An informed consent of a patient is an institute in the area of medical law, which is still being developed and deals with both private and public legislation. It is one of the legal reasons for interference into physical and mental integrity of a patient, without which every act would be unlawful. This thesis provides an overview of the current legislation of this institute in the light of the new Civil Code, outlines possible application issues between the new legislation and the legislation that is no longer effective. The aim of this thesis is to give a comprehensive review of the criminal aspects of the informed consent, especially its role as a circumstance of justification. The content of this thesis is an analogous legislation in the Federal Republic of Germany, which is being compared to the Czech legislation in the final chapter. The thesis consists of seven chapters. The first one deals with the relationship between the doctor and the patient and its changes in time periods, which are necessary for the new legislation to be well understood. The second chapter gives an overview of the current legislation starting with the constitutional law, including international treatments, statutes, the Code of Ethics, all over to the regulation of the Czech Medical Chamber. It focuses on specific parts...

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LEGAL ASPECTS OF PROVIDING HEALTH CARE TO MINORS This thesis deals with the legal aspects of providing health care to minors in the Czech Republic and in Ireland, and compares the approach to regulation. Regulation of healthcare has undergone a significant change since the ratification of the Convention on Human Rights and Biomedicine. The traditional notion of the doctor-patient relationship as a paternalistic relationship has been abandoned and replaced by an equal relationship - partnership. This change culminated in the adoption of the Health Services Act as well as in other laws adopted in the framework of the reform of health care law. The adoption of the Civil Code could be seen as the final contribution in the discussion of the doctor-patient relationship. The Civil Code includes provisions regulating health care treaty, as a named type of a contract, leaving no doubt about the private-law nature of the doctor-patient relationship. The relationship between the Civil Code and the Act on the Provision of Health Services is complicated and requires the principle called lex specialis derogat generali to be applied. However, for the correct application of this principle it should be remembered that the Civil Code provisions are in some cases very detailed and that some provisions of the Civil...

As mudanças sociais ocorridas nas últimas três décadas fizeram com que o respeito à autonomia do usuário e o direito ao consentimento livre e esclarecido assumissem posição de destaque na ética em saúde e fossem incorporados aos Códigos de Ética Médica e de Enfermagem vigentes no país. Estudos desenvolvidos em serviços de saúde, mormente os hospitalares, têm evidenciado que os usuários obtêm poucas informações sobre suas condições de saúde, tratamento, cuidado e que a prática profissional tem oscilado entre o paternalismo, o autoritarismo e o respeito à autonomia. Esta investigação foi realizada com o objetivo verificar como o consentimento esclarecido é concebido na prática das enfermeiras de quatro Centros de Saúde Escola (CSE) de São Paulo. A análise do material empírico, obtido através de entrevistas junto a essas profissionais foi feita à luz da ética principialista. O resultados demonstram que essas profissionais, apesar de desconhecerem o termo consentimento esclarecido, respeitam as suas normas básicas, reconhecem o direito dos usuários em participar de decisões que digam respeito à sua saúde, oferecem informações para subsidiar essas decisões. O padrão de informação é personalizado, porém, alternativas de decisão, além daquelas estipuladas em programas e protocolos, raramente são apresentadas. Assim, o consentimento esclarecido na prática das enfermeiras em CSE é limitado por esses programas e protocolos. As enfermeiras têm como preocupação o benefício do usuário, o estímulo às participação dos usuários no seu cuidado e a prevenção ou remoção de riscos e danos. No geral, estas enfermeiras acatam a decisão tomada pelo usuário, mesmo quando há recusa em seguir a orientação dada, mas por vezes demonstram dificuldade em aceitá-la quando a mesma põe em risco a saúde de terceiros. Enquanto profissionais que participam na implementação políticas de saúde demonstram preocupação com sua \"missão\", sentem-se impotentes e demonstram desconhecer aliados e instrumentos que poderiam ser utilizados nessa situação. / The social changes occurred in the last three decades were instrumental for causing the customers\' autonomy and right to free-informed consent to be respected assuming a leading rank in the health ethics as well as being incorporated into the Nursing and Medical Ethical Codes in force in the country. Studies carried out in health services, moreover in hospital facilities, disclosed that the customers usually obtain few information on their health condition, treatment and, care and that the professional practice has been oscillating among being either paternalistic, authoritarian or respecttul regarding the patient\'s autonomy. The purpose of this investigation was to ascertain how the informed consent is conceived by the nurses\' practice in four School/Health Centers in São Paulo, State of São Paulo. Brazil. The empirical material obtained in interviews along with these professionals was analyzed in the light of Bioethics principles. Results were as follows: these professionals do not know the term informed consent; however, they act in accordance with its basic norms, recognizing the customers\' right to participate in the decision-making regarding their health, besides providing information in order to subside these decisions: the pattern of the information provided is personalized, although decision alternatives other than those stipulated in programs and protocols are rarely presented. Informed consent, in nursing practice in School/Health Centers is restricted within these programs and protocols. These nurses are concerned about users\' beneficence, their participation in self care and about preventing or removig risks or harm. In general, these nurses respect the decision taken by the customers, even when they refuse to comply with the orientation provided, however showing sometimes difficulties in accepting it when the health of a third-part is in jeopardy; while professionals participating in the implementation of health policies, they demonstrate being concerned with their \"mission\", sometimes feeling themselves impotent to deal with this situation, disclosing therefore a lack of knowledge concerning allied institutions and instruments which might be used to face these kind of circumstances.

Transparency of personal data processing is enforced by most Western privacy laws, including the new General Data Protection Regulation (GDPR) which will be effective from May 2018. The GDPR specifies that personal data shall be processed lawfully, fairly, and in a transparent manner. It strengthens people's rights for both ex-ante and ex-post transparency and intervenability. Equally important is the strict legal requirements for informed consent established by the GDPR. On the other hand, the legal privacy principles have Human-Computer Interaction (HCI) implications. People should comprehend the principles, be aware of when the principles may be used, and be able to use them. Transparent information about personal data processing should be concise, intelligible, and provided in an easily accessible form, pursuant to the GDPR. Nonetheless, the answer to the question about how HCI implications can be addressed depends on the attempts to decrease the gap between legal and user-centric transparency, intervenability, and consent. Enhancing individuals' control in a usable way helps people to be aware of the flow of their personal information, control their data, make informed decisions, and finally preserve their privacy. The objective of this thesis is to propose usable tools and solutions, to enhance people's control and enforce legal privacy principles, especially transparency, intervenability, and informed consent. To achieve the goal of the thesis, different ways to improve ex-ante transparency and informed consent are investigated by designing and testing new solutions to make effective consent forms. Moreover, ex-post transparency and intervenability are improved by designing a transparency enhancing tool and investigating users' perceptions of data portability and transparency in the tool. The results of this thesis contribute to the body of knowledge by mapping legal privacy principles to HCI solutions, unveiling HCI problems and answers when aiming for legal compliance, and proposing effective designs to obtain informed consent. / The new General Data Protection Regulation (GDPR) strengthens people’s rights for transparency, intervenability, and consent. The legal privacy principles have Human-Computer Interaction (HCI) implications. Besides aiming for legal compliance, it is of paramount importance to investigate how to provide individuals with usable and user-centric transparency, intervenability, and consent. The objective of this thesis is to propose usable tools and solutions, to enhance people's control and enforce legal privacy principles, especially transparency, intervenability, and informed consent. To achieve the goal of the thesis, different ways to improve ex-ante transparency and informed consent are investigated by designing and testing new solutions to make effective consent forms. Moreover, ex-post transparency and intervenability are improved by designing a transparency enhancing tool and investigating users' perceptions of data portability and transparency in the tool. The results of this thesis contribute to the body of knowledge by mapping legal privacy principles to HCI solutions, unveiling HCI problems and answers when aiming for legal compliance, and proposing effective designs to obtain informed consent. / <p>The 3. article was in manuscript form at the time of the licentiate defense: Karegar, F. / User Evaluations of an App Interface for Cloud-based Identity Management / / Manuskript (preprint)</p>

INTRODUÇÃO: Em ensaios clínicos o termo de consentimento livre e esclarecido é fundamental para a preservação da ética na pesquisa clínica e precisa ser lido e assinado pelos pacientes. No entanto, dada a sua complexidade este documento pode não ser entendido pelos mesmos. Para avaliar o entendimento destes sobre a pesquisa realizamos esta investigação. MÉTODOS: Convidamos os sujeitos participantes de ensaios clínicos de hipertensão arterial sistêmica e doença arterial coronária, fase II, III ou IV ambulatoriais e com fármacos, de jan/2002 a dez/2006, para responder questionário estruturado com 29 questões. Estes foram divididos em dois grupos, com uso (grupo I) ou não (grupo II) de placebo, após a randomização. Ao final, 80 pacientes compareceram de 106. Doutros 26 sujeitos, sete se recusaram, nove não foram localizados, oito foram excluídos e dois faleceram. As variáveis de cada questão foram consideradas por freqüência de ocorrência. A comparação entre as médias dos grupos foi realizada pelos testes t de Student ou Wilcoxon. Para avaliar associações utilizou-se o Qui-Quadrado, o teste de Razão de Verossimilhança ou Fisher. Para confirmar as informações, realizou-se também o grupo focal, tendo participado 8 do grupo I e 11 do grupo II. RESULTADOS: Avaliamos 80 sujeitos (grupo I- 47, grupo II- 33). As características sócio demográficas foram similares em ambos. Quanto à motivação para participar da pesquisa, 66,2% atribuíram-na ao benefício próprio, 42,5% pelo bem da ciência, e atendendo ao pedido médico 25,0%, em ambos os grupos. Quanto ao termo de consentimento livre e esclarecido, 50% não entenderam o seu conteúdo e 32,9% sequer o leram, mas o assinaram. No grupo I, 66,7% dos sujeitos não entenderam o significado de placebo e dos que afirmaram ter entendido (n=23) somente doze de fato comprovam o entendimento correto. Foram realizadas associações entre o não entender o significado do termo placebo com as variáveis de interesse para o estudo, e encontramos forte correlação com a escolaridade (p=0,022), evidenciando que quanto menor o nível de instrução menor também o entendimento. Houve também tendência entre ter um companheiro e ler o termo de consentimento livre e esclarecido antes de assinar (p=0,052), e o nível de escolaridade dos sujeitos e conversar sobre o termo de consentimento livre e esclarecido com o pesquisador (p=0,053). No que tange ao grupo focal, este corroborou os resultados e evidenciou que o termo de consentimento livre e esclarecido é considerado difícil pelos pacientes, porém a compreensão é favorecida pela equipe que complementa as informações de maneira clara e dispensa a leitura em virtude do vínculo de confiança estabelecido com esta. CONCLUSÕES: O termo de consentimento livre e esclarecido é pouco compreendido pelos sujeitos e para alguns a confiança no seu médico é crucial para a sua decisão em participar de um ensaio clínico com fármaco; evidenciou-se também influência do nível de instrução dos sujeitos no entendimento do termo placebo. Por outro lado, não houve repercussão na vida dos sujeitos em participar de ensaios clínicos com ou sem placebo, uma vez que a maior motivação para participar é pela expectativa do benefício terapêutico. / INTRODUCTION: To participate in a clinical trial patients have to sign an informed consent, often with misinterpretation words. Herein we addressed the issue of what do patients understand about the informed consent. METHODS: Patients that have participated in clinical trials in our institution were invited to an interview. From a data bank, between 2002 to 2006, patients were contacted by phone call. The questionnaire patients were submitted to was composed of 29 questions. To confirm some data, we did a second interview using the focal technique. Patients were allocated in two groups: Group 1- those that could have taken placebo for the treatment of their illness after a randomization, Group 2- those that did not take placebo during the treatment period but could have taken during the wash-out period. Statistics: were done with the t-Student test, or the Wilcoxon test. To evaluate associations we used the Qui-Square, Similarity test or the Fisher test and we considered a p value of 0,05. RESULTS: 80 patients, 60 (75%) males, age (average in years + SD) of 58.8 + 9.2; 47 in group 1 (58.3 ± 9.0) and 33 in group 2 (59.4 ± 9.8). Except for the job situation, both groups were similar. Of notice is the number of patients that were illiterate or have not completed the primary school. The most quoted motivation to participate was in their own benefit (66.2%), and second to the interest of science (42.5%). It is noteworthy that 50% of patients did not understand the informed consent but even in this case they did sign it. 66% did not understand the meaning of placebo that was correlated to the patients level of education (p= 0.02). Also, 36.2% of patients in group-I were not aware they could have taken tablets with no effect. In 19 patients (eight in group I and 11 in group II) submitted to the focal technique interview, what came out as the more important to their decision making to participate or not in a clinical trial, was the opinion of their assistant doctor. This was stood by almost all (90%) patients in this second interview. CONCLUSION: The informed consent was poorly understood, and for some patients the trust in their assistant doctors is crucial for their agreement to participate in a trial. This raised concerns about long and boring informed consent, and also how important are doctors´ words in the decision making of patients, probably due to their education level.

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.

DOCTOR - PATIENT RELATIONSHIP RESUMÉ The topic of the doctor - patient relationship is so broad that this graduation thesis cannot cover nearly all of its aspects. The aim is to capture the most basic institutions of doctor - patient relationship in period just before the effectiveness of the reform of health services. Historical development of medical law in the Czech Republic is summarized in the very first chapter. The aim was mainly to express complicated role of post-communist countries in connection with their efforts to integrate into the modern system, which was then for the rest of Europe completely natural. The second chapter issues the basic elements controlling the relationship between doctor and patient, including the definition of the term lege artis, whose explanation is an essential part of every publication dealing with medical law. Chapter provides a comprehensive view of the institutes, which are largely discussed in subsequent chapters. The next three chapters deal with the issues of informed consent, duty of confidentiality of medical staff and management of medical documentation. Informed consent is the central institute of medical law and most important element of the relationship between doctor and patient. The topic of the consent of the patient with the health care is treated in...

As mudanças sociais ocorridas nas últimas três décadas fizeram com que o respeito à autonomia do usuário e o direito ao consentimento livre e esclarecido assumissem posição de destaque na ética em saúde e fossem incorporados aos Códigos de Ética Médica e de Enfermagem vigentes no país. Estudos desenvolvidos em serviços de saúde, mormente os hospitalares, têm evidenciado que os usuários obtêm poucas informações sobre suas condições de saúde, tratamento, cuidado e que a prática profissional tem oscilado entre o paternalismo, o autoritarismo e o respeito à autonomia. Esta investigação foi realizada com o objetivo verificar como o consentimento esclarecido é concebido na prática das enfermeiras de quatro Centros de Saúde Escola (CSE) de São Paulo. A análise do material empírico, obtido através de entrevistas junto a essas profissionais foi feita à luz da ética principialista. O resultados demonstram que essas profissionais, apesar de desconhecerem o termo consentimento esclarecido, respeitam as suas normas básicas, reconhecem o direito dos usuários em participar de decisões que digam respeito à sua saúde, oferecem informações para subsidiar essas decisões. O padrão de informação é personalizado, porém, alternativas de decisão, além daquelas estipuladas em programas e protocolos, raramente são apresentadas. Assim, o consentimento esclarecido na prática das enfermeiras em CSE é limitado por esses programas e protocolos. As enfermeiras têm como preocupação o benefício do usuário, o estímulo às participação dos usuários no seu cuidado e a prevenção ou remoção de riscos e danos. No geral, estas enfermeiras acatam a decisão tomada pelo usuário, mesmo quando há recusa em seguir a orientação dada, mas por vezes demonstram dificuldade em aceitá-la quando a mesma põe em risco a saúde de terceiros. Enquanto profissionais que participam na implementação políticas de saúde demonstram preocupação com sua \"missão\", sentem-se impotentes e demonstram desconhecer aliados e instrumentos que poderiam ser utilizados nessa situação. / The social changes occurred in the last three decades were instrumental for causing the customers\' autonomy and right to free-informed consent to be respected assuming a leading rank in the health ethics as well as being incorporated into the Nursing and Medical Ethical Codes in force in the country. Studies carried out in health services, moreover in hospital facilities, disclosed that the customers usually obtain few information on their health condition, treatment and, care and that the professional practice has been oscillating among being either paternalistic, authoritarian or respecttul regarding the patient\'s autonomy. The purpose of this investigation was to ascertain how the informed consent is conceived by the nurses\' practice in four School/Health Centers in São Paulo, State of São Paulo. Brazil. The empirical material obtained in interviews along with these professionals was analyzed in the light of Bioethics principles. Results were as follows: these professionals do not know the term informed consent; however, they act in accordance with its basic norms, recognizing the customers\' right to participate in the decision-making regarding their health, besides providing information in order to subside these decisions: the pattern of the information provided is personalized, although decision alternatives other than those stipulated in programs and protocols are rarely presented. Informed consent, in nursing practice in School/Health Centers is restricted within these programs and protocols. These nurses are concerned about users\' beneficence, their participation in self care and about preventing or removig risks or harm. In general, these nurses respect the decision taken by the customers, even when they refuse to comply with the orientation provided, however showing sometimes difficulties in accepting it when the health of a third-part is in jeopardy; while professionals participating in the implementation of health policies, they demonstrate being concerned with their \"mission\", sometimes feeling themselves impotent to deal with this situation, disclosing therefore a lack of knowledge concerning allied institutions and instruments which might be used to face these kind of circumstances.

The purpose of this research project was to determine if there was a significant difference between women who had unplanned pregnancies and the amount of information those women received about their pregnancy options regarding parenting, adoption, and abortion, and those who were not. Additionally, the level of information about pregnancy options, and whether it would reduce termination of pregnancies was examined. The aspects explored included the information available to clients and the decision making process for women who have experienced an unplanned pregnancy. The methods for this study involved using an anonymous survey via Survey Monkey. Additionally, this study examined the importance of clients being informed and the role information plays in the social work field. A detailed examination of the research which has been conducted in pregnancy options counseling and what that counseling consists of was conducted and discussed. An overview of "Woman’s Right to Know Laws" was also addressed and what theories have an impact on what woman experience during an unplanned pregnancy. Finally, an independent samples t-test was conducted to determine if there were significant differences between groups of women who had chosen to keep and parent their child, those who chose to have an abortion, and those who chose to relinquish their child for adoption and the amount of information they received about their pregnancy options. The study found a significant difference between women who chose to parent their children and women who iv chose to have an abortion in terms of the level of information they were provided about those options. The abortion group received significantly more information about abortion than the parenting group. This may be due to the type of information received being more about cost and recovery periods versus the actual abortion procedure and mental health concerns post-abortion. Based on the findings, most women know what they will do in the case of an unplanned pregnancy and only a significant intervention will change their course of action. Based on the findings, educating women about their pregnancy options will not change their decision to keep, abort or relinquish their child for adoption. Instead, prevention efforts are more effective in preventing abortion than providing them with information.