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The therapeutic privilege is a defence in terms of which a doctor may withhold information from a patient if disclosure of such information could harm the patient. This study explores the defence of therapeutic privilege and provides a critical evaluation. A comparative investigation is undertaken, while arguments springing from a variety of disciplines are also incorporated. A number of submissions are made for limiting the ambit of the defence. The main submission is that the therapeutic privilege should comply with all the requirements of the defence of necessity. In addition, it should contain some of the safeguards afforded to the patient by the requirements of the defence of negotiorum gestio so that therapeutic privilege is out of the question if medical treatment is administered against the patient's will, or the doctor has reason to believe (or knows) that the patient will refuse to undergo an intended intervention once properly informed. / Jurisprudence / L.L.M. (Jurisprudence)

O presente trabalho avaliou através de um questionário e entrevistas pessoais no período de maio a setembro de 2004, cinqüenta participantes voluntários sujeitos de pesquisas envolvendo seres humanos, nas unidades de saúde do âmbito da Secretaria Municipal de Saúde – SMS, espalhadas pelo município de São Paulo e na Faculdade de Odontologia da Universidade de São Paulo – FOUSP. Colheu a opinião destes, sobre a experiência da voluntariedade nos experimentos de que participaram nestes locais, abordando questões como: o motivo de terem contribuído, grau de conhecimento do Termo de Consentimento Livre e Esclarecido -TCLE e a importância dispensada a este documento, com que concordaram e autorizaram a participação, de acordo com a determinação da Resolução 196/96, diretriz nacional que regulamenta as pesquisas envolvendo seres humanos. O estudo observou que, passados oito anos da entrada em vigor da Resolução 196/96, o processo de obtenção do consentimento livre e esclarecido ainda carece de cuidados. Participantes efetivamente não são esclarecidos ou não entendem o que lhes foi proposto. Consideramos a necessidade de uma maior difusão, através de ações educativas, do assunto “experimentação com seres humanos”, para um maior entendimento dos voluntários de pesquisas dos seus direitos e deveres, no sentido de manter as pesquisas num elevado padrão ético. O presente estudo pretende contribuir com a hermenêutica desta Resolução e suscitar maiores discussões e reflexões sobre o assunto / The present assignment evaluated through a questionnaire and personal interviews in the period within May and September 2004, fifty volunteered participants subjects of researches involving human beings, in the units of health SMS) in São Paulo city and at Odontology University of São Paulo - FOUSP. It collected the opinion of these volunteers about the experience of voluntariness in the experiments that took part in these locals, tackling matters as: their reason of having contributed, knowledge degree of free consent form – TCLE and the dispensed importance of this document, to which they agreed and authorized the participation, according to the determination of the Resolution 196/96, national guideline that regulates the researches involving human beings. The study observed that eight years after the Resolution 196/96 was put into effect, the obtainment process of the informed consent still lacks of cares. Participants are not clear or do not understand what they were proposed. We consider the need of a larger diffusion through educational actions, of the subject experimentation with human beings, for volunteers larger understanding of their right and duties, in the sense to maintaining the researches in an elevated ethical standard. The present study intends to contribute with the hermeneutics of this Resolution and to raise larger discussions and reflections on the subject

The literature suggests that informed consent documents (ICDs) are not well understood by research participants. The patient decision aid model may suggest improvements for the informed consent process, particularly in the critical care setting (ICU) because of patient capacity issues. Our goal was to evaluate the extent to which existing ICDs used in ICU research adhere to standards and recommendations for high quality informed consent. Eighteen items from recommendations specific to ICU trials were added to a previously developed ICD evaluation tool. A sample of ICU trials was identified from clinicaltrials.gov database and the investigators contacted for their trial ICD. Conformity to the recommendations was variable. Some information are found routinely in consent documents for critical care research and some are not. Efforts should aim to establish tools for measuring decision quality in the ICU with the goal of facilitating and helping patients and surrogates work through trial participation decisions.

Behandlingar inom hälso- och sjukvården måste överensstämma med kravet på vetenskap och beprövad erfarenhet (VBE) för att erbjudas patienter enligt svensk rätt. Däremot underställs inte medicinsk forskning som avser människor kravet på VBE eftersom behandlingar som ges till människor inom ramen för forskning inte har beprövats i samma utsträckning som behandlingar inom hälso- och sjukvården och anses såldes inte lika effektiv och säker. Behandlingar inom ramen för forskning får i stället utföras på människor efter ett godkännande av Etikprövningsmyndigheten i enlighet med lag (2003:460) om etikprövning av forskning som avser människor (EPL).  Experimentella behandlingsmetoder har inget uttryckligt lagstöd i svensk rätt men tillämpas i den medicinska praktiken; det handlar om metoder utöver gängse behandlingspraxis som syftar till att ge bot eller lindring till en enskild patient. Sådana behandlingsmetoder uppfyller inte kravet på VBE men anses inte heller omfattas av EPL. Metoderna är således oreglade men motiveras med hjälp av medicinska normer. Att utöva vård inom hälso- och sjukvården som inte lever upp till kravet på VBE är ansvarsgrundande, men enligt nödrätten i 24:4 brottsbalken (BrB) kan utövandet av experimentella behandlingsmetoder innebära ansvarsfrihet vid skuldfrågan. Således finns det utrymme att utföra oreglerade experimentella behandlingar utan att ställas till svars om patienter kommit till skada, eller till och med avlidit.  Det nuvarande rättsliga systemet skiljer med andra ord på människor som utgör patienter och människor som undergår medicinsk forskning och benämns som forskningspersoner. Den kliniska forskningen är däremot inte sällan beroende av vårdens resurser samt strukturer och den grupp som oftast rekryteras till forskningsstudier är just patienter. I praktiken kan alltså en patient också vara en forskningsperson. Hälso- och sjukvårdslagstiftningen skall således vara tillämpbar på en patient som dessutom genomgår forskning och som också enligt EPL utgör en forskningsperson, men varken författningstext eller förarbeten till aktuella regelverk klargör varandras samexistens och således skapas ett juridiskt ingenmansland.  Enligt internationella konventioner om mänskliga rättigheter som Sverige förbundit sig till får ingen utsättas för vetenskapliga och medicinska ingrepp utan ett frivilligt och informerat samtycke. Den svenska rätten är däremot inte förenlig med internationell rätt eftersom det är möjligt att enligt EPL forska på människor utan inhämtandet av ett informerat samtycke.  Patienter och forskningspersoner är en sårbar grupp eftersom sjukdom och nedsatt hälsa inte sällan försvagar oss. Det kan handla om människor som på olika sätt har en nedsatt funktionsförmåga. Patienter och forskningspersoner kan således ha svårt att ta tillvara sina egna intressen och det kan innebära att det kan vara svårt att förstå risker och konsekvenser som är förenade med olika ingrepp. Legala ställföreträdare som kan ta beslut i frågor som rör en annan människas vård och behandling om denne inte själv är kapabel till att ta ett beslut saknas i svensk rätt, vilket också strider mot traktat som Sverige har ingått.  Den svenska hälso- och sjukvårdslagstiftningen är dessutom inte en rättighetsbaserad lagstiftning vilket innebär att enskilda inte kan gå till domstol och få sina rättigheter prövade. Enskildas enda rättsliga möjlighet är i sådana fall att söka anhängiggöra svensk domstol genom åberopandet av Europakonventionen (EKMR) genom 3:4 Skadeståndslagen (SkL), under förutsättningen att rättigheter enligt konventionen har överträtts. Det kan alltså ifrågasättas om människor som genomgår medicinska behandlingar i Sverige innehar adekvata rätts- och skyddsmekanismer och om det rättsliga systemet på ett tillfredsställande sätt skyddar och respekterar människors rätt till ett fritt och informerat samtycke.

Thesis (MCur)--Stellenbosch University, 2012. / ENGLISH ABSTRACT: Background Informed Consent (IC) has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. IC is a vital part of the research process and as such entails more than obtaining a signature on a form. The IC must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Aim The overall aim of this study was to attain an understanding of participants' knowledge regarding informed consent when participating in a research project. Methods The study was conducted at two public hospitals in a city in the Eastern Cape Province of South Africa. The quantitative study used descriptive survey design. A self administered questionnaire was used as a tool for data collection. Results The sample size consisted of 170 women with an average of 25.9 years. The majority had completed secondary level education. More than half of the participants did not have knowledge of the purpose of the original study. The majority of participants did not have knowledge of their responsibilities. Forty-two percent gave uninformative responses and 26% indicated they did not know their responsibilities. None of the participants understood the concept of randomization. The majority (85.9%) of participants indicated that information provided on the IC forms was sufficient for them to decide to participate. Conclusion Despite extensive efforts to ensure that participants understood their participation in the original studies, this study found poor recall of vital information for IC. A signed informed consent does not guarantee that participants understand information given. Recommendations The existing methods of communicating and obtaining of an informed consent seem to be insufficient for participants to make an informed decision. A new approach with more interactive features such as combination of audio-visual techniques might increase the possibilities of the understanding. / AFRIKAANSE OPSOMMING: Agtergrond Ingeligte toestemming (IT) is voorgestel as die optimale metode om die etiese toelating van die pasiënte vir kliniese toetse te verseker. IT is 'n belangrike deel van die navorsingsproses en as sodanig behels dit meer as die verkryging van 'n handtekening op 'n vorm. Die IT moet vrylik gegee word, sonder dwang en moet gebaseer wees op 'n duidelike begrip van wat die deelname behels. Doel Die algemene doel van hierdie studie is om 'n begrip van die deelnemers se kennis met betrekking tot ingeligte toestemming te bepaal, wanneer hulle deelneem aan 'n navorsingsprojek. Metodes Die studie is uitgevoer by twee openbare hospitale in ’n stad in die Oos-Kaap in Suid-Afrika. Die navorsingsontwerp is beskrywend van aard en ’n kwantitatiewe benadering is toegepas. ‘n Self-geadministreerde vraelys is as 'n instrument gebruik om data in te samel. Resultate Die steekproefgrootte het bestaan uit 170 vroue met 'n gemiddelde ouderdom van 25.9 jaar. Die meerderheid van die vroue het opleiding tot op sekondêre vlak. Meer as die helfte van die deelnemers het geen kennis van die doel van die oorspronklike studie gehad nie. Die meerderheid van die deelnemers het ook nie kennis van hul verantwoordelikhede gehad nie. Twee-en-veertig persent het nie toepaslike antwoorde gegee nie en 26% het aangedui dat hulle nie weet wat hul verantwoordelikhede in die studie is nie. Nie een van die deelnemers het die konsep van verewekansiging verstaan nie. Die meerderheid (85.9%) van die deelnemers het aangedui dat die inligting wat deur die IT verskaf word voldoende was om te besluit of hulle aan die studie wou deelneem. Gevolgtrekking Ten spyte van uitgebreide pogings om te verseker dat deelnemers hulle deelname verstaan het in die oorspronklike toetsing, het hierdie studie die swak herroeping van belangrike inligting aangaande IT bewys. ‘n Ondertekende ingeligte toestemming gee geen waarborg dat die deelnemers die inligting waarvoor toestemming geteken is, verstaan nie. Aanbevelings Die bestaande metodes van die kommunikasie en verkryging van ingeligte toestemming blyk onvoldoende te wees om deelnemers ingeligte besluite te laat neem. ‘n Nuwe benadering met meer interaktiewe eienskappe soos ’n kombinasie van oudio-visuele tegnieke mag die moontlikhede om te verstaan, meer duidelik maak.

La problématique du consentement éclairé en santé mentale demeure au coeur des préoccupations des cliniciens, médecins spécialistes et médecins experts. Le travail auprès des cérébrolésés ou des patients souffrant de troubles mentaux graves, tout comme les questions qui me sont adressées depuis près de 20 ans par les médecins spécialistes, juristes ou résidents en psychiatrie, m’ont amenée à y réfléchir davantage. J’ajouterais que le constat personnel d’une compréhension des comportements, attitudes, motivations et jugements des patients vulnérables qui s’est modifiée au fil des ans, et le constat de l’importance de la notion du consentement vs le flou de sa définition et la fragilité des paramètres établis pour l’évaluer et la définir ont ravivé cette réflexion. La présente étude n’a aucunement pour but d’élaborer quelque règle de conduite que ce soit, ni de définir ce que devrait être le consentement éclairé en psychiatrie, mais plutôt d’explorer les dilemmes éthiques et les questionnements cliniques auxquels sont confrontés les médecins psychiatres afin de raviver une réflexion éthique qui semble s’estomper au profit de procédures juridiques et administratives. / In the mental health field, the topic of informed consent has always been among the most important problems to address for clinicians and psychiatrists. My clinical work with head injured patients and patients with severe mental health disorder, as well as all the questions addressed by physicians, residents or lawyers for the last decade lead me to think about it more deeply. Moreover, the personal observation of cognitively impaired patients and the fact that the concept of informed consent is so present compared to the lack of parameters to assess it has lead me to think about it otherwise. This study does not pretend to lead the actions or clinical behaviour, nor as it pretend to find a better definition of the concept of informed consent. It is only a way to explore some aspects of the complexity and clinical difficulties over the legal and administrative frame in which the medical field is evolving.

The selected aspects of the legal relationship of doctor, parents and minor patient - the criminal aspects. (Abstract) This paper discusses various legal aspects of the relationship, which may arise between a minor patient, his parents and his doctor (or other appropriate health professional). The most important general rule holds good also in the Czech healthcare law. The general rule says that any interference with bodily integrity, and therefore each therapeutic medical intervention, can take place only with the consent of the patient. To be eligible to make such an agreement is a crucial legal capacity according to the arrangements of the Czech Civil Code. If someone is not eligible in this way about himself decide to grant consent to an intervention, it must be done by his legal guardian. In the case of minors it is usually intended by both parents. The most important regulation of the legal issues that arise in the care of the patient is found in Act No. 20/1966 Coll. Health Care. However from the perspective of the Convention on Human Rights and Biomedicine this regulation appears to be somewhat outdated and patients and physicians (as well as other medical staff) find the law like overly complex, unintelligible and therefore unsuitable for their use. Unfortunately this law should help and serve...

Informed consent is a basic institution of health services. This work aims at comparison of the basic components of informed consent in the Czech and English law. The beginning is dedicated to the development and the current relationship between patient and doctor. The traditional paternalistic approach that was prevailing until recently in the health care will be examined more in detail. Furthermore, the work deals with the concept of informed consent as such. The components of the informed consent will be specified as well as the form of the informed consent. Disclosure of the risks and other information must precede for the informed consent to be valid and the consent also have to meet the requirements of legal actions. Text will also focus on informed consent of the minors. Finally, an advance decision will be examined including its conditions of validity. Powered by TCPDF (www.tcpdf.org)

Trata-se de pesquisa quali-quantitativa que envolve observação participante, análise de documentos e realização de entrevistas com usuários de um hospital do SUS e um particular. O foco da investigação é o consentimento informado na assistência à saúde, entendido como o processo decisório compartilhado no qual há troca de informações, impressões e valores entre os usuários do serviço e os profissionais de saúde. Objetivou-se verificar sua prática no sistema de saúde brasileiro, com recorte para a área da oncologia. Para a análise estatística, as variáveis categóricas foram avaliadas por meio do teste exato de Fisher e, as variáveis numéricas, comparadas utilizando o teste t, com nível de significância de 5 por cento . Quanto aos termos de consentimento, os testes de Flesch e Flesch-Kincaid apontaram legibilidade inadequada segundo padrões internacionais, bem como diante dos níveis educacionais de fato encontrados nos hospitais. Mais de 70 por cento dos entrevistados do SUS não tinham escolaridade compatível com a exigida para a leitura dos documentos. Apesar de a quase totalidade dos usuários dos hospitais ter relatado satisfação com as informações recebidas sobre o procedimento que iria realizar, apenas 58 por cento souberam elencar ao menos um risco relacionado ao mesmo. Conforme o esperado, houve associação entre nível educacional e renda dos usuários com a compreensão de riscos dos procedimentos. Mesmo que não se tenha notícia da variável renda ter sido considerada em estudos anteriores, por meio de regressão logística múltipla, observou-se que teve peso muito maior do que a escolaridade em predizer a chance de a pessoa citar um dos riscos do procedimento, embora ambos os fatores sejam preditores independentes. Não houve relação entre a compreensão de riscos e se o hospital era SUS ou particular, e nem em relação ao tempo de tratamento. Diferentemente de pesquisas em outros países, tampouco houve associação entre nível educacional e leitura do termo de consentimento. Entretanto, quando foi o médico, dentre os profissionais de saúde, quem entregou o termo, este foi mais lido pelos usuários. Houve associação entre o usuário estar no hospital particular e acreditar que o termo de consentimento serve para proteger os médicos, em contraposição a servir à sua própria garantia. Pela análise qualitativa, os usuários do SUS tiveram maior habilidade que o esperado na compreensão do diagnóstico e histórico da doença. Acredita-se que o bom acolhimento conseguiu superar em parte o nível educacional e de renda que foram detectados como barreiras ao entendimento das informações, de forma que a humanização da saúde parece impactar positivamente na compreensão das informações pelos usuários. Contudo, em ambos os hospitais, apesar de conseguirem relatar bem os procedimentos pretéritos e futuros, muitos usuários pareciam não saber se contextualizar em seus tratamentos e nem entender os motivos e objetivos dos procedimentos realizados. Em geral, tanto usuários como profissionais mostraram não entender o que é o consentimento informado e a diferença deste para os termos de consentimento, comumente tratados como mera burocracia jurídica. Tudo isso pode estar prejudicando os objetivos do consentimento informado e são questões que necessitam ser repensadas no sistema de saúde / This qualitative-quantitative research includes participant observation, document analysis, and interviews with users from both SUS and private hospitals. It focuses the informed consent in the health care, understood as the shared decisionmaking process in which information, opinions, and values are exchanged between the service users and their health professionals. The goal is to analyze the practice of the informed consent within the Brazilian Health Systems oncology field. The evaluations of categorical variables associations used the Fisher\'s exact test, while the numerical variables were compared through a t-test, at the 5 per cent significance level. Through Flesch and Flesch-Kincaid methods, it was found that the hospitals informed consent terms are of inadequate readability according to international standards, and also inappropriate compared to the actual users literacy level: more than 70 per cent of the SUS interviewees do not match the required literacy standard for comprehending the documents. In addition, although almost all users reported satisfaction with the information they received about their procedure, only 58 per cent were able to name at least one related risk. As expected, there was an association between the educational and income levels of the participants and their ability to understand the risks of a medical procedure. It is noteworthy that previous studies, both national and foreign, do not seem to have considered income level as a variable. Although both factors were independent predictors, multiple logistic regressions showed that income level had a greater weight than educational level in predicting a person\'s chance of citing one of the procedural risks. Additionally, no matter the timing of the treatment, there was no relation between knowledge of risks and whether the hospital is SUS or private. Unlike results found in other countries, there appears to be no association between educational level and the reading of consent terms. Nevertheless, when the doctor is the health professional who applies the term, it is read more often by the users. The research demonstrated that there was an association between the user being in the private hospital and believing that the consent term exists to protect the rights of the doctor instead of their rights as health service users. Through qualitative analysis, this study found that the SUS hospital users had greater ability than expected to understand disease diagnosis and history. The hospitals effective patient care appears to have partly overcome the educational barrier that often prevents patients from understanding diagnostic and medical procedures information, so that humanization of healthcare seems to have a positive impact on users understanding of information. Despite of both hospitals users satisfactorily report past and future procedures, several of them appear not to contextualize their treatments either understand the performed procedures reasons and objectives. In general, users and health professionals in both hospitals do not seem to understand the informed consent concept, neither the difference between informed consent and informed consent terms, generally seen as mere legal bureaucracy. All of these issues may jeopardize the goals of informed consent, if they are not addressed properly at the health care