Dissertations / Theses: 'Informed consent form'

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Cai, Yinghong. "The legal rights in informed consent form for treatment in China." View the Table of Contents & Abstract, 2007. http://sunzi.lib.hku.hk/hkuto/record/B38478730.

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Cai, Yinghong, and 蔡映紅. "The legal rights in informed consent form for treatment in China." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2007. http://hub.hku.hk/bib/B39724347.

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Pithan, Livia Haygert. "O consentimento informado na assistência médica : uma análise jurídica orientada pela bioética." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2009. http://hdl.handle.net/10183/137774.

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Pour la bioéthique, le consentement éclairé est un processus dialogique qui, au travers d’un échange d’informations, garantit le respect du droit du patient à l’autodétermination. Or, il est souvent confondu avec le formulaire de consentement éclairé, document signé par le patient ou son responsable légal, à la demande du médecin ou de l’établissement hospitalier, reconnaissant que toutes les informations sur le traitement et ses risques lui ont été fournies. Cette thèse se propose de vérifier dans quelle mesure, pour ce qui est des soins médicaux, l’usage du « formulaire de consentement éclairé » sans ce processus communicatif dialogique dit de « consentement éclairé » suffit, en soi, à déclarer irrecevables les actions en responsabilité civile pour non respect ou manquement au respect du devoir d’expliquer les risques inhérents aux procédures diagnostiques et thérapeutiques. Notre méthode d’investigation s’appuie sur une révision bibliographique et une recherche documentaire des arrêts contenant l’expression « consentement éclairé » (ou un de ses équivalents). Elle examine 60 arrêts de cours de justice d’états brésiliens pour déterminer le profil des actions et vérifier leur résultat. Le test exact de Fisher a également été utilisé pour déterminer l’association entre les variables « utilisation ou non du formulaire » et « recevabilité ou non des demandes ». Il en ressort que, bien qu’aucune norme brésilienne ne réglemente les formes d’expression du consentement éclairé, un fondement juridique a surgi de l’association systématique de l’intitulé de l’Art. 5 de la Constitution fédérale, du Code civil, en particulier de ses Arts.11 à 21 qui protègent les droits de la personnalité, de l’Art. 6-III du code de la consommation, qui dispose des devoirs d’information et de transparence, et du code de déontologie médicale qui exige l’éclaircissement et le consentement préalables du patient ou de son responsable légal (Art. 22) et interdit toute limitation du droit du patient à disposer de lui-même et de son bien-être (Arts. 24 et 31). Les devoirs d’information des médecins intègrent donc le processus de consentement éclairé, dont la violation peut entraîner la responsabilité civile de ce professionnel, à condition qu’existent les présomptions de dommage au patient, de culpabilité du médecin et de rapport causal entre cette culpabilité et le dommage découlant de la violation du devoir d’information sans que rien ne justifie le manquement au devoir du docteur.
O consentimento informado é entendido, pela Bioética, como um processo dialógico que, por meio da troca de informações, garante o respeito à autodeterminação do paciente, sendo, porém, freqüentemente confundido com o Termo de Consentimento Informado, documento assinado pelo paciente ou seus familiares, a pedido do médico ou da instituição hospitalar, dando ciência de ter recebido informação pertinente ao tratamento e aos seus riscos. Esta tese tem como objetivo verificar em que medida o uso do “termo de consentimento informado”, na assistência médica, de forma desacompanhada do processo comunicativo dialógico chamado “consentimento informado” é de per si suficiente para afastar a procedência de demandas judiciais de responsabilidade civil por ausência ou deficiência do dever de informar riscos inerentes aos procedimentos diagnósticos e terapêuticos. Utilizou-se como método de pesquisa a revisão bibliográfica e a pesquisa documental em acórdãos que contém a expressão “consentimento informado”(ou equivalentes). A análise foi realizada sobre uma base de 60 acórdãos de Tribunais de Justiça estaduais para verificar o perfil e resultado das demandas. Também aplicou-se o Teste Exato de Fisher, para medir a associação entre variáveis “uso ou não do termo de consentimento” e “procedência ou improcedência das demandas”. Verificou-se que, embora não haja norma nacional que o regulamente as formas de expressão do consentimento informado, há fundamentação jurídica, decorrente da coligação sistemática entre o Art. 5º, caput, da Constituição Federal; o Código Civil, especialmente nos direitos de personalidade, entre os Arts.11 a 21 do Código Civil, que resguardam os Direitos de Personalidade; o Art. 6, III do Código de Defesa do Consumidor, relativo aos deveres de informação e transparência; e o Código de Ética Médica, que exige o esclarecimento e o consentimento prévios do paciente ou de seu responsável legal (Art. 22) e veda qualquer limitação ao exercício do direito do paciente de decidir livremente sobre sua pessoa ou seu bem-estar (Arts. 24 e 31). Os deveres informativos dos médicos integram o processo de consentimento informado e sua violação pode ter como conseqüência a responsabilidade civil do profissional, desde que verificados os pressupostos do dano ao paciente, da culpa do médico e do nexo causal entre a culpa e o dano decorrente da violação de dever informativo e não haja excludente ao dever.
According to Bioethics, informed consent is a dialogic process that, by means of information sharing, accords respect to patients’ self-determination. However, this is often confused with the Informed Consent Form, which is a document signed by patients and family members at the doctor’s or hospital administrator’s request, confirming that they have received information about the treatment and its risks. This thesis is aimed at checking to what extent the use of the “informed consent form” in medical assistance, unaccompanied by the dialogic communicative process called “informed consent”, is per se sufficient to prevent civil liability claims for absence of or deficiency in the duty to inform people about the risks inherent in diagnostic and therapeutic procedures. The adopted research method was bibliographical review and documental investigation into appellate decisions containing the expression “informed consent” (or equivalents). The analysis was conducted based on 60 appellate decisions reached by state Appellate Courts in order to examine the profile and result of claims Fisher's Exact Test was also administered to measure the association between the variables “use or non-use of the “consent form” and the “validity or invalidity of claims”. It was found that, although there are no national rules governing the forms of expression about informed consent, there are legal foundations arising from the systematic link among the head provision of Art. 5 of the Federal Constitution; the Civil Code, especially in reference to personality rights, Articles 11-21 of the Civil Code, which protect the Personality Rights; Art. 6, III of the Consumer Protection Code concerning information and transparence duties; and the Code of Medical Ethics, which requires the clarification and prior consent of the patient or his/her legal guardian (Art. 22) and forbids any limitation to the patient’s right to freely decide on his/her person or well-being (Articles 24 and 31). Doctors’ informative duties are an integral part of the informed consent process and violation thereof might result in the professional’s civil liability if harm to the patient, the doctor’s fault, and the causal relation between the fault and the harm resulting from violation of the informative duty are confirmed and if no duty exclusion mechanism exists.

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Mendonça, Louise Camargo de. "Processo de consentimento : recomendações para os pesquisadores com base nas vivências dos participantes de pesquisa clínica." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2018. http://hdl.handle.net/10183/181269.

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A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica.
Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

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Sakaguti, Nelson Massanobu. ""O conhecimento de usuários de serviços públicos de saúde envolvidos em pesquisas clínicas, sobre seus direitos"." Universidade de São Paulo, 2005. http://www.teses.usp.br/teses/disponiveis/23/23148/tde-06062005-155926/.

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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

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Scott, John. "Informed consent and respect for autonomy." Thesis, University of Sunderland, 2007. http://sure.sunderland.ac.uk/3561/.

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In this thesis I examine the medical concept of informed consent and the philosophical concept of autonomy in conjunction with the relationship between them. This examination is complicated because autonomy can refer to decisions or persons. Further autonomy may have instrumental or intrinsic value. These differences mean autonomy may be respected in different ways. This examination is further complicated because whilst a vast wealth of medical literature exists on informed consent and mentions autonomy, very little of this literature does more than mention autonomy. As a result of my examination I argue for the following. Firstly I argue the form of autonomy underlying informed consent should be personal autonomy and to respect autonomy means accepting autonomous decisions. Secondly I show in certain contexts a surrogate decision maker cannot make a decision on behalf of an incompetent patient that would be generally agreed to be in his best interests. I will argue in such contexts a patient’s decision should always be accepted as the concept of competence becomes detached from the concept of informed consent. Thirdly I show a patient may make an autonomous decision based only on understanding the purpose of the procedure he is consenting to. I will argue it follows a patient should not be required to understand details of the nature of the procedure he is consenting to for his consent to be accepted. Fourthly I argue an autonomous decision must be one an agent identifies with and has some persistence. I will show these conditions are satisfied by an autonomous agent’s absence of restlessness to change his decision Lastly I argue informed consent decisions should be linked to a patient’s ability to understand the risk involved in his decision and not directly linked to the degree of risk involved in his decision.

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Gamboa, Maryelle Moreira Lima. "Análise da frequência de submissão de um projeto de pesquisa aos comitês de ética e da aplicação do termo de consentimento de um estudo clínico cooperativo de oncologia pediátrica." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2012. http://hdl.handle.net/10183/55164.

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OBJETIVO: Analisar a frequência da submissão do protocolo de pesquisa aos Comitês de Ética em Pesquisa e da aplicação do Termo de Consentimento Livre e Esclarecido do projeto intitulado “Protocolo Brasileiro para o Tratamento de Pacientes com Tumores da Família de Sarcoma de Ewing”. MÉTODOS: Trata-se de estudo transversal retrospectivo. Através das fichas clínicas dos pacientes foi realizada uma análise do trâmite regulatório, bem como, do processo de obtenção do Termo de Consentimento Livre e Esclarecido de 180 pacientes de 16 instituições. RESULTADOS: Dez dos dezesseis centros submeteram o Protocolo ao Comitê de Ética em Pesquisa local. Em relação ao Termo de Consentimento Livre e Esclarecido, 161 dos 180 pacientes e/ou seus representantes legais consentiram e assinaram o Termo aplicado pelo pesquisador. Destes, 123 assinaram o Termo de Consentimento específico do protocolo e 38 assinaram o Termo de Consentimento institucional. Em relação à data da assinatura do consentimento, 141 dos 161 pacientes assinaram o Termo de Consentimento após receberem as informações referentes ao estudo clínico e antes de iniciar o tratamento. CONCLUSÃO: A maioria das instituições participantes apresenta uma estrutura adaptada ao assistencialismo e não estavam familiarizadas com aspectos éticos, legais e regulatórios que envolvem um projeto desta natureza.
OBJECTIVE: To analyze the frequency of submission of the research protocol to the Institutional Research Board and application of Informed Consent Form related to a clinical trial entitled “Treatment of Patients with Ewing Sarcoma Family of Tumors: A study of the Brazilian Cooperative Group”. METHODS: Retrospective cross-sectional study. Through patient records were performed an analysis of the regulatory proceeding and the signing of the Informed Consent Form by 180 patients from 16 institutions. RESULTS: Ten of the sixteen centers submitted the Protocol to the local Institutional Review Board. Regarding the Informed Consent Form, 161 of 180 patients and/or their legal representatives consented and signed the Form applied by the researcher. Of these, 123 signed the consent form specific to the protocol and 38 signed an institutional form. Regarding the date the consent form was signed, 141 of 161 patients signed it after receiving information about the trial and before starting treatment. CONCLUSION: Most of the participating institutions had a structure adapted to welfare and were not familiar with the ethical, legal and regulatory systems involved in a project like this.

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Stone, Tracey Jayne. "Rationality, informed consent and patient decision making for clinical trials." Thesis, University of Bristol, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.509761.

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ATWERE, PEARL. "Evaluation of Informed Consent Documents used in Critical Care Trials." Thesis, Université d'Ottawa / University of Ottawa, 2015. http://hdl.handle.net/10393/33356.

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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.

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Goldsmith, Lesley. "Informed consent for pharmacogenomic testing in people with a learning disability." Thesis, University of Plymouth, 2011. http://hdl.handle.net/10026.1/316.

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Informed consent for pharmacogenomic testing in people with a learning disability Background Advances in genomic healthcare will enable medication to be tailored to each individual’s needs, based on subtle genetic variations. This will result in individuals being asked to consent to genetic testing for this purpose. The recent political agenda for social change has emphasised the right of people with learning disabilities to have more autonomy and make their own decisions. There have also been significant changes in the way healthcare practitioners relate to their patients, with a shift away from paternalism towards shared decision-making. Research Aim The aims of the study were (1) to explore the information needs of people with mild to moderate learning disabilities with respect to pharmacogenomic tests and (2) to identify ways of facilitating informed consent. Methods An integrative literature review was conducted to identify research on informed consent to healthcare interventions in people with learning disabilities (Phase 1). Subsequent phases (Phases 2-4) of the study were conducted using an ethnographic approach. Phase 2 involved observation of six participants with learning disabilities undergoing a routine blood test consultation in general practice. This was followed by Phase 3, in which semi-structured interviews with 14 participants with learning disabilities were conducted. In Phase 4, three different methods were used: focus groups with carers (four paid carers, five family carers), an on-line bulletin board for healthcare professionals (five participants) and interviews with six key informants from the field of learning disability. Findings The data showed consent procedures were often inadequate and there was inconsistent knowledge of mental capacity law amongst health professionals. Provision of information to patients prior to a blood test was variable, but interviews with people with learning disabilities revealed the fact that this information may not be wanted by them. People with learning disabilities viewed pharmacogenomic tests as similar to other blood tests and would want access to them. The attitudes of paid carers and family carers differed in terms of decision-making opportunities for people with learning disabilities. Conclusions Healthcare practitioners, carers and people with learning disability need to be familiar with the principles of the Mental Capacity Act to facilitate valid consent in the healthcare context. Healthcare practitioners also need to be made aware of developments in pharmacogenomics if it is to become part of routine health care. Finally, this study demonstrated the value of qualitative research in exploring the knowledge and attitudes of people with learning disability.

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Nieuwkamp, Garry Anthony Aloysius, and res cand@acu edu au. "The Theory of Informed Consent in Medicine: problems and prospects for improvement." Australian Catholic University. School of Philosophy, 2007. http://dlibrary.acu.edu.au/digitaltheses/public/adt-acuvp166.22072008.

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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.

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Flanagan, Ellen Cecelia. "AN URBAN BIOETHICS APPROACH TO PARENTAL INFORMED CONSENT FOR PEDIATRIC CLINICAL RESEARCH." Master's thesis, Temple University Libraries, 2018. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/537038.

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Urban Bioethics
M.A.
In the current healthcare landscape, parents generally make decisions regarding whether or not their children are allowed to take part in clinical research, with the general assumption being that parents know what is best for children. Investigations have been conducted regarding what is likely to lead parents to consent or not consent to their child’s participation in a trial, but research plans seldom incorporate the consideration that not all parents come into the consent process with equal social, academic, and economic footing. Since the burden of the ultimate decision lies primarily on the parents, it is supremely important that they are capable of making a well-informed and thoughtful choice. Bioethical understanding of the influence of parental decisions in clinical research must consider demographic variables and how they may affect parents’ decisions to allow or disallow their child to participate in a clinical trial. Those differences could affect the consent process and have ramifications for the research findings, as research results are affected in numerous ways by which children do, and do not, participate in studies. This paper looks specifically at parents in the process of informed consent for pediatric research, taking into account several social determinants of health and how they affect who participates in research and how that affects research as a whole.
Temple University--Theses

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Sand, Kari. "Informed consent documents for cancer research : Textual and contextual factors of relevance for understanding." Doctoral thesis, Norges teknisk-naturvitenskapelige universitet, Institutt for kreftforskning og molekylær medisin, 2012. http://urn.kb.se/resolve?urn=urn:nbn:no:ntnu:diva-19797.

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Dersom pasienter eller friske personer er villige til å delta i medisinsk forskning, må de gi sitt informerte samtykke til denne deltakelsen. Informert samtykke innebærer at de har fått grundig informasjon om hva forskningen går ut på, og hva som er konsekvensene av å delta. Etter at de har mottatt muntlig og skriftlig informasjon, bekrefter pasientene at de er informert, og at de ønsker å delta i forskningen ved å signere en samtykkeerklæring. Den skriftlige informasjonen, pasientinformasjonsskrivet, er temaet for denne avhandlingen. Innholdet i slike skriv er regulert av internasjonale etiske retningslinjer for medisinsk forskning (hvorav den mest innflytelsesrike er Helsinkideklarasjonen utviklet av Verdens legeforening), nasjonalt lovverk og nasjonale og regionale retningslinjer, for eksempel fra regional komite for medisinsk og helsefaglig forskningsetikk (REK). REK skal også vurdere og godkjenne pasientinformasjonsskrivet før forskningsprosjektet kan starte. Målet med denne avhandlingen har vært å undersøke forhold som kan påvirke pasienters forståelse av pasientinformasjonsskriv, og hvordan tidligere forskning har målt pasienters forståelse av informasjonen de har fått i samtykkeprosessen. Kravene til hva pasientinformasjonsskriv skal inneholde er omfattende, og man kan spørre seg om skriv som etterfølger alle kravene, blir så kompliserte at det blir vanskelig for leserne å sortere ut hva som er det viktigste budskapet. Selv om reguleringene av innhold er laget i pasientenes interesse, så er det tenkelig at mange av innholdselementene ikke er relevante for leserne. Gjennom å intervjue lungekreftpasienter fant vi at pasientene var mest opptatt av praktisk informasjon om sin egen sykdom og behandling, og at kontekstuelle aspekter ved lesesituasjonen gjorde det vanskeligere å forstå skrivene. Pasientene var mindre opptatt av formell informasjonen om forskningsprosessen. De fleste var likevel klar over det overordna målet med forskning, dvs. å generere ny kunnskap som kan komme framtidige pasienter til gode. For å undersøke hvordan pasientinformasjonsskriv er skrevet, og om de er leservennlige ble det foretatt to dokumentanalyser. Den første var en undersøkelse av lengde og antall innholdselementer i 87 pasientinformasjonsskriv godkjent for bruk i studier mellom 1985 og 2007. Analysene viste at antall ord var nesten tredoblet i løpet av denne perioden, og at antall innholdselementer var mer en fordoblet. Antallet innholdselementer angående såkalte formaliteter, dvs. juridisk informasjon, finansiering, lagring av innsamlet materiale, erstatningsordninger, hadde økt mest. Problemer med å forstå et informasjonsskriv kan også skyldes skrivets lesbarhet, som i tidligere forskning har vært analysert vha. kvantitative lesbarhetsformler. I tillegg kan faktorer som tekststruktur, overskrifter og ordvalg være relevante for om skrivene er lesbare eller funksjonelle for de som faktisk skal lese og forstå dem. I en oppfølgingsstudie ble de ti eldste og de ti nyeste pasientinformasjonsskrivene av utvalget i ovennevnte studie analysert med mål om å finne ut hvilke tekstuelle faktorer som bidrar til funksjonelle pasientinformasjonsskriv og å sammenligne gamle og nye skriv i så måte. Resultatene viste at nye, lange informasjonsskriv ikke nødvendigvis var mindre funksjonelle enn de kortere, gamle skrivene. Nye informasjonsskriv var for eksempel mer rettet mot hovedtemaet i informasjonen (forskningen) og den viktigste handlingen som gjøres i skrivet (å spørre leseren om han er villig til å delta). Gamle informasjonsskriv var mer orientert mot pasientens sykdom og behandling, noe som ikke er funksjonelt som hovedtema i en tekst om medisinsk forskning. I Helsinkideklarasjonen påpekes det at legen har ansvar for at pasienten forstår informasjonen, men det utdypes ikke noe videre hva det egentlig innebærer å forstå informasjon om medisinsk forskning. En systematisk review av tidligere studier om forståelse ble gjennomført for å vise hvordan begrepet forståelse er definert og målt. Resultatene viste at tidligere studier ikke er basert på en felles definisjon av forståelse, at de fleste målemetodene er utviklet for hver enkelt studie, og at målemetodene er forskjellige med tanke på antall spørsmål og innholdet de dekker. Dette gjør det vanskelig å sammenligne tidligere studier for å finne ut hva som kjennetegner effektiv informasjon til forskningsdeltakere. Oppsummert viser studiene i denne avhandlingen at norske pasientinformasjonsskriv har blitt lengre og lengre de siste årene, og at de inneholder flere innholdselementer, men at de likevel ikke nødvendigvis blitt mindre leservennlige. Intervjuanalyser tydet på at innholdet i skrivene ikke var tilpasset det som pasientene var mest opptatt av. I forskningsfeltet mangler det dessuten standardmetoder for å måle pasienters forståelse av informasjon, samt en felles definisjon ‘forståelse’.
Participation in medical research must be completely voluntary, and a patient's or healthy volunteers’ decision to take part must be documented through an informed consent. Informed consent is the process in which the patient makes his/her decision about whether to participate or not based upon thorough information about the procedures of the research and the consequences of participating. After receiving oral and written information, the patients confirm that they are informed and that they are willing to participate in research by signing a consent form. The written information, the informed consent document (ICD), is the topic of this thesis. The contents of the ICDs are regulated by international ethical guidelines for medical research (the Declaration of Helsinki, developed by the World Medical Association, is the most important), national laws, and national and regional regulations, for instance developed by the Regional Committees for Medical and Health Research Ethics (REC) in Norway. An ICD is approved by REC before the actual reader receives it. The overall aim of this thesis has been to investigate factors that can affect patients’ understanding of informed consent documents, and how previous research has assessed patients’ understanding of consent information. The regulations regarding mandatory content of ICDs are extensive, and one might consider whether ICDs written according to the guidelines contain so much information that it becomes difficult for the reader to grasp the overall message. Even if lists of mandatory content in ICDs have been developed in the patient’s best interest, it is conceivable that several of the content elements are of no particular interest for the patients. Through semistructured interviews, we found that lung cancer patients were mostly concerned with information about their own treatment and prognoses, and that aspects surrounding the ICD reading situation might hamper the patient’s ability to understand it. The patients were less concerned with formal information about the research process. In order to investigate how the Norwegian ICDs are written, and whether they are patientoriented, two document analyses were performed. In the first one, the length and content of a sample of 87 ICDs approved for use in research from 1987 to 2007 were investigated. The results showed that there had been a threefold increase in the number of words in ICDs during this period, and that the number of content elements was more than doubled. The presence of formal content elements (juridical information, financing, insurance and storage of data) increased the most. However, difficulties with the understanding of ICDs might also be caused by the readability of the documents, which previously has been analysed by quantitative readability formulas. Additionally, aspects such as text structure, headings and vocabulary are possible contributing factors for making documents readable or functional for the actual audience. In order to investigate the functional readability of ICDs, the ten oldest and the ten newest ICDs from the above-mentioned study were analysed in order to find out which textual characteristics might contribute to making ICDs readable, and to compare the readability in old and new ICDs. The findings indicate that even though newer ICDs are longer than the old ones, they are not necessarily less readable. New ICDs were, for instance, more oriented towards the main topic of an ICD (the research) and the main function (to ask the patient to take part). The older ICDs were more oriented towards the patient’s disease and treatment, which are not functional as main topics in an ICD for medical research. The Declaration of Helsinki states that the physician must ensure that the potential research subject has understood the information. However, no further instructions are given to clarify what this means and how it should be done. A systematic review was conducted on the concept of understanding and how patients’ understanding of research information has been measured. The findings confirmed that a definition of the term “understanding” is lacking, and there is a large degree of variation between the measuring instruments, for instance concerning the number of questions and the content they cover. This variation hinders comparisons of findings, thus making it impossible to improve ICDs based upon the results of these empirical studies. In summary, the studies in this thesis showed that Norwegian ICDs had become increasingly longer during the last years, and that they contain more information, bur that newer ICDs not necessarily less readable than old ones. The interview analysis suggested that the content in the ICDs were not adjusted to the patients’ preferences. In the field of research, there is also a lack of standardized methods for measuring patients’ understanding of information and a common definition of the term ‘understanding’.

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Gyi, Rebecca Therese. "Perspectives of experienced parents about the informed consent process for cancer patient trials." Thesis, Boston University, 2012. https://hdl.handle.net/2144/12407.

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Thesis (M.A.)--Boston University PLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you.
Background: Soon after receiving a cancer diagnosis, parents are often asked to consider enrolling their child in a clinical study. It has been shown, however, that this understandably emotional and upsetting time may serve to limit and skew parents' decision-making capabilities and comprehension of the study during the informed consent process. In order for parents to be adequately prepared for what they and their children will experience when deciding to join a study, it is important to understand from parents' perspectives which aspects of the informed consent process are the most meaningful and influential. Objective: This pilot study aims to better understand how well parents' experiences of their child's cancer clinical trial matched the expectations they formed from the informed consent process before enrolling their child in a study. Methods: To gain their perspectives and insights of the informed consent process, 12 parents of children who have recently completed active treatment on a cancer clinical trial participated in a semi-structured interview that asked them to reflect on their decisions and how their experiences in the study compared to the initial expectations they had before joining. Interviews were digitally-recorded, transcribed and coded according to how well experiences matched expectations in four categories: procedures, benefits of treatment, toxicity of treatment and relationships with medical staff. Parents were also asked to complete a Decision Regret Scale and two sociodemographic questionnaires. Results: Most parents reported that being in a study had little to no effect on their experiences, the treatment their child received, and their interactions with medical staff. When asked how their experiences matched their expectations, parents reported the most satisfaction with the accessibility and communication of the medical team, what to expect in terms of benefits of treatment, and the importance of the side effects discussed in the consent form. The most frequently-cited suggestion for improvement was better preparation for follow-up care and planning once child has completed active treatment on the study. Conclusions: The results of the current study show that parents who decide to enroll their child in a cancer clinical trial are better equipped to handle the experiences ahead when they have established realistic expectations of treatment during the informed consent process.

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Taliaferro, Andrew S. "Introducing iPad-Based Multimedia Education During Informed Consent for Image-Guided Breast Procedures." Thesis, Harvard University, 2017. http://nrs.harvard.edu/urn-3:HUL.InstRepos:32676113.

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Purpose: To determine whether multimedia education during informed consent for image-guided breast procedures improves patient understanding and experience. Methods: 240 women having ultrasound-guided or stereotactic breast biopsy at Beth Israel Deaconess Medical Center were included in the study. Each was randomized to one of four study arms (A-D). Arm A consisted of standard paper informed consent by the radiology resident, fellow, nurse practitioner, or breast imaging attending. Arm B added informed consent on an iPad. Arm C added real-time review of the patient’s breast imaging. Arm D consisted of a prototype iPad application in which the patient watched an educational video discussing the standard informed consent followed by iPad consent. Objective understanding was assessed for all patients using the MacArthur Competency Assessment Tool for Treatment (MacCAT-T). Subjective patient experience, including anxiety, provider trust, and user experience with the multimedia was assessed through pre-consent, peri-consent, and post-procedure surveys. One-way ANOVA, Pearson’s r correlation, and chi-squared analysis was performed to evaluate for a difference between the 4 study arms. Results: The mean age of study participants was 53.3 years ( 12.4 years SD). The study population to date was 59.6% White, 17.5% Black, 7.5% Hispanic, 12.1% Asian, 0.4% Pacific Islander, 1.7% Biracial, and 1.3% Other. 78.3% of patients spoke English and did not use an interpreter, and 21.7% of patients required an interpreter. There was no significant difference between study arms in MacCAT-T understanding summary rating among all patients (P = 0.19). Among all patients, patients in arm D were more likely to agree that the video improved their understanding of procedure steps than those in the imaging arm reported about the imaging presentation (2 = 9.8, P=0.04). Non-White patients in arm C reported improved subjective understanding (9.8 0.7 SD) than those in arm B (9.0 1.6 SD, P = 0.05). Non-White patients in arm C also reported improved overall experience (9.8 0.5 SD) compared to those in arm B (9.2 0.9 SD, P = 0.02). Non-English-speaking patients in arm C reported improved post-procedure comfort with the provider who performed the procedure (9.9 0.6 SD vs. 8.8 1.7 SD, P = 0.04) and overall experience (9.9 0.3 SD vs. 9.0 0.9 SD P < 0.01) than those in arm B. Non-White patients in arm B experienced increased anxiety between the pre-consent and peri-consent surveys (0.6 0.9 SD) as compared to those in arm A whose anxiety decreased between those two points in time (-0.2 1.1 SD, P = 0.03). Conclusions: Viewing an informational procedure video detailing the benefits, risks, alternatives and steps of the procedure has no effect on objective patient understanding, but significantly improves subjective understanding of the steps of the procedure among all patients and overall patient experience among non-White patients. Review of imaging as part of the consent process significantly improves subjective understanding among non-White patients, as well as post-procedure comfort with the provider who performed the procedure and overall experience among non-English-speaking patients. Future studies should evaluate the utility of the informational procedure video during the informed consent process for image-guided breast procedures in patients who speak languages other than English.

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Moore, Allison Louise. "Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?" Master's thesis, Faculty of Health Sciences, 2021. http://hdl.handle.net/11427/33851.

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Purpose To assess patient satisfaction with the use of Portable Video Media (PVM) for the purpose of taking informed consent for common urological outpatient procedures performed under local anaesthesia. Methods Patients undergoing the following procedures were approached for recruitment: flexible cystoscopy with or without biopsy, transrectal ultrasound-guided prostate biopsy or flexible cystoscopy with insertion or removal of a ureteric stent. Audio-visual media were developed for each procedure, with each script translated from English into isiXhosa and Afrikaans. The study involved a cross-over for each patient between Standard Verbal Consent (SVC) and PVM consent, with each patient randomised to start with SVC or PVM consent. Each of these consent-arms were assessed via a questionnaire. Results 60 patients completed participation, with PVM as the first exposure for 28 patients and 32 patients receiving SVC as their first arm of the study. When comparing the overall satisfaction between SVC and PVM consent (the total scores out of 18 for the questionnaire), patients scored significantly higher for PVM consent (M = 16.3 ± 2.4) compared to SVC (M = 15.4 ± 2.9) (p = 0.002). 92% of the total patient sample preferred PVM consent. Conclusion PVM proved superior to SVC in improving satisfaction in the consent process for common outpatient urological procedures performed under local anaesthesia.

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Leopeng, Makiti Thelma. "Translations of informed consent documents for clinical trials in South Africa: are they readable?" Master's thesis, Faculty of Health Sciences, 2019. http://hdl.handle.net/11427/31021.

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1. Introduction: Obtaining Informed consent is an ethical prerequisite for enrollment in clinical research. There is a perception that Informed consent documents used in biomedical research are lengthy, overly complex and above the reading capability of typical research participants. In South Africa, ethical committees regulating research on human participants (HRECs) are mandated by the Department of Health’s National Health Research Ethics Council’s (NHREC) guidelines to ensure that researchers have made special considerations for vulnerable groups when conducting research. This includes considerations made for populations with low literacy. For example, the Standard Operating Procedure (SOP) of the University of Cape Town’s Human Research Ethics Committee (UCTHREC), requires that the language used in Informed consent documents should be directed at a reading level of grade 6 to 8 and that common, everyday words should be used rather than complex language syntax. The HREC expects researchers to translate the approved English version documents into local languages such as isiXhosa and Afrikaans. Since ethics committee focus approval on the English language consent documents and only acknowledge translated versions, a potential gap in this process is whether the translated versions meet the same required readability levels. This study aims to investigate whether translated versions of English language informed consent documents used at a single busy clinical research site are readable and meet the readability levels specified by UCTHREC. 2. Methodology: A quantitative descriptive statistical design was used to explore readability levels of informed consent documents used at a single clinical research facility based in a semi-rural community. Informed consent documents approved by UCTHREC over the past thirteen years (2004 to 2017) that met the inclusion criteria were analysed for readability. The LIX readability test tool was used to calculate readability scores and the levels of reading difficulty. These scores were then matched to a grade level conversion chart to determine the equivalent number of education years required to be able to easily understand the information. Readability levels were determined for isiXhosa and Afrikaans translations of the documents and compared to the levels of the English document. 3. Results: The results indicate that informed consent documents used at this single clinical research facility, independent of language type, are difficult to read. A total of 259 sub-sections of informed consent documents from 10 different studies were analysed. The analysis showed that informed consent documents were classified as “very difficult to read” according to the LIX readability tool in a large proportion of English, isiXhosa and Afrikaans languages: 41 (16%), 255 (98%), and 85 (33%) of informed consent sections respectively. Of all the subsections of English, isiXhosa and Afrikaans documents respectively, 98 (38%), 0 (0%) and 126 (49%) were classified as “difficult to read”, while 79 (31%), 3 (1%) and 38 (15%) were found to have an “average” readability level. Twenty eight (11%), 1 (0%) and 10 (4%) were found to be “easy to read” and 13 (5%), 0 (0%) and 0 (0%) had a “very easy” readability level. The mean LIX readability scores across English, isiXhosa, and Afrikaans languages were respectively 42.27 (95% CI 41.20 – 43.34) corresponding to a readability level of “average”, 74.64 (95% CI 73.79-75.49), corresponding to “very difficult to read” and 46.73 (95% CI 45.66-47.8) “difficult to read”. These findings suggest a high level of difficulty in reading of the text in the Informed consent documents. 4. Conclusion: Translations of Informed consent documents used at a single busy clinical research site are difficult to read and are written at high school to tertiary reading level. These reading levels are above the recommended level prescribed by the site’s research ethics committee (UCTHREC). Local ethics committees should employ more stringent guidelines and checks to ensure readability of translated informed consent documents. Researchers and Sponsors should include readability outcomes in the design and with submissions of new protocols.

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Afolabi, M. O. "Evaluation of an alternative informed consent procedure for clinical trials conducted in The Gambia." Thesis, London School of Hygiene and Tropical Medicine (University of London), 2015. http://researchonline.lshtm.ac.uk/2124337/.

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Background: Comprehension of informed consent poses greater challenges to clinical trial participants in The Gambia because of low literacy and absence of standardised formats for writing the local languages. This thesis reports the development and evaluation of a locally developed informed consent tool that addresses these challenges. Objectives: 1. Develop and validate an audio digitised tool for assessment of comprehension of informed consent. 2. Develop a multimedia consent tool for Gambian research participants. 3. Evaluate acceptability and ease of use of the multimedia tool. 4. Assess the effectiveness of the multimedia tool compared to ‘standard’ consent among participants in a clinical trial. Methods: A 34-item questionnaire was developed and audio-recorded in three major Gambian languages. This was digitised and validated among clinical trial participants in Gambian urban and rural areas. The informed consent document of a malaria drug trial was developed into a multimedia tool which integrated video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the tool were assessed using quantitative and qualitative methods. Participants in the drug trial were randomised to either receive consent information through the multimedia tool or ‘standard’ procedure. Participant comprehension was assessed using the digitised questionnaire at baseline and follow-up visits. Results: The questionnaire was deemed to be valid and reliable (Cronbach’s alpha: 0.73- 0.79). Majority of the participants (70%) reported that the multimedia tool was clear and easy to understand. Participants in the intervention arm had significantly higher comprehension scores than those in the control arm at baseline and follow-up visits. Higher comprehension scores were associated with being a male participant (p=0.03), resident in a peri-urban area (p=0.02) and having basic formal education (p=0.005). Male participants (OR = 0.29, 95% CI: 0.12-0.70, p=0.006) and living in a peri-urban area (OR= 0.33, 95% CI: 0.13-0.82, p=0.017) were independent predictors of comprehension. Survival analysis showed that participants in the intervention arm took longer time to drop to 50% of the baseline comprehension scores than those in the control arm (hazard ratio=0.22, 95% CI: 0.16-0.31). Conclusions: A customised multimedia tool was more effective in delivering consent information and sustaining participant comprehension than ‘standard’ consent procedure. Further research is needed to compare the tool with conventional consent method in other sub-Saharan Africa settings.

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Roux, Paul. "Informed consent for voluntary counselling and testing for HIV infection in South African mothers and children: An assessment of burdens and consequences and an argument for a modification in the process of informed consent." Master's thesis, University of Cape Town, 2001. http://hdl.handle.net/11427/18412.

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The HIV / AIDS epidemic is devastating Africa. The continent lacks the material resources to treat infected persons or to support those affected by the epidemic. One great resource in Africa is the cohesive strength of families. Because of a fear of stigma, HIV infected persons tend not to disclose their diagnosis to their families. This non-disclosure perpetuates stigma, because ordinary people do not discover that their own family may be affected by the epidemic. Non-disclosure also results in the loss of specific family support to infected individuals and the loss of general family support as a national resource. The standard method of taking informed consent prior to HIV testing of pregnant mothers has the effect of enhancing non-disclosure, because of its inherent focus on the patient as an isolated, autonomous decision maker. This dissertation advances the thesis that an alteration in the process of informed consent, to involve the family in deliberation prior to consent, will facilitate disclosure of an HIV-positive diagnosis to the family. Disclosure will have the positive effects firstly of giving the mother access to the emotional support of her family and secondly of serving to educate the family, and through the family society as a whole, that ordinary, virtuous women can be infected with HIV.

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Lasseter, Gemma Michelle. "Consent study : assessing the public's willingness to provide informed consent for their identifiable general practice medical records to be accessed for different research purposes." Thesis, University of Bristol, 2016. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.702735.

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Objectives: Patient involvement in primary care research is often hindered by confidentiality concerns regarding the use of their identifiable medical records. Consequently there is no universal 'pre-consent' process in England, whereby patients provide prior informed consent for their identifiable data to be accessed for different research purposes. This mixed-methods two-phase study investigated patients' opinions about this proposed 'pre-consent' process and the effectiveness of different invitation methods. Methods: Phase 1 used cognitive and semi-structured interview methods to optimise recruitment documents for, and ascertain participants' attitudes towards, providing an informed consent decision for the 'pre-consent' process. Phase 2 tested the feasibility of different recruitment documents ('standard' and 'modified') and invitation methods (postal, consultation and new) to determine the most effective in terms of allowing patients the opportunity to provide an informed consent decision. Results: Phase 1: Readability of the 'standard' recruitment documents impacted on participants' abilities to provide consent decisions, consequently a 'modified' version was created using participant feedback. Opinions about the 'pre-consent' process were chiefly affected by an individual's personal attitudes; key findings were 'data security' concerns and 'public benefit' motives. Phase 2: Recruitment documents affected response rates, with patients that received 'standard' documents 43% less likely to re~pond than those receiving the 'modified' documents. Postal, consultation and new invitation methods biased the types of patients invited, the number and types of patients responding, and the consent levels provided. Of the 2550 patients invited to participate in the 'pre-consent' process, only 30% (n=767/2550) responded, undermining the feasibility of this process. Discussion: The 'pre-consent' process seems currently unfeasible. However, engaging with the public to identify the most effective recruitment documents, invitation methods and consent options could streamline research in primary care. These approaches, employed on a study-by-study basis, would ensure primary care research remains cost-effective and representative of the general population.

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Fitzgerald, Rhian. "The reporting of ethical approval and informed consent for clinical trials in four major orthodontic journals." Thesis, University of Liverpool, 2012. http://livrepository.liverpool.ac.uk/9055/.

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Background: All research involving human participants should have ethical approval and informed consent. There is no recent evidence on the incidence of reporting of compliance with these ethical criteria in orthodontic journals, nor is there evidence on which factors predict the compliance of Randomised Controlled Trials (RCTs) with ethical approval and informed consent. Aims: This study aimed to: • Assess the number of Randomised Controlled Trials and Controlled Clinical Trials (CCTs) published in the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Orthodontic Journal and Journal of Orthodontics (formerly British Journal of Orthodontics) between 1st January 2001 and 31st December 2010. • Determine the number of these papers which recorded having obtained ethical approval and informed consent. • Determine the number of authors, number of centres, location, involvement of a statistician, year of publication and the presence of “random*” in either the title or abstract or body of the RCTs. • Determine whether the factors above influenced an RCT’s likelihood of having recorded ethical approval and informed consent. • Determine the sensitivity of identifying RCTs in the four journals under consideration using various electronic search methods, through a MEDLINE search via PubMed and Ovid, for publication type “RCT” and PubMed free text search for “random* AND orthodontic”. Compare results with previously published findings. • Compare the electronic search methods with handsearching as the gold standard. Design: Retrospective observational study. Data Sources: Articles published between 1st January 2001 and 31st December 2010 in the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), The Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) (formerly British Journal of Orthodontics). Sample: All CCTs and RCTs published in the AJODO, AO, EJO and JO between 1st January 2001 and 31st December 2010 were included. Method: • RF passed the Cochrane Oral Health Group Handsearching test. • A search of all CCTs and RCTs published in the AJODO, AO, EJO and JO between 1st January 2001 and 31st December 2010 was performed. • The RCTs and CCTs were assessed for a statement that the paper had obtained ethical approval and informed consent. • The RCTs were further analysed to determine the following criteria: publication journal, number of authors, number of centres, location of origin, involvement of a statistician, year of publication, and whether random* was in the title or abstract or body of the article. Results: Over the ten year period 4748 articles were identified, of which 218 reported RCTs and 89 CCTs. RCTs comprised 4.6% and CCTs 1.9% of all articles published over that time period. Of the CCTs, 36% had reported both ethical approval and informed consent and 39.3% had neither. Of the RCTs, 48.6% had reported both ethical approval and informed consent and 27.1% had neither. Factors associated with an RCT reporting that ethical approval and informed consent had been obtained were: Number of authors (p<0.001), Random* in Title (p<0.001), Random* in Abstract not Title (p<0.001), Location of origin (p=0.001), Year of publication (p=0.003), The journal of publication (p=0.004) and Number of centres (p=0.008). A logistic regression analysis showed that the most significant indicators of ethical approval and informed consent having been reported were: Publication in the JO (p=0.018), 6 or more authors (p<0.001), Random* in the abstract not title (p=0.004) and Publication after 2004 (p=0.001). A comparison of handsearching with three commonly used electronic search methods showed that handsearching was more accurate. Ovid was significantly less sensitive than PubMed (OR 8.43, 95% CI 5.48, 12.97) missing 157 RCTs (72.0%), while PubMed missed 51 (23.4%). The free text PubMed search, using the terms orthodontic AND random*, was the most sensitive missing 45 RCTs (20.6%); though this was not statistically significant (OR 0.85, 95% CI 0.54, 1.34) Only 56 RCTs (25.7%) were found by all 3 electronic searches. However 37 RCTs (17%) were not identified by any of the electronic search strategies. Conclusions: The reporting of whether ethical approval and informed consent had been obtained are inadequately reported in papers reporting orthodontic RCTs and CCTs. RCTs published in the JO, those with 6 or more authors, with Random* in the abstract but not the title and those published after 2004, were most likely to have reported that ethical approval and informed consent had been obtained. Handsearching was more accurate than electronic searching and PubMed more sensitive than Ovid.

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Masiye, Francis. "Ethical challenges in obtaining informed consent for the genomic study of rheumatic heart disease: a qualitative study." Master's thesis, University of Cape Town, 2016. http://hdl.handle.net/11427/20915.

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INTRODUCTION: Advances in genetic and genomic research have introduced new challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for a genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand the ethical challenges in obtaining informed consent in the RHDGen study. METHODS: We used a qualitative study methodology involving in-depth interviews and participant observations. Our research participants were RHDGen cases and controls as well as research staff involved in the recruitment of RHDGen research participants. In total, we conducted 32 in-depth interviews with RHDGen research participants, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen research participants. The in-depth interviews were conducted in English, audio-recorded and transcribed verbatim. All the data were analysed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa, and these sites were the Groote Schuur Hospital in Observatory, the Vanguard Community Health Centre in Bonteheuwel and the Heideveld Community in the Cape Flats.

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Kwinda, Munyadziwa Albert. "Informed consent procedures for pregnant women before undergoing caesarean section at Donald Fraser Hospital, Limpopo Province, South Africa." Thesis, University of Limpopo ( Medunsa Campus ), 2010. http://hdl.handle.net/10386/422.

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Thesis ( M Med (Family Medicine))--University of Limpopo, 2010.
nformed consent procedures in pregnant women before undergoing caesareaction at Donald Fraser Hospital, Limpopo Province, South Africa Aim: To determine the adequacy of information received by pregnant women before undergoing caesarean section Study Design: Cross – sectional descriptive quantitative study Setting: Donald Fraser Hospital maternity ward Methods: 128 patients where surveyed using a standardized questionnaire 2 – 3 days after caesarean section. The study extended from November 2009 to May 2010. Data was collected by a trained research assistant. The data entered on the questionnaire was entered and frequencies and percentages were analyzed on Stata. Results: 126(98.44%) admitted that they were informed of the reason why a caesarean section had to be performed and 124(98.41) could recall the information provided. 108(84.38%) of participants admitted to being informed about the benefits of having a caesarean section as a mode of delivering their babies, however, only 7(6.48%) participants remembered the information provided. 6(4.69%) and 3(2.34%) of the participants admitted to being informed about complications that may occur during and after caesarean section, respectively; and 33.33% could recall the information provided for both. 50(39.06%) admitted to being informed about the implications of the caesarean section to future pregnancies and 12(24%) could remember the information provided. Majority of participants, 124(96.88%) admitted to being informed about the type of anaesthesia to be administered, however, 89(71.77%) could remember the information provided and 10(7.81%) were informed about the viii possible complications of anaesthesia although only 4(40%) could remember the information provided. The strength of association between participants’ profile and their responses was generally weak, except those with previous caesarean section and their responses to the question that seek to understand if they were informed about the future implications of the caesarean section to future pregnancies. Conclusions: Pregnant women are not informed about the complications or risks associated with caesarean section and anaesthesia to be administered. This makes informed consent procedures to be inadequate.

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Zale, Andrew. "PARENTAL UNDERSTANDING OF ANESTHESIA RISK FOR DENTAL TREATMENT." VCU Scholars Compass, 2012. http://scholarscompass.vcu.edu/etd/2697.

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Purpose: To determine which method of anesthesia risk presentation parents understand and prefer across their demographic variables Methods: As a cross-sectional study, questionnaires were distributed to 50 parents of patients (<7 years of age) in the VCU Pediatric Dental Clinic. Parents were asked of their own and their children’s demographics, previous dental and anesthesia experiences, and anesthesia understanding. Parents were then asked to rate the level of risk of several risk presentations and finally asked which method of risk presentation they most understood or preferred. Data analysis was performed using descriptive statistics, correlation coefficients, likelihood chi square tests, and repeated measures logistic regression. Results: There was no evidence of a differential preference due to gender (P = 0.28), age (P > .9), education (P = 0.39) or whether they incorrectly answered any risk question (P > 0.7). There was some evidence that the three types were not equally preferred (likelihood ratio chi- square = 5.31, df =2, P-value = 0.0703). The best estimate is that 60% prefer charts, 34% prefer numbers, and 36% prefer activity comparisons. There was a relationship between the average relative risk of general anesthesia and age (r = –0.38, P = 0.0070). Younger individuals indicate High risk more often and older individuals indicate Low risk more often. Conclusion: There was no preference of risk presentation type due to gender, age, or education, but there was evidence that each was not equally preferred. Healthcare providers must be able to present the risk of anesthesia in multiple ways to allow for full patient understanding.

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Mwanyisa, Fungisayi Patricia. "Exploring community based social mobilisation strategies for the advancement of the right to legal capacity for people with psychosocial disabilities in Zambia." Diss., University of Pretoria, 2017. http://hdl.handle.net/2263/60074.

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The aim of this study is to explore the importance of community based social mobilisation strategies in advancing human rights, in particular, strategies that could be used advance exercise of the right to legal capacity for persons with psychosocial disabilities in the face of societal barriers in the African context. The results of the study are aimed at providing useful and practical considerations in addressing the gap that exist in human rights implementation, between the promises of the law and its impact in reality. To this end, secondary desk top data was collected from existing text on the CRPD, mental illness and social mobilisation strategies. The latter was based on an analysis of the mobilisation strategy employed by Tostan in West Africa to successfully challenge female genital mutilation/cutting. Primary data was obtained through focus groups held in Lusaka and at Nsadzu Mental Health Rehabilitation Centre in Chadiza, in rural Zambia. The significance of legal capacity in Zambia was established and three main categories of concern emerged as barriers to the exercise of legal capacity: a) lack of state and community based supports and social networks; b) inadequate training of health and justice system officials; and c) stigma of mental illness and stereotypes. The benefits of social mobilisation in addressing these barriers are manifold, as demonstrated through the Tostan model.
Mini Dissertation (MPhil)--University of Pretoria, 2017.
Centre for Human Rights
MPhil
Unrestricted

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Guarino, Peter David. "Consumer participation in the design of informed consent documentation for entry into randomised clinical trials : a cluster randomised trial." Thesis, London School of Hygiene and Tropical Medicine (University of London), 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.422313.

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Sharp, Kelly Susan. "Voluntary resettlement for improved livelihoods? : examining food security, nutrition, and informed consent amongst land reform participants in southern Malawi." Thesis, University of British Columbia, 2015. http://hdl.handle.net/2429/56245.

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Land scarcity and food insecurity are critical concerns for billions of individuals worldwide; voluntary resettlement, as a type of land reform, offers governments and aid agencies a controversial approach to address these concerns. This thesis examines the case of a US$38-million World Bank-funded voluntary resettlement scheme in southern Malawi known as the Community Based Rural Land Development Project, through which 15,000 low-income farming households moved internally from densely populated areas to underutilized plantations between 2004 and 2011. The project and its explicit goals (to increase participant income and agricultural productivity) have been the subject of several studies, but the wider range of indirect outcomes and possible unintended consequences are lesser known, which this thesis works to address. The first analytic chapter assesses the extent to which the project was ‘voluntary’, and considers the real versus perceived land tenure claims established by the programme. To enhance understanding this analysis, this chapter also considers factors influencing household participation and withdrawal in the resettlement. Quantitative and qualitative analysis of surveys (N=203), focus group discussions (N=5) and interviews (N=20) suggest that participants did not have a clear understanding of the project conditions, and that they perceived their new ownership rights to be more secure and individual than they were by law. Additionally, attrition rates were analyzed: despite numerous influences factoring into participant decisions to withdraw and return ‘home’, availability of land in the district of origin and access to infrastructure in the district of resettlement played significant roles. The second analytic chapter assesses the effectiveness of voluntary resettlement in improving food security, including its effects on dietary diversity. Regressions and statistical analyses of Dietary Diversity Scores indicate that participants had statistically significant lower levels of food security and dietary diversity than former and non-beneficiaries, possibly due to a lack of infrastructure and access to markets. These findings highlight the importance of participatory holistic planning for voluntary resettlement, particularly to ensure participant understanding of future living conditions, and ultimately challenge the utility of voluntary resettlement as a policy tool to improve the well-being of subsistence farmers.
Science, Faculty of
Resources, Environment and Sustainability (IRES), Institute for
Graduate

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Rosas, Tovar Jazmin Isamar. "Informe Jurídico de la Resolución de Consejo Directivo N° 95-2017-CD/OSIPTEL." Bachelor's thesis, Pontificia Universidad Católica del Perú, 2021. http://hdl.handle.net/20.500.12404/19978.

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El presente informe pretende analizar las decisiones adoptadas por el Organismo Supervisor de Inversión Privada en Telecomunicaciones (en adelante, “OSIPTEL” o “Regulador”) en la Resolución de Consejo Directivo N° 95-2017-CD/OSIPTEL, de fecha 21 de agosto (en adelante, la “Resolución”), mediante la cual se resuelve sancionar a la empresa América Móvil Perú S.A.C. (en adelante, “CLARO”), por incumplir en 31 acciones de supervisión con la entrega de constancias de arribo a sus centros de atención. En este mismo informe, pretendemos analizar si la sanción impuesta a CLARO por medio de la Resolución de OSIPTEL se encuentra conforme a los principios de la potestad sancionadora, a efectos de manifestar si fue razonable, proporcional y debidamente motivada

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Castillo, Chávez Christian Daniel. "Informe profesional de la Resolución de Consejo Directivo N° 042-2009- CD-OSITRAN." Bachelor's thesis, Pontificia Universidad Católica del Perú, 2021. http://hdl.handle.net/20.500.12404/20068.

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El presente informe tiene como objetivo resolver los problemas de relevancia jurídica que se encuentran en la opinión interpretativa emitida por OSITRAN en la Resolución de Consejo Directivo N° 042-2009-CD-OSITRAN, a través de la cual se interpreta el término “debidamente saneado” regulado en el numeral 2 del Anexo11 del contrato de concesión para la administración y operación del Aeropuerto Internacional Jorge Chávez suscrito entre Lima Airport Partners SRL y el Ministerio de Transportes y Comunicaciones. En ese sentido, la controversia que dio origen a la opinión interpretativa gira en torno a si el contenido del término “debidamente saneado” determina a cuál de las partes se debe asignar los riesgos referidos al i) saneamiento ambiental, y ii) el retiro de escombros, puesto que ello no se encuentra regulado expresamente en el numeral 2 del Anexo 11 del contrato de concesión. Por este motivo, resaltamos la importancia del análisis de la presente resolución de consejo directivo puesto que nos permite analizar a los siguientes puntos: i) a quien le corresponde asumir los riesgos referidos al saneamiento ambiental y el retiro de escombros, y si su asignación se realizó de una manera correcta; y ii) sí el pronunciamiento del OSITRAN es vinculante para las partes en el contrato de concesión y si esta vía administrativa es la idónea

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Abebe, Adem Kassie. "The power of indigenous people to veto development activities: the right to Free, Prior and Informed Consent (FPIC) with specific reference to Ethiopia." Diss., University of Pretoria, 2009. http://hdl.handle.net/2263/12643.

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Discusses how to ascertain the meaning and implications of Right to Free Prior and Informed Consent (FPIC). Discusses the difference between meaningful participation of FPIC and the relationship between ‘national interest’ and the right to FPIC. Also analyses the protection of the rights of indigenous peoples, including mainly the right to FPIC in Ethiopia. Introduces recommendations concerning the middle ground between ‘national interest’ and the right to FPIC. Discusses how the right to FPIC can be legally recognised in Ethiopia and Africa in general, including particularly by the African Commission, and outlines specific recommendations on the relevant policies of the World Bank and African Development Bank.
Dissertation submitted to the Faculty of Law University of Pretoria, in partial fulfilment of the requirements for the degree Masters of Law (LLM in Human Rights and Democratisation in Africa). Prepared under the supervision of Odile Lim Tung, Faculty of Law and Management, University of Mauritius.
Mini Dissertation (LLM (Human Rights and Democratisation in Africa))--University of Pretoria, 2009.
http://www.chr.up.ac.za/
Centre for Human Rights
LLM

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Rossouw, Theresa Marie. "Identity, personhood and power : a critical analysis of the principle of respect for autonomy and the idea of informed consent, and their implementation in an androgynous and multicultural society." Thesis, Stellenbosch : Stellenbosch University, 2012. http://hdl.handle.net/10019.1/19906.

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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.

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Desai, Sagar S. "For Whom the Time Stops: Picking Up the Pieces in a World of Constant Motion." University of Cincinnati / OhioLINK, 2016. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1460731395.

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Lim, Jennifer NW, Rosa Almeida, Vjera Holthoff-Detto, Geke DS Ludden, Tina Smith, and Kristina Niedderer. "What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia?: Our experience in a multi-centre study." TUDpress, 2019. https://tud.qucosa.de/id/qucosa%3A36687.

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Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.

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Kelly, Katherine Patterson Ganong Lawrence H. "Stepping up, stepping back, being pushed, and stepping away the process of making treatment decisions for children with cancer by parents who no longer live together /." Diss., Columbia, Mo. : University of Missouri-Columbia, 2008. http://hdl.handle.net/10355/6867.

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The entire dissertation/thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file (which also appears in the research.pdf); a non-technical general description, or public abstract, appears in the public.pdf file. Title from PDF of title page (University of Missouri--Columbia, viewed on April 1, 2010). Vita. Thesis advisor: Lawrence H. Ganong. "May 2008" Includes bibliographical references

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Cruzado, Saavedra Víictor Andrés. "Informe sobre las Resoluciones del Consejo Directivo de OSITRAN N° 050-2005-CD-OSITRAN y N° 034-2009-CDOSITRAN del Expediente N° 043 - 2009 – OSITRAN." Bachelor's thesis, Pontificia Universidad Católica del Perú, 2020. http://hdl.handle.net/20.500.12404/18452.

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Lima Airport Partners (concesionario del Aeropuerto Internacional Jorge Chávez) solicita interpretar a OSITRAN el numeral 2 del anexo 11 del Contrato de Concesión del Aeropuerto Internacional Jorge Chávez, el cual regula la obligación del Estado de entregar los terrenos “debidamente saneados” para el Proyecto”. OSITRAN emitió su Resolución de Consejo Directivo N° 050-2005-CD-OSITRAN en la cual interpreto la citada cláusula del Contrato de Concesión; posteriormente LAP solicita una “interpretación complementaria” de la resolución ya indicada. Este último requerimiento es declarado IMPROCEDENTE en primera instancia, mientras que en segunda instancia fue declarado INFUNDADO el pedido de reconsideración

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De, Villiers Suzanne. "The principle of respect for autonomy and the sterilization of people with intellectual disabilities." Thesis, Stellenbosch : Stellenbosch University, 2002. http://hdl.handle.net/10019.1/53148.

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Thesis (MPhil)--University of Stellenbosch, 2002.
ENGLISH ABSTRACT: The implementation of eugenic policies reached its peak during the zo" century when thousands of people with intellectual disabilities and other "undesirable qualities" were involuntary sterilized. Although most of the eugenic policies have been removed, countries such as South Africa, still make legally provision for the involuntary sterilization of people with intellectual disabilities. Torbjërn Tannsjë (1998) used the "argument from autonomy" to argue that involuntary sterilization practices are wrong because it involves compulsion. According to him, society should never interfere with people's reproductive choices and people should never be required to qualify for the right to have children. The aim of this assignment was to systematically assess the "argument from autonomy" as far as the policy of involuntary sterilization of people with intellectual disabilities is concerned. To this end, the concept of autonomy and the principle of respect for autonomy are discussed and applied to the intellectually disabled. It is argued that autonomy and respect for autonomy are useful concepts to apply to some people with intellectual disabilities. These individuals should not be automatically assumed to be incompetent, but their competence needs to be determined on an individual level, with reference to the complexity of the decision to be made. Special effort is needed from health care professionals to obtain (where possible) informed consent from people with intellectual disabilities. The application of the principle of respect for autonomy to matters of reproduction leads to the conclusion that people with severe to profound levels of disability, are unable to provide informed consent for sexual intercourse. Therefore some form of paternalistic protection is needed for these individuals. People with mild to moderate intellectual disabilities who are however competent to consent to sexual intercourse should never be prohibited from procreation by means of involuntary sterilization. State interference in matters of reproduction should be limited to interventions where (i) children are seriously harmed by parents and (ii) to protect those who are incompetent to consent to sexual interactions with others. Apart from these exceptions, the intellectually disabled is entitled to the same procreative rights as all other citizens.
AFRIKAANSE OPSOMMING: Die implementering van eugenetiese beleid het gedurende die 20 ste eeu 'n hoogtepunt bereik met die onwillekeurige sterilisering van duisende persone met intellektuele gestremdhede en ander "ongewensde kwaliteite". Alhoewel meeste van die eugenetiese wetgewing verwyder is, maak lande soos Suid-Afrika steeds wetlik voorsiening vir die onwillekeurige sterilisasie van persone met intellektuele gestremdhede. Torbjërn Tannsjo (1998) maak gebruik van die "outonomie argument" om te argumenteer dat onwillekeurige sterilisasie praktyke onaanvaarbaar is omdat dit dwang bevat. Hy voer aan dat die samelewing nooit in die reproduktiewe keuses van mense behoort in te meng nie en dat dit nooit vir mense nodig moet wees om vir ouerskap te kwalifiseer nie. Die doel van hierdie werkstuk was om sistematies die "outonomie argument" te analiseer ten opsigte van die beleid van die onwillekeurige sterilisasie van persone met intellektuele gestremdhede. Met hierdie doel voor oë word die konsep outonomie en die beginsel van respek vir outonomie bespreek en toegepas op die intellektueel gestremde persoon. Daar word aangevoer dat outonomie en respek vir outonomie nuttige beginsels is om in ag te neem in kwessies rakende intellektueel gestremdes. Hierdie individue moet nie outomaties as onbevoeg beskou word nie, maar hul bevoegdheid moet eerder op 'n individuele basis beoordeel word, inaggeneem die kompleksiteit van die besluit wat geneem moet word. Voorts word daar van gesondheidsorgpersoneel verwag om moeite te doen met die verkryging van oorwoê toestemming (waar moontlik) by persone met intellektuele gestremdhede. Die toepassing van die beginsel van respek vir outonomie op aspekte rakende reproduksie, lei tot die gevolgtrekking dat persone met ernstige intellektuele gestremdhede nie in staat is om toestemming tot seksuele omgang te verleen nie. Dus, is 'n vorm van paternalistiese beskerming in hierdie gevalle aangedui. Persone met intellektuele gestremdhede wat egter wel bevoeg is om toestemming tot seksuele omgang te verleen, moet nooit weerhou word van voortplanting deur middel van onwillekeurige sterilisering nie. Inmenging deur die staat in kwessies rakende reproduksie moet beperk word tot intervensies waar (i) kinders ernstige skade berokken word en (ii) die beskerming van persone wat onbevoeg is om toestemming tot seksuele interaksies met ander te verleen, benodig word. Afgesien hiervan, is die intellektuele gestremde persoon geregtig op dieselfde reproduktiewe regte as alle ander landsburgers.

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Muriithi, Paul Mutuanyingi. "A case for memory enhancement : ethical, social, legal, and policy implications for enhancing the memory." Thesis, University of Manchester, 2014. https://www.research.manchester.ac.uk/portal/en/theses/a-case-for-memory-enhancement-ethical-social-legal-and-policy-implications-for-enhancing-the-memory(bf11d09d-6326-49d2-8ef3-a40340471acf).html.

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The desire to enhance and make ourselves better is not a new one and it has continued to intrigue throughout the ages. Individuals have continued to seek ways to improve and enhance their well-being for example through nutrition, physical exercise, education and so on. Crucial to this improvement of their well-being is improving their ability to remember. Hence, people interested in improving their well-being, are often interested in memory as well. The rationale being that memory is crucial to our well-being. The desire to improve one’s memory then is almost certainly as old as the desire to improve one’s well-being. Traditionally, people have used different means in an attempt to enhance their memories: for example in learning through storytelling, studying, and apprenticeship. In remembering through practices like mnemonics, repetition, singing, and drumming. In retaining, storing and consolidating memories through nutrition and stimulants like coffee to help keep awake; and by external aids like notepads and computers. In forgetting through rituals and rites. Recent scientific advances in biotechnology, nanotechnology, molecular biology, neuroscience, and information technologies, present a wide variety of technologies to enhance many different aspects of human functioning. Thus, some commentators have identified human enhancement as central and one of the most fascinating subject in bioethics in the last two decades. Within, this period, most of the commentators have addressed the Ethical, Social, Legal and Policy (ESLP) issues in human enhancements as a whole as opposed to specific enhancements. However, this is problematic and recently various commentators have found this to be deficient and called for a contextualized case-by-case analysis to human enhancements for example genetic enhancement, moral enhancement, and in my case memory enhancement (ME). The rationale being that the reasons for accepting/rejecting a particular enhancement vary depending on the enhancement itself. Given this enormous variation, moral and legal generalizations about all enhancement processes and technologies are unwise and they should instead be evaluated individually. Taking this as a point of departure, this research will focus specifically on making a case for ME and in doing so assessing the ESLP implications arising from ME. My analysis will draw on the already existing literature for and against enhancement, especially in part two of this thesis; but it will be novel in providing a much more in-depth analysis of ME. From this perspective, I will contribute to the ME debate through two reviews that address the question how we enhance the memory, and through four original papers discussed in part three of this thesis, where I examine and evaluate critically specific ESLP issues that arise with the use of ME. In the conclusion, I will amalgamate all my contribution to the ME debate and suggest the future direction for the ME debate.

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Kinuthia, Wanyee. "“Accumulation by Dispossession” by the Global Extractive Industry: The Case of Canada." Thèse, Université d'Ottawa / University of Ottawa, 2013. http://hdl.handle.net/10393/30170.

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This thesis draws on David Harvey’s concept of “accumulation by dispossession” and an international political economy (IPE) approach centred on the institutional arrangements and power structures that privilege certain actors and values, in order to critique current capitalist practices of primitive accumulation by the global corporate extractive industry. The thesis examines how accumulation by dispossession by the global extractive industry is facilitated by the “free entry” or “free mining” principle. It does so by focusing on Canada as a leader in the global extractive industry and the spread of this country’s mining laws to other countries – in other words, the transnationalisation of norms in the global extractive industry – so as to maintain a consistent and familiar operating environment for Canadian extractive companies. The transnationalisation of norms is further promoted by key international institutions such as the World Bank, which is also the world’s largest development lender and also plays a key role in shaping the regulations that govern natural resource extraction. The thesis briefly investigates some Canadian examples of resource extraction projects, in order to demonstrate the weaknesses of Canadian mining laws, particularly the lack of protection of landowners’ rights under the free entry system and the subsequent need for “free, prior and informed consent” (FPIC). The thesis also considers some of the challenges to the adoption and implementation of the right to FPIC. These challenges include embedded institutional structures like the free entry mining system, international political economy (IPE) as shaped by international institutions and powerful corporations, as well as concerns regarding ‘local’ power structures or the legitimacy of representatives of communities affected by extractive projects. The thesis concludes that in order for Canada to be truly recognized as a leader in the global extractive industry, it must establish legal norms domestically to ensure that Canadian mining companies and residents can be held accountable when there is evidence of environmental and/or human rights violations associated with the activities of Canadian mining companies abroad. The thesis also concludes that Canada needs to address underlying structural issues such as the free entry mining system and implement FPIC, in order to curb “accumulation by dispossession” by the extractive industry, both domestically and abroad.

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Chih-Yi, Lin, and 林芝伊. "Clinical Practice of Informed Consent in Taiwan: Content Analysis of Informed Consent Form for Cardiac Surgery." Thesis, 2005. http://ndltd.ncl.edu.tw/handle/28295501214826159754.

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碩士
長庚大學
醫務管理學研究所
93
A new Model Surgical Consent Form (SC Form) was put into effect on Jan. 1, 2004, which was designed to facilitate doctor-patient communication so as to promote patient autonomy. Does the new form really bring in a new practice in clinical reality? Given the general style of the new form, it is essential for hospitals to design a more detailed Surgical Explanation Form (SE Form) to aid patient understanding. This study is to investigate whether the SC and SE forms now in use in hospitals meet accepted standards of informed consent, and whether they deliver needed medical information? To answer the above-mentioned questions, this study collected 48 SE forms about 8 cardiac surgeries in 6 major hospitals in Northern Taiwan. Then, this study created a 32-item list of necessary content of informed consent by reviewing related literatures. The 48 SE forms were examined accordingly for evidence of the basic elements of informed consent (nature of the procedure, risks, benefits, and alternatives) and items that might enhance patient-physician interactions and encourage shared decision making. The study findings are as followed: (1) 4 items, including name of disease, reason of suggested operation, name of suggested operation, and responsible surgeon, appeared in all 48 SE forms. (2) 13 items, such as body part to be operated, prognosis of refusal of surgery, approximate time of operation, prognosis, fees and charges, etc, were not mentioned in all 48 SE forms. (3) The rest 15 items are displayed in minor different style. In general, information about risks, complications, and alternatives are most apparent in the reviewed forms. This study revealed that there is no big difference among hospitals in information-giving. Though most SE forms contain much information, to truly facilitate patient autonomy, the current SE form does not provide enough and necessary information.

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LaBine, Lisa. "A qualitative study of informed consent : moving the discussion beyond the consent form." 2009. http://hdl.handle.net/1993/21357.

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Parreira, Bruna da Conceição Correia. "Biobanco “AZORBIO”: organização de recursos biológicos para a investigação." Master's thesis, 2013. http://hdl.handle.net/10400.3/1653.

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Dissertação de Mestrado em Ciências Biomédicas.
INTRODUÇÃO: Os biobancos são essenciais em investigação, por possuírem coleções de amostras e dados armazenados de forma organizada. O biobanco Açores (AZORBIO) do Serviço Especializado de Epidemiologia e Biologia Molecular (SEEBMO) possui uma coleção de material biológico e dados associados de doentes açorianos com diversas patologias. A Litíase Urinária (LU) é uma entidade clínica de etiologia multifatorial, cujo desenvolvimento resulta de um processo complexo que envolve vários mecanismos fisiopatológicos. OBJETIVO: Melhoria das condições de colheita, acondicionamento, transporte, receção, processamento e controlo de qualidade das amostras e dados destinados ao AZORBIO, através da aplicação de novos procedimentos padronizados. METODOLOGIA: Foi realizada uma revisão da literatura sobre normas e leis aplicáveis aos biobancos e foram verificadas as condições do AZORBIO. Foi elaborado um termo de consentimento informado e um questionário e foram estabelecidos procedimentos operacionais padrão para que todo o circuito de colheita, receção, processamento e armazenamento das amostras de LU seja uniformizado. Todos os procedimentos foram posteriormente aferidos com as primeiras amostras de LU recebidas no AZORBIO. As amostras de DNA e RNA foram submetidas a controlo de qualidade para verificar a concentração e pureza, integridade e funcionalidade. RESULTADOS E CONCLUSÃO: O AZORBIO apresenta as instalações e os equipamentos necessários para o seu funcionamento. A documentação produzida (consentimento informado, folha informativa, questionário e procedimentos operacionais padronizados) permitiu uniformizar todo o circuito para as amostras de LU. As amostras de DNA e RNA obtidas, através dos procedimentos realizados, apresentaram boa qualidade. Com este trabalho o AZORBIO, num futuro próximo, poderá garantir amostras e dados de qualidade de LU e consequentemente contribuir para o melhoramento dos cuidados de saúde e redução da morbilidade desta doença. Para além disso, os procedimentos aqui propostos poderão servir de base para outras patologias de interesse para o AZORBIO.
INTRODUCTION: The biobanks are essential in research, by having collections of samples and data stored in an organized manner. The biobank Azores (AZORBIO) of the Specialized Service of Epidemiology and Molecular Biology (SEEBMO) has a collection of biological material and associated data of Azorean patients with different pathologies. The pathology of interest, chosen for this thesis was the Urinary lithiasis (LU), a multifactorial clinical entity that results from several pathophysiologic mechanisms. OBJECTIVE: The application of new standardized procedures for collection, packaging, transportation, reception, processing, storage and quality control of the samples and data for the AZORBIO. METHODOLOGY: Literature review of rules and laws applicable to biobanks. An informed consent form and a specific LU questionnaire were performed and standard operating procedures for the entire circuit were established. All procedures were subsequently assessed with the first ten samples received on AZORBIO. Nucleic acid samples were subjected to quality control to verify the concentration and purity, integrity and functionality. RESULTS AND CONCLUSION: AZORBIO has the facilities and equipment necessary for its operation. The documentation produced (informed consent, informative document, questionnaire and standard operating procedures) contributed for the standardization of the entire circuit for samples of LU. Although the overall circuit assessment showed good quality results, minor changes were suggested to improve the final outcome. With this work the AZORBIO in the near future, will ensure good LU quality samples and data contributing to the improvement of health care and reduce morbidity of this disease. In addition, the procedures proposed here can be adapted to other pathologies of interest to AZORBIO.

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Huang, Hui-Yi, and 黃蕙怡. "The Study of Informed Consent Forms and Clients’ Experiences Involved in the Informed Consent Process in Psychotherapy." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/72961865402604466112.

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碩士
中國文化大學
心理輔導學系
102
The researcher used both quantitative and qualitative methods to investigate the content of informed consent forms which are used in 44 student counseling centers of universities in Taiwan and clients’ experiences involved in informed consent process in psychotherapy. The investigation of 44 informed consents forms were analyzed and presented by using descriptive statistics. The elements included in informed consent forms are itemized, and the content and format of informed consent vary depending upon the schools. The limits of confidentiality, the right to request or to refuse any particular treatment technique or to withdraw from therapy at any time and the right to request a referral to another therapist are the elements which are included in every informed consent forms; however, just few of them mention about the information regarding clients’ right to examine personal records, alternative treatments or options and potential risks and benefits of treatment. Generally, the consent for audio or video recordings and the information of destruction timeframe as well as who will have access to the recordings and where they will be stored are ambiguous and scanty. A total of 5 interviewees (3 females and 2 males) with a mean age of 26 years, who had at least 6 times of individual counseling experiences in the student counseling centers in universities were recruited by purposive sampling for in-depth interviews in this study. Interviewees described their informed consent experiences as confusing and oppressive. The signed informed consent form and a clear verbal interpretation of situation cannot ensure the clients really understand the nature of psychotherapy and what its process. While confronting dilemma, they tend to react in a passive way such as withdrawal, conformity or surmise. Finally, basic on their personal experiences, interviewees give suggestions to therapists conducting informed consent. Recommendations and suggestions for future research are also provided.

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Chen, Shu-Yu, and 陳書毓. "Readability and Comprehensibility of Informed Consent Forms for Clinical Trials." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/qqe32x.

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博士
國立臺灣大學
護理學研究所
106
Background: With the environmental changes in clinical trials, there are more and more clinical trials in the world. There are currently 266,161 clinical trial cases in 50 states in the United States and 203 countries. The clinical trial registration number from Taiwan is up to 5241 (National Institutes of Health, 2018). Various laws, regulations and ethical norms emphasize the informed consent process, consent form content and importance of informed consent, but there is room for improvement. The purpose of this study was to explore the level of understanding and key influencing factors in the informed consent process, to explore the practical experience of cancer clinical trial subjects, principal investigator and research nurses, and to investigate the readability of consent form. Methods: This study uses between-method triangulation with qualitative and quantitative research. The cross-sectional survey was used to explore the subjects'' experience and understanding in the process of informed consent. The qualitative interview was used to explore the experience of the clinical trial investigators, research nurses and patients in explaining the clinical trial consent. Content analysis method was to use to analyze the consent formed from the institutional review board, and the quantitative research methods to test the readability of consent forms. Results: We recruited 375 participants who had signed an informed consent of clinical trials to join the cross-sectional survey, the provider of informed consent form information were research nurse (51.7%), Research assistant(17.9%), and Doctor(17.9%). The demeanor of the information provider was Friendly (84.8%), and used the familiar language of the subjects to explain the study (97.3%). The understanding level scores were between 3.81~4.17(out of 5). The item of “I feel I know the risks of the study” (score is 3.81), “I feel I know the benefits of the study” (score is 3.98), “I had enough time to read the consent document” (score is 3.99) were lower than others. In Exploratory factor analysis (EFA), three major themes were found in the scale: Factor 1: “Understanding of the research” , factor loading is from 0.581 to 0.759, variance is 26.763%, Cronbach’s α is 0.925. Factor 2: “Trust and confidence” , factor loading is from 0.359 to 0.658, variance is 16.817%, Cronbach’s α is 0.865. Factor 3: “Doubt and uncertainty”, factor loading is from 0.531 to 0.707, variance is 9.74%, Cronbach’s αis 0.713. The total variance is 52.954%, with Cronbach’s α of 0.917. The Kaiser–Meyer–Olkin value was 0.937, and indicating excellent sampling adequacy and relatively compact patterns of correlation. Bartlett’s test of sphericity was significant( x2= 4185.925, df = 190, p <0.0001). Nine interviewees received in-depth interviews. After text encoding and analysis, we developed four themes, including "preparation", "communication", "hesitation" and "decision making" and twelve themes. We explored 29 cancer clinical trial consent forms were submitted for review in the institutional review board of a medical center in Central Taiwan during 2015-2017. The average number of consent form pages was 24.7 pages with an average of 15643.5 words. The common questions were "Investigation Methods, Procedures and Related Testing "(42.3%). In the readability analysis of consent form study, we obtained 54 test data, the average correct rate was 91.9537 points (out of 100 points); difficult words average rate of 0.35172 points. We found that the readability of the consent forms for phase III new drug clinical trial were lower than others and having better readability to those with "biomedical science and technology background". Conclusion: This study establishes local empirical data to find out the important factors that affect the understanding of consent and the readability of consent, which can be used as a reference for clinical practitioners to improve and education.

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Kalala, Tshimanga Willy. "Patients' perceptions and understanding of informed consent for surgical procedures." Thesis, 2011. http://hdl.handle.net/10539/10425.

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MMed, Family Medicine, University of the Witwatersrand, 2011
Background Informed consent is required for any surgical procedure. It is a demonstration of a patient‟s agreement to have surgery performed. Many studies have considered the quality of informed consent in clinical trials. However, only few studies have assessed patients‟ understanding of the process of informed consent in clinical practice. This descriptive cross-sectional study has looked at patients‟ perceptions and understanding of informed consent process for surgical procedures. Aim To explore patients‟ perceptions on informed consent and ascertain if those who have signed for surgical procedures have adequate understanding of the informed consent process. Objectives 1. To ascertain patients‟ perceptions of the process of informed consent; 2. To determine patients‟ recollection of elements of this process that were considered when they signed the consent. 5 3. To explore if patients understand the meaning and implications of the informed consent process; 4. To determine whether patients obtained information about procedures from sources other than the healthcare workers; Methods This was a descriptive cross-sectional study conducted among patients admitted at Leratong hospital for elective surgery. A sample of patients (n=98) selected from those booked for elective surgery at Leratong theatres between April 2008 and June 2008 were interviewed. Different aspects of information were analysed. Specifically: social and demographic profile, formal education, previous medical and surgical history, perceptions of informed consent, process of informed consent and knowledge of the procedure‟s indication, risks and alternatives. Equally considered were sources and value of external medical information. Results Patients interviewed represented 5.5% of the total of those booked for elective surgery. The median similar to the modal age was 38 years, 58.2% being females. Only 4.1% had tertiary education, 32% did not reach secondary school of which 11.2% had no formal education at all. Concerning their prior medical /surgical background, 26.5% were on chronic medical treatment and 48% had previous surgery. More than two third (91%) of them had stayed in the hospital for more than 12 hours prior to surgery. 6 Only 27% perceived the signing of consent form as a proof that they understood the procedure. It was demonstrated that the higher the education level the better the perceptions of informed consent process (P=0.0006). More than 2/3 of patients needed further explanation in their mother tongue to understand the information. Seventy-four per cent did not read the consent form. The understanding of information was more likely to be checked when the information was given by a doctor than by a nursing sister (P=0.014). Only 8% admitted to know some alternatives to the proposed procedure, 13% of patients knew the risks. Formal education was not linked to better understanding of the informed consent process (P=0.245). Patients claiming to have received further information on the procedure from sources other than the healthcare system did not show an added advantage on understanding (P=0.152). The study has demonstrated the low level of understanding of informed consent process in this provincial public hospital. It has shown the public perceptions of the consent form, and the advantage granted by the formal education in this regards. Based on these results, it is therefore recommended that an approved translation of the consent form be made available to patients as an alternative to those who are not English speakers. A proper guideline should be established for physicians to ensure disclosure of information in language of choice of patients to obtain better informed consent.

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蘇以青. "Counselors' ethical experiences of the process for obtaining informed consent." Thesis, 2011. http://ndltd.ncl.edu.tw/handle/86473370300122263085.

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博士
國立高雄師範大學
輔導與諮商研究所
99
The purpose of this study was to present counselors’ ethical experiences in the process of obtaining informed consent during counseling. This study explored the ethical meaning of the informed consent process by using phenomenology. We invited counselors who had practiced counseling for over an year for in-depth interviews by purposive sampling. A total of 10 counselors (7 females, 3 males) with a mean age of 36.5 years were recruited. All counselors were licensed and in practice. Most of their clients were adults and students. Based upon the participants' experiences, we identified the contents and methods of the informed consent process. The contents included 3 categories: material of frame, education with heart, and opportunity of psychotherapy. Throughout the counseling process, these contents were communicated through conducted methods to make counseling work. The common experience of these participants was the ethical story composed by the counselors and clients. Using the ethical story as the context, we adopted a phenomenological approach to analyze the interview transcripts to explore the participants’ beliefs and values in the informed consent process and the ethical meaning. Five themes were identified: (a) person-based and returning to clients’ subjectivity, (b) portraying blueprint and planning boundary, (c) probability of building on expertise, (d) creating space for balance and collaboration, and (e) returning to counseling in itself. Each theme contained 2 to 5 individual sub-themes. The “person-based and returning to clients’ subjectivity” and “portraying blueprint and planning boundary” took person-centered principles into consideration, and the “probability of building on expertise” and “returning to counseling in itself” emphasized the maintenance of professionalism. Through “creating space for balance and collaboration,” all of those above made counselors and their clients work together and compose graceful melody. The relationship between the informed consent process and the development of counseling relationship was illuminated by timelines as navigation, resonance, and coming ashore. The finding indicated that the informed consent process and the development of counseling relationship were complementary to each other during counseling. This study suggests that both systematic continuing education in professional ethics and case based discussion be provided for counselors in practice. Professional norms and ethical codes that meet the needs for the implementation of school counseling should also be developed. This study also provides suggestions for future research studies.

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Silva, Sofia Marques Correia Rodrigues da. "O Testamento Vital: Renúncia ao Direito à Vida?" Master's thesis, 2020. http://hdl.handle.net/10316/92818.

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Dissertação de Mestrado em Ciências Jurídico-Forenses apresentada à Faculdade de Direito
O direito à vida é um pilar básico e fundamental no ordenamento jurídico em que vivemos. A sua importância leva a que este seja inviolável, constituindo crime os actos que o coloquem em causa, nomeadamente as situações que levam a mortes provocadas e não naturais, como por exemplo a morte medicamente assistida. Posto isto, justifica-se que se explore o consentimento informado médico e a relação médico-paciente, sendo matérias importantes para posterior abordagem do testamento vital e das suas características.Mais assim, tendo em conta os avanços na medicina e na sociedade, as directivas antecipadas de vontade, designadamente sob a forma de testamento vital, entram em vigor com a Lei n.º 25/2012, de 16 de Julho, que vem reforçar o respeito pela autonomia e vontade dos pacientes. Sendo estas uma forma de interrupção ou abstenção de tratamentos e intervenções médicas por vontade do paciente, é necessário reflectir até que ponto este documento não é uma verdadeira renúncia à vida, possibilitando a prática da eutanásia, punível em Portugal. Posto isto, vamos iniciar este estudo com a abordagem ao direito à vida, como direito subjectivo, como direito constitucionalmente consagrado e como direito de personalidade, mencionando igualmente qual é a sua tutela no ordenamento jurídico português. Numa segunda fase, explora-se a matéria do consentimento informado médico, incluindo os seus requisitos e o seu procedimento, essencial para posteriormente compreender melhor a análise da Lei n.º25/2012, de 16 de Julho. Por fim, pretende-se a compatibilização entre as ideias defendidas nos primeiros capítulos e as regras acerca do testamento vital, para que se consiga dar resposta à problemática que é tema desta dissertação.
The right to life is a basic and fundamental pillar of the legal system in which we live. Its importance means that it is inviolable, and acts that question it constitute a crime, in particular the situations that lead to caused and unnatural deaths, such as medically assisted death. Having said that, it is justified to explore medical informed consent and the doctor-patient relationship, important matters for a later approach to the living will and its characteristics.Moreover, in view of the advances in medicine and society, advance directives for medical decisions, in particular in the form of a living will, enter into force with Law no.25/2012, of July 16th, which reinforces the respect for the autonomy and the will of the patients. Since these are a form of interruption or abstention from medical treatments and interventions at the patient’s will, it is necessary to reflect on the extent to which this document is not a true renunciation of life, enabling the practice of euthanasia, punishable in Portugal.Having said that, this study starts with the approach to the right to life, as a subjective right, as a constitutional right and as a personality right, also mentioning what its protection in the Portuguese legal system is. In a second phase, the subject matter of medical informed consent is explored, including its requirements and its procedure, essential to further understand the analysis of Law no.25/2012, of July 16th. Finally, it is intended to align the ideas defended in the first chapters and the rules of the living will, in order to adress the matter on which this dissertation focuses.

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"Individualizing the Informed Consent Process for Whole Genome Sequencing: A Patient Directed Approach." Doctoral diss., 2013. http://hdl.handle.net/2286/R.I.20945.

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abstract: ABSTRACT Whole genome sequencing (WGS) and whole exome sequencing (WES) are two comprehensive genomic tests which use next-generation sequencing technology to sequence most of the 3.2 billion base pairs in a human genome (WGS) or many of the estimated 22,000 protein-coding genes in the genome (WES). The promises offered from WGS/WES are: to identify suspected yet unidentified genetic diseases, to characterize the genomic mutations in a tumor to identify targeted therapeutic agents and, to predict future diseases with the hope of promoting disease prevention strategies and/or offering early treatment. Promises notwithstanding, sequencing a human genome presents several interrelated challenges: how to adequately analyze, interpret, store, reanalyze and apply an unprecedented amount of genomic data (with uncertain clinical utility) to patient care? In addition, genomic data has the potential to become integral for improving the medical care of an individual and their family, years after a genome is sequenced. Current informed consent protocols do not adequately address the unique challenges and complexities inherent to the process of WGS/WES. This dissertation constructs a novel informed consent process for individuals considering WGS/WES, capable of fulfilling both legal and ethical requirements of medical consent while addressing the intricacies of WGS/WES, ultimately resulting in a more effective consenting experience. To better understand components of an effective consenting experience, the first part of this dissertation traces the historical origin of the informed consent process to identify the motivations, rationales and institutional commitments that sustain our current consenting protocols for genetic testing. After understanding the underlying commitments that shape our current informed consent protocols, I discuss the effectiveness of the informed consent process from an ethical and legal standpoint. I illustrate how WGS/WES introduces new complexities to the informed consent process and assess whether informed consent protocols proposed for WGS/WES address these complexities. The last section of this dissertation describes a novel informed consent process for WGS/WES, constructed from the original ethical intent of informed consent, analysis of existing informed consent protocols, and my own observations as a genetic counselor for what constitutes an effective consenting experience.
Dissertation/Thesis
Ph.D. Biology 2013

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Winterbottom, Melissa. "Informed Consent for Chiropractic Care: Comparing Patients’ Perceptions to the Legal Requirements." Thesis, 2014. http://hdl.handle.net/1807/65612.

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Purpose: Patients’ perspectives of informed consent for chiropractic care have not been investigated. This study explored how patients of chiropractors perceived the exchange of risk information during informed consent. Methods: Interviews were conducted with 26 participants, recruited from chiropractic clinics. Interview transcripts were analyzed using a constant comparative method of analysis. Findings: Participants experienced informed consent as an on-going process where risk perceptions were shaped throughout four distinct stages. In the first stage information acquired prior to arriving at the clinic for treatment shaped perceptions of risk. In the second stage participants assessed the perceived competence of the practitioners. Participants then signed the consent form and discussed the risks with t heir practitioner. Finally, they communicated with their practitioners during treatment to ensure their pain threshold was not crossed. Conclusion: These findings suggest that patients perceive informed consent as a social process involving on-going communication with their practitioners.

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VanLandschoot, Toby W. "Orthognathic surgery patient values and professional judgments : a thesis submitted in partial fulfillment ... for the degree of Master of Science in Orthodontics ... /." 2004. http://catalog.hathitrust.org/api/volumes/oclc/68962661.html.

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Hui, Lee Chia, and 李嘉慧. "The Obstetrics and Gynecology Physician for Informed Consent Concern While Patient of Hysterectomy." Thesis, 2003. http://ndltd.ncl.edu.tw/handle/89158107172231342465.

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碩士
長庚大學
醫務管理學研究所
91
The objectives of this research are to study the perceptions of gynecologists and current practice on the rights to information of hysterectomy patients. Analysis is focused on the provision method and content of diagnostic information, reasons of inability to provide diagnostic information, and ways to improve it. Furthermore, the relationship between the provision of information, hospital’s accreditation status, as well as physicians’ demographic data are being explored. The research findings aim to aid hospital administrators in planning future supportive policies, measures and management schemes. The researcher had designed a questionnaire which was mailed to Gynecology departments of 19 Hospitals accredited as regional hospital or above in Taipei City from April 28 to May 16, 2003. A total of 161 questionnaires were sent, and 72 responses were received. Hence, the response rate is 44.72%. It is found that, according to the responding physicians, “Diagnosis of disease” (83.83%) and “Pathology finding” (75.76%) are the most important information to potential hysterectomy patients. “Providing channels of related information on the illness”, “Payment by National Health Insurance and out-of-pocket expenses” are of lowest importance. In addition, “patient’s inability to understand” (23.83%) is deemed to be one of the major reasons affecting provision of related information. In conclusion, the researcher has proposed the following four recommendations: establishing inter-active education materials, creating “standard procedures on providing necessary information to hysterectomy patients”, infusing important information related to patient’s right into clinical care and health insurance system and preparing a checklist on information provision by treatment procedures with designated personnel.

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