This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy

This thesis began with a research project on suicide that was abandoned after many hurdles were encountered in terms of reaching participants and after various applications to ethics committees. The ultimate research question was then recast as ‘Do Human Research Ethics Committees influence the conduct of suicide research in Australia?’ The conceptual framework for setting up the research was derived from literature on Critical Theory, Feminism and Weberian concepts of power and rationality. Subsidiary questions were then derived from this literature and the starting exemplar case of my own research attempts. These considered whether suicide research was problematic for ethics committees, the nature of the experiences of ethics committee members in making decisions regarding suicide research and whether the influences of disciplinary background, patriarchal medical dominance and pro-positivism were evident. In addition, questions were raised about whether and how other researchers who sought approval to conduct research into suicide-related issues were appraised. [...] / Doctor of Philosophy

published_or_final_version / Medical Sciences / Master / Master of Medical Sciences

The purpose of the study was to examine critical care nurses' perceptions of the usefulness of hospital ethics committees as a coping strategy for resolving ethical dilemmas. The conceptual framework was Lazarus and Folkman's theory of stress, appraisal, and coping (1984).The convenience sample was five critical care nurses from five midwestern hospitals. Confidentiality was maintained by identifying participants as numbers.The research design for the study was an exploratory case study. The research question, nurses perceptions' of the usefulness of hospital ethics committees as a coping strategy to resolve ethical dilemmas, was analyzed using a qualitative methodology. Findings indicated that the nurses did not perceive hospital ethics committees as useful resources in ethical conflicts. Barriers to use of committees included lack of education about the committees, lack of timely intervention by committees in a crisis and risks involved in confronting physicians via committees.Conclusions were that ethics committees were not fulfilling a role as support systems empowering nurses to act as patient advocates in ethical dilemmas. Results can be used to develop strategies to increase the ethics committees' effectiveness in ethical dilemmas. / School of Nursing

Thesis (M.S.I.S.)--Baylor University, 2009. / Includes bibliographical references (p. 59-60).

<p>We now live in an era of experts on virtually everything, among which we have professional medical ethicists, who gained prominence in the late 60s due to dramatic advances in medical technology. Before then, medical ethics issues were not thought as separable from the warp and woof of the everyday life. Medical technology’s advancement cascades legions of moral problems in medicine and biomedical research. Series of innovative interventions in medicine raise throngs of ethical questions. In most cases that have to do with issues of life and death, there are perceived moral conflicts. Due to this swath of problematic issues that need solutions, some apologists favour medical ethics experts as fit for the job, while critics argue that no one has the knowledge or skill for dealing with moral quandaries because objective truth is not feasible in ethics and moral judgment is relative to cultures, beliefs and values. The necessity for medical ethicists to take active role in Medical Ethics Debates, either in Committees at the institutional level, or at any other decision-making mechanisms is justified in this thesis. In addition to this, the thesis also justifies medical ethicists’ role as expert consultants to clinicians and individuals alike This justification is based on complex moral problems accentuated by medical technology, which are far from being easily solved through mere appeal to individual reason, but rather by involving medical ethicists based on their specialized knowledge and high level understanding of research and practice. Although critics question the authority with which experts speak on these issues, nevertheless, the thesis unravels the roles, functions, significance and components of expert’s expertise that separate him/her from the crowd. Arguments are critically analysed and medical ethicists’ limits and professional flaws are addressed, with a view to establishing a virile foundation for the profession of medical ethics.</p>

We now live in an era of experts on virtually everything, among which we have professional medical ethicists, who gained prominence in the late 60s due to dramatic advances in medical technology. Before then, medical ethics issues were not thought as separable from the warp and woof of the everyday life. Medical technology’s advancement cascades legions of moral problems in medicine and biomedical research. Series of innovative interventions in medicine raise throngs of ethical questions. In most cases that have to do with issues of life and death, there are perceived moral conflicts. Due to this swath of problematic issues that need solutions, some apologists favour medical ethics experts as fit for the job, while critics argue that no one has the knowledge or skill for dealing with moral quandaries because objective truth is not feasible in ethics and moral judgment is relative to cultures, beliefs and values. The necessity for medical ethicists to take active role in Medical Ethics Debates, either in Committees at the institutional level, or at any other decision-making mechanisms is justified in this thesis. In addition to this, the thesis also justifies medical ethicists’ role as expert consultants to clinicians and individuals alike This justification is based on complex moral problems accentuated by medical technology, which are far from being easily solved through mere appeal to individual reason, but rather by involving medical ethicists based on their specialized knowledge and high level understanding of research and practice. Although critics question the authority with which experts speak on these issues, nevertheless, the thesis unravels the roles, functions, significance and components of expert’s expertise that separate him/her from the crowd. Arguments are critically analysed and medical ethicists’ limits and professional flaws are addressed, with a view to establishing a virile foundation for the profession of medical ethics.

Aim: Whilst there is a wide range of research that explores ethics guidance and committee perspectives of research ethics processes, there is a lack of research into trainee experiences. The aim of this study was to explore Trainee Clinical Psychologists experience of the research ethics process and provide a platform to those voices. It was hoped that this research may be able to create a deeper understanding of applicants’ experiences, in which both positive and negative experiences of the application process can be shared and explored. This understanding could then potentially support ethics committees, training courses and applicants to work together and thus improve the application process and resulting research at a national level within the context of Clinical Psychology training. Method: This study adopted a qualitative approach in conducting semi-structured interviews with three Trainee and three Newly Qualified Clinical Psychologists who had applied for ethical approval for their Doctoral thesis. Interpretative Phenomenological Analysis (IPA) was used in an attempt to illuminate the lived experience of applying for research ethical approval. Results: From the analytic procedure, three main themes emerged regarding the experience of research ethics processes from participants’ accounts: The emotional intensity and personal impact of the ethics process; Responses to and ways of managing the ethics process; and Challenges within the ethics process. Implications: This study highlights the importance of recognising the impact of the relationships between Trainee Clinical Psychologists, Clinical Psychology training courses and Research Ethics Committees upon trainees’ journey through the research ethics process. A ‘them and us’ dynamic is being maintained by misunderstandings about each other’s roles, uncertainty and stereotyping, amongst other factors. Potential ways to change this dynamic and improve the research ethics process during clinical Psychology Training has been explored.

El presente trabajo constituye una investigación sobre las razones de la tendencia, existente en la actualidad, a una creciente regulación de carácter ético y deontológico en el campo particular de la medicina (a través de la proliferación de códigos éticos y deontológicos, creación de instituciones de control (bio)ético, procedimientos protocolizados de decisión en ética clínica, etc.), paralelamente a una creciente externalización por parte del Estado de las funciones normativas y potestades decisorias a sujetos, organismos y corporaciones privadas. Este análisis del auge de la bionomía ética, y de diferentes formas de codificación ética, centra su atención, por un lado, en la llamada «sociología del riesgo» -que estudia el fenómeno de los riesgos tecnológicos y, entre otros aspectos, las respuestas jurídico-políticas que se dan a ellos-, particularmente sobre los avances en medicina, biotecnología e investigación clínica y farmacéutica. Por otro lado, dicho análisis se centra en el fenómeno de la penetración, en el campo de autonomía de poder médico y tecno-científico, de la lógica del mercado y su sistema de poder decisorio. El presente trabajo concluye que ese fenómeno autorregulatorio ético de las profesiones y corporaciones médicas y tecno-científicas crece a costa de una creciente evasión de una regulación jurídico-pública de las actividades tecno-científicas en el campo de la medicina: un mínimo jurídico-público frente una máxima autorregulación ética con implicaciones en las garantías jurídico-públicas y en el proceso de democratización de los Estados. / ETHICS WITH CODES: A PHILOSOPHIC AND JURIDICAL ANALYSIS OF DEONTOLOGICAL RULES IN MEDICINE AND HIS RELATIONS WITH THE LEGAL SYSTEM AND THE STATE This work constitutes an investigation about the reasons of the current tendency to an increasing ethic and deontological regulation in the specific field of medicine (through the proliferation of ethical -deontological- codes, the creation of (bio)ethics institutions of control in medicine issues, protocolized proceedings of taking decisions in clinical ethics, etcetera), in the line with a growing externalization by the State of the regulation function and authority decisions to private subjects, organizations and corporations. This analysis about the growth of bioethic rules and different shapes of ethic codification, focuses, on one side, on the called «risk sociology» -that studies the technological risks phenomenon and, among other things, the legal and political answers to it-, especially about the medical and biotechnological advances and clinical and pharmacological investigations. On the other side, this analysis is centered on the phenomenon of the penetration of the market logic and its decision power system on the medical and on the scientific and technical autonomous field. This work concludes that this phenomenon of ethic self-regulation of the medical profession and medical, technical and scientific corporations, growths at expense of an increasing evasion of a legal and public regulation of the technical and scientific activities in the sphere of medicine: it produces a minimum of public law in front of a maximum of ethic self-regulation with implications in the legal and public guaranties and in the democratization process of the states.

The Council of Australian Therapeutic Advisory Groups (CATAG) (2013) define a Pharmaceutical and Therapeutics Committee (PTC) as a ‘multi-disciplinary team committee with a commitment to the overall governance of the medicines management system in health service organizations to ensure the judicious, appropriate, safe, effective and cost-effective use of medicines’. The multi-disciplinary team includes the health care providers, who are actively participating in the health care systems, such as doctors, pharmacists, nurses, administrators, finance officers, quality improvement managers and other staff members who participate in the medicine use processes according to their knowledge and skills. The major role of this committee is to evaluate and promote rational drug use by health care providers and consumers. In addition, this committee is responsible for developing systems and strategies to prevent adverse medicine reactions and medication errors, enhance rational prescribing and dispensing, provide educational activities and ensure the use of quality and cost-effective medicines. This is a cross-sectional study that was aimed at exploring the structure, activities and functions of public sector institutional Pharmaceutical and Therapeutics Committees (PTC) in the Eastern Cape (EC) Province in South Africa (SA). The primary objectives of the study were to (i) investigate and describe the structure, functions and the activities of the institutional PTCs, and (ii) explore and describe the perception of PTC secretariats on the functionality of the institutional PTCs. A purpose-designed questionnaire including both quantitative and qualitative aspects adapted from other international studies was piloted prior to being used for data collection. The secretariats of the institutional PTCs were requested to complete the questionnaire. Data were analysed using descriptive statistics for the quantitative aspects and thematic analysis for the qualitative component of the questionnaire. Data collection commenced after approval by the relevant ethics committees had been granted. The findings of the study reflected that the majority of the PTCs in the EC province, SA are district/sub-district PTCs which are a cluster of a number of health care institutions in close proximity. The PTC members were appointed by the executive authority as recommended by the literature and other guiding documents. As expected the nurses were dominant as the members of the PTCs in these district/sub-district PTCs. The secretariats were the pharmacists where pharmacists were available and chairperson were doctors. These findings correspond to the recommendations by the National Department of Health PTC policy (2015) and the studies conducted in other countries. A number of PTCs had sub-committees formed e.g. ABC analysis review committee, medicine utilization evaluation (MUE) committee and pharmacovigilance committee to optimise their functionality. Out of 15 PTCs only five PTCs with sub-committees reported functions and interventions, establishment of policies and SOPs. The rest had no outcomes or interventions reported. Poor production of policies and SOPs was observed which differs from other countries’ PTCs. The focus of sub-committees in other countries is the development of formulary and policies related to medicine use. These findings pose a question regarding the functionality and effectiveness of the existing institutional PTCs in the province. In addition, the basic documents that are required to run the PTC were unavailable in a number of PTCs. Barriers to the functionality of PTCs were reported i) Lack of pharmacists and training in PTCs. ii) The rural nature of the EC province and iii) Unavailability of resources including lack of re-imbursement of personal costs. These findings reveal that budget allocation for institutional PTCs is crucial for their functionality. It can be concluded that in the EC province the institutional PTCs which are active and effective are low in number and do not cover all geographical areas. Secondly there is a need for training and educating the PTC members on the role of the PTC members, role of sub-committees, development of policies, SOPs and the basic documents for the functionality of the committee. It is also important that during training the monitoring and evaluation of the effectiveness of the committee is emphasised. Therefore, the choice of the PTC objectives should be measurable as they can assist as indicators of effectiveness. Support by the executive authority has been observed.