Academic literature 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.