Made available in DSpace on 2014-06-11T19:27:45Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-02-22Bitstream added on 2014-06-13T20:56:48Z : No. of bitstreams: 1 freire_acgf_me_araca.pdf: 755676 bytes, checksum: 7a092fa66a756e57e901651ea75ca554 (MD5) / Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) / 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... / 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)

Medical records are being adjusted to match the practical way of understanding an illness as a disorder in the balanced state of the organism. This approach has also modified opinions regarding the form of medical documentation, the determination of necessary examinations and treatment. The progress in medicine along with the growing need for specific medical information made it necessary to look for new ways of making medical information available. One of these ways is to make the system of health care documentation electronic. The main tool of this system is an electronic health card. The objective of my work was to find out the following: the extent of utilization of electronic health cards; doctors´ opinions regarding the use of electronic medical documentation; the attitude of patients to medical documentation and the willingness of doctors to join the IZIP project of electronic health cards. Two hypotheses were checked for the purpose of the graduation work. Hypothesis no. 1 {--} Medical personnel expect that the project of electronic health cards will speed up the process of providing information about patients´ state of health. Hypothesis no. 2 {--} Health care facilities are willing to keep electronic documentation only if they receive compensation for increased administrative activities. To check the hypotheses, the author used the method of quantitative research. Data was collected by means of a questionnaire. The research was carried out between January and March 2009. The research was performed in health care facilities in South Bohemia represented by private doctors. 200 questionnaires were printed out. 152 of these could be fully used for the research. Hypothesis no. 1 was confirmed since 58% of the people who filled out the questionnaire agreed with the statement that the project of electronic health cards would accelerate the process of sharing information about patients´ state of health. Hypothesis no. 2 was not confirmed. There are two main problems preventing the use of IZIP; one of them is that patients are not interested and the other that doctors do not trust the system. That is why the necessary information is not always found in the IZIP since some health care facilities do not work with the system. Doctors would have to be forced or sufficiently motivated to transfer to the use of electronic medical documentation and they would have to change their negative attitude to modern technologies. This work could extend the information about medical documentation and electronic health cards among health care providers and the broader public and give feedback to people working in health care facilities.

El presente artículo explora la disputa vigente sobre el principio queindica que se requiere el consentimiento libre, previo e informado(CLPI) de un pueblo indígena para autorizar la extracción industrialen su territorio. A partir de los aportes de la obra de Tsing acerca delas conexiones globales, el trabajo analiza cómo es que los actoresinterconectados en redes se empeñan en llevar adelante ampliosproyectos de colaboración (como el reconocimiento de los derechosindígenas) empleando estrategias de persuasión. Se discutenlos esfuerzos realizados por el movimiento indígena transnacionalpara promover el concepto del CLPI, así como tres ejemplos en losque diferentes actores buscan apropiarse y recaracterizar el CLPIpara que calce en sus propias metas.En este trabajo propongo examinar cómo los proyectos gubernamentalesglobales rivales son promovidos y disputados por las redesdescentralizadas que unen a actores que operan a diferentes escalas.Sostengo que la noción de Tsing de «paquetes itinerantes» ofreceuna manera útil de conceptualizar los medios por los cuales loselementos de estos proyectos son difundidos, traducidos, acogidosy adaptados en diferentes localidades alrededor del mundo. Analizoestas dinámicas en relación con el cuestionamiento al modelo degobernanza basado en el principio de que se necesita el consentimientolibre, previo e informado (CLPI) de un pueblo indígenapara autorizar acciones que puedan impactar sobre un territorio o derechos indígenas. A través de la promoción de diferentes versionesde CLPI, los actores interconectados en red están disputandola naturaleza y la forma de la responsabilidad social empresarial,la autoridad del Estado y la relevancia de la gobernanza indígena.Propongo explorar las implicaciones de las diferentes estrategias deempaquetamiento para la disputa entre modelos rivales de gobernanzay para su propensión a ser acogidos en los sitios locales. / In this paper, I propose to examine how rival global governmentalprojects are asserted and contested by decentralized networks thatlink actors operating at different scales. I argue that Tsing’s notionof «travelling packages» provides a useful way of conceptualizingthe means by which elements of these projects are diffused, translated,taken up, and adapted into different localities around theworld. I explore these dynamics in relation to the contestation of agovernance model based on the principle that the free, prior andinformed consent (FPIC) of an indigenous people is required toauthorize actions that may affect upon indigenous territory or indigenousrights. Through the assertion of different versions of FPIC,networked actors are contesting the nature and shape of corporatesocial responsibility, the authority of the state, and the significanceof indigenous governance. I propose to explore the implicationsof different packaging strategies on the contestation between rivalgovernance models and on their propensity for uptake in local sites.

The subject of this thesis is one very important relationship of health care - the doctor- patient-relationship. During a recent decades a big attention was paid to this theme both on international and czech field. In the Czech Republic the doctor-patient-relationship went through the essential change, when instantly changed from a paternalistic relationship to a partnership. Many legal changes followed this change finishing it by accepting the Act on Healthcare Services which for example describes rights and duties of subjects of this relationship. The first part is dedicated to a doctor-patient-relationship itself. Its history and evolution, placement in a legal system, legal form. One part is dedicated to an ethic aspect of doctor-patient-relationship. The second part discusses about rights and duties of both participants of this relationship. Specifically, rights determined by the Act on Healthcare Services. The third part is dedicated to detailed analysis of some basic patient's rigths and the doctor's duties characterizing doctor-patient-relationship in its current form. These are informed consent, where I describe, why it is needed. I was concerned about its requisites, possibility to abandon informed consent, to informed dissent including its form while a short look on an issue of...

O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira / Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual\'s willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn\'t know the type of study they participated in, 38,6% didn\'t know about the research they participated, 64,7% didn\'t receive information regarding other types of treatment, 62,7% didn\'t have information about compensation, 66,2% didn\'t read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population

1 Abstract Contract for health care under the Civil Code The subject of this thesis is a new type of contract, which was brought into Czech civil law by the Civil Code effective since 1 January 2014 - contract for health care. By including this special type of contract, the legislators practically agreed with a group of legal experts stating that health care is provided under contract, even before the new Civil Code became effective. This paper deals with the very conception of health care used in Czech legislation and with its comparison with the interpretation on this matter in legal codes, which were used by the authors of the provisions on contract for health care as inspiration. First part of this thesis discusses the legal regulation of health care in the Civil Code. With aim to provide a coherent point of view of this type of contract, this part briefly describes other possible conceptions of this legal institute. Besides the solutions, which provided a source of inspiration to Czech legislators, and those which are similar to the new Czech regulation, conceptions of health care used in other states of mainly continental Europe are mentioned. That is followed by introduction of interpretation of relation between provider of care and patient applied in the Czech Republic before the new Civil Code...

The concept of personality rights and their protection, as well as the view on provision of health services has changed a lot. In relation to recent development in the field of private law there is a need to examine the aspects of personality rights separatelyy and also in broughter context. This Master's thesis sets as its goal to follow the current legislation and to point out situations where the personality rights can be especially endangered. The second goal is to evaluate current legal issues in foreign countries of the protection of personality rights in relation to the provision of health services in order to see if there is a probability that Czech law will have to deal with similar problems in the future as well. In the first part the concept of personality rights and their protection is introduced. The aspects related to the provision of health services that may be especially endangered are highlighted. Also the possibilities of resolving situations where there is infringement of personality rights are presented. The second part, which is also the most comprehensive of the thesis, deals with the specific institutes that help the protection of the personality rights in the field of health services. These include primarily informed consent, the way of providing it and the consequences of...

Magister Legum - LLM / There is a growing interplay of competing realities facing the international community in the general areas of innovation, technological advancement and overall economic development. The highly industrialised wealthy nations, largely located on the Northern hemisphere are on the one hand undoubtedly at the forefront in global research, technology and infrastructure development. The developing and least developed countries on the other hand are mostly situated on the Southern hemisphere. They are not as wealthy or technologically advanced as their Northern counterparts, but are naturally endowed with unique variations of plant, animal and micro-organism species occurring in natural ecosystems, as well as the traditional knowledge on how to use these unique species. This knowledge has been adjudged to be responsible for the sustainable maintenance of the earth biodiversity. Increasing exploitation of biodiversity spurred on by the competing realities identified above, has left the earth in a present state of alarm with respect to the uncontrolled loss of biodiversity. The traditional knowledge of local peoples has significantly offered leads to research institutes from the North in developing major advancements in drugs, cosmetics and agriculture. Little or no compensation has however been seen to go back to the indigenous communities and countries that provide resources, and indicate various possibilities through their traditional knowledge to the use of such resources. Efforts by some biodiversity rich countries to ddress this trend through legislation developed in accordance with the principles of the Convention on Biological Diversity have been frustrated due to the inability to enforce their domestic laws outside their borders. Theft of genetic resources and its associated traditional knowledge from such countries has therefore remained a major challenge. Against this backdrop, and on the insistence of biodiversity-rich developing countries, an international regime on access and benefit sharing was negotiated and its final text adopted in 2010. This international regime is as contained in the Nagoya Protocol. This research sets out to examine whether the Nagoya Protocol offers a final solution to the protection of traditional knowledge associated with biodiversity in biodiverse countries. It further examines the importance of domestic legislation in achieving the objectives of the Protocol. The research has been tailored to African biodiverse countries, and seeks these answers within the context of Africa. / South Africa

Philosophiae Doctor - PhD / All research involving human subjects should be conducted in accordance to the general ethical principles of autonomy or respect for persons, beneficence and justice. Competent adults can exercise their autonomy and can choose to take on risk for the sake of others, therefore are able to protect their own interests while in the pediatric research the ‗best interests of the child‘ takes precedence over autonomy. In other words giving informed consent in the pediatric context, is not ‗who decides‟ but „what is the best decision for the child‟. Due to lack of consensus gold standard to guide researchers and assess the quality of parental informed consent in Botswana, the practical and ethical challenges posed in obtaining parental informed consent for child enrolment in pediatric HIV clinical trials were examined. The study aimed to determine the readability of the consent forms used in pediatric HIV clinical trials; assess communication methods, practices and perceptions of the trial staff regarding the informed consent process; assess the extent to which parents recall and understand the information disclosed to them and their satisfaction with the informed consent process as well as to identify and describe the reasons for parental approval to child enrolment into HIV clinical trial studies.

The aim of this dissertation is an analysis of the regulatory framework for the procurement and distribution of stem cells in South Africa. This research includes aspects of the law of obligations, medical law and human rights law as found in the Bill of Rights. More specifically however, this dissertation attempts to bring to attention the shortcomings of chapter 8 of the National Health Act. An examination is undertaken according to the multilayered approach and therefore the proposed regulatory framework is examined within a constitutional framework, an ethical framework, the framework as established by common law, in this case the doctrine of informed consent and lastly within the national legislation framework as found in the National Health Act of 2003 and the regulations made in terms of the Act. This dissertation further entails a brief comparative study of the regulatory mechanisms of the United Kingdom as entrenched in the Human Fertilisation and Embryology Act of 2008 and the Human Tissue Act of 2004 and as practiced by the Human Fertilisation and Embryology Authority and the Human Tissue Authority. The analysis in this dissertation firstly provides an overview of the clinical manifestations and science of stem cell technology. Secondly, the impact of the Constitution of the Republic of South Africa is discussed with particular reference to the Bill of Rights on stem cell research and therapy. The most noteworthy conclusion to be made in this regard is that the embryo is not the bearer of constitutional rights. The ethical guidelines which act as regulatory tools in this field are then discussed with attention to general ethical principles as provided for by the Health Professions Council of South Africa as well as the Medical research Council. The doctrine of informed consent further enjoys attention as it is discussed in context of medical research and key issues are addressed regarding the process of obtaining consent in context of stem cell technologies. Certain recommendations are then made pertaining to the minimum scope required for lawful consent. Lastly a critical analysis is made of chapter 8 of the National Health Act. The findings which are made here lead to further recommendations regarding the regulation of stem cells. / Dissertation (LLM)--University of Pretoria, 2011. / Public Law / unrestricted