IMPORTANCIA DE LA MATERIA ORGÁNICA (MO) EN EL SUELO.

Objectivity is an important ruling concept in ethics review. The lay/non-lay question is important in relation to this. The public website pronouncements are intended to demonstrate objectivity achieved in part by the inclusion of lay members. There are

even distinctions between lay and lay plus. In the everyday world of the REC, there was a straightforward practical understanding/working of this. Lay meant non- medical. Medical members did not feel the need to assert their knowledge where lay members did. The ruling concept here which is hardly acknowledged is the ‘objectivity’ of decision-making. The overarching rules about the composition of RECs are presumably intended to fulfil this requirement for objectivity when what happens in practice is that the RECs just work with what they have. There was no clear process for how Chairs allocated applications for review. I was told by various committee members that Chairs would usually try to assign studies which suited the particular areas of expertise. Everyone I interviewed was keen to point out the value of lay members.

In interviews, committee members were usually happy with the way meetings were chaired and the allocation of applications to lead reviewers.

It’s a good friendly team. In other meetings I’ve been to, lay members are viewed as second-class.

Interview with reviewer: REC A

In general, there are two reviewers. It’s not always a good idea if there are two reviewers from similar backgrounds - there needs to be a spread on the committee in membership, lay and clinical for example.

Interview with reviewer: REC E

One new committee member was unsure how members were selected as lead reviewers.

Are they selected according to experience by the Chair or does the Secretary allocate on the advice of the Chair? Even if you don’t have specific knowledge or experience, you can still comment on ethics.’

Interview with reviewer 1: REC E

Lay members were seen as important to the process of decision-making.

We negotiate a decision. People are encouraged to participate. The Mental Capacity Act covers a massive area of research – emergency work, old age psychiatry, unconscious people – we need the wide spectrum of perspectives on the committee.

Interview with reviewer 2: REC E

The reviewers I interviewed were not all medical but those who told me they were lay were generally not from a medical background. The range of expertise represented by these members was drawn upon in REC discussions. When I interviewed two

reviewers following one REC, the dietician identified herself as a lay member whilst the other, a pharmacologist did not. In relation to the study reviewed (which was a psychiatric study), neither was ‘expert’ and yet there seemed to be an unspoken hierarchy here of lay simply meaning ‘not medical’ or not or ‘not medical enough.’ I am not suggesting that the status of members is a problem for RECs and the ways in which they operate. There did not seem to be a standard way of allocating applications for review. Particular expertise was valued but there was also an acknowledgement of the value of a breadth of experience. However, the lay issue was not seen as straightforward.

JM: How do you go about allocating applications?

Chair: Well the REC managers allocate – they sometimes consult with the Chair. We assume that by the end of a year all members can review. It’s fairly indiscriminate. Lay members are included. And all MCA (capacity) applications are included. There’s no difference in allocation. There used to be someone we used a lot for capacity studies because he developed an interest – but he wasn’t a psychiatrist. Most of the committee can deal with most of the applications.

JM: Can you describe what lay means?

Chair: Well it’s tricky to define- have you seen the ‘lay-plus’ issue?

JM: Does lay mean ‘not medical’ – that’s what a coordinator explained to me. Chair: Yes, that’s probably it. I am lay because I’m not a medic though I worked for the NHS. We have a retired teacher who is ‘lay-plus’. We had a barrister who was lay.

Interview with Chair: REC H

Lay members may be valued and included in allocation but this question of what lay membership is, is significant. What is unacknowledged is the dominance of medicine and scientific concerns. The official discourse is one of openness and the aim of wide membership is indicated by the 1/3 lay membership. However, by terming members as ‘lay’ the issue of dominance of certain professions (usually medicine) is not addressed. The implications of this are that there is a model of research review in which there is a privileging of quantitative and positivist research (especially medical) at a time when NHS ethics review is being extended to all kinds of research. Again, I am not concerned with identifying negative attitudes among reviewers (for example towards their ‘lay’ colleagues or to qualitative research). However, there is an important point here in this unravelling of lay and expert. The very idea of ‘lay’ implies that there is a pre-existing ‘expert’ version of what research really is. Currently, that expert version is predominantly medical. This is an example of what Smith terms ‘relations of ruling’. Overarching ways of understanding about

what constitutes science and research are embedded in official discourse, in documentation, in web-based information, in the ‘rules’ adhered to in committees. To extend this analysis, lay membership also seemed to me to be required in order to show evidence of objectivity. The HRA may attempt to draw on a diverse range of backgrounds in the RECs. The co-ordinator who I interviewed about this said that in practice lay often simply meant ‘not medical’. Given this dominance and the fact that RECs (particularly flagged for capacity RECs) need to review all research whether medical or not, the lay issue becomes crucial. The theory informing institutional ethnography would suggest that the settings investigated are organized and ruled in definite ways (Campbell and Gregor, 2008). Examining the detail of connections between people in the setting and across settings is important in helping to establish links and highlighting relations of ruling. This means that a critical analysis of this practice of appointing membership and apportioning who is counted as ‘lay’ would lead to a questioning of the purpose(s) of this practice and raise questions about why committees ae constituted in these ways. I propose that the lay membership issue is crucial in demonstrating objectivity. Objectivity can be referred to here as a ‘ruling concept’. What I mean by this is that objectivity is a powerful concept with an extensive reach. ‘Objectivity’ seems unproblematic – who would not want an objective review system? Further, the players themselves repeat that lay contributions are valued and imperative in decision-making. Yet the everyday working out of who is lay or not is at the same time complicated and practical. In the end, decisions are made as the RECs ‘work with what they’ve got’ on the day of the meeting or who REC coordinators know will be attending. It seemed important to all those interviewed to point out the lack of a formal hierarchy. However, the hierarchies were present but unacknowledged. Again, institutional ethnography assures us that settings are organized and ruled in particular ways which might not be fully acknowledged and realised by participants.