Thesis (MPhil (Philosophy))--University of Stellenbosch, 2009. / ABSTRACT: The European Enlightenment secured man’s freedom from doctrinal thought. Scientific progress and technological innovation flourished in the 18th Century, radically changing the lives of all. Man’s mastery and transformation of his environment was matched by revolutionary political reform, resulting in the dissolution of empire and the transfer of power into the hands of the people. Social transformation saw the city-states of pre-modern man supplanted by a globalized community whose existence grew from time and space distantiation facilitated by the new technologies and the development of symbolic forms. These sweeping social, political and ideological changes of the 18th Century fostered the belief that man’s transformative authority was indeed his to command. Man believed he had a right to self-governance and to autonomous decision-making. Kant described moral autonomy as the freedom men have to show rational accountability for their actions and he saw in men a dignity beyond all price because of this moral autonomy. Personal autonomy is seen as the expression of the free will of individuals and is justifiably constrained by the need to respect the interests and agency of others. The principle of autonomy, in the context of medical practice, was not clearly articulated until the early 20th century. Prior to this, the ethical practice of medicine relied upon the beneficent intentions of the practitioners. The limits to patient autonomy have been delineated largely by issues of social justice based upon the need to share scarce resources fairly among members of society. However, autonomy remains a dominant principle and is most clearly exemplified by the process of informed consent obtained prior to any medical intervention. This thesis provides a conceptual analysis of autonomy in the context of informed consent. Following this, several different clinical scenarios are examined for evidence of justifiable limitations to patient autonomy. Each scenario is examined in the light of different moral theories including deontology, utilitarianism, communitarianism and principlist ethical reasoning. Kantian ethical reasoning is found to be resilient in rejecting any limitation to the autonomy principle whereas each of the other theories allow greater scope for morally-justified curtailment of individual autonomy. The thesis concludes with reflection on post-modern society in which the radicalization of what began with the European Enlightenment sees the transformation of pre-modern society into a global community in which epistemological certainty is no longer available. In this environment, the emerging emphasis on global responsibility requires ethical accountability, not only when individuals secure transactions between one another but also between individuals and unknown communities of men and women of current and future generations. The thesis concludes that patient autonomy is justifiably limited in South African medical practice because of issues related to social justice but that the impact of the new genetic technologies and post-modernity itself may in future set new limits to individual patient autonomy. / OPSOMMING: Die Europese Verligting het die mensdom bevry van verstarde, dogmatiese denke. Wetenskaplike en tegnologiese ontwikkelinge het tydens the 18de Eeu die lewens van almal radikaal verander. Die mens se bemeestering en transformasie van sy omgewing het gepaard gegaan met revolusionêre politieke hervormings wat gelei het tot die ontbinding van tradisionele politieke ryke en die oordrag van mag aan die mens. Sosiale transformasie het veroorsaak dat die politieke ordeninge van voor-moderne mense deur ‘n globale gemeenskap vervang is wat ontstaan het as gevolg van onder meer die ontkoppeling van tyd en plek (Giddens), en wat deur nuwe tegnologiese ontwikkelings en die ontstaan van simboliese vorms moontlik gemaak is. Hierdie uitgebreide ontwikkelinge het die idee laat ontstaan dat niks vir die 18de Eeuse mens onmoontlik is nie. Die mens het geglo dat hy ‘n reg het op self-bestuur en outonome besluite. Kant het die morele outonomie van die mens beskou as sy vryheid om verantwoordlikheid te neem vir sy eie rasioneel-begronde handelinge en verder het hy ‘n besondere waardigheid in die mens geïdentifiseer vanweë sy morele outonomie. Omdat ‘n mens hierdie eienskap besit, beskik hy oor ‘n hoër waardigheid as alle alle ander lewensvorme. Persoonlike outonomie is die uitoefenimg van die vrye wil van die individu en word om geregverdigde redes beperk deur die regte van ander mense. Die beginsel van outonomie met verwysing na mediese etiek het nie voor die begin van die 20ste eeu prominent geword nie. Voor hierdie tyd het mediese etiek staatgemaak op die goeie voorneme van die praktisyn. Die grense van individuele outonomie word nou bepaal deur die noodsaak van sosiale geregtigheid. Al is dit die geval, bly die beginsel van outonomie die belangrikste beginsel in die etiese debat en word meestal gesien as ‘n deel van die proses van ingeligte toestemming. Hierdie tesis verskaf ‘n omvattende ontleding van outonomie met betrekking tot ingeligte toestemming. Daarna word verskillende kliniese gevalle beskryf en ontleed, en verskeie etiese teorieë gebruik om die wyse waarop pasiënt outonomie reverdigbaar ingekort behoort te word, te bespreek. Die teorie van Kant is in staat om enige inkorting van outonomie in alle gevalle the weerstaan. Elkeen van die ander teorieë verskaf redes waarom die outonomie van individuele pasiënte legitiem ingekort mag word. Hierdie werk sluit af met besinning oor die post-moderne gemeenskap wat ‘n globale samelewing moet aanvaar sowel as die ontoereikenheid van enige kenteoretiese sekerheid. Die ontwikkelende verantwoordelikheid vir die totale mensdom in hierdie wêreld veroorsaak dat individue nie meer slegs moet besluit oor die morele verhouding met sy medemens nie, maar ook oor sy verhouding met mense van gemeenskappe wat geskei is in tyd en ruimte, insluitend sy verhouding met die mense van toekomstige generasies. Hierdie werk sluit af met die gevolgtrekking dat pasiënt outonomie regverdigbaar beperk word in die Suid Afrikaanse mediese praktyk deur die noodsaaklikheid van sosiale geregtigheid. Die verwagte impak van nuwe genetiese tegnologieë en die ontwikkeling van ‘n post-moderne gemeenskap mag nuwe beperkings bring vir pasiënt outonomie.

Using mainly quantitative methods of evaluation, as well as patient comment assessment, this study evaluated whether changing the current informed consent process for labor epidural analgesia to a longer, more informational process resulted in a more satisfied patient. Satisfaction with the labor epidural informed consent process was evaluated using a questionnaire that was mailed and also available online. Half of the patient population was given a written labor epidural risk/benefit document at their 36-week obstetric check up. All patients received the standard informed consent. Survey responses were evaluated based on three independent variables dealing with the modality, timing, amount of informed consent information and one dependent variable, whether the patient's expectations of the epidural were met, which is equated with satisfaction. Patients in this study clearly indicated that they want detailed risk/benefit information on epidural analgesia earlier in their pregnancy. A meaningfully larger percentage of patients who received the written risk/benefit document were satisfied with the epidural process as compared to those who did not receive the document.

This dissertation focuses on the issue of health care provision without the consent of a patient within the system of intensive care provision. Situations when its possible to hospitalize a patient without his or her consent are defined in § 38 ZZS (Health Services and Terms and Conditions of Health Service Provision Act as amended). In the intensive care unit we are very often faced with patients that need to be urgently treated without their consent. Also very frequently a treatment is provided to patients that are under the influence of addictive substances therefore are dangerous to themselves and to others. Health of these patients is damaged and even their lives are at risk. A treatment without a patient's consent is debatable from the ethical point of view. A conflict occurs between the fundamental ethical principles (benefit principle and principle of autonomy) because it is not entirely clear which one of the two principles should be prioritize during the treatment. Work and moral obligation of every medical personnel is to provide a medical treatment in accordance with the law and ethical principles. A theoretical part of the paper is dedicated to the legal and ethical sides of the examined issue. The empirical part of the paper is dedicated to the research. A qualitative analysis of...

Zugl.: Mannheim, University, Diss., 2006.

Introduction and background Recruitment to cancer clinical trials needs to be improved, as does patient understanding about clinical trials, to enable patients to make an informed choice about whether or not to take part. The main reason that clinically eligible patients do not take part in clinical trials is because they refuse; poor understanding of the research has been associated with patient refusal. Audiovisual patient information (AVPI) has been shown to improve knowledge/understanding in various areas of practice but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to recruitment rates. Understanding the research is necessary for informed consent, and it was hypothesised that if patient understanding about clinical trials was increased with AVPI, then this could result in a reduction in the number of patients refusing clinical trials, and therefore provide an ethical approach to improving recruitment. This study aimed to test the impact of an audiovisual patient information intervention on recruitment to randomised cancer clinical trials (refusal rates), patient understanding of the information given, and levels of anxiety. Reasons for patients’ decisions about trial participation were also assessed. Method An AVPI intervention was developed that aimed to address the common misconceptions associated with randomisation and clinical equipoise, as well as improve patient understanding generally of randomised cancer trials, and of other core clinical trial informational requirements, such as voluntariness. Patients were randomised to receive either AVPI in addition to the standard trial-specific written information, or the written information alone. A new questionnaire was developed to assess patient understanding (also referred to as knowledge) in the randomised trial setting and, following testing with patients and research nurses, this was shown to be reliable and valid. Patients completed self-report questionnaires to assess their understanding (new knowledge questionnaire) and anxiety (Spielberger State-Trait Anxiety Inventory), at baseline and after they had made their decision about clinical trial entry, when their perceptions of the intervention, as well as factors contributing to their decision were also determined (this tool incorporated Jenkins and Fallowfield’s (2005) questionnaire which assessed reasons for accepting and declining randomised cancer trials). Results A total of 173 patients with breast cancer (65%), colorectal cancer (32%) and lung cancer (3%) were entered into the main study. The median age was 60 (range 37-92 years). There was no difference in clinical trial recruitment rates between the two groups: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores increased more in the intervention group compared to the standard group (U= 2029, p=0.0072). The change in anxiety score between the arms was also statistically significant (p=0.011) with anxiety improving in the intervention arm more than in the no-intervention arm. The estimated difference in the median anxiety change score between the groups is –4.6 (95% ci –7.0 to –2.0). Clinical trial entry was not influenced by tumour type, stage of cancer, age, educational qualifications or previous research experience, however, there was a modest association with deprivation status (p=0.046) where more affluent patients were the least likely to consent to a trial. Educational qualifications and stage of cancer were independently associated with knowledge: patients who were better educated had higher levels of knowledge about randomised trials, and patients who had limited stage of cancer had higher baseline knowledge than patients with advanced cancer. Acceptability of the intervention was high with 93% of those who watched it finding it useful, and 42% stating that it made them want to take part in the clinical trial. Personal benefit and altruism were key motivating factors for clinical trial participation, with reasons for refusal being less clear. Discussion and conclusions Although the potential for AVPI to increase clinical trial recruitment rates was highlighted in the literature, in this study, AVPI was not shown to have any effect on refusal rates to randomised cancer trials. However, by improving patient understanding prior to decision making, AVPI was shown to be a useful addition to the consent process for randomised cancer trials. AVPI addresses the fundamental ethical challenges of informed consent by improving patient understanding, and supports the ethical framework integral to Faden and Beauchamp’s (1986) theory of informed consent. The new knowledge questionnaire was shown to be a sensitive and effective instrument for measuring understanding of randomised clinical trials in the cancer setting, although it would benefit from further testing. The AVPI appears to reduce anxiety at the decision making time point and has been shown to be an acceptable medium for patients. This study confirms existing findings from studies assessing factors affecting decision making, with personal benefit and altruism being key motivating factors, and reasons for refusal being less clear. The need for further qualitative work in this area is highlighted to gain a deeper understanding of what is important to patients, in terms of why they refuse clinical trial participation. Implications for practice and further research Several implications for practice have been identified, including using AVPI as part of the standard information package for patients considering randomised cancer trials, and focussing on patient and staff education in this area. The knowledge questionnaire could be introduced to routine practice as a tool to determine patient understanding prior to decision making, allowing clinicians the opportunity to correct any misconceptions prior to consent. Further research focussing on AVPI specific to individual trials would be helpful, to determine if a more customised approach would be of benefit in terms of clinical trial recruitment. The importance of studying other aspects of the consent process such as the interaction between the clinician and the patient, in addition to more detailed exploration of the factors affecting patients’ decisions were highlighted.

Thesis (PhD)--Stellenbosch University, 2012. / ENGLISH ABSTRACT: Autonomy and informed consent are two interrelated concepts given much prominence in contemporary biomedical discourse. The word autonomy, from the Greek autos (self) and nomos (rule), originally referred to the self-governance of independent Hellenic states, but was extended to individuals during the time of the Enlightenment, most notably through the work of Immanuel Kant and John Stuart Mill. In healthcare, the autonomy model is grounded in the idea of the dignity of persons and the claim people have on each other to privacy, self-direction, the establishment of their own values and life plans based on information and reasoning, and the freedom to act on the results of their contemplation. Autonomy thus finds expression in the ethical and legal requirement of informed consent. Feminists and multiculturalists have however argued that since autonomy rests on the Enlightenment ideals of rationality, objectivity and independence, unconstrained by emotional and spiritual qualities, it serves to isolate the individual and thus fails to rectify the dehumanisation and depersonalisation of modern scientific medical practice. It only serves to exacerbate the problematic power-differential between doctor and patient. Medicine is a unique profession since it operates in a space where religion, morality, metaphysics, science and culture come together. It is a privileged space because health care providers assume responsibility for the care of their patients outside the usual moral space defined by equality and autonomy. Patients necessarily relinquish some of their autonomy and power to experts and autonomy thus cannot account for the moral calling that epitomizes and defines medicine. Recognition of the dependence of patients need not be viewed negatively as a lack of autonomy or incompetence, but could rather reinforce the understanding of our shared human vulnerability and that we are all ultimately patients. There is however no need to abandon the concept of autonomy altogether. A world without autonomy is unconceivable. When we recognise how the concept functions in the modern world as a social construct, we can harness its positive properties to create a new form of identity. We can utilise the possibility of self-stylization embedded in autonomy to fashion ourselves into responsible moral agents that are responsive not only to ourselves, but also to others, whether in our own species or in that of another. Responsible agency depends on mature deliberators that are mindful of the necessary diversity of the moral life and the complex nature of the moral subject. I thus argue that the development of modern individualism should not be rejected altogether, since we cannot return to some pre-modern sense of community, or transcend it altogether in some postmodern deconstruction of the self. We also do not need to search for a different word to supplant the concept of autonomy in moral life. What we rather need is a different attitude of being in the world; an attitude that strives for holism, not only of the self, but also of the moral community. We can only be whole if we acknowledge and embrace our interdependence as social and moral beings, as Homo moralis. / AFRIKAANSE OPSOMMING: Outonomie en ingeligte toestemming is twee nou verwante konsepte wat beide prominensie in moderne bioetiese diskoers verwerf het. Die woord outonomie, van die Grieks autos (self) en nomos (reël), het oorspronklik verwys na die selfbestuur van onafhanklike Griekse state, maar is in die tyd van die Verligting uitgebrei om ook na individue te verwys, grotendeels deur die werk van Immanuel Kant en John Stuart Mill. In medisyne is die outonomie model gegrond op die idee van die waardigheid van die persoon en die beroep wat mense op mekaar het tot privaatheid, selfbepaling, die daarstelling van hulle eie waardesisteem en lewensplan, gebasseer op inligting en redenasie, en die vryheid om op die uitkoms van sulke redenasie te reageer. Outonomie word dus vergestalt in die etiese en wetlike bepaling van ingeligte toestemming. Feministe en multikulturele denkers beweer egter dat, siende outonomie gebasseer is op die Verligting ideale van rasionaliteit, objektiwiteit en onafhanklikheid, sonder die nodige begrensing deur emosionele en spirituele kwaliteite, dit die individu noodsaaklik isoleer en dus nie die dehumanisering en depersonalisering van moderne wetenskaplike mediese praktyk teenwerk nie. As sulks, vererger dit dus die problematiese magsverskil tussen die dokter en pasiënt. Die beroep van medisyne is ‘n unieke professie aangesien dit werksaam is in die sfeer waar geloof, moraliteit, metafisika, wetenskap en kultuur bymekaar kom. Dit is ‘n bevoorregde spasie aangesien gesondheidswerkers verantwoordelikheid vir die sorg van hulle pasiënte aanvaar buite die gewone morele spasie wat deur gelykheid en outonomie gedefinieer word. Pasiënte moet noodgedwonge van hulle outonomie en mag aan deskundiges afstaan en outonomie kan dus nie genoegsaam die morele roeping wat medisyne saamvat en definieer, vasvang nie. Bewustheid van die afhanklikheid van pasiënte hoef egter nie in ‘n negatiewe lig, as gebrek aan outonomie of onbevoegtheid, beskou te word nie, maar moet eerder die begrip van ons gedeelde menslike kwesbaarheid en die wete dat ons almal uiteindelik pasiënte is, versterk. Dit is verder nie nodig om die konsep van outonomie heeltemal te verwerp nie. ‘n Wêreld sonder outonomie is ondenkbaar. Wanneer ons bewus word van hoe die konsep in die moderne wêreld as ‘n sosiale konstruk funksioneer, kan ons die positiewe aspekte daarvan inspan om ‘n nuwe identiteit te bewerkstellig. Ons kan die moontlikheid van self-stilering, ingesluit in outonomie, gebruik om onsself in verantwoordelike morele agente te omskep sodat ons nie slegs teenoor onsself verantwoordelik is nie, maar ook teenoor ander, hetsy in ons eie spesie of in ‘n ander. Verantwoordelike agentskap is afhanklik van volwasse denkers wat gedagtig is aan die noodsaaklike diversiteit van die morele lewe en die komplekse aard van die morele subjek. Ek voer dus aan dat die ontwikkeling van moderne individualisme nie volstrek verwerp moet word nie, siende dat ons nie na ‘n tipe premoderne vorm van gemeenskap kan terugkeer, of dit oortref deur ‘n postmoderne dekonstruksie van die self nie. Ons het verder ook nie ‘n nuwe woord nodig om die konsep van outonomie in die morele lewe mee te vervang nie. Ons het eerder ‘n ander instelling van ons menswees in die wêreld nodig; ‘n instelling wat streef na volkomendheid, nie net van onsself nie, maar ook van die morele gemeenskap. Ons kan slegs volkome wees wanneer ons ons interafhanklikheid as sosiale en morele entiteite, as Homo moralis, erken en aangryp.

Different people can have different cultural interpretations of the person—atomic versus embedded—and these may affect health care decision-making. This study examines both the ethics of variations in personhood as well as their implications for the doctrine of informed consent and the duty to warn of genetic disease risk. It argues that variations in personhood are consistent with the ethics of the Principle of Autonomy and the Canadian stand on informed consent, though autonomy and consent play out differently in practice on the two models. Also as a result of different interpretations of the person, the duty to warn of hereditary risk is found to be relevant to the atomic conception but unnecessary among embedded individuals. / Graduate / 0422 / 0566 / 0326 / pkdheri@uvic.ca

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...