Diagnóstico y caracterización de aislados

Searches were conducted in the usual ways but my intention was not to conduct a meta-analysis of what was identified, but rather to interpret the literature. In their account of meta-ethnography, Noblit and Hare (1988) argue that review and synthesis of research should not be driven by technical meta-analysis but instead ought to reflect the paradigm within which ethnographic research is located. This means that the desire to construct ‘adequate interpretive meanings’ in a broad interpretive paradigm extends to the review of existing research and literature. This runs counter to the traditional review which aims to provide a kind of balanced approach, evidencing that the thesis simultaneously can demonstrate a level of 'generalizability' and 'originality'. Methodologies and approaches to review and synthesis usually suggest tools or strategies for evaluating the quality of papers and determining how many articles to include. Critical appraisal of papers is followed by analysis and grouping into themes which have emerged for a discussion of the literature. (See for example, Aveyard, 2014).

My approach differs slightly in that I conducted searches using research terms which inevitably in the field of research ethics brought up literature which spanned qualitative and quantitative paradigms. The comparisons and juxtaposition of these has produced a review which is original in that new meanings have been developed which could not have emerged in a more traditional or systematic approach. An example of this is the synthesis in the review of critiques of ethical regulation which look at the overlap in the complaints about bureaucracy from biomedicine and sociologists. I also reviewed literature which problematizes informed consent from sociological perspectives and from moral philosophers. My interpretation of the literature reviewed resulted in some key findings. The perception of increased regulatory requirements was viewed as problematic by researchers from a range of different disciplines and professional backgrounds. Engagement with the difficulties

in the perceived primacy of consent requirements in regulation was similarly critiqued by sociologists and in bioethics.

1.9.1 The gap in existing research and originality of this study

There was limited literature on how researchers view their experience of the interface with RECs and how they practically seek consent especially where people are viewed as not able to make rational and autonomous choices for themselves. There is some limited literature and research available on RECs but these have mostly focused on ‘outcome’ decisions rather than ‘what happens’ at committees. Correspondingly there has been little investigation on how researchers think about consent and capacity in the process of ethics review, for example in the preparation of written formal applications or attendance at RECs. Limited attention has been paid to what influences committee members in their decision –making in the context of the committee. What their views are about vulnerability and protection and how that relates to consent requirements is hardly described in current literature. What happens at RECs is important and yet we know little about RECs from the standpoint of those involved – both the reviewers and the researchers who attend.

There is a lack of studies exploring the activity of RECs from an observational starting point. Two notable exceptions are Adam Hedgecoe in the United Kingdom and Laura Stark in the United States. Hedgecoe (2008) undertook an observational study across a number of RECs and compared their attitudes to qualitative research. He has highlighted that assumptions about REC activity cannot be made based only on decision outcome. This suggested that richer or more in depth analysis of REC activity may shed light on what takes place in the committee meeting which leads to the decisions taken. Stark (2012) undertook an observational study of Institutional Review Boards (IRBs) in the United States. Her research revealed the ‘Behind Closed Doors’ world of these Boards to assist understanding of how they did their work. She described Boards’ discussions about applications, how they reached consensus and the differences between what was said at the meetings and what was produced in subsequent official accounts. Her study is the closest to mine that I have found, though Stark does not have a focus on capacity and her analysis takes

a different form. Her observations of the Boards play a part in her overall project which is a description of the origins of ethics in research in the United States. Though IRBs differ to NHSRECs in the United Kingdom (for example, it is not usual for researchers to attend meeting, this study is highlighted because it uses parallel methods to the research I have undertaken (observation of meetings) and is a detailed description of some of the deliberations which take place at those meetings. My descriptions of deliberations have different emphases. Further references to Stark’s work are made in the thesis (particularly, 3.11 on trusting researchers and 6.4 on categories of membership) and where relevant, have illuminated my own findings.

The uniqueness of the present study that its focus is on the (internal) practices of the RECs to enable a description of how the work of ethical regulation is achieved. The study is also distinctive in that it is orientated to the conceptualization and operationalization of capacity and consent. Its context and field are RECs flagged to review capacity studies. Observations are extended through interviews with significant players – the committee members and the researchers. The aim of the study was to develop an analysis of what ‘capacity’ means in the context of the regulation of research and how this is linked to concepts of consent and vulnerability. This has been partly achieved. However, what emerged as more significant questions, related to how ethical regulation was achieved in the everyday. The study researches the internal practices, the work, of the RECs.

Although I set out with particular concerns about research with those people deemed to lack capacity, it was not possible to look at how consent worked without contextualising in the organisational setting of the REC, and exploring everyday ways in which ethical regulation is achieved. In addition to this, despite research on the outcome decisions of RECs, there was little research available on what happened in the meetings and the content of discussions about consent or other ethical issues. In short, how judgements and decisions were negotiated. Furthermore, despite substantial critique of the bureaucracy involved in review, attention had not been given to how procedural requirements work in practice. However, what was startlingly obvious from the outset of my fieldwork was the small number of applications which involved people with mental health problems. It was

maintain a focus on research applications for people who lacked capacity, that ‘incapacity’ may relate to a range of conditions and (ii) that the scope of the study would extend to how the work of RECs was accomplished.

As I stated above, despite my initial interest in capacity and consent relating to those with mental health difficulties, it emerged early on that these would only form a small proportion of the applications heard. Whether the lack of studies involving those people with a psychiatric diagnosis is a result of the perceived consent barriers is beyond the scope of this study. Most RECs invited me to stay for the duration of the meeting. This enabled observation of discussions about studies which were not specifically highlighted by NRES as capacity studies, nonetheless these did include discussions about consent. The table below gives a brief description of the specific ‘capacity’ applications which I heard being discussed. Identifying features have been taken out and only outline details provided. In all a total of 17 applications were heard.

Table 2: Range of applications Studies

• Pharmaceutical - emergency medicine • Dementia - communication

• Implants in eyes – people may lack capacity • Use of device - unconscious

• Use of device - unconscious (2)

• Taking tissue samples – (to include patients lacking capacity due to anaesthesia or ICU)

• Service – user perspectives on a service approach - substance misuse • Dementia – communication method

• Medical intervention in intensive care • Mother and Baby Unit (psychiatric)

• Links between substance-misuse and eating disorder • Anonymized psychiatric register for researchers • Dementia - occupational health

• Quality of parent/baby interaction where baby has ‘abnormalities’

• Radiography and other assessments of musculoskeletal conditions in rare disorder (learning disability)

• Learning disability health outcomes database (affects people with Down’s Syndrome)

Whether studies are highlighted as having capacity issues or not, consent to research is a central concern of all inquiry with human ‘subjects’ and is scrutinised in ethical regulation. The fact that I accessed those committees ‘flagged’ for capacity, meant that I could focus on those studies which were perhaps more problematic or raised more challenging questions in relation to consent.

In this introductory chapter, I have provided an overview of how the research evolved. Its origins were in the concern with how capacity and consent were understood in ethical regulation and the perceived over-bureaucratisation in regulatory processes. What was evident was that there had been limited focus on the work of RECs and I sought to undertake an ethnographic project which would look at how the work was done, where the work of decision-making happened. This can be distilled into the single question:

How does ethics review ‘work’ in the real-life setting of a REC?

Finally, in this chapter, I summarise below the structure of the thesis in the hope that this might guide the reader through the development of my thinking and the interpretation of findings.

1.10 Structure of the thesis