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

The thesis analyzes the requirement-based childhood vaccination programs of Ontario, New Jersey and the recommendation-based programs of UK and Australia. It complicates the prima facie distinction between the requirement and recommendation-based programs by applying the common law requirement of the voluntariness of consent to the vaccination programs. In particular, the voluntariness light is shone on the nature of the “requirement” and “recommendation” to vaccinate distinction; exemptions from the requirement to vaccinate; the choice to refuse vaccination; and financial incentives to doctors and parents. The thesis concludes that on a spectrum of “most voluntary” to “least voluntary,” the aforementioned programs would be located close to each other in terms of actual, practical presence of voluntariness, demonstrating the complexity of the dichotomy between the requirement and recommendation-based vaccination programs.

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.

Obtaining a patient’s informed consent to treatment is an expected component of clinical interactions. The notion that a person as an autonomous being has a right to decide whether or not to consent to medical treatment from an informed basis has its origins in both law and ethical theory. In this research I investigate the issue of informed consent from two overall perspectives. The first concerns its basis in ethical theories of autonomy and its interpretation by the law and by health professional guidelines. The second involves an empirical examination of its occurrence within the communicative interaction between a physiotherapist and their patient, and its interpretation by the physiotherapist. I use qualitative research methods involving analysis of individual audio-taped treatment encounters in private physiotherapy practice and interviews with the treating physiotherapist. A central tenet of this study is that the translation of both legal and ethical criteria into the context of the clinical encounter requires a process of negotiation and communicative interaction between the patient and health professional. This research seeks to understand this process, and the factors that influence it in the specific context of physiotherapists and the private practice clinical encounter. (For complete abstract open document)

Tissue banks are thought to be an essential resource for medical research in the post-genomic age. Collections of tissue, usually removed in the course of diagnostic or therapeutic procedures, enable laboratory-based epidemiological studies to be carried out, linking abnormalities in the tissue to disease aetiology, prognosis and treatment responsiveness. There are, however, a number of technical, regulatory and ethical concerns that challenge those wishing to engage in tissue banking research. It is becoming increasingly apparent that tissue banking research is not without risk of harms, even though there is no direct physical risk to donors. This is because, in order to be most useful, banked specimens need to be linked to personal information about tissue donors and this poses the risk of inadvertent disclosure of personal─ particularly genetic─ information to those who might exploit such information (eg. insurance companies and employers). Furthermore, the long-term storage of specimens, and the impossibility of predicting all potential types of research programs for which they might be useful, raises the possibility that future projects will be carried out that are unacceptable to some (past) tissue donors. The ethical principles of autonomy and respect for persons demand that research subjects be informed of such risks and of the nature of the research, and that they participate willingly. On the other hand, there is a desire for science to progress unhindered by stringent consent requirements. For these reasons, a debate has emerged in the academic (bioethical and biomedical) literature and in the legal (law reform) sphere over what would constitute adequate consent. Despite an extensive discourse, it is still unclear whether it is permissible to carry out research on archival tissue that was originally taken for diagnostic purposes and whether project-specific (as opposed to open-ended) consent is required for research on tissue collected today. This lack of clarity is of concern to researchers, ethics committees and research subjects, all of whom recognise the importance of tissue banking research, yet fear that current consent procedures may be ethically or legally inadequate. Thus it is important that the consent dilemma be resolved as quickly and definitively as possible. Ongoing controversy and regulatory ambiguity are appropriate when morally contentious issues are at stake, and their existence does not, on its own, signal any flaws in the discourse process. There are, however, two reasons to suspect that the current �consent to tissue banking� debate, as portrayed in the academic literature and law reform documentation, is problematic. Firstly, the debate appears to be mired in an intractable conflict between those who want to maximise personal autonomy through stringent consent requirements, and those who want the scientific endeavour to progress in a manner that is unconstrained by what are viewed as arduous consent procedures. Secondly, the possible practical options (consent models) being generated by the debate are all limited because they are underpinned by a restricted notion of consent as an individualistic, legalistic and static activity, without consideration of any alternative conceptualisations of consent. Through a thematic analysis of the current �consent to tissue banking� debate in the academic and law reform literature (Section 3), this thesis shows that debate is essentially occurring between those who see individual autonomy (and stringent consent) as being of primary importance, and those who see unimpeded, market-driven scientific progress as the more important social good, which should not be impeded by unnecessarily stringent consent. Thematic analysis also confirms the existence of the two problems described above, and a failure of those engaged in the debate to reflect on, and challenge, the value-level assumptions underpinning their arguments and those of their opponents. It is argued that this lack of reflection accounts for the two problems: � Firstly, it precludes recognition of the cause of─ and, therefore, ways of resolving─ the intractable conflict at the centre of the debate. Value-level reflection shows that this is a result of the logical and moral conflict within western liberalism, between two modernist goods: individual freedom and scientific progress. � Secondly, it precludes the generation of varied conceptions of consent. Value-level reflection shows that the current range of consent models is restricted to procedures which are individualistic, abstract, static and legalistic, since they are underpinned by western liberal notions of autonomy and scientific progress. This recognition paves the way to consideration of alternative notions of autonomy, scientific progress and, therefore, consent, such as those derived from communitarian and feminist systems of values. A conceptually enriched model of tissue banking consent is then developed (Section 4). This model incorporates dominant (liberal) conceptions of autonomy and scientific progress as well as alternative notions of autonomy and scientific progress espoused by communitarian and feminist systems of values. It is argued that this conceptually-enriched model provides a practical solution to the two problems associated with the standard �consent to tissue banking� debate. In relation to the philosophically intractable conflict─ or what is termed the �modernist dilemma�─ between those privileging autonomy and those privileging scientific progress, it shows how the two apparently conflicting �modernist� goods can both be accommodated at a practical level, thus making the �consent to tissue banking� debate more tractable and fruitful. In relation to the restricted range of consent models being generated by the current debate, it provides new insights into the ways in which consent might be obtained such that a broader range of community values can be accommodated. More specifically, it stimulates the construction of a model that 1) involves communities, as opposed to merely individuals, in all stages of the scientific process; 2) is flexible and able to adapt consent procedures to specific contexts, rather than predefining procedures in abstract terms; and 3) is transactional and relational rather than static and legalistic. This outcome has interesting philosophical as well as practical implications. It shows that despite apparently unresolved, and possibly irresolvable, normative-level conflicts between the two modernist elements of western liberalism (autonomy and scientific progress), and between liberal, feminist and communitarian systems of values, a multi-perspectival, inclusive, model-building approach provides a practical solution that circumvents these normative-level conflicts.

Thesis (Ph. D.)--University of North Texas, May, 2008. / Title from title page display. Includes bibliographical references.

Thesis (J.C.L.)--Catholic University of America, 1997. / Includes bibliographical references (leaves 73-77).

Thesis (M.A.)--Ohio State University, 2009. / Title from first page of PDF file. Includes vita. Includes bibliographical references (p. 56-57).

Thèse - Caen - Droit, 1925. / Contient une bibliographie.

Proefschrift Universiteit Maastricht. / Auteursnaam op omslag: Ron Schellings. Met lit. opg. - Met een samenvatting in het Nederlands.