Medical decision making is complicated and requires a full understanding of the options being presented. It is easy as a practitioner to assume that a patient has capacity, when in fact they might not. Evidence indicates that frequently with the best intentions, health care practitioners allow people to make medical decisions when they do not understand the implications of that choice. I believe that this happens when practitioners feel that the patient is autonomously making a choice that promotes beneficence. This too creates an ethical dilemma, as it does not fully promote autonomy if the patient does not have capacity to make the decision. I believe that further reflection can help physicians understand what motivates their patient’s, and their own, decision making. / Urban Bioethics

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.

This qualitative action research concentrates on examining the best practices for teachers in trauma-informed practices by producing an implementation guide to train the trainer. The theoretical framework utilized to help inform the development of this research was Bronfenbrenner’s ecological systems theory (1989) in relation to human development for identifying the emerging best practices with being trauma informed. The scope of this research focuses on low-socioeconomic status (SES) urban youth, so cultural sensitivity is naturally always a component of a complete train-the-trainer, trauma-informed teaching program. I identified the emerging best practices in two ways: (a) by gathering and summarizing supporting sources of literature and (b) by holding collaborative conversations with acknowledged experts in culturally competent trauma-informed training. The findings revealed six components essential to prepare the trainer on trauma-informed education training. First, culturally responsive pedagogy and culturally responsive teaching were identified to aid in bridging the gap in providing support. Social capital based upon lived experiences of students was recognized by acknowledging their needs through appropriate modeling of positive attitudes and behavior while increasing confidence in student learning using inclusive resources demonstrated throughout academic content. Next, the key principles of brain science were acknowledged showing a relationship between impact of trauma and learning affects such as: processing, decoding, self-regulation, and impulse control. Then, mental health was addressed to show there is an impact of negative interactions and disciplinary actions, according to Bronfenbrenner’s (1979) ecological systems theory. Attitude and language were acknowledged as both verbal and non-verbal and having an impact on instructional behavior, which influences student climate in learning and behavior. Lastly, the equity and accountability components were identified to require teachers to move away from implicit bias issues by creating more cultural-normative behavior through designing more restorative practices while building partnerships with students and families alike. The result of this action research provided a set of emerging best practices embedded in the implementation guide to support the trainer in training educators on how to teach trauma-impacted youth in California’s culturally diverse public-school classrooms.

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.

Univerzita Karlova v Praze Právnická Fakulta Katedra trestního práva Centrum zdravotnického práva Lukáš Malý The Informed Consent, particularly the criminal aspects Thessis Short summary This thesis deals with a current problem of informed consent of a patient to a medical treatment, with a special regard to aspects of such consent pertaining to criminal law. Current healthcare in a vast majority of modern countries is based on the principle of informed consent. Following an introductory review of the history of the physician-patient relationship, the current legislation surrounding the informed consent is analyzed. These laws are undergoing major changes as this thesis is being finished, giving me the chance to describe both past and future legal regulation. I proceed to describe in detail when the informed consent is required, in what form must it be granted and what sort of medical information is needed to be given to the patient prior to his decision. To adequately weigh the aspects of criminal responsibility in relation to informed consent, the analysis of all possible forms of legal responsibility is performed, with some comparisons to relevant criminal regulation in other countries being made.

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.

acase@tulane.edu / The current study examined the impact of a professional development training in trauma-informed approaches on teacher attitudes. The current study had two main purposes: first, to determine whether two components of attitudes, perception of the problem and self-efficacy, became more trauma-informed among teachers following a professional development training; and second, to investigate whether that change in attitudes was linked to initial levels of familiarity with trauma-informed approaches and/or years of experience. Teachers from 6 schools that are part of the New Orleans Trauma-Informed Schools Learning Collaborative participated in the study (N = 163; 68.7% female, 58.9% White). Teachers filled out demographic information and completed the ARTIC scale (Baker, Brown, Wilcox, Overstreet & Arora, 2015) both before and after training. A paired-samples t-test revealed that perception of a problem and self-efficacy among teachers did become significantly more aligned with trauma-informed approaches following the training. However, contrary to the hypothesis, familiarity and years of experience did not moderate perception of a problem or self-efficacy. Regardless, these results have important implications for the trauma-informed schools movement as they show that PD trainings can positively impact teacher attitudes, potentially increasing teacher motivation to carry out trauma-informed practices in the classroom. / 1 / Juliana Vanderburg

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