Master-Arbeit Univ. St. Gallen, 2006.

No / The challenges associated with patient-based research in palliative care are well documented. This paper focuses on the ethical challenges and discusses them in the context of a pilot study to explore the palliative-care needs of patients with moderate and severe chronic obstructive pulmonary disease. The main ethical challenge encountered related to problems surrounding the use of terminology, specifically the terms ‘palliative care’ and ‘chronic obstructive pulmonary disease’. The approving ethics committee specified that these terms be removed from all patient materials in order to protect patients from undue distress. The impact of this ethical advice on patients’ ability to give fully informed consent is discussed. This paper highlights a requirement for appropriately resourced and well-managed studies in palliative care, and identifies a need for the development of appropriate strategies in order to ensure the informed participation of patients with non-cancer diagnoses in palliative-care research.

The informed consent doctrine is based on the idea that an individual possesses the right of self-determination and therefore should retain control over his or her own body. For consent to be valid, the patient must have the capacity to consent, and give the consent knowingly, and voluntarily. In defining these terms and developing guidelines for the implementation of the informed consent doctrine, the law has made many assumptions regarding human behavior. Three of these assumptions became the foci of this study. First, the law assumes that minors lack the overall competence necessary to render legally valid consent. Second, it is assumed that the provision of all treatment information will interfere with the individual's ability to provide a valid consent. And finally, it is assumed that physicians disclose treatment information in a neutral fashion. The purpose of this study was to examine the impact of the variables: age, information provided, and professional recommendation in the context of the first two components of the informed consent doctrine, capacity and knowledge. In addition, this study investigated the relationship between these variables and the treatment decision made. Sixty junior high school students and sixty college students were randomly assigned to one of six treatment variations in which the amount of information provided and the professional recommendation varied. The groups in each variation listened to two treatment dilemmas. One involved the problem of depression while enuresis was the topic of the second. The dependent measures included (1) the Capacity Scale, (2) the Knowledge Scale, and (3) the Choice Scale. It was found that adults scored significantly higher on the Capacity and Knowledge Scales than minors. Detailed information did not improve nor decrease subjects' Knowledge Scale scores. In addition, professional recommendation was found to significantly affect treatment choices made by subjects. The results was discussed in relation to the legal assumptions underlying the doctrine of informed consent as well as their implications for future research.

Orientadores: Ellen E. Hardy, Maria Jose Duarte Osis / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-11-09T15:33:56Z (GMT). No. of bitstreams: 1 Bento_SilvanaBento_M.pdf: 941638 bytes, checksum: db46ec0ea7c28aec47376a653ccf046c (MD5) Previous issue date: 2006 / Resumo: Os documentos nacionais e internacionais que estabelecem as normas que regulamentam as pesquisas em seres humanos, fazem menção ao consentimento informado. O consentimento de um possível voluntário para participar de uma pesquisa deve ser obtido através de um processo que permita à pessoa compreender as informações dadas. Esse processo envolve respeito mútuo, diálogo, paciência e persistência. Começa no primeiro contato do pesquisador com o possível participante e continua durante todo o estudo. No Brasil, a Resolução 196/96 determina que toda pesquisa que envolva seres humanos deve ter um Termo de Consentimento Livre e Esclarecido (TCLE) a ser assinado pelos sujeitos. Objetivo: Identificar as informações que as mulheres ¿ possíveis voluntárias - gostariam de receber antes de aceitar participar ou não de uma pesquisa, bem como o que pensam com relação ao processo a ser seguido para obter seu consentimento. Conhecer a opinião de mulheres voluntárias de um ensaio clínico sobre que informações gostariam de receber e sobre como deveria ser o processo de obtenção do consentimento informado. Sujeitos e Método: estudo qualitativo, utilizando a técnica de grupos focais. Realizaram-se oito grupos com mulheres, moradoras da Região Metropolitana de Campinas e que estavam participando ou haviam participado de um ensaio clínico na área de saúde da mulher nos doze meses anteriores ao estudo. Ao todo participaram 51 mulheres, alocadas em grupos distintos conforme a idade e a escolaridade. O roteiro para as discussões abordava questões sobre quais informações mulheres convidadas a participar de uma pesquisa sobre um método contraceptivo gostariam de receber, e como achavam que essas informações deveriam ser dadas. As discussões nos grupos foram gravadas e transcritas para realizar a análise temática de seu conteúdo. As categorias de análise estudadas foram: profissional que deveria fornecer as informações sobre a pesquisa, atitude do profissional, quantidade de informação, forma de passar a informação, informações que gostariam de receber, recursos didáticos que poderiam ser utilizados. O projeto de pesquisa foi aprovado pelo Comitê de Ética em Pesquisa da Faculdade de Ciências Médicas da Unicamp. Resultados: Na opinião das participantes, em geral, quem deve convidar uma mulher para participar é um membro da equipe de pesquisa e não o pesquisador responsável, por estar ocupado e distante da realidade delas. As informações deveriam ser dadas oralmente e por escrito, individualmente e em grupo. As participantes entendiam que não existe uma quantidade de informações específica a ser dada aos possíveis sujeitos de pesquisa. Enfatizaram que o mais importante não é a quantidade de informações, mas a maneira como são dadas, de forma clara e objetiva para que as mulheres as entendam. Segundo elas, para poder tomar uma decisão consciente, as possíveis voluntárias de uma pesquisa devem ser informadas, entre outros aspectos, sobre os riscos, possíveis efeitos colaterais e desconfortos, inclusive a longo prazo. Sugeriram o uso de recursos audiovisuais: vídeos, cartilhas e folhetos. Conclusão: As informações que as mulheres, possíveis voluntárias, gostariam de receber são, em geral, as mesmas estabelecidas pela Resolução 196/96. Elas não consideraram o processo de obtenção do consentimento como um mero ritual, mas como um meio de estabelecer um vínculo entre as possíveis voluntárias e o pesquisador/ equipe de pesquisa. Além disso, consideraram que os recursos audiovisuais facilitariam a compreensão das informações / Abstract: The national and intemational documents that establish the norms regulating research with human subjects refer to informed consent. The agreement of a potential volunteer to participate in research should be obtained by means of a process that ensures that the person understands the information given. This process involves mutual respect, dialogue, patience and persistence. It begins with the first contact of the investigator with the potential participant and continues throughout the study. In Brazil, the Resolution 196/96 determines that ali research involving human subjects should have an Informed Consent form to be signed by the subjects. Objective: To evaluate the opinion of women regarding the information they would like to receive before accepting or refusing to participate in a study, as well as how the process to obtain informed consent should be conducted. Subjects and Methods: This was a qualitative study carried out with the focus group technique. Eight focus groups were carried out with women who lived in the Metropolitan Region of Campinas (São Paulo state, Brazil) and who were participating or had participated in a clinical trial in the field of women's health during the twelve-month period preceding the investigation. Fifty one women participated, divided into distinct groups according to age and schooling. The discussion guide included questions on what information women invited to participate in a study on a contraceptive method would like to receive, and how they believed this information should be provided. Group discussions were tape recorded and transcribed for subsequent thematic analysis. The categories of analysis studied were: professional who should supply the information on the study; attitude of that professional; amount of information to be provided; manner in which the information should be given; information they would like to receive; teaching aids that could be used. The research project was approved by the IRB of the School of Medical Sciences of the Universidade Estadual de Campinas (Unicamp). Results: According to the participants, in general the person who invites a woman to participate should be a member of the research team - and not the principal investigator, who is busy and distant from the women's reality. The information should be given orally and in writing, individually and in a group. The participants believed that there is no specific amount of information to be given to potential study subjects. They emphasized that the amount of information was not the most important but, rather, the process followed to provide it, clearly and objectively so that the women understand. consent as a mere ritual, but as a means to establish a bond between the potential volunteers and the investigator/research team. Furthermore, they believed that audiovisual . aids would facilitate the understanding of the information provided. / Mestrado / Ciencias Biomedicas / Mestre em Tocoginecologia

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.

Background: Informed consent is the autonomy of the patient who involves decision-making after being informed of and understanding the physician. Objectives: This study sought to investigate and compare patients¡¦ and physicians¡¦ perceptions of informed consent and the factors that influence their viewpoints on informed consent. Methods: The subjects were citizens without medical background and physicians working in four hospitals. Self-structured questionnaire was used to gather information. The physicians were recruited from two medical centers, a regional hospital and a district hospital in Kaohsiung. The data is analyzed by SPSS 14.0 and used descriptive statistics, item analysis, factor analysis, chi-square test, Fisher's exact probability test, t-test, and ANOVA. Results: The response rates were 97% in citizens (n=891) and 79 % in physicians (n=158). As for the concept of informed consent, 55.7% citizens thought that doctor should respect the opinion from the patient and family during the informed consent process. Furthermore, 91.2% the citizens prefer to know the information about their health condition from the physicians rather than from family (8.8%). Regarding the sequence of informing the physical condition, 29.9% citizens also prefer directly from the physician. As for the decision-making process, 55% respondents thought that patient¡¦s own decision is the most important. 52.5% physicians thought that doctor should respect the opinion from both the patient and family and the bad news should be informed by physicians (88.0%) rather than by family. As for the sequence of knowing the bad news, 46.2% physicians preferred to inform family first and inform patient after discussing with family. In decision-making process, 48.7% physicians thought that physician¡¦s opinion was still more important than opinion of patients and family. Further analysis revealed that patients¡¦ gender and the level of family visited hospital have significant difference on the perception of informed consent (p=0.027; p=0.000); gender, age, educational background and living locations also have significant difference on ¡§who to deliver the bad news.¡¨ (p=0.006; p=0.004; p=0.035; p=0.012); Citizens¡¦ age, educational background and career have significant influence on their opinion of informed consent of recently visiting doctor (p=0.014; p=0.006; p=0.001). The variables in the physicians¡¦ background have no relation with the means of informing and decision-making. The gender and position of the physician have significant effect on the opinion of practice of informed consent (p=0.015 and p=0.001). Conclusions: We concluded that the perceptions of informed consent, there was no difference between physicians and citizens; however the citizen chose the patient first, and the physician chose the family first during the process of informed consent. Physicians have better perceptions of informed consent than the common citizens.

Thesis (Ph. D.)--UCLA, 2009. / Vita. Description based on print version record. Includes bibliographical references (leaves 149-151).

Professionals whose job it is to counsel patients must be cognizant of the role played by communication in the establishment of a trusting working relationship. This is no less true for those within the medical community who must obtain informed consent for surgical interventions than it is for those working within the area of mental health. In order to determine what role communication plays in the obtaining of informed consent within a pediatrics setting, a qualitative study was conducted of 20 surrogates (those individuals giving consent on behalf of legally incompetent children) and of 5 surgeons performing surgical interventions on those children. Two sets of questionnaires were administered in order to elicit information pertaining to how surgeons communicate information to surrogates and to investigate how that information is received and processed by the surrogate. Results showed that while the obtaining of signed informed consent itself may not be a major problem, there are some difficulties in the communication between surgeons and surrogates in this domain. Based on the findings, recommendations for improved communication between surgeons and surrogates are proposed.

Informed consent is a requirement by law. Informed consent is a two part process: giving the patient sufficient information so that an educated choice can be made and obtaining assent in writing (Coy, 1989; Fiesta 1991; Sweeney, 1991;). The purpose of this study is to determine the ability to recall information and the perception of patients about the process of receiving information after signing a consent to participate in a large research trial. Patients signing consents for participation in the Breast Cancer Prevention Trial were asked to complete the surveys. Thirty three patients were asked to complete the questionnaires. Twenty - four (72%) of the respondents returned the completed questionnaires. Confidentiality will be maintained since no names or identifying markers will be used.A modified Patient Recall Survey (Casselith, Zupkis, Sutton - Smith, & March, 1980) and a modified Consent Form Survey (Casselith et al, 1980) were used. The significance of the study is that the results will assist in improving the type of information given to patients and how that information is provided. By increasing patients awareness about the need for and rights of giving informed consent patients will be more knowledgeable health care consumers. Imogene King(1981) provides the theoretical framework for this study using the concept of perceptions as the basis.The first research question illustrated that the majority of the respondents were able to recall at least three risks or complications of participation in the Breast Cancer Prevention Trial. The second research question revealed eighty - seven percent of the patients agreed that informed consents are necessary. However, 27.8 % of the respondents perceived the informed consent as a legal document to protect the physician rights, while only 19.6 % felt that the consent represented a legal document to protect patient rights. Eighty three percent of the respondents understood that a consent did not have to be signed. However, responses to a second question revealed only 21.3 % understood that the informed consent was a chance to refuse or change treatment. Results to research question 3 illustrated that patients felt that informed consents are necessary. Finally, 79.2 % of patients reported that nurses provided the majority of informed consent information. When patients are able to understand and participate in health care decisions, patients will feel more control in determining outcomes. / School of Nursing

Informed consent, based on patient autonomy, is seen as necessary if medical interventions are to be seen as legally and ethically acceptable. While 'informed consent' protocols within antenatal care, including prenatal screening regimes are presumed to be robust, emerging research outside of Australia suggests most women do not adequately understand the medical purpose, limitations or potential ethical implications, such as selective termination, of the medical procedures 'consented' to. While the consent given in these situations may well fulfil the minimal legal criteria for informed consent, the required level of knowledge and understanding necessary to meet the ethical standards informed or understood consent often appears not be met. The presumption that legally informed consent equates to morally informed consent inherent within institutional protocols for screening must therefore be questioned, and the ethical integrity of these increasingly routine interventions demand further scrutiny. The purpose of this research was to explore whether the problems identified in research overseas might also exist locally. Underpinned by a phenomenological philosophical approach to understanding the ethical dimensions of clinical practice, the research sought to engage with a small cohort of mothers and practitioners locally. The study adopted a qualitative narrative methodology, analysing individual in-depth interviews using the Listening Guide (Gilligan et al, 2003). The experiences of mothers and health practitioners interviewed exposed a range of institutional, social, personal and philosophical constraints that mirrored the overseas research findings and also illuminated how informed consent may be unintentionally undermined in the clinical setting. A positive outcome of the study was that it provided a locally informed and contextually sensitive basis from which to strengthen existing organisational informed consent protocols and thus support women's ethical decision making. As the process of becoming 'informed' to consent is largely educational, promoting patient learning in the clinical context is an ethical imperative. However, there seems limited awareness at either the clinical or theoretical level of the critical link between patient education and ethically robust medical intervention. Hence a significant contribution of this research was to explore this underdeveloped but practically important link. As the process of gaining informed consent has far reaching applications across a broad spectrum of medical interventions, the contextual and educational insights offered throughout this research may have significant relevance beyond the immediate context of this research.