Informed consent of a patient is currently one of the fastest developing subjects of medical law. Its fundamental principles are based on human anatomy and one's freedom of choice with respect to decisions concerning his or her well-being. The aim of this thesis is to present informed consent in light of the newly enacted legislation concerning medical services, to highlight some of the consequences of the new legislation, as well as to discuss certain aspects of criminal liability of medical personnel in connection with informed consent. The thesis consists of six chapters, which are further divided in to subchapters. The respective chapters outline informed consent of a patient with respect to its basic elements, associated consequences and selected aspects of potential criminal liability. Following the introduction, the first chapter describes the relationship between a doctor and a patient and identifies the upcoming trend of the transformation of the historical paternalistic relationship into a partnership. The second chapter features an overview of the both the national and the international legal sources, which govern informed consent. The third chapter represents the main focus of the thesis and describes the respective elements of an informed consent - disclosure and consent. The...

Practice and law around informed consent in healthcare have undergone a revolution for the better over recent decades. However the way we obtain informed consent remains problematic and is imbued with irreducible but not ineliminable uncertainty. The reasons for this uncertainty are varied. The uncertainty is partly due to the conceptual opacity of important core concepts. The complexity of communication in clinical encounters is another. The role of autonomy, and the changing nature of the clinician patient relationship, have also contributed to this uncertainty remaining. This thesis is not a panacea for these difficulties. However there have been two quite profound revolutions in healthcare over the last decade or so, namely, the introduction of evidence-based medicine into clinical decision making, and the institutionalization of clinical governance and the application of quality improvement philosophy. I have examined ways in which these two “movements” can help in reducing some of the uncertainty in the practice of informed consent.

The Western liberal approach to informed consent defines autonomy as an independent choice or decision made by an individual as the final authority in medical decision-making. This approach is so dominant that one can fail to see the merits of other traditional and cultural perspectives. In this dissertation, another approach to informed consent is considered -that of communal culture of Africa, a process used in African traditional medicine (ATM) wherein patients make medical decisions and give consent in consultation with the members of their community and the ATM doctor. Often, but not necessarily, the final consent rests on the consensus reached in consultation with the group rather than on that by the individual patient alone. <br>This dissertation argues that the ATM form of consent constitutes legitimate informed consent based on the concept of relational autonomy, commonly called relational autonomy in informed consent (RAIC) in this dissertation. To interpret and enlighten the significance of the ATM approach to RAIC, the analysis in this dissertation examines the ethics of care movement in Western bioethics which also advocates a relational approach to informed consent. This movement presents a concept of persons as relational beings who are socially embedded, thereby interpreting patient autonomy in their relationships with others. This movement provides the hermeneutic to enlighten the significance of the ATM approach as a legitimate model of RAIC. <br>By comparison of the ethics of care approach with that of ATM to RAIC, this dissertation further provides a relational approach to informed consent in order to inform the restrictive emphasis on individual autonomy practiced in Western bioethics, all with a view towards fostering current discourse on global bioethics. The dissertation also provides an applied example of the contribution of ATM's RAIC approach to ethics committees in Africa, focusing in particular, on the decision-making process for patient informed consent. <br>This dissertation is distinct insofar as it focuses on informed consent in ATM, employs ethics of care as a hermeneutic to interpret ATM, advocates integrated model of healthcare ethics committees in ATM. Because ATM forms a large portion of the healthcare systems in Africa, it follows that ATM and its practices should receive more attention in bioethics in the present global era. / McAnulty College and Graduate School of Liberal Arts; / Health Care Ethics / PhD; / Dissertation;

Syftet med studien är att undersöka hur en population av potentiellt blivande föräldrar i åldrarna 20-40 år önskar att handläggning av informationen kring ultraljudsmarkörer bör se ut. Studien utformades som en pilotstudie med bekvämlighetsurval, och en enkät med parametrar fördelade på 11 scenarion utarbetades. Enkäten delades ut på föreläsningar i och omkring Stockholm i april 2012. 49 kvinnor och 36 män deltog i undersökningen. Potentiellt blivande föräldrar vill ofta få information om upptäckta softmarkers. Dock svarar en betydande del av försökspersonerna att de för vissa scenarion inte vill ta del av all tillgänglig information. Flest vill ha information vid obotliga tillstånd och när markören sitter i fostrets hjärna eller hjärta. De scenarion där flest svarar att de inte vill bli informerade är då markören sitter i fostrets tarm eller skelett samt när tillståndet är bortbart. Signifikanta skillnader uppmättes mellan olika gruppers svar. Kvinnor svarar oftare än män att de inte vill ha information om funna softmarkers. Detsamma gäller för sambos/gifta när man jämför dem med de som är singlar. De som hade barn vill oftare inte veta om att en softmarker har upptäckts jämfört med de som inte har barn. / The aim of the study was to investigate how potential new parents aged 20-40 would prefer the information about soft markers to be handled. The study was designed as a pilot study, and a questionnaire was made with parameters divided into 11 scenarios. The questionnaire was handed out at lectures in the Stockholm area in April of 2012. Answers were analyzed in SPSS with chi-2 tests. 49 women and 36 men participated in the study. Potential new parents often wish to be informed of discovered soft markers. However, a significant portion of the participants say they prefer not to know about soft markers in their foetus in some scenarios. Scenarios where the condition is incurable or where the soft marker is placed in the brain or heart of the foetus are the ones where the most people say they want the information. A soft marker placed in the foetus’ intestines or skeleton is when the most people answer that they do not wish to recieve this information. Significant differences are seen between different groups. Women more often than men say they do not want information about a discovered soft marker. The same is true for those who are married or cohabitating when compared to singles. Those who are already parents want information about a soft marker to a lower degree than those who do not have children.

Aim of the study. To evaluate mental health care institution staff’ and patients’ opinion about application of the doctrine of informed consent. Objectives: 1. To evaluate personal health care specialists’ opinion about application of the doctrine of informed consent in the health care institution. 2. To evaluate patients’ opinion about procedure of the written consent. 3. To compare personal health care specialists’ and patients’ opinion about application of the doctrine of informed consent. Methods. Anonymous survey of 138 personal health care specialists (response rate – 84 percent) and 315 patients (response rate – 90 percent) at Vilnius mental health centre was carried out. SPSS 13.0 version of statistic analysis packet was used to process the data. Diagrams and tables were prepared using Microsoft Excel 2003 program. Results. In evaluation of necessity of given information, 54,1% of personal health care specialists indicated that patient should be fully informed about his health status and diagnosis, 42,2% indicated that such information for mental health patients should be given just partially. 21,7% of patients claimed that information about prognosis and possible results of treatment given by doctors was unclear. In evaluation of procedure of written consent, 31,2% of specialists evaluated it as a manner for the doctor’s insurance and 24,9% – as an instrument for the protection of patient’s rights. Half of patients (49,9%) maintained that procedure of written consent... [to full text]

This thesis deals with the concept of the medical duty to inform focusing on the rights of the patient. It emerges that the notions governing medical responsibility do not adequately address the question of the protection and application of the rights of the patient. Existing conceptions of the notions of dereliction, causality and damage are analysed in order to point out the many inadequacies with the rights of the patient, source of the obligation to inform. Particular emphasis is given to the situation in Quebec and to the eventual place that could be occupied by conception of the duty to inform that is more sensitive to the situation and rights of the patient.

Thesis (Ph. D.)--University of Toronto, 2004. / Adviser: Michele Peterson-Badali.

Thesis (Ph. D.)--University of California, San Diego and San Diego State University, 1998. / Vita. Includes bibliographical references (leaves 152-164).

Thesis (DClinPsychol)-Salomons Centre. BLDSC no.DX220778.

El consentimiento informado es una de las aportaciones más innovadoras e importantes de la ciencia jurídica a la medicina. Pues en el ámbito de la medicina, la concepción tradicional de la relación médico-paciente ha sido paternalista, es decir, una relación en la que el médico era considerado como un sabio, capaz de tomar las decisiones más adecuadas para el paciente respecto al tratamiento que éste debía seguir, sin tener en cuenta su voluntad; en cambio el paciente, era considerado un individuo carente de racionalidad e incapaz de saber lo que le conviene para mejorar su salud. Hoy en día, resulta indiscutible la función esencial que cumple la autonomía de la voluntad del paciente, por el cual se le atribuye un papel mucho más activo y participativo en la toma de decisiones frente al que tenía en generaciones pasadas. Ello implica, el reconocimiento del derecho que tiene el paciente a decidir lo que resulta mejor para sus intereses, esto es, la autonomía que tiene para consentir o rechazar un procedimiento, diagnóstico o terapia recomendado. Como consecuencia de este reconocimiento, es que surge en garantía de éste el derecho a la información, ello como una manifestación de protección a la salud. Y es que resulta indiscutible el carácter fundamental de este derecho en las relaciones médico-paciente, cuyos avances en investigación clínica y el rápido desarrollo de la tecnología médica han hecho que se planteen nuevas medidas y normativas con miras a proteger los derechos de los pacientes. 7 Por tanto, la presente investigación tiene por objeto el realizar un estudio jurídico sobre el consentimiento informado en las relaciones médico-paciente tanto en el ámbito nacional como en el internacional. Y es que el consentimiento informado como tal, no ha sido un tema frecuentemente desarrollado a profundidad por la doctrina e incluso por los tratados de biomedicina; ello quizás porque su aplicabilidad se ha visto reducido a la elaboración de un complejo protocolo del acto médico a realizar, lo que finaliza con la aceptación por parte del paciente. El asombro e indignación que este hecho causa, acompañado además de la insensibilidad del médico por explicar con claridad el proceso a seguir y de las posibles complicaciones que puede generar este procedimiento o tratamiento, así como la vulneración del derecho a la información que tiene todo paciente, nos ha conducido a desarrollar esta investigación por capítulos, en los cuales de manera clara y sencilla se explica la problemática, los objetivos de la investigación, su regulación y el planteamiento de posibles soluciones. Tal es el caso, que en el Capítulo I se describe de forma concreta la problemática de la presente investigación, estableciendo las hipótesis a responder, la importancia y los objetivos a obtener. Seguidamente, el Capítulo II desarrollamos el derecho a la salud como derecho fundamental de todo ser humano, derecho importante para definir posteriormente al consentimiento informado, toda vez que éste es una manifestación del mencionado derecho y que por ende merece ser tratado a profundidad a fin de determinar su importancia. 8 En el Capítulo III, hacemos un breve recuento de los antecedentes históricos del consentimiento informado, expresado en sus inicios a través de la jurisprudencia norteamericana en cuyos casos, se explica y se trata con detalle por primera vez el término consentimiento informado. El Capítulo IV, se darrolla el contenido, titular y momento del Consentimiento Informado. Asimismo, el Capítulo V se explica el tratamiento del consentimiento informado tanto en el ordenamiento jurídico como en la jurisprudencia nacional; así como en la normativa y jurisprudencia internacional, en específico de los países de Costa Rica y España. En el capítulo VI, se desarrolla la ausencia del consentimiento informado, punto relevante ya que ante la omisión de brindar la información al paciente, este hecho constituye una vulneración no sólo al derecho a la información del paciente sino que también, vulnera los derechos a la salud, a la determinación y a la dignidad que todo ser humano por su condición de tal posee. Finalmente, el Capítulo VII abarca la propuesta legislativa como posible solución ante el incorrecto uso de este derecho, toda vez que no se subsume a un simple protocolo o formulario escrito, sino que su principal objetivo es mantener informado de forma clara y comprensible al paciente, de manera que éste puede otorgar su consentimiento en un total plano de conciencia-juicio de valor sobre la situación dada.