Dissertations / Theses on the topic 'Research ethics'

Thesis (MPH)--University of Limpopo, 2010.<br>Background The National Health Research Ethics Council (NHREC) of South Africa (SA) is mandated to oversee health research ethics activities within the country. The oversight role is achieved through registration and auditing of Health Research Ethics committees (RECs). This study indicates that 22 RECs are registered with the NHREC. Purpose This study examines compliance levels of registered RECs with the SA DOH national health research ethics guidelines regarding composition and operational procedures as well as highlight commonalities and differences. Methods Secondary data of 22 RECs registered with NHREC were used to examine the level of compliance related to composition and operational procedures disaggregated by REC. Data were processed using Statistical Package for Social Scientists (SPSS). Categories of systematic compliance, non-systematic compliance and non-compliance were used to determine RECs compliance levels with the standards specified in the DOH national ethics guidelines in research. Results Registered RECs in South Africa have an average membership of 16 ranging from 6 to 35. The RECs membership on gender has a 6% marginal difference and is dominated (68%) by scientists or clinicians. Majority (82%) of RECs have lay persons and 77% legal representatives. Eighty six percent of RECs xvi complied with operational procedures as stipulated by DOH national health research ethics guidelines. Conclusions Most RECs in SA registered with NHREC have a functional structure and are well organized. However, RECs demonstrated a non-systematic compliance with composition and procedures of DOH national guidelines. Most RECs based at public hospitals, government department and private organizations experienced high variations. Disparities related to gender, professional identity, legal and lay representations are noticeable and could be easily addressed.

Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of ‘capacity building’ activities in biomedical research ethics, through following the trainings, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies, and development anthropology. Drawing on material from ethnographic fieldwork with the NGO in Sri Lanka, Thailand, the Philippines, Taiwan and mainland China over 12 months between March 2009 and November 2010, it advances an argument that the uptake of ethics through forms such as the Ethics Review Committee implicates social relations in new forms of management, with the moralities assumed to be part of ethics attaching to varied understandings of obligation, accountability, trust and personhood. Central to the analysis is the exploration of the co-existence of standardisation with practices of differentiation within the activities of FERCAP, a tension explored through a theoretical framework informed by attention to fractal imageries replicated across the settings of research.

Published Article<br>This paper argues for a professional ethic in research and the contribution of theological ethics thereto. The author points out that although theological ethics is poor at dealing with issues related to professional ethics and its application to research, theological ethics can nevertheless make a fundamental contribution towards a professional ethic for research. It is also emphasised that although there is very limited (South African) literature on this topic, some theological ethics studies can contribute towards the understanding of such ethics. The author works with a triple helix approach to (theological) ethics. This approach to ethics is built upon the concept of responsible acts (Douma), making decisions (Fisher) and a growth ethic (Burggraeve). The article concludes with pointers for a professional ethic in research from a theological ethics perspective.

Evidence available shows that the ethics review process in Malaysia suffers from a range of problems (Kaur, 2011). These problems may be the result of a lack of training given for REC members and relatedly, it may stem from a lack of understanding of the role of RECs. Since Malaysia is striving to promote the country as a research hub for international collaboration, it is important that the ethics review system that is in place is well set up to ensure only ethical research are being approved. The aim of this thesis is to develop three important key elements of a framework that can be used to provide practical guidance for RECs and their governance in Malaysia. These three important elements of the ethics review process are: - the role of RECs, the criteria of REC membership and the acceptability of variation in decisions made between different RECs. These analysis is then applied to the Malaysian context. My initial recommendation is for RECs to adopt the Daniels and Sabin (1997) accountability for reasonableness model to assist with the decision-making process. The adoption of the model helps to clarify the role of RECs and can be used as a basis to develop the criteria for REC membership as well as to provide a better understanding of the acceptability of variation in decisions between different RECs.

My research and publications over the past 25 years can be related to two major themes: building up the case for business ethics education in UK Business schools, and the development of a virtue ethics approach to institution building in business and management. My business ethics research papers have been focused on the exploration and use of virtue theory as an approach to applied ethics in the context of business and organisational life, exploring subjects such as loyalty, codes of conduct, executive remuneration, job security, health hazards, service work, shareholder responsibilities, temperance, maritime piracy. Virtue theory is a useful framework to approach ethical issues in work organizations. First, this is because its emphasis on the shared values in a community (rather than a set of universal rules) lends itself to understanding ethical standards within communities of practice or professions. Second, because of its emphasis on moral education and development, virtue ethics has useful purchase on issues around management and professional development. These two themes were combined in the study of corporate governance and accountability. The relationship between business and society is a complex phenomenon and requires a multi-disciplinary approach to understand its full ramifications. My book, Corporate Governance and Accountability is an analysis and a synthesis of the politics of corporate governance and draws upon economics, management, law, politics, ethics, and sociology to examine the representative institution of business in our society, the company. An analysis is made of how its legal form has changed over the years in response to social drivers and political imperatives. The book attempts to track the nature and course of these developments and tries to understand the present situation, and then attempts to give some insights into how companies may be expected to develop in the future. The perspective of the study, although multi-disciplinary, in many aspects is perhaps, in the final analysis, predominantly political, because it is the relationship of the company to society that is the major focus of the analysis. In this respect, a major theme of the study is to examine to what extent the corporate form changed in response to socio-political factors as well as economic factors.

Urban Bioethics<br>M.A.<br>Minority underrepresentation in clinical research is an ongoing dilemma that is an impediment to discovering the most innovative therapies for all patients. Additionally, the lack of engagement of underserved minority populations in clinical research limits these patients to traditional standard of care treatment, preventing the potential for innovative therapies clinical research may have to offer. Healthcare providers in underserved communities may struggle with a plethora of barriers they must strategize to overcome to increase access and awareness regarding clinical research for minority patients. Some of these barriers may include: mistrust, lack of awareness of clinical trials for minorities, socioeconomic issues, health literacy and education, and communication. These can be improved with planning, better trials for minorities, commitment to the community, and patient education.<br>Temple University--Theses

Background: The effects of ethical regulation in the form of review and bureaucratic procedures on research are perceived as challenging for researchers. The centrality of the achievement of informed consent in ethical regulation and review has also been problematised from a range of perspectives which view it as unachievable in some methodologies, as necessary but problematic, or as an overly bureaucratic requirement which makes it informed but not genuine. However, in the existing critiques of regulation, there is limited attention paid to ethics review which is where decisions are made about the ethics of research. Much is claimed about the barriers and limitations the review of ethics presents to researchers, however, there is little evidence which starts from the standpoint of committee members and explores how the work of National Health Service Research Ethics Committees (NHSRECs) is accomplished in the everyday contexts in which decisions are made. This study aimed to reveal new knowledge about how NHSECs work to reach decisions about applications with a particular emphasis on consent and capacity. The RECs included in the study were ‘flagged’ for capacity which meant that members had undergone additional training in the requirements for research with people who lack capacity in the Mental Capacity Act 2005. Methods: The study used ethnographic approaches and institutional methodology to ‘map’ the work of RECs. Theoretically, institutional ethnography starts with the standpoint of those involved in the seemingly mundane and everyday work of institutions. The research sought to deepen understanding and provide insights into how committee members view their work and their perspectives on research and researchers. Interpreting the everyday is foundational to institutional ethnography and the endeavour also seeks to describe how work is shaped and organised by wider social discourses. The methods employed were observation, interview and an analysis of a significant text. Altogether, there were nine observations of RECs with a total of seventeen research applications heard. Twelve interviews were conducted with reviewers and eight with researchers who had attended the REC at the time of my observations. Data was managed using NVivo software, organised into themes and then analysed with the aim of producing a detailed ethnographic description of the work undertaken. Findings: The study produced an ethnographic ‘mapping’ of the work of NHSRECs. Findings and subsequent analysis revealed (i) how the setting, order and membership of committees shaped their work and supported the institutional and social imperatives for ethics review to be transparent, fair and objective; (ii) that ‘judgement’ and ‘decisions’ could be distinguished in deliberations. Much of reviewers’ discussion of applications is subjective and discerning. Relationships with each other and with researchers were significant. Committee members considered abstracted principles of ethical regulation and the framework of bureaucratic procedure, but used subjective means to translate these into meaningful and practical concepts and requirements; (iii) that ‘texts’ in the form of requirements were important in decision-making. Committee members made reference to procedures in order to legitimise their judgements. Finally, a text used in NHSRECs, the ‘Mental Capacity Checklist’ is the focus of analysis and this demonstrates how committees make their judgements ‘fit’ with requirements, looking for evidence of the required categories in the application and in the dialogue with researchers Conclusions and implications: NHSREC reviewers are committed to their work, to research and researchers in general regardless of the nature of research. However, procedural ethics delineates and draws boundaries around the field of review. In addition, wider social structures and discourses of trust and transparency influence and shape formal review. These may constrain and limit REC members as much as researchers. RECs may benefit from a reflexive analysis of their work which would enable them to consider the local and wider influences on their judgements and decision-making. There is potential for this to be included in training programmes which already exist for REC members. Researchers may benefit from gaining insights from ‘within’ the ethics committee increasing their knowledge of review from the perspective of those making decisions. This may assist in them feeling better equipped to overcome the challenges of ethics review. Approvals and scientific review: Organisational approval for the study was given by the National Research Ethics Service (NRES) whose functions became part of the Health Research Authority during the course of this study. Scientific review of this study was undertaken by my Lead Supervisor at the start of the PhD and reviewed internally by the Executive Committee of the School of Nursing, Midwifery and Social Work at the University of Salford. The University of Salford’s Research Ethics Committee gave ethical approval.

Published Article<br>In this article the focus is on the role of ethics in the research cycle. The author argues that current thinking with regard to ethics in research is very often scattered and limited to certain disciplines and certain activities only. It is also pointed out that research ethics is not only applicable to the actual doing of research but also processes associated with research such as supervision, the commercialization of research and the presentation of research within the public domain.

The aimso f this thesisa ret o outlinet he ethicalc hallengesp osedb y neonatarl esearch, to propose solutions to these challenges and to consider whether Scanlon's contractualism can accommodate these solutions. The thesis does not offer a comprehensive appraisal of contractualism, but applies important contractualist ideas, particularlyr easonablere jectabilitya ndj ustifiability to others,t o neonatarl esearch. The circumstances in which neonatal research is conducted pose constraints on equipoise and parental consent, particularly when promising experimental treatment is accessible only through trial participation. While randomised trials generally produce more rigorous evidence than uncontrolled studies, they raise concerns about the use of sick infants to glean this evidence. Participation in relevant research cannot be guaranteed to serve the best interests of sick infants. Whether conducting neonatal researchis imperativeo r optionald ependso n the moral statusa ccordedto futurehumans. Compromisesa ren eededto reconcilet he conflicting ethicali mperatives.T hese include developing alternative forms of parental authorisation, providing access to promising new treatment before there is definitive evidence supporting its safety and efficacy, and using observational studies when randomised trials are impractical or unethical. Pro-triallist approaches, emphasising the benefits of research and sceptical approaches, emphasising individual rights and interests, offer inadequate moral justification for these compromises.The pluralism and mutual consideration espoused by contractualism render it a more promising theory of the ethics of neonatal research than pro-triallist and sceptical accounts.T he priority accordedb y contractualismto justifiability andr easonable acceptability to others could allow the theory to justify the compromises needed to reconcile these conflicting standpoints. To meet this challenge, however, contractualism must provide more specific guidance to determine whether or not moral disagreement is reasonable, and it must offer a more defensible account of the moral status of future humans.

This thesis offers a comprehensive examination of the dilemmas posed by cyberspace for contemporary social research and in how far current ethical frameworks can manage the risks that may emerge in this new research environment. The study is situated in the period of 1998 to 2010, during which the social uses of rapidly converging technological tools led to the extension of the social world into a new social sphere of social interaction called cyberspace. Social scientists have been quick to explore this sphere; however, as the dominant discourses are based on ideas of newness and difference there is uncertainty over what kind of space it is, whether we can transfer existing methods and ethics and what rules apply in the conduct of research. The thesis first investigates the extent to which the technological tools and ethical dilemmas encountered in cyberspace are in fact new or different. This then necessitates a detailed engagement with the conceptualisation of cyberspace. Thereafter it closes a gap in dominant conceptualisations of cyberspace by offering insights into its legal and regulatory foundations. Next, the thesis reflects on legislation and regulations to identify emerging risks that emerge in everyday social research practice in the online environment. These risks are then used as vignettes to test current ethical guidance’s ability to manage them. The thesis argues that disciplines within the social sciences need to be continually reflexive about their encounters with new spaces, and concludes that cyberspace demands significant engagement with the difficulties posed by the rapid pace of change of technological development and regulatory and legislator foundations in order to manage risk in online social research. Thus while online research is the focus, the potential of this thesis is to offer a historical insight into the reflexivity of the discipline in particular in how successfully it encounters new spaces of/for research.

Background: The maternity system has a complexity of everyday ethical issues. The bioethical principles: non maleficence, beneficence justice and autonomy, that govern health care practice have been criticised as abstract, patriarchal and even rhetorical in maternity care practice (MacLellan, 2014) and consequently may be insufficient in guiding care of childbearing women. Midwifery-led care is guided by the International Confederation of Midwives International Code of Ethics, which considers more than the bioethical principles, such as the importance of relationship. Care ethics is a relational based feminist ethics first described by Gilligan (1983) and has been theorised as an alternate paradigm for midwifery (Newnham & Kirkham, 2019). A paper was published in Nursing Ethics as a result of the literature review; Care ethics framework for midwifery practice: A scoping review and it was determined that care ethics is demonstrated in practice with four domains; Relationship, Context, Caring Practices and Attention to power. In addition, there is limited empirical evidence as to women’s experiences of care from an ethical perspective, and importantly what women describe as ethical, revealing a gap in the literature that has yet to be explored. Objective: The aim of the study reported in this thesis was to investigate women’s experience of maternity care from an ethical perspective and to determine whether a care ethics paradigm would better suit midwifery. Methods: The transformative research was undertaken using Feminist Participatory Action Research (FPAR). FPAR is a feminist and transformative research design, which includes participants as central to research design. Purposive sampling was used to recruit women who had experienced midwifery-led care. Nine women formed the Community action research group (CARG), they worked with me over three years, guided the research and planned action. The CARG participated in five focus groups, for data collection and organising action toward the changes they wished to see. Their involvement in the research included: defining the research problem, creating a priori codes for analysis, reviewing analysis, disseminating findings and provided recommendations for policy change. A paper was published in Woman and Birth: Navigating midwifery solidarity: A feminist participatory action research framework, describing some of the finer points of FPAR including a framework for novice researchers. In phase two a further ten women who had had midwifery-led care were involved in this study and interviewed about their experiences of ethical maternity care. Data were collected from September 2019 to April 2022 via five focus group interviews and ten one-on-one semi-structured interviews. The interviews were recorded, and transcribed, and template and Reflexive thematic analysis was applied (Braun & Clark, 2021). Findings: The findings in this study were presented in two parts. The first phase of the study revealed midwifery-led care demonstrated care ethics in practice. The Community Action Research Group (CARG) created a priori codes and a template analysis determined that midwifery models of care demonstrate care ethics. A paper of these findings was published in Nursing Ethics; Does midwifery-led care demonstrate care ethics? A template analysis. In the second phase of the study, the data corpus was analysed using reflexive thematic analysis and the primary theme, Radical desires: Individuals’ values and context, captures the woman at the centre of the care, her values and context, as central to understanding ethics. The quality of the relationship, the knowledge that was shared, and the manner of the care given were deemed important elements of ethical care. I assigned categories Woman-centred ethics or Authoritarian ethics to describe these elements of ethical or unethical aspects of care. Woman-centred ethics contains the subcategories of: harmonised relationship, transparent wisdom, and midwifery solidarity. The category Authoritarian ethics contains the subcategories of: uneasy alliance, opaque information, and saving women from themselves. How the woman experienced these categories affected the liminality and sense of self, and are described in subthemes, Claiming power and Surrendered power. Discussion: The themes were explained, discussed, and contrasted against the extant literature in the discussion. Pregnancy and birth as a transformative rite of passage was valued by the women in this study and they perceived care as more ethical when the care providers respected this. Authoritarian ethics, when viewed with a feminist and care ethics lens highlighted continued female oppression from the maternity system structures and culture. A conceptual model, Woman-centred ethics, was developed based on midwifery philosophy and feminist care ethics, which may help midwives embody a different kind of ethics and provides a way to enhanced ethical practice. A paper was published that shared the conceptual model in Midwifery Journal: Woman-centred ethics: A feminist participatory action research. Conclusion: This study has contributed to the body of knowledge that describes how women perceive ethics in maternity, and honours women’s voices as central to ethical care. The study advances midwifery philosophy through exploring midwifery ethics and offers a conceptual model to guide practice. The woman-centred ethics model describes an embodied way of practicing ethical care and may provide a starting point for moving the field forward in ethical discussion. The CARG group involvement in the research and action together were an important feature of this project. Several recommendations arose from this study for practice, organisational, and educational processes.

The law defines the sexuality of bodies in limited terms. The law draws lines across the body which force it into identification and categorisation (male, female, straight, gay, human, non-human). These definitions conflict with the materialities of the body and the materialities of the encounter of sex, which are inclined to ‘push’ at and reterritorialize these boundaries. Legal and ethical frames restrict the ability of law and of research to access the encounter of sex, where bodies push these limits by moving, touching, kissing, fucking, caressing and becoming. I claim that ethics as contextual laws that derive from encounters carry the potential to subvert the subjugation of bodies from law’s inside. This subversion is dependant on establishing access to the encounter, which I argue is possible through methodologically radical sexuality research. The researcher’s body is also a sexed body, and I claim that by situating, and tracing the process of situating the ‘I’ within research, the ‘soul’ of the individual finds itself connected to the collective, through lines drawn across it by law. These lines can be ‘ruptured’ through their reconnection to the encounter of sex, which draws law deeper into the encounter itself, such that law can be disrupted through desire into becoming radically ‘ethical’. Through the deployment of Deleuzian Conceptual and Methodological Tools, I frame the basis through which law can become-ethical. The creation of this theoretical frame brings me and my thesis to wade through the ‘waves’ of real encounters with the field, at a nudist beach at Cap D’Agde in Southern France. In the course of doing so, I become reflexive and critical of the Deleuzian conceptual and methodological tools and whether even radical and immanent philosophy is equipped to assist the law in becoming-ethical in its judgment of sex. I claim that access to the encounter and to disrupting law towards radically bodily-sensitive judgment and ‘measuring’ of encounters is a ‘practical’ endeavour. This is the radically ethical responsibility of the Researcher-Practitioner: A lawyer-researcher body who is deployed into the field to subvert the spectres of law and sexuality through practice, which is traced presence within the real, fleeting, everlasting, intimate, joyful, painful, banal, profound, hot, heavy, fast, slow, violent, gentle and sand-drenched encounter of sex itself.

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.

The requirement for consent to be both informed and voluntary is a keystone of contemporary bioethics. The need for consent before including people in clinical research demonstrates respect for participants. Demonstrating respect goes beyond mere acknowledgment of the right for people to make their own decisions. To be meaningful, consent must promote and support participant self-governance and enable decisions that align with participant values. A relational perspective of autonomy places people within a web of social and cultural histories and influences that frame the concept of respect. A relational approach to consent can create opportunities to promote respect for autonomy.

Drawing on the classification of expertise developed by Collins and Evans, this study explores the expertises held by members of NHS Research Ethics Committees (RECs) and how they differ from the ones described by the regulations. The study used Q methodology followed by ten semi-structured interviews with Lay and Expert REC members. The results show that committee members see themselves as part of a team, with individual members making different contributions to a collective task. Viewing REC members in this way allows their different expertises to be formally recognised and leads to the creation of two new membership categories, specialist and generalist, based on these expertises. Specialists have expertises such as statistics and pharmacy that are required by the current legislation and which would be present on recruitment. Generalists possess the other expertises needed by the committee but which not required by statute. These include the clinical expertises possessed by healthcare professionals and the other professional expertises – legal, academic, IT and so on – that are typically found amongst those currently classed as Lay members. All REC members, be they specialist or generalist, would also be trained in the ethical and regulatory expertises required to deliver an ethical review. Emphasising how all REC members, whether specialist or generalise, have expertises that contribute to the ethical review enables recruitment activities to focus on the skills needed by the committee rather than current concerns with population demographics. This provides a solution to many of the recruitment issues identified by participants. In particular, it enables the replacement of skills on a ‘like for like’ basis using clearly defined person specifications. Not only would such a process comply with the Nolan principles it be more likely to maintain the integrity and function of the committee regardless of personnel changes.

The aim of the thesis is to explore and discuss the distinct ethical issues raised by the conduct of health-related cluster randomised trials in developing countries, in particular those related to informed consent and representation. The thesis has four objectives: First, it seeks to identify ethical issues and their importance arising in CRTs and present how they are currently being addressed in published trial reports and papers on the ethics of CRTs. Second, it aims to discuss the limitations of addressing such ethical issues within the existing research ethics framework. Third, by relying on a human right to health, it aims to suggest a broader research ethics framework, beyond the existing clinical ethics paradigm, that takes into account the variety of health studies conducted in developing settings, as well as the broader socio-political context where collaborative health research takes place. Fourth, by examining the common moral features between cluster health studies and public health interventions, it aims to inform current research ethics guidelines and discussions on the ethics of cluster research by suggesting solutions to the problem of informed consent and cluster representation in developing countries, as well as to demonstrate the strength of the suggested research ethics framework in dealing with such complex issues. I argue that under specific conditions a cluster trial is morally legitimate to proceed despite the absence of informed consent and that a decision regarding the conduct of research should be within the responsibilities of the legitimate political authorities of the host country. I conclude that collaborative health research, which aims to improve the health status of a developing population, should be part of a country’s policy, similarly to decisions concerning the implementation of public health measures, and that human subjects should be protected at individual, social and institutional level.

In negotiating research relationships with Aboriginal and Torres Strait Islander peoples, the question of colonisation runs deep. Often, as a gesture to counter the colonising effects of the research gaze, ‘participation’ is hailed as a methodological solution, as a means of healing and transforming power relations. In practice however, the ethical implications of research activities remain complex and contested (Cornwall, 2008, p.276). Much is written about why participatory methods offer remedial qualities of empowerment to counter colonialism in research, but there is little discussion of what happens when participatory research with Indigenous Australians does not operate as a smooth process of reclamation. Often, researchers avoid accounting for resistance to participation because this is viewed as a personal ‘failure’ to accurately represent the interests of a colonised group. The basis of these assumptions comes from a moral compulsion to alter power relations towards social justice: such logic cannot accept that ‘oppressed’ peoples would reject opportunities for empowerment. Yet, international literature (Kothari, 2001) shows that subjectivities comprising participatory research must be carefully considered when constructing research relationships. Drawing from a case study of my own participatory research experience with an Aboriginal community development organisation in Western Sydney, I consider how a non–Indigenous researcher might approach an understanding of their ethics when attempting to ‘decolonise’ their research. I reflexively investigate my own practice to offer a discussion of the ways in which researchers can understand how they come to determine what is ethical and what is not. My account begins with a description of a case study involving multiple forms of participation over a three–year period, which I explore as a series of ‘invited spaces’ (Cornwall, 2004). Drawing from my case study, I incorporate Foucault’s ethics (2005) by discussing how ethics codes create subjectivities, which not only shape the participants in the research, but also shape the kind of ‘selves’ researchers seek to become through participatory research. I consider the contingencies that have led to the construction of a remedial role for participatory methods in research involving Indigenous Australians by critically analysing the discourses within the National Health and Medical Research Council’s ethics guidelines. This research offers a multi–layered approach to reflexivity, by attending to transparency, interpersonal relationships, and a collective evaluation of the process with participants (Nicholls, 2009). Collective reflection about (re)presenting research findings to a variety of audiences highlights the importance of examining one’s own motives as crucial to ‘ethical’ practice. Researchers seeking to achieve a form of participation without resistance set themselves an impossible task. Resistance is not to be feared, but is to be expected within the mechanics of power relations amongst subjectivities within ‘communities’. Incorporating resistance into accounts of participatory research enables an ability to acknowledge ‘internal conflicts and contradictions’ (Fawcett and Hearn, 2004, p. 211) without deeming participation a failure. I argue that participation is a liminal space between trust and resistance, containing tensions and productive possibilities. By attending to one's ethics (Foucault, 2005), participatory researchers might now understand fluidity, uncertainty, and dynamism within research relationships as a rich source of reflexive work towards countering the colonising gaze.

Thesis (Ph.D.)--University of Western Sydney, 2009.<br>A thesis presented to the University of Western Sydney, College of Arts, Social Justice and Social Change Research Centre, in fulfilment of the requirements for the degree of Doctor of Philosophy. Includes bibliographies.

What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility? In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research. Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

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.

The purpose of this study was to examine how students perceive the most common methods of recruitment for research participation, and whether these recruitment strategies are perceived by the participants to be coercive. Ethical research guidelines prohibit the use of coercion in recruiting participants. Previous studies in this area have either focused on the perceptions of the researchers, or have approached the concept of coercion in a limited way. This study treated coercion as a multidimensional construct and examined student perceptions. Additionally, participant responses indicated which recruitment practices resulted in a decision to participate in the research. Findings indicate that some of the most common research recruitment methods are perceived by students to be coercive.

One of the central problems concerning research with children is the delineation of appropriate levels of risk exposure. In the U.S. Code of Federal Regulations, the "minimal risk" concept serves as an anchoring measure for allowable risk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimal risk" have given rise to a great deal of confusion. Research ethics boards and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recent research demonstrating an apparent increase in risk without corresponding benefit in pediatric research. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowable risk, calls for a reassessment of the concept of "minimal risk," and recommends modifications to the federal regulations.<br>Un des principaux problèmes associés à la recherche en pédiatrie concerne la définition des limites appropriées d'exposition au risque. Dans le « Code des règlements fédéraux » des États-Unis le concept de « risque minime » sert de balise pour mesurer le niveau permissible de risque. Cet ensemble de règles cherchait à créer l'équilibre entre le progrès scientifique et la protection du statut de vulnérabilité des enfants, mais certaines ambiguïtés linguistiques dans les textes ainsi que la définition légale du « risque minime » ont causé beaucoup de confusion. Les comités d'éthique de la recherche et la communauté médicale adhèrent à une multitude d'opinions face à l'interprétation et à l'application des règlements fédéraux, et les recherches plus récentes affichent une tendance vers un risque augmenté, sans bénéfice correspondant dans la recherche pédiatrique. Fondée sur des principes de théorie éthique, de droit et de science, cette recherche analyse l'augmentation du risque, suggère une réévaluation du concept du risque minime, et recommande une série de modifications aux règlements fédéraux.

Embryonic stem cell research has the potential to revolutionise both the practice of medicine and our understanding of the human body. Although the usual technical and financial limitations of research apply, perhaps the greatest obstacle to the progress of this research at the present time is the ethical concerns surrounding the destruction of early human embryos. The established debate over the ethical significance of the early embryo has thus taken on renewed importance. Within biology stem cell research has begun to overturn some long held assumptions about the roles of genes and cellular interaction in development. Building on recent advances in stem cell biology I develop a concept of Form that neatly captures what it is to be individuals like us in biological terms. Form not only defines a biological individual that exists across time regardless of changes in its physical constituents but also provides the biological foundation for our higher mental properties and our identity as persons. At the heart of the embryo debate is confusion over what human individuals are and therefore when they began. Defining when we began as the ethically significant individuals that we are now is the key to the embryo debate. Our metaphysics of identity is thus crucial to understanding the moral significance of the embryo. Compared to alternative understandings of identity within the debate surrounding the embryo Form provides compelling reasons why the very early embryo, at the stage that embryonic stem cells are derived, lacks any right to life or associated ethical significance. The derivation of embryonic stem cells is thus found to be ethically permissible.

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.

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.

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. [...]<br>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. [...]<br>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. [...]<br>Doctor of Philosophy

A mail survey of a nationwide sample of department heads in university departments of mechanical engineering, physiology, and psychology was conducted, in order to determine what these departments were doing to educate their Ph.D. students in research ethics. Department heads were also asked to supply names of the Ph.D. students in their departments. Based on the survey responses, departments within each discipline were then divided into those placing a relatively high versus low emphasis on teaching research ethics. Random samples of students in each emphasis category for each discipline were then surveyed and asked to rate the seriousness of 44 different hypothetical acts of misconduct, to determine if students from departments placing relatively higher emphasis on research ethics education had stricter standards than those from departments placing relatively lower emphasis on research ethics education. The two major findings of the study were (a) the majority of departments in physiology and psychology require some form of formal education in research ethics of their Ph.D. students, but only a very small percentage of mechanical engineering departments require such training; (b) the present study found no evidence that education of Ph.D. students in research ethics has any effect on the strictness of their stated ethical standards.

Thesis (DPhil)--University of Stellenbosch, 2004.<br>ENGLISH ABSTRACT: Human participant research raises a conflict between medical progress as a societal good and the protection of participants as an individual good. Prior to 1960 the discretionary authority for the protection of participants resided in the hands of individual investigators. However, a wave of research atrocities from Tuskegee in 1932 to the Beecher expose in 1966 stimulated a change to a principle based system of regulation. Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) were henceforth charged with the responsibility of human participant protection. Since 1966, this system of research review was established internationally and at one institution in South Africa. In 1997, placebo-controlled HIV vertical transmission trials in a number of developing countries including South Africa raised unprecedented controversy in research ethics internationally and nationally. In 2000, the fraudulent breast cancer trials conducted by Dr Bezwoda at Baragwanath Hospital drew international attention to research ethics in South Africa. However, the events that called into question the efficiency of the system of ethical review most poignantly were the recent deaths of volunteers in research at centres of excellence in the United States. It was charged that if there were deficiencies in the research ethics review system in developed countries, these were more likely to be present in developing countries. Around the same time the Interim National Health Research Ethics Committee (INHREC) was established in South Africa to explore and regulate the ethical review system in South Africa. Cognisant of these issues, the current study was undertaken to establish the various structural, procedural and substantive ethical challenges facing justifiable and ethical review of research in South Africa. A combination of conceptualphilosophical reflection and empirical research was employed in this dissertation. The empirical work employed both quantitative and qualitative research methodology. The quantitative survey explored the composition of RECs reviewing clinical trials research in South Africa with an emphasis on committee composition and structure as well as the review process. The qualitative research was conducted using semi-structured interviews of ten REC Chairpersons in South Africa to explore complex substantive issues like informed consent, standards of care and participant remuneration, inter alia. While the review system in South Africa is functioning at a reasonable level, there is wide variation from one REC to the next. RECs are geographically distant and function in isolation without opportunity to communicate and share ideas. Amongst institutional RECs, there is a stark contrast between historically disadvantaged institutions and historically advantaged institutions. REC membership, ten years into democracy remains white male dominated. Community representation is inadequate. Most RECs are dominated by scientists and clinicians. The review process is widely variable with delays in review ranging from ten days to ten weeks. Procedural and bureaucratic demands impact on the ability of REC members to engage in debate on important substantive ethics issues like standards of care, informed consent and participant remuneration. Research ethics training and educational needs vary widely across the country. Serious attention must be paid to the way in which RECs are constituted in South Africa. Restructuring of RECs with a view to improving representation in terms of race, gender and religion must be prioritized. There is a need for community representation and non-scientific membership to be explored. RECs in South Africa need to revisit the question of whether they should be conducting both scientific and ethics review or ethics review alone. The review process requires a paradigm shift in emphasis from adverse event reporting to monitoring, from informed consent forms to a culturally relevant informed consent process. Aparadigm shift is indicated to shift the focus from informed consent to a more comprehensive review framework. Policies regarding standards of care and participant remuneration must be clarified and articulated. Although the role of RECs in human participant protection has been questioned, it is clear that in the vast majority of cases, they are fulfilling an important role. Their function could certainly be enhanced. This is being facilitated by training programs and an electronic newsletter. However, responsibility for human participant protection does not reside in the domain of the REC alone. A collective responsibility shared by researchers, institutions, research ethics committees, sponsors and participants is integral to human participant protection and the generation of new, valid and relevant scientific knowledge.<br>AFRIKAANSE OPSOMMING: Navorsing op menslike subjekte gee aanleiding tot ‘n konflik tussen mediese vooruitgang as ‘n voordeel vir die samelewing en die beskerming van deelnemers as iets waarby die individu direkte belang het. Voor 1960 het die diskresionêre gesag vir die beskerming van deelnemers by die individuele navorsers berus. ‘n Golf van navorsingsvergrype, van Tuskegee in 1932 tot die Beecher onthulling in 1966, het egter veranderinge in die rigting van ‘n stelsel van beginsel-gebaseerde regulasie gestimuleer. Navorsingsetiekkomitees (NEKs) en Institusionele Beoordelings- en toesigrade (IBRs) is gevolglik belas met die verantwoordelikheid om toe te sien dat mense wat deelneem, sover moontlik beskerm word. Sedert 1966 is hierdie stelsel van navorsingshersiening en -toesig internasionaal tot stand gebring – ook, aanvanklik, by een instansie in Suid-Afrika. In 1997 het plasebo-beheerde HIV-vertikale oordrag-proewe in ‘n aantal ontwikkelende lande, insluitend Suid-Afrika, tot ongekende kontroversie op die terrein van navorsingsetiek aanleiding gee, internasionaal en nasionaal. In 2000 het die bedrog met borskankerproewe, uitgevoer deur dr Bezwoda by Baragwanath Hospitaal, internasionale aandag op navorsing in Suid-Afrika gevestig. Hierdie gebeure het egter die effektiwiteit van die stelsel van etiese toesig in Suid-Afrika en elders in die wêreld bevraagteken. Die mees kommerwekkende onlangse insident was die dood van navorsingsvrywilligers by sentra van uitmuntendheid in die Verenigde State. Daar is beweer dat as daar tekortkominge in die navorsingsetiektoesigsisteem in ontwikkelende lande is, daar ‘n groter moontlikheid bestaan dat dit ook (en moontlik meer) in ontwikkelende lande voorkom. Ongeveer dieselfde tyd is die Interim Nasionale Gesondheidsnavorsings-etiekkomitee (INGNEK) [Interim National HealthResearch Ethics Committee (INHREC)] in Suid-Afrika gestig om die etiekoorsigstelsel in Suid-Afrika te ondersoek en te reguleer. Met dit in gedagte is die huidige studie onderneem om die verskillende strukturele-, prosedurele- en substantiewe etiese uitdagings wat regverdigbare en etiese oorsig van en toesig oor navorsing in Suid-Afrika in die gesig staar, vas te stel. Daar is van ‘n kombinasie van konseptuele, filosofiese refleksie en empiriese navorsing in hierdie proefskrif gebruik gemaak. Die empiriese werk maak gebruik van sowel kwantitatiewe as kwalitatiewe navorsingsmetodes. Die kwantitatiewe opname bestudeer die samestelling van NEKs wat toesig hou oor kliniese proewe in Suid-Afrika, met die klem op komiteesamestelling, -struktuur en die toesigproses. Die kwalitatiewe navorsing is gedoen met behulp van van semi-gestruktureerde onderhoude van tien NEK-voorsitters in Suid-Afrika om die komplekse substantiewe aspekte, soos onder andere ingeligte toestemming, standaard van versorging en deelnemervergoeding, te ondersoek. Terwyl die etiek-toesigstelsel in Suid-Afriks op ‘n redelike vlak funksioneer, is daar ‘n groot verskil tussen verskillende NEKs. NEKs is geografies verspreid en funksioneer dikwels in isolasie sonder ‘n geleentheid om te kommunikeer en idees te deel. Ten opsigte van die institusionele NEKs bestaan daar ‘n duidelike kontras tussen histories benadeelde instansies en histories bevoordeelde instansies. NEK-lidmaatskap word, tien jaar na demokrasie, steeds gedomineer deur blanke mans. Gemeenskapsverteenwoordiging is onvoldoende. Die meerderheid NEKs word gedomineer deur wetenskaplikes en klinici. Die toesig- en hersieningsprosesse in die verskillende komitees verskil grootliks, met vertragings wat wissel van 10 dae to 10 weke. Prosedurele- en burokratiese vereistes het ‘n impak op die vermoëns van NEK-lede om by debatte oor belangrike substantiewe etiese aangeleenthede betrokke te raak, soos byvoorbeeld die standaard van versorging, ingeligte toestemming en deelnemervergoeding. Opleiding en opvoedkundige behoeftes verskil wyd oor die land.Ernstige aandag moet geskenk word aan die wyse waarop NEKs in Suid-Afrika saamgestel is. Herstrukturering van NEKs met ‘n visie op verbeterde verteenwoordiging in terme van ras, geslag en geloof is ‘n prioriteitsvereiste. Gemeenskapsverteenwoordiging en lidmaatskap van nie-wetenskaplikes moet verder ondersoek word. NEKs in Suid-Afrika moet die vraag of hulle sowel wetenskaplike- as etiektoesig moet uitvoer, of sl slégs etiektoesig, opnuut ondersoek. Die nasiensproses vereis ‘n paradigmaskuif, vanaf ‘n klem op rapportering van gebeurtenisse, na monitering van ingeligte toestemmingsvorms sowel as na ‘n kultureel toepaslike ingeligte toestemmingsproses. ’n Paradigmaskuif is noodsaaklik ten einde die fokus te verskuif vanaf ingeligte toestemming na ‘n meer omvattende toesig- en nasiensraamwerk. Beleid rakende standaard van versorging en deelnemervergoeding moet verduidelik en geartikuleer word. Alhoewel die rol van NEKs in die beskerming van menslike deelnemers aan navorsing bevraagteken word, is dit duidelik dat NEKs in die meerderheid van gevalle wel ‘n belangrike rol vervul. Hul funksie kan natuurlik uitgebrei word. Dit sal gefasiliteer word deur opleidingsprogramme en ‘n elektroniese nuusbrief. Verantwoordelikheid vir die beskerming van mense wat deelneem aan navorsing berus egter nie uitsluitlik by NEKs nie. ‘n Kollektiewe verantwoordelikheid, gedeel deur navorsers, instellings, navorsingsetiekkomitees, borge en deelnemers is ‘n integrale vereiste vir hierdie beskerming sowel as vir die verwerwing van nuwe, geldige en relevante wetenskaplike kennis.

Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity. IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced. Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised. Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process. Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered. The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.

The most valuable resources common to all human health research endeavors are those individuals who voluntarily subject themselves to potential risks for the hope of improving human health and advancing medical science. Although human subjects’ participation in health research is acknowledged as instrumental to our understanding of health and illness and thereby an interest to society, the role of human subjects in determining how research is conducted, monitored, and, if successful, translated into health care, has been minimal until fairly recently. This paper argues from both moral and political grounds that meaningful and effective partnerships between human subjects and research communities ought to be mandated as a standard practice within Canadian policy guidelines for all health research initiatives that are conducive to collaborative engagements. By rendering decision-making a truly democratic endeavor, with the implementation of collaborative relationships between scientific and human subject communities with a similar framework to the Tri-Council Policy Statement and the Canadian Institute of Health Research’s guidelines on research involving Aboriginal People, a more transparent and accountable health research system will ensue. As a result, I argue, the health research enterprise in Canada as a whole will engender greater public trust.

India is rapidly becoming established as a major player in the stem cell sector. However, concerns have been raised about the use of unproven stem cell therapies and the exploitation of parents for cord blood banking. This study aims to explore the nature of stem cell activities, how key stakeholders generate expectations around them and frame the ethical issues they raise, and why the biomedical governance system is unable to regulate these emerging practices. The study involved a survey, documentary analysis and qualitative interviews with key scientists, clinicians, representatives of firms and policymakers. The thesis observes that, unlike international commentaries which largely focus on embryonic stem cell treatments, in India it is adult and cord blood stem cells which are dominant in research and clinical settings. Expectations are configured on the basis that stem cells have the potential to: solve the problem of organ shortage; help patients with ailments; provide affordable health care; and establish India as a global player. The creation of expectations is ethically problematic given the potential health risks and economic exploitation of both native and international patients. However, the ethically contested activities are justified by clinicians on the basis that the Helsinki Declaration allows to use an experimental therapy; there are many 'desperate patients' demanding these treatments; and adult stem cells are safe. To date, the government of India appears to be unable to prevent these activities. Contrary to suggestions in previous literature and by some informants that new legislation is needed to address the problem, this thesis finds that state-led mechanisms for biomedical governance lack the ability to implement existing oversight measures. This implementation gap is partly because other forms of governance are not strong enough and partly because there are high expectations at state level aimed at establishing India as a global player in the stem cell sector.

<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.