the area of Toudinga— where essentially demographic and medical research have been held since 1964 by the IRD (Institut de recherche pour le développement) formerly Orstom (Office de la recherche scientifique dans les territoires d’outre-Mer). At the crossroads of medical anthropology and African ethnology and sociology of science and organizations, the theoretical position adopted in this thesis allows for the examination of numerous social aspects related to medical research in sub-Saharan Africa. This PhD deals with the social organisation of the area of Toudinga. It describes the representations of medical research and the interactions between the research professionnals and the inhabitants of the region and highlights the influence of historic, identity and instititional factors on the local construction of ethics. Futhermore, this work examines wider thematics related the anthropology of medical research such as the influence of the social context on the consentent collection (gender, age group, gift and conter-gift), the impact of medical research on local medical care and the analysis of blood stealing rumors

Physical and mental integrity of an individual represents one of the components of a human personality, which may be regarded as a personal sphere of everyone and which is protected by the law against any unauthorized interference. Legislation regarding the interference with the integrity of an individual is based on the principle of inviolability of a human being, according to which no one is entitled to interfere with the integrity of another individual without his consent, except as provided by law. The consent of the individual concerned is therefore the most fundamental circumstance excluding illegality of the interference. The aim of this diploma thesis is to analyse current legislation regarding the interference with the integrity of an individual, especially relevant provisions of the new civil code, and to point out its potential deficiencies or problematic aspects. It focuses on particular circumstances under which it is possible to interfere with the integrity of an individual, or which represent the reasons for such interference and therefore exclude its illegality. Even though the thesis aims to elaborate the topic from the point of view of civil law, with regard to the fact that most of the serious interferences with the integrity of an individual occur when health services are...

The purpose of this study was to investigate the process used by Haitians and Haitian Americans who must make healthcare decisions for a terminally ill family member. There is a large population of Haitians and Haitian Americans in South Florida and there has been no research regarding their decision-making process about end-of-life healthcare. The study design was descriptive, applying constructivist grounded theory methodology. Data were collected using semi-structured, face-to-face qualitative interviews. Data analysis and collection occurred simultaneously. Participants (n=12) were purposefully recruited, with 11 from a single, faith-based community. The findings resulted in six concepts: (1) imminent or actual death, (2) disrupted unity, (3) managing disrupted unity, (4) consequences, (5) restoring unity, and (6) creating memories you can live with. These six concepts, elaborated by an additional 17 dimensions, were incorporated into a process model relating to the cultural value of communal unity to the end-of-life decision-making process. The implications of this study include a need to improve the congruence between the nursing care provided at this vulnerable time and the cultural values of this population. Successful access to this population through the structure of the faith-based community points the way to increasing access to appropriate end-of-life healthcare. Practice implications informed by caring science include the importance of nurses’ coming to know the family and listening to the unique care needs. / Includes bibliography. / Dissertation (Ph.D.)--Florida Atlantic University, 2015. / FAU Electronic Theses and Dissertations Collection

Doctor protection vs. patient protection. This diploma thesis deals with the medical law, namely the protection of physicians and the protection of patients, and their mutual comparison as entities standing more or less against each other. The main objective of the thesis was to analyse the protection of both sides; the practical example provides describes a controversial situation which may happen in reality, also gives better understanding of the issue for readers. The aim was to capture the complex and also very extensive legal regulation of the topic, focusing on the touchpoints between the medical and civic laws. In view of the wide range of the topic in question, I consider specifically some sections of the thesis as the most important. At the beginning, the thesis provides a specification of the elementary legislation regulating the medical law. This is not a comprehensive list of resources, due to the enormous extent of the legislation regulating the medical law. Individual chapters describe the topics of informed consent and the protection of personal data, the provision of healthcare without the patient's consent and the special arrangement concerning the consent of underage patients, the relationship between the physician and the patient, the confidentiality duty, previously expressed...

Submitted by Maicon Juliano Schmidt (maicons) on 2015-07-10T16:55:55Z No. of bitstreams: 1 Rodolfo Souza da Silva.pdf: 9923682 bytes, checksum: 9f79c4fb3d2f53bcdc1f92ae3f2b6fa0 (MD5) / Made available in DSpace on 2015-07-10T16:55:55Z (GMT). No. of bitstreams: 1 Rodolfo Souza da Silva.pdf: 9923682 bytes, checksum: 9f79c4fb3d2f53bcdc1f92ae3f2b6fa0 (MD5) Previous issue date: 2014-03-24 / CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / PROSUP - Programa de Suporte à Pós-Gradução de Instituições de Ensino Particulares / Diante da chamada "Era do Acesso" o conhecimento tradicional associado à biodiversidade das sociedades tradicionais tornou-se uma verdadeira matéria-prima da indústria biotecnológica, sendo objeto de bioprospecção e direitos de propriedade intelectual por empresas alimentícias, farmacêuticas e entidades de pesquisa e desenvolvimento. Com base nos princípios do consentimento prévio informado e da repartição justa e equitativa dos benefícios, previstos na Convenção de Diversidade Biológica e na Medida Provisória 2.186-16, devem os interessados na bioprospecção do saber tradicional ser autorizados pelos seus detentores, assim como dividir os benefícios oriundos dos bioprodutos e das pesquisas desenvolvidas. Entretanto, no que pertine à repartição de benefícios, esta pode acarretar a imposição de valores privados e de cunho capitalista, causando riscos à dinâmica social e às práticas culturais dessas comunidades, as quais são construídas sob valores coletivos e comunitários. A partir desta constatação, o presente trabalho pretende analisar em que medida os princípios do consentimento prévio informado e da repartição de benefícios são capazes de promover a conservação dos bens socioambientais das sociedades tradicionais, quando os produtos desenvolvidos têm como base os conhecimentos tradicionais associados. Para tanto, a pesquisa utiliza quanto ao método de abordagem o dialético, com objetivo exploratório, mediante uma pesquisa bibliográfica e documental, a partir de uma perspectiva interdisciplinar. Mesmo diante de uma regulamentação internacional e nacional, indústria e pesquisadores se utilizam constantemente de discursos que pretendem desproteger o saber tradicional e legitimar a não obtenção e realização do consentimento prévio informado e da repartição de benefícios. Em razão das peculiaridades das sociedades tradicionais, as quais se autodeterminam em aspectos coletivos, comunitários e de solidariedade, estas possuem uma cultura diferenciada, pelo que o conhecimento tradicional associado à biodiversidade integra a sua diversidade cultural. Diante dessa diversidade e a sua relação com o meio ambiente, os movimentos sociais na América Latina e no Brasil, influenciaram a incorporação de direitos na Constituição Federal de 1988, fazendo surgir a sociobiodiversidade como nova categoria jurídica. Com a lógica capitalista e de desenvolvimento da indústria biotecnológica, a qual não considera os aspectos da sociobiodiversidade, um diálogo intercultural e uma gestão da inovação biotecnológica mostram-se um caminho para gerenciar a complexidade e as diferentes visões dos atores envolvidos na prática bioprospectiva do saber tradicional, inserindo os direitos socioambientais nesse contexto. A partir da constatação da existência de outros pressupostos jurídicos para bioprospecção, como os princípios da precaução, equidade intergeracional e da função social da propriedade, critica-se o consentimento prévio informado e a repartição de benefícios, demonstrando que o atendimento destes deve ser feito em harmonia com os demais pressupostos jurídicos existentes, de maneira a ser possível conservar a sociobiodiversidade das sociedades tradicionais, garantindo o seu uso sustentável e a manutenção de suas vidas. Sugere-se, nesse fio condutor, critérios a serem considerados quando da definição dos benefícios e sua repartição: 1) os aspectos da sociobiodiversidade dos grupos tradicionais, a partir dos valores, práticas culturais e organizações sociais; 2) o meio ambiente onde vivem esses grupos e onde será acessado o recurso genético da biodiversidade; 3) requerimento e concessão de patentes e de quaisquer benefícios de forma compartilhada com as sociedades tradicionais. / In the face of “The Age of Access", traditional knowledge associated with biodiversity of traditional societies has become raw material of the biotechnology industry, being subject of bioprospecting and intellectual property rights for food, pharmaceutical and research and development companies. Based on the principles of prior informed consent and benefits sharing, benefits provided by Convention on Biological Diversity and Medida Provisória nº.2.186-16/01, the interested in bioprospecting of traditional knowledge must be authorized by their holders and share the benefits derived from research and development of bioproducts. However, in respect the benefits sharing, this can lead to the imposition of private and capitalist values, causing risks to the social dynamics and cultural practices of these communities, which are performed under collective and community values. From this finding, the present study aims to analyze to what extent the principles of prior informed consent and benefit sharing are able to promote the conservation of environmental goods of traditional societies, when the developed products are based on the traditional knowledge. For this, the research uses the dialectic approach method, with exploratory objective, through a bibliographic and documentary research, from an interdisciplinary perspective. Even in the face of a international e and national regulation, researchers and industry constantly use discourses that seek unprotect the traditional knowledge and legitimize the non-obtainment and non-realization of the prior informed consent and benefit sharing. Because of the peculiarities of traditional societies, which consider themselves in collective, community and solidarity aspects, these communities have a different culture, being the traditional knowledge associated integrated in your cultural diversity. Given this diversity and its relationship with the environment, social movements in the Latin America and Brasil influenced the incorporation of rights in the Federal Constitution of 1988, emerging sociobiodiversity as new legal category. With the capitalist and development logic of the biotechnology industry, which does not consider aspects of sociobiodiversity, intercultural dialogue and management of biotechnology innovation shows a way to manage the complexity and the different views of the actors involved in the practice of bioprospecting traditional knowledge, inserting socioenvironmental rights in this context. From the establishment of the existence of other legal requirements for bioprospecting, such as the principles of precaution, intergenerational equity and social function of property, is criticized the prior informed consent and benefits sharing, showing that the treatment of these should be done in harmony with other existing legal requirements in order to be able to conserve the sociobiodiversity of traditional societies, ensuring the sustainable use of their resources and maintenance of their lives. It is suggested in this context, some criteria to be considered when defining the benefits and its allocations: 1) sociobiodiversity aspects of traditional groups, from the values, cultural practices and social organizations;2) the environment where live these groups and where will be accessed and where the genetic resources of biodiversity; 3)application and granting patents and any benefits jointly with traditional societies.

Pour la bioéthique, le consentement éclairé est un processus dialogique qui, au travers d’un échange d’informations, garantit le respect du droit du patient à l’autodétermination. Or, il est souvent confondu avec le formulaire de consentement éclairé, document signé par le patient ou son responsable légal, à la demande du médecin ou de l’établissement hospitalier, reconnaissant que toutes les informations sur le traitement et ses risques lui ont été fournies. Cette thèse se propose de vérifier dans quelle mesure, pour ce qui est des soins médicaux, l’usage du « formulaire de consentement éclairé » sans ce processus communicatif dialogique dit de « consentement éclairé » suffit, en soi, à déclarer irrecevables les actions en responsabilité civile pour non respect ou manquement au respect du devoir d’expliquer les risques inhérents aux procédures diagnostiques et thérapeutiques. Notre méthode d’investigation s’appuie sur une révision bibliographique et une recherche documentaire des arrêts contenant l’expression « consentement éclairé » (ou un de ses équivalents). Elle examine 60 arrêts de cours de justice d’états brésiliens pour déterminer le profil des actions et vérifier leur résultat. Le test exact de Fisher a également été utilisé pour déterminer l’association entre les variables « utilisation ou non du formulaire » et « recevabilité ou non des demandes ». Il en ressort que, bien qu’aucune norme brésilienne ne réglemente les formes d’expression du consentement éclairé, un fondement juridique a surgi de l’association systématique de l’intitulé de l’Art. 5 de la Constitution fédérale, du Code civil, en particulier de ses Arts.11 à 21 qui protègent les droits de la personnalité, de l’Art. 6-III du code de la consommation, qui dispose des devoirs d’information et de transparence, et du code de déontologie médicale qui exige l’éclaircissement et le consentement préalables du patient ou de son responsable légal (Art. 22) et interdit toute limitation du droit du patient à disposer de lui-même et de son bien-être (Arts. 24 et 31). Les devoirs d’information des médecins intègrent donc le processus de consentement éclairé, dont la violation peut entraîner la responsabilité civile de ce professionnel, à condition qu’existent les présomptions de dommage au patient, de culpabilité du médecin et de rapport causal entre cette culpabilité et le dommage découlant de la violation du devoir d’information sans que rien ne justifie le manquement au devoir du docteur. / O consentimento informado é entendido, pela Bioética, como um processo dialógico que, por meio da troca de informações, garante o respeito à autodeterminação do paciente, sendo, porém, freqüentemente confundido com o Termo de Consentimento Informado, documento assinado pelo paciente ou seus familiares, a pedido do médico ou da instituição hospitalar, dando ciência de ter recebido informação pertinente ao tratamento e aos seus riscos. Esta tese tem como objetivo verificar em que medida o uso do “termo de consentimento informado”, na assistência médica, de forma desacompanhada do processo comunicativo dialógico chamado “consentimento informado” é de per si suficiente para afastar a procedência de demandas judiciais de responsabilidade civil por ausência ou deficiência do dever de informar riscos inerentes aos procedimentos diagnósticos e terapêuticos. Utilizou-se como método de pesquisa a revisão bibliográfica e a pesquisa documental em acórdãos que contém a expressão “consentimento informado”(ou equivalentes). A análise foi realizada sobre uma base de 60 acórdãos de Tribunais de Justiça estaduais para verificar o perfil e resultado das demandas. Também aplicou-se o Teste Exato de Fisher, para medir a associação entre variáveis “uso ou não do termo de consentimento” e “procedência ou improcedência das demandas”. Verificou-se que, embora não haja norma nacional que o regulamente as formas de expressão do consentimento informado, há fundamentação jurídica, decorrente da coligação sistemática entre o Art. 5º, caput, da Constituição Federal; o Código Civil, especialmente nos direitos de personalidade, entre os Arts.11 a 21 do Código Civil, que resguardam os Direitos de Personalidade; o Art. 6, III do Código de Defesa do Consumidor, relativo aos deveres de informação e transparência; e o Código de Ética Médica, que exige o esclarecimento e o consentimento prévios do paciente ou de seu responsável legal (Art. 22) e veda qualquer limitação ao exercício do direito do paciente de decidir livremente sobre sua pessoa ou seu bem-estar (Arts. 24 e 31). Os deveres informativos dos médicos integram o processo de consentimento informado e sua violação pode ter como conseqüência a responsabilidade civil do profissional, desde que verificados os pressupostos do dano ao paciente, da culpa do médico e do nexo causal entre a culpa e o dano decorrente da violação de dever informativo e não haja excludente ao dever. / According to Bioethics, informed consent is a dialogic process that, by means of information sharing, accords respect to patients’ self-determination. However, this is often confused with the Informed Consent Form, which is a document signed by patients and family members at the doctor’s or hospital administrator’s request, confirming that they have received information about the treatment and its risks. This thesis is aimed at checking to what extent the use of the “informed consent form” in medical assistance, unaccompanied by the dialogic communicative process called “informed consent”, is per se sufficient to prevent civil liability claims for absence of or deficiency in the duty to inform people about the risks inherent in diagnostic and therapeutic procedures. The adopted research method was bibliographical review and documental investigation into appellate decisions containing the expression “informed consent” (or equivalents). The analysis was conducted based on 60 appellate decisions reached by state Appellate Courts in order to examine the profile and result of claims Fisher's Exact Test was also administered to measure the association between the variables “use or non-use of the “consent form” and the “validity or invalidity of claims”. It was found that, although there are no national rules governing the forms of expression about informed consent, there are legal foundations arising from the systematic link among the head provision of Art. 5 of the Federal Constitution; the Civil Code, especially in reference to personality rights, Articles 11-21 of the Civil Code, which protect the Personality Rights; Art. 6, III of the Consumer Protection Code concerning information and transparence duties; and the Code of Medical Ethics, which requires the clarification and prior consent of the patient or his/her legal guardian (Art. 22) and forbids any limitation to the patient’s right to freely decide on his/her person or well-being (Articles 24 and 31). Doctors’ informative duties are an integral part of the informed consent process and violation thereof might result in the professional’s civil liability if harm to the patient, the doctor’s fault, and the causal relation between the fault and the harm resulting from violation of the informative duty are confirmed and if no duty exclusion mechanism exists.

No description available.