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Title: Mapping the review of ethics in research : the work of National Health Service (NHS) Research Ethics Committees in England
Author: Morton, J. W.
Awarding Body: University of Salford
Current Institution: University of Salford
Date of Award: 2016
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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.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available