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No / This article explores the concept of internationally acceptable codes of ethics within the context of an Egyptian nurse’s PhD studies. Theoretical work, including gaining ethical approval for the project, took place in the UK, while the data collection phase of the study was done in Egypt. This highlighted areas where the Arab Muslim interpretation of some ethical principles, especially around the issue of gaining informed consent, differed from that currently accepted in British research ethics. The authors argue that it may not be possible, or even desirable, to standardize codes of ethics globally in areas such as academic research. Ethical principles develop from a unique mix of culture and religion. It may be more important to develop cultural competence that includes the ability to understand and respect the way in which ethical principles are interpreted by various societies.

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.

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.

A Autorização por Representação é utilizada quando uma pessoa está impossibilitada - ou não habilitada legalmente - para consentir com um determinado procedimento assistencial ou com a participação em um projeto de pesquisa. Um dos diversos fatores que podem influenciar o representante durante o processo de autorização é a idade da pessoa representada. Com o objetivo de avaliar a diversidade no processo de obtenção da Autorização por Representação em situações assistenciais e de pesquisa em crianças e idosos foram desenvolvidos dois estudos. O primeiro foi um estudo transversal que visou avaliar o Desenvolvimento Psicológicomoral como um indicativo da capacidade para consentir em uma amostra de adolescentes e idosos. Não houve diferença entre o grupo de adolescentes e o de idosos em relação ao Desenvolvimento Psicológico-moral. O segundo estudo comparou o processo de obtenção da Autorização por Representação quanto ao grupo etário dos representados e a situação assistencial ou de pesquisa, através de uma simulação de um processo de autorização por representação. Os instrumentos utilizados foram Termos de Consentimento fictícios, compreendendo situações de assistência e pesquisa clínica em crianças e idosos. Do total de participantes, 97,0% responderam que autorizariam a realização do procedimento assistencial, 81,5% deles lembravam dos riscos do procedimento descritos no Termo de Consentimento e 78,0% lembravam dos benefícios. Em relação à participação em pesquisa, 23,5% dos entrevistados já haviam participado de projetos de pesquisa, sendo que 61,1% autorizariam a participação de seu familiar representado em um projeto de pesquisa. O fato de o maior índice de Autorizações por Representação corresponder ao procedimento assistencial provavelmente seja em razão da assistência representar uma necessidade e a pesquisa uma possibilidade. Quanto aos participantes lembrarem mais dos benefícios do que dos riscos provavelmente seja porque os benefícios vislumbrariam uma possibilidade de melhora da situação clínica em que supostamente o familiar encontrava-se. / Consent by proxy is obtained when a person is unable or legally unauthorized to provide consent for the performance of a medical procedure or participation in a research project. One of the several factors that may affect proxies during the consent process is the age of the person that they represent. The same procedure may be authorized for the elderly but not for a child, or vice-versa. A better understanding of the variables that make up the complex process of obtaining consent by proxy contributes to improving the management of these situations by the involved professionals. Two studies were conducted in order to evaluate several variables of the process of obtaining consent by proxy for medical care or clinical research involving children and the elderly. The first was a cross-sectional study to evaluate moral development as a marker of the competence to provide consent in a sample of adolescents and elderly people using a specific instrument. No differences were found in moral development between the groups of adolescents and elderly people according to the references used in the study. The second study compared the process of obtaining consent by proxy for medical care or clinical research in different age groups. The study was a simulation of the process of obtaining consent by proxy. The instruments were simulated consent terms for medical care or participation in research involving children or the elderly. Of all participants, 97.0% would authorize the medical procedure, 81.5% recalled the risks of the procedure described in the consent term, and 78.0% recalled its benefits. The analysis of participation in research showed that 23.5% of the respondents had already participated in research projects and 61.1% would provide consent for the participation of a family member in a research project. Medical procedures were mostly consented by proxies, which may be explained by the fact that medical assistance is a need, whereas research remains as a possibility. Participants recalled more benefits than risks, which may be assigned to the fact that benefits would indicate a possibility of clinical improvement of the condition that was simulated for their family member.

A Autorização por Representação é utilizada quando uma pessoa está impossibilitada - ou não habilitada legalmente - para consentir com um determinado procedimento assistencial ou com a participação em um projeto de pesquisa. Um dos diversos fatores que podem influenciar o representante durante o processo de autorização é a idade da pessoa representada. Com o objetivo de avaliar a diversidade no processo de obtenção da Autorização por Representação em situações assistenciais e de pesquisa em crianças e idosos foram desenvolvidos dois estudos. O primeiro foi um estudo transversal que visou avaliar o Desenvolvimento Psicológicomoral como um indicativo da capacidade para consentir em uma amostra de adolescentes e idosos. Não houve diferença entre o grupo de adolescentes e o de idosos em relação ao Desenvolvimento Psicológico-moral. O segundo estudo comparou o processo de obtenção da Autorização por Representação quanto ao grupo etário dos representados e a situação assistencial ou de pesquisa, através de uma simulação de um processo de autorização por representação. Os instrumentos utilizados foram Termos de Consentimento fictícios, compreendendo situações de assistência e pesquisa clínica em crianças e idosos. Do total de participantes, 97,0% responderam que autorizariam a realização do procedimento assistencial, 81,5% deles lembravam dos riscos do procedimento descritos no Termo de Consentimento e 78,0% lembravam dos benefícios. Em relação à participação em pesquisa, 23,5% dos entrevistados já haviam participado de projetos de pesquisa, sendo que 61,1% autorizariam a participação de seu familiar representado em um projeto de pesquisa. O fato de o maior índice de Autorizações por Representação corresponder ao procedimento assistencial provavelmente seja em razão da assistência representar uma necessidade e a pesquisa uma possibilidade. Quanto aos participantes lembrarem mais dos benefícios do que dos riscos provavelmente seja porque os benefícios vislumbrariam uma possibilidade de melhora da situação clínica em que supostamente o familiar encontrava-se. / Consent by proxy is obtained when a person is unable or legally unauthorized to provide consent for the performance of a medical procedure or participation in a research project. One of the several factors that may affect proxies during the consent process is the age of the person that they represent. The same procedure may be authorized for the elderly but not for a child, or vice-versa. A better understanding of the variables that make up the complex process of obtaining consent by proxy contributes to improving the management of these situations by the involved professionals. Two studies were conducted in order to evaluate several variables of the process of obtaining consent by proxy for medical care or clinical research involving children and the elderly. The first was a cross-sectional study to evaluate moral development as a marker of the competence to provide consent in a sample of adolescents and elderly people using a specific instrument. No differences were found in moral development between the groups of adolescents and elderly people according to the references used in the study. The second study compared the process of obtaining consent by proxy for medical care or clinical research in different age groups. The study was a simulation of the process of obtaining consent by proxy. The instruments were simulated consent terms for medical care or participation in research involving children or the elderly. Of all participants, 97.0% would authorize the medical procedure, 81.5% recalled the risks of the procedure described in the consent term, and 78.0% recalled its benefits. The analysis of participation in research showed that 23.5% of the respondents had already participated in research projects and 61.1% would provide consent for the participation of a family member in a research project. Medical procedures were mostly consented by proxies, which may be explained by the fact that medical assistance is a need, whereas research remains as a possibility. Participants recalled more benefits than risks, which may be assigned to the fact that benefits would indicate a possibility of clinical improvement of the condition that was simulated for their family member.

A Autorização por Representação é utilizada quando uma pessoa está impossibilitada - ou não habilitada legalmente - para consentir com um determinado procedimento assistencial ou com a participação em um projeto de pesquisa. Um dos diversos fatores que podem influenciar o representante durante o processo de autorização é a idade da pessoa representada. Com o objetivo de avaliar a diversidade no processo de obtenção da Autorização por Representação em situações assistenciais e de pesquisa em crianças e idosos foram desenvolvidos dois estudos. O primeiro foi um estudo transversal que visou avaliar o Desenvolvimento Psicológicomoral como um indicativo da capacidade para consentir em uma amostra de adolescentes e idosos. Não houve diferença entre o grupo de adolescentes e o de idosos em relação ao Desenvolvimento Psicológico-moral. O segundo estudo comparou o processo de obtenção da Autorização por Representação quanto ao grupo etário dos representados e a situação assistencial ou de pesquisa, através de uma simulação de um processo de autorização por representação. Os instrumentos utilizados foram Termos de Consentimento fictícios, compreendendo situações de assistência e pesquisa clínica em crianças e idosos. Do total de participantes, 97,0% responderam que autorizariam a realização do procedimento assistencial, 81,5% deles lembravam dos riscos do procedimento descritos no Termo de Consentimento e 78,0% lembravam dos benefícios. Em relação à participação em pesquisa, 23,5% dos entrevistados já haviam participado de projetos de pesquisa, sendo que 61,1% autorizariam a participação de seu familiar representado em um projeto de pesquisa. O fato de o maior índice de Autorizações por Representação corresponder ao procedimento assistencial provavelmente seja em razão da assistência representar uma necessidade e a pesquisa uma possibilidade. Quanto aos participantes lembrarem mais dos benefícios do que dos riscos provavelmente seja porque os benefícios vislumbrariam uma possibilidade de melhora da situação clínica em que supostamente o familiar encontrava-se. / Consent by proxy is obtained when a person is unable or legally unauthorized to provide consent for the performance of a medical procedure or participation in a research project. One of the several factors that may affect proxies during the consent process is the age of the person that they represent. The same procedure may be authorized for the elderly but not for a child, or vice-versa. A better understanding of the variables that make up the complex process of obtaining consent by proxy contributes to improving the management of these situations by the involved professionals. Two studies were conducted in order to evaluate several variables of the process of obtaining consent by proxy for medical care or clinical research involving children and the elderly. The first was a cross-sectional study to evaluate moral development as a marker of the competence to provide consent in a sample of adolescents and elderly people using a specific instrument. No differences were found in moral development between the groups of adolescents and elderly people according to the references used in the study. The second study compared the process of obtaining consent by proxy for medical care or clinical research in different age groups. The study was a simulation of the process of obtaining consent by proxy. The instruments were simulated consent terms for medical care or participation in research involving children or the elderly. Of all participants, 97.0% would authorize the medical procedure, 81.5% recalled the risks of the procedure described in the consent term, and 78.0% recalled its benefits. The analysis of participation in research showed that 23.5% of the respondents had already participated in research projects and 61.1% would provide consent for the participation of a family member in a research project. Medical procedures were mostly consented by proxies, which may be explained by the fact that medical assistance is a need, whereas research remains as a possibility. Participants recalled more benefits than risks, which may be assigned to the fact that benefits would indicate a possibility of clinical improvement of the condition that was simulated for their family member.