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.

Islam, its texts and lived practice, finds growing importance within the global discourse on bioethics, as there is an increasing Muslim population and burgeoning interest in biomedical research and biotechnologies in the Muslim world. The aim of this thesis is to assess if and how Islam influences the ethical decision making of researchers, REC (researcher ethics committee) members, guideline developers and Islamic scholars in the biomedical research context. I began addressing this question by first reviewing the literature that has been published to explore the role that Islam plays in the literature on biomedical research ethics. There is evidence that some Muslim countries have developed "Islamic" guidelines. That is, guidelines with the explicit aim of setting out Islamic values and stating their relevance to the ethics of research. A review of research guidelines employed within countries with a significant Muslim population, was carried out, to investigate the role of Islam in such guidelines. The literature and guideline review revealed that although international guidelines have been adapted to incorporate Islamic views, studies have shown that the latter are of limited practical application within a "Muslim country" setting. An empirical study was carried out in two case study sites to assess the extent to which Islam influences ethical decision making within the context of biomedical research. 56 semi-structured interviews were carried out in Malaysia (38) and Iran (18) with researchers, REC members, guideline developers and Islamic scholars to understand whether Islam influences what they consider to be an ethico-legal problem, and if the latter emerges, then how such issues are addressed. The empirical study indicates five main conclusions. The first is that Islam and its institutional forms do impact ethical decision making in the day-to-day practice of biomedical research in countries with a Muslim population and/or in the research careers of Muslim researchers. Secondly, it shows that there are many distinctive mechanisms, such as the involvement of Islamic scholars, the process of ijtihad (independent reasoning) and the production of fatawah (legal edicts), by which Islam does identify and develop ethical views about biomedical matters. Thirdly, HIV/AIDS poses major challenges to the world of Islam as it does the rest of world. The epidemic raises issues that touch on cultural sensitivities that are important to Islamic societies and this study has shown that no simple or single response was observed to the ethical issues arising from HIV/AIDS. Fourthly, researchers face practical challenges when deliberating women's autonomy in contexts where Islam is appropriated within 'male dominated' contexts. The role and status of women is disputed in such contexts with views ranging from women needing their husband's permission to leave the home to men and women having equal freedoms. Finally, this study describes and analyses how the personal faith of researchers and their deep commitment to Islamic ethics and law influences their understanding of their legal and moral accountability and ethico-legal decision making. It shows that researchers adopt multiple roles and are required to balance numerous value systems and priorities and face moral anxiety and frustration when these different moral sources are in conflict. Overall, this study indicates that, in the countries studied, Islam does influence biomedical research ethics, and that this can be appreciated through the growing reference to Islam and its scriptural sources in biomedical research ethics literature, research ethics guidelines and the role of Islam in the day-to-day practice of biomedical researchers in the case study sites, that has been captured in the empirical study.

<b>Background</b>: The world is at risk of epidemics of novel and reemerging infectious diseases. These may be national, regional or international as in the case of Nipah, African Viral Haemorrhagic Fevers, SARS and H1N1 respectively. It is crucial that public health and clinical research is conducted in such epidemics. Yet the conduct of heath research during rapidly evolving epidemics or disasters represents an enormous challenge. In addition to the large number of practical challenges to undertaking such research there are also major ethical issues to consider. However, there is very little understanding of these ethical issues and very little empirical evidence of the views of patients, their families, society and key stakeholders. <b>Objective</b>: To collect and analyse data on ethical considerations arising in the setting of research on rapidly evolving epidemics posed by the urgent and unpredictable nature of epidemics. <b>Design</b>: The study was conducted in Oxford University Clinical Research Unit (OUCRU), Viet Nam and 3 other hospitals in Viet Nam with experience of epidemics. Data were collected by semi-structured interviews with key stakeholders representing research staff, IRB members, patients/family members and study sponsors/funders who have participated in or reviewed research projects on infectious diseases including SARS, H5N1, H1N1, dengue and Hand, Foot, Mouth disease. <b>Result</b>: A total of 64 interviews with all key stakeholders were conducted. Analysis of the ethical problems/challenges discussed in the interviews led to the identification of three themes 1) International research collaboration, 2) IRB review and 3) Consent. These tended to arise at three levels of relationship: macro (between institutions internationally), meso (within and between institutions nationally) and micro (within institutions and between health professionals and patients). <b>Conclusion</b>: The issues and types of considerations and their relative importance were raised and/or valued differently by the members of different key stakeholder groups due to their role and experience in research participation. Some of the issues raised also related to health research in other settings. However, many were unique to the setting of rapidly evolving epidemics. Addressing these issues is crucial for successful and appropriate research in the context of epidemics. It is inevitable that epidemics of emerging and reemerging infectious diseases will occur in the future and there is a clear need to undertake crucial scientific research in such settings. It is therefore imperative that we understand the challenges and ethical issues surrounding such research. It is desirable that further research into the ethical challenges identified in this thesis takes place in the inter-epidemic period in order to better prepare for the next epidemic.

NHS research ethics committees (RECs) serve as the gatekeepers of health research involving human participants. They have the power to decide, through a regulatory 'event licensing' system, whether or not any given proposed research study is ethical and therefore appropriate to undertake. RECs have several regulatory functions. Their primary function has been to protect the interests of research participants and minimise risk of harm to them. Yet RECs, and other actors connected to them, also provide stewardship for the promotion of ethical and socially valuable research. While this latter function traditionally has been seen as secondary, the 'function hierarchy' is increasingly blurred in regulation. Regulatory bodies charged with managing RECs now emphasise that the functions of RECs are to both protect the interests of research participants, and also promote ethical research that is of potential benefit to participants, science, and society. Though the UK has held in some of its previous regulations (broadly defined) that RECs equally function to facilitate (ethical) health research, I argue that the 'research promotionist' ideology has moved 'up the ladder' in the regulation of RECs and in the regulation of health research, all the way to implementation in law, specifically in the Care Act 2014, and in the regulatory bodies charged with overseeing health research, namely the Health Research Authority. This thesis therefore asks: what impact does this ostensibly twinned regulatory objective then have on the substantive and procedural workings of RECs? I invoke a novel 'anthropology of regulation' as an original methodological contribution, which enables me to study empirically the nature of regulation and the experiences of actors within a regulatory space (or spaces), and the ways in which they themselves are affected by regulation. Anthropology of regulation structures my overall empirical inquiry to query how RECs, with a classic primary mandate to protect research participants, now interact with regulatory bodies charged with promoting health research and reducing perceived regulatory barriers. I further query what this changing environment might do to the bond of research and ethics as seen through REC processes of ethical deliberation and decision-making, by invoking the original concept of 'regulatory stewardship'. I argue that regulatory stewardship is a critical, but hitherto invisible, component of health research regulation, and requires fuller recognition and better integration into the effective functioning of regulatory oversight of research involving human participants.

The present study is an existential phenomenological investigation of the experiences of maternal guilt of five first-time mothers with infant children. Maternal guilt is a powerful, pervasive, and complex phenomenon that effects and is experienced by mothers in different ways. This research explores the experiences of these five mothers in feeling guilt related to being a mother and, using an adapted research methodology utilizing Focusing Technique (Gendlin, 1981), their embodied reflections about a particular memory of feeling maternal guilt. This study utilizes procedures explicated by Colaizzi (1978), Giorgi & Giorgi (2003), Todres (2007), von Eckartsberg (1998), Walsh (1995; 2004) and Wertz (1984). All participants provided data via a written account of a particular memory of feeling a sense of guilt related to being a mother, an individual interview which incorporated a modified Focusing component, and written and verbal feedback related to the write-up of the provisional thematic analysis of the interview. The interpreted analyses of the five interviews indicate seven formulated themes; physical and emotional connection to their babies, intense feelings of responsibility, feelings of being divided, multi-dimensionality of guilt with other emotions, pre-verbal miscommunication, anxiety over the unknown in the beginning, and social expectations and comparisons. The findings suggest that the process of embodied reflection regarding a new mother's emotional experiences of guilt can foster important awareness for how she can care for her own and her child's needs. Relationships between contemporary cultural discourses on motherhood and philosophical interpretations of guilt are discussed. Implications for creating networks of support and community for new parents are also explored. / McAnulty College and Graduate School of Liberal Arts; / Clinical Psychology / PhD; / Dissertation;

Essay 1: Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. We then point to some of the issues that need to be addressed for a systematic approach to the ethics of traffic research. Essay 2: The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. In this paper, research situations where informed consent is unobtainable are described and categorised. Some of these kinds of situations, common in biomedicine and psychology, have been previously much discussed, whereas others, more prevalent in for example infrastructure research, introduce new perspectives. The advancement of new technology may lead to an increase in research of these kinds. The paper also provides a review of methods intended to compensate for a lack of consent and their applicability and usefulness for the different categories of situations are discussed, thereby providing insights into one important aspect of relevance for the question of permitting research without informed consent: how well that which informed consent is meant to safeguard can be achieved by other means. Essay 3: This paper starts with the assumption that it is morally problematic when people in need are offered money in exchange for research participation if the amount offered is unfair. Such offers are called “coercive”, and the degree of coerciveness is said to be determined by the offer’s potential to cause exploitation and its irresistibility. Depending on what view we take on the possibility to compensate for the sacrifices made by research participants, a wish to avoid “coercive offers” leads to policy recommendations concerning payment for participation. For sacrifices considered compensable we ought to offer either no payment or payment at a level deemed fair, while for sacrifices deemed incompensable we always ought to offer no payment. Essay 4: It is commonly thought that transactions that are the result of voluntary gift-giving do not constitute exploitation. This paper argues that exploitation is indeed possible in such situations, by showing how gift-giving can fulfil the two commonly proposed criteria for exploitation, namely that in an interaction between two persons one receives disproportionally little and the other disproportionally much of the resulting benefits, and that this disproportion is caused by the latter making inappropriate use of a disadvantage of the former. A theoretical approach to what such inappropriate use would amount to in cases of gift-giving is lacking. The paper therefore aims at spelling out such an approach. The method of reflective equilibrium inspires this endeavour, which proceeds by testing intuitions about examples that embody a set of possible conditions. It is concluded that three of the conditions are necessary for exploitation of gift-giving, namely (1) the giver incurs a loss, (2) the recipient has aimed for the gift, and (3) the gift is undeserved. / <p>QC 20140407</p>

abstract: Within ethics, a number of scholars advocate an interdisciplinary approach of combining the two traditionally different professions of science and philosophy with the confidence that this collaboration will be a mutually beneficial experience. Current ethicist-scientist interactions include embedded-ethicists and research ethics consultation services. Both methods are employed with the hope that they will reduce social and ethical problems that could arise from scientific research, and enhance the reflective capacity of investigative teams. While much effort has been put forth in the endeavor of creating ethicist-scientist interactions, there remains opportunity to refine these new interaction models to make them more robust. There is need for ethicists to understand the context of ethical decision-making in the laboratory. By extension, before interacting with scientists in a research lab, research ethicists ought to have the ability to understand the science and also be familiar with the different factors that influence scientific research, such as funding, productivity requirements, time constraints, politics of laboratories and institutional reward structures. Through literature review and the analysis of qualitative data obtained from the ethnographic study in a neuroscience laboratory, this thesis explores the strengths and weaknesses of ethicist-scientist interactions and aims to understand the culture, traditions and values of this community and their perspectives on their role as scientists and their relationship to ethics. This study shows that the quantity and quality of ethics discussions in the lab are limited and dictated by time constraints and minimal incentives. Other influencing factors are the researchers' perspectives on ethics and how they view their role as a scientist in relation to the public. / Dissertation/Thesis / M.S. Applied Biological Sciences 2012

Introdução: A pesquisa na área farmacológica envolvendo seres humanos é fundamental para a geração de novos conhecimentos, com a finalidade de trazer benefícios na assistência, porém apresenta riscos associados. Conforme o Manual para Boas Práticas em Pesquisa Clínica (GCP), Evento Adverso (EA) é “qualquer ocorrência médica inconveniente, sofrida pelo participante da pesquisa ou sujeito em investigação clínica com fármacos e que não possui, necessariamente, uma relação causal com este tratamento”. Objetivo: Verificar a incidência de Eventos Adversos (EAs) relacionados aos riscos gastroenterológicos mais citados em protocolos de pesquisa farmacológica. Métodos: Trata-se de um estudo de casos incidentes (coorte não-controlada). O fator em estudo foi o conjunto dos eventos adversos gastrintestinais (EA-GI) relatados. Foram avaliados os relatos de eventos adversos comunicados ao Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre no período de janeiro a dezembro de 2010. Nos últimos doze meses foram monitorados 110 diferentes projetos de pesquisa farmacológica com um acumulado de 8179 relatos de eventos adversos avaliados. Resultados: Da amostra de 26 diferentes projetos envolvidos ao longo de 2010 (jan-dez), foram relatados 63 ocorrências de EA-GI. Os EA-GI mais frequentes foram náusea/vômitos com 21 (33,3%) das ocorrências; outras dores abdominais e as não especificadasl com 12 (19%); alteração do hábito intestinal com dez (15,9%) das ocorrências; elevação das enzimas hepáticas com nove (14,3%) e os demais EA-GI com 17, 5%. Estes EA-GI comparativamente aos riscos descritos não estavam adequadamente descritos nos documentos dos protocolos de pesquisa. Conclusão: As presentes conclusões evidenciam a necessidade de uma avaliação criteriosa dos Comitês de Ética em Pesquisa com relação à documentação dos protocolos de pesquisa a serem avaliados e dos relatos de eventos adversos a serem monitorados. O conjunto destas avaliações - prévia e continuada - devem sempre buscar a proteção adequada dos participantes dos projetos de pesquisa. / Background: Human pharmacological research is essential for the generation of new knowledge in order to generate benefits in health care, but risks are associated. According to the Handbook for Good Clinical Practice (GCP), Adverse Event (AE) is "any untoward medical occurrence inconveniences suffered by the participant or subject of research in clinical research with drugs and do not necessarily have a causal relationship with this treatment ". Objective: To determine the incidence of adverse events (AEs) related to the most cited gastroenterological risks in pharmacological research protocols. Methods: An incident cases study (non-controlled cohort) was performed. The factor under study was the set of GI adverse events (AE-GI) reported. We assessed reports of adverse events reported to the Hospital de Clinicas de Porto Alegre Research Ethics Committee from January to December 2010. In the last twelve months have been monitored more than 110 different pharmacological research projects with a cumulative 8,179 adverse event reports evaluated (3). Results: The sample involved 26 different projects in 2010 (Jan-Dec), 63 occurrences were reported as EA-GI. The EA-GI were more frequent nausea / vomiting 21 (33.3%) of cases, abdominal pain with 12 (19%), diarrhea with ten (15.9%) of cases, elevated liver enzymes with nine (14 3%) and other GI with EA-17, 5%. The reports occurred in other associated centers totaling 87.3% and 12.7% at HCPA. Conclusion: These findings highlight the need for a careful evaluation of the Research Ethics Committee specially when documents of research protocols were evaluated and when adverse events reports were monitored. All these evaluations - prior and ongoing - should always seek appropriate protection of participants in research projects.

Magister Commercii - MCom (Business and Finance) / This master's thesis report is a record of my action research study conducted at a traditional bank in South Africa. The report follows a narrative writing style. It contains my personal learnings and reflections. In it I record my practices aimed at promoting Islamic banking products of a traditional bank. In undertaking this action research, I employed interventions whereby I improved my own learning and behaviour through practice. This action research took place within the customer facing division of a national traditional bank in the Western Cape. While conducting my situational analysis, I found that front-line employees lacked knowledge and awareness about Islamic banking products, which negatively impacted their attitude and willingness to promote the Islamic banking offering. As the action research progressed, another concern was identified, namely, the lack of awareness of Islamic banking by customers. In order to guide activities that are directed at improving the behaviour of front-line employees and customers, I drew insights from the Theory of Planned Behaviour (TPB) by Icek Ajzen (1991) for my theoretical framework. Observations, interviews and interview schedules were used to collect data and continuously analysed using content analysis and univariate analysis for the respective data types. Evidence was generated by measuring the data against a standard of judgments as required for an action research project. This resulted in the identification of key factors that influence front-line employees' willingness to promote the Islamic banking products. These factors were their attitudes and perceived behavioural control. It was further identified that the lack of awareness by customers had a negative impact on their attitudes towards using the Islamic banking offering. Both issues were addressed, by following the cyclical approach of action research. In order to influence front-line employees' behaviour, with the support of the necessary stakeholders, I implemented internal marketing programmes such as training and development. To increase the level of customer awareness, I implemented activities directed at external customers such as brochures and poster displays within branches. The study finds that through my ethical and political practices, front-line employees were motivated and stakeholders actively participated in planning and executing interventions designed to improve the performance of Islamic banking sales. The practices implemented by myself, as an Islamic banking product champion, were identified as a key influence in the promotion of Islamic banking. I also identified that senior management and middle management influenced front-line employees' acceptance and implementation of internal marketing practices.

Introdução: A pesquisa na área farmacológica envolvendo seres humanos é fundamental para a geração de novos conhecimentos, com a finalidade de trazer benefícios na assistência, porém apresenta riscos associados. Conforme o Manual para Boas Práticas em Pesquisa Clínica (GCP), Evento Adverso (EA) é “qualquer ocorrência médica inconveniente, sofrida pelo participante da pesquisa ou sujeito em investigação clínica com fármacos e que não possui, necessariamente, uma relação causal com este tratamento”. Objetivo: Verificar a incidência de Eventos Adversos (EAs) relacionados aos riscos gastroenterológicos mais citados em protocolos de pesquisa farmacológica. Métodos: Trata-se de um estudo de casos incidentes (coorte não-controlada). O fator em estudo foi o conjunto dos eventos adversos gastrintestinais (EA-GI) relatados. Foram avaliados os relatos de eventos adversos comunicados ao Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre no período de janeiro a dezembro de 2010. Nos últimos doze meses foram monitorados 110 diferentes projetos de pesquisa farmacológica com um acumulado de 8179 relatos de eventos adversos avaliados. Resultados: Da amostra de 26 diferentes projetos envolvidos ao longo de 2010 (jan-dez), foram relatados 63 ocorrências de EA-GI. Os EA-GI mais frequentes foram náusea/vômitos com 21 (33,3%) das ocorrências; outras dores abdominais e as não especificadasl com 12 (19%); alteração do hábito intestinal com dez (15,9%) das ocorrências; elevação das enzimas hepáticas com nove (14,3%) e os demais EA-GI com 17, 5%. Estes EA-GI comparativamente aos riscos descritos não estavam adequadamente descritos nos documentos dos protocolos de pesquisa. Conclusão: As presentes conclusões evidenciam a necessidade de uma avaliação criteriosa dos Comitês de Ética em Pesquisa com relação à documentação dos protocolos de pesquisa a serem avaliados e dos relatos de eventos adversos a serem monitorados. O conjunto destas avaliações - prévia e continuada - devem sempre buscar a proteção adequada dos participantes dos projetos de pesquisa. / Background: Human pharmacological research is essential for the generation of new knowledge in order to generate benefits in health care, but risks are associated. According to the Handbook for Good Clinical Practice (GCP), Adverse Event (AE) is "any untoward medical occurrence inconveniences suffered by the participant or subject of research in clinical research with drugs and do not necessarily have a causal relationship with this treatment ". Objective: To determine the incidence of adverse events (AEs) related to the most cited gastroenterological risks in pharmacological research protocols. Methods: An incident cases study (non-controlled cohort) was performed. The factor under study was the set of GI adverse events (AE-GI) reported. We assessed reports of adverse events reported to the Hospital de Clinicas de Porto Alegre Research Ethics Committee from January to December 2010. In the last twelve months have been monitored more than 110 different pharmacological research projects with a cumulative 8,179 adverse event reports evaluated (3). Results: The sample involved 26 different projects in 2010 (Jan-Dec), 63 occurrences were reported as EA-GI. The EA-GI were more frequent nausea / vomiting 21 (33.3%) of cases, abdominal pain with 12 (19%), diarrhea with ten (15.9%) of cases, elevated liver enzymes with nine (14 3%) and other GI with EA-17, 5%. The reports occurred in other associated centers totaling 87.3% and 12.7% at HCPA. Conclusion: These findings highlight the need for a careful evaluation of the Research Ethics Committee specially when documents of research protocols were evaluated and when adverse events reports were monitored. All these evaluations - prior and ongoing - should always seek appropriate protection of participants in research projects.