Riles (2006) observes that a document is a means; it points to an end beyond itself. Under discussion in the grand hall in the Hotel Equatorial, Shanghai, the draft of the new WHO Standards (2011) certainly hoped for an end beyond itself. Carl Coleman, the lawyer whose articles framed the previous chapter, was presenting the draft to FERCAP for consultation. ‘Let me preface this,’ he began:
by saying the standards are all phrased in the same way: phrased as describing a state of affairs that would be a good state of affairs, the way things should be. There’s no verb in there, such as ‘should’ or ‘must’ or ‘encouraged’. It’s simply saying that in an ideal world, this is what happens.[...] They’re describing the situation as it should be. The question in evaluating any given system is whether in fact this description is being satisfied.
A document that intends to bring the system into being by describing it is, I would suggest, a powerful mode of description. In this examination of the production of ‘authoritative knowledge’ (Jasanoff 2005:19), the story I compose from the meeting takes up the question of what an ethics committee should look like, and how that description — one we already know as
‘ideal’ — is reached. Carl tells us that this description of the world as it should be is also a world that can be measured. A discussion of standards forces a description of the ideal, and of the gap between the ideal and what people consider practicable. The first problem the FERCAP attendees
raise is medical expertise. The second, developing out of the first, we might initially gloss as ‘social expertise.’ Let us look at the discussion surrounding the second Standard. Carl introduces it as:
moving from the system to the entity that is establishing the REC, which could be a national or subnational entity; it could be an institutional entity. The REC is [he reads from the screen]
“appointed according to a charter or other document which establishes the manner in which members will be appointed. The appointing official ensures that the REC has a multidisciplinary and multisectorial membership, that its composition includes both genders, that it reflects the social and cultural diversities of the communities from which research participants are most likely to be drawn, and that it includes individuals with backgrounds relevant to the areas of research that the committee is likely to review. Committee members recognise the limits of their knowledge and seek external input where necessary, particularly in relation to research that involves participants whose life experiences may differ significantly from those of the committee members.”
Carl summarises the Standard as being about ‘a diverse representation on the committee and it goes into a little bit of detail about what diversity means.’ He asks for questions and Vasantha, the Senior Deputy Director General of the Indian Council of Medical Research65 raises a hand. ‘Of course’ she begins,
[the standard] only talks about backgrounds relevant to areas of research the committee is likely to review. It’s not always possible. That’s why you need consultants, experts who are attendant to the committee to do the expert views.
The session chair points out that this is addressed in the next sentence, that committee members
‘recognise their limitations,’ but the chair thinks it’s important that the standard notes that
‘individuals have backgrounds relevant to the areas of research’, even if this is not always going to be possible. Carl agrees, and takes up the point:
I think part of the question is what the purpose of the standard is, the way this was discussed it was a standard to describe the ideal. Ideally you would have representation from all the areas of expertise. In reality, that may be a standard that is going to be difficult to meet in a lot of cases because the committee just doesn’t have a lot of options to draw from.
That’s where the next sentence about limits of knowledge would come in.
Vasantha worries that by making ‘representation from all areas of expertise’ mandatory, it becomes impossible for committees, particularly those in developing world settings, to achieve the standard.66 At this point we are about to shift from the limits on available scientific expertise to the limits on a committee’s social knowledge. To solve the problem, the chair proposes a link between sentences. If ‘committee members recognise the limits of their knowledge and seek
65 Whom we met first at the Regional Collaborative Workshop, in Chapter 1.
66Finding ways to ensure ‘appropriate expertise’, from all areas is indeed a challenge in developing world settings, and is acknowledged by documents such as the 2005 Nuffield Discussion paper. I develop this important point below.
external input where necessary’, perhaps this will help? But for Carl this linkage produces a new kind of problem : ‘[t]he sentence wasn’t intended to apply just to expertise, it was also intended to apply to community representatives.’ There is a pause. Cristina speaks first: ‘I think I’d still emphasize that an EC should have the expertise to review the types of research it reviews,’ she says:
If it has no expertise it should not review it, no? I like this guideline because it emphasises that this EC should have expertise, otherwise what’s your business accepting that protocol?
And you seek external input where necessary. That’s the consultant.
Vasantha notes that she expects the protocol to have already undergone an expert scientific review,67 to which Cristina rapidly responds, ‘We don’t assume that, that’s just India!’ which raises a laugh. At this point, an invited speaker from the USA raises a hand. The chair motions for him to speak. ‘This is only a suggestion’, he begins. ‘Not imposing?’ jokes the chair. ‘Just a suggestion’, he repeats:
When it says that the appointing official will ensure that [the committee] reflects the social and cultural diversity of the committees, you imply that you must have representation from that participating population you are doing research in. Perhaps it should say that they ensure that they have knowledge about social and cultural diversity. Not every REC has an HIV infected person on their board, nor do they have poor people, or others from these vulnerable populations that we’ll do work with. So it may want to say that rather than ensuring the committee reflect the diversity, that the committee have the knowledge of that diverse population.
‘I see your point,’ replies Carl, tentatively:
I think that’s probably something we should discuss a little more, because I think there were some people who felt very strongly in previous versions that the committee should include, or strive to include those people, though it may not always be possible.
In enlarging on a problem which started in the possible limitations of medical expertise in developing countries, the discussion has suddenly shifted to what kinds of knowledge are sufficient, who might possess them, and how both people and knowledge should be made present on a committee. ‘How can we get those people from that community?’ asks one audience member.
‘I think it’s about having the relevant knowledge,’ continues another, ‘I think it should say that,
“The committee should have the relevant knowledge, rather than the committee itself reflecting those…”’ We reach a point where this change is being contemplated, when Carl speaks again:
I’m not sure everyone would agree with that. I see your point, but I’m thinking of the comments we received on earlier versions of this. There were a lot of people saying that
67 See above.
there wasn’t enough in the existing Silver Book to emphasise that this isn’t a committee that is looking at the community and making decisions for it but that it is a committee of the community. At first it said something like ‘represents’ and then there was some concern that that was a little ambiguous and what does it mean to represent a community? So reflects was seen as a little bit... But knowledge of is almost expressly saying that its people who are not [of that community], it’s someone from the outside who knows of.
Li Ling, one of the Chinese delegates suggests ‘emphasis on the cultural or community consideration of the committee composition,’ worried that unless this is specified, it will be ignored. Cristina replies to her, returning discussion to the layperson:
It’s about the layperson not a community representative. [The standard] says that members whose primary background is not in science or research should be appointed in sufficient numbers to ensure that they feel comfortable voicing their views. And that was intended to emphasise that you shouldn't just have a token member that is the community or a lay member, but there really should be a critical enough group.
The shift from sufficient breadth of scientific expertise to ‘social and cultural’ issues provokes the invocation of three distinct terms: reflects, represents and ‘has knowledge of’, each carrying its own connotations. Why do these words and terms matter?
As I suggested initially, the creation of the standard is a powerful mode of description. While Vasantha’s concern with the scientific whole can be fairly readily supplied with ‘experts’ and
‘external consultants,’ the breadth of ‘the social’ is less easily satisfied. From the discussion above, we have (at least) two types of person for this category: the layperson and the community representative. The deliberation over which of these to use reveals questions about who these
‘others’ are to be, and how this ‘social’ field is to be ‘brought in.’ How are their qualities described? American literature on the topic is clear:
While no committee can represent all elements of the community where research will be conducted, the REC must be capable of assessing the impact of the research on the community and determining whether the research is relevant in the local setting. This often leads to the inclusion of REC members who do not have a scientific background but are professionally grounded in the community, such as a member of the clergy, social worker, teacher or nurse. [...] They should exhibit commitment, knowledge and concern for their communities. The nonscientific and community representative members must be given the same level of respect as their scientific counterparts (River and Borasky 2009:50).
Li Ling’s intervention allows Cristina to reframe the problem of representation as one of the committee’s expertise. This in turn becomes a question of quantity: ‘you shouldn’t just have a token member that is the ‘community’ or ‘lay member’, but there really should be a critical enough group,’ Cristina says.
Quantity is the reason given for a recent innovation, community advisory boards (CABs), which provide another approach to involving non-scientific persons in committee decisions (Diallo et al.
2005, Quinn 2004, Weijer and Emanuel 2000, Thaitawat and Chinaworapong 2008). A researcher who worked with a CAB in India said during the 2009 FERCAP Conference that:
CABs can be conceptualised as an intermediary between the community and researcher. It gives them strength of argument, because on a REB/ERB/ERC, a community member might not have the strength to make their presence felt, they might be intimidated.
Researchers try to ameliorate such intimidation when conducting research. Consider these notes from a discussion at a workshop in Canada in 2005, following presentations on community consent in the ‘Promotion of Equitable Research Practices’:
One way to achieve informed community consent is through community REBs. Then it will not simply be a traditional band or tribal leader consent — one person who decided for the group — but a more balanced consent. It is an epistemological question: are we individuals first or members of groups? The answer seems to be neither, and this is the problem (Lemmens and Archibald 2006: 63).
When confronted with community consent, the certainty of the researchers (and of their ‘ethics’) in the primacy of the individual evaporates. Anthropologists are likely to recognise this
‘epistemological question.’ Strathern writes that the concept of ‘society’ construed the individuality of its members as primary; individuals first, their relationships second (Strathern 1996a:62). What the apparent problem of “applying” principles of individual informed consent to others reveals (again) is that — as anthropologists have long known — the individual is a particular way of thinking about the person (see also Corrigan 2003). In the closing of her contribution to the 1989 Manchester debate, Strathern puts the consequences strongly: ‘The unfortunate outcome of conceiving of society itself as an entity has actually been to make relationships seem secondary and not primary to human existence’ (Strathern 1996a: 55). Informed consent is the ground upon which this tension becomes most evident, and has garnered a large share of academic attention (Sankar 2004, Reubi 2012, Molyneux et al. 2005). But effects of this mode of thought are far reaching and, I suggest, sustained and promoted through the way in which research ethics is framed. When the individual whose consent must be sought is not found, indeed the concept not found to hold, researchers look for groups. Groups then require representatives, and the problem recurs.68 If representation is the outcome of a Euro-Americanism that splits one reification
68Sometimes they find themselves caught up in loops, where in order to research problems of informed consent, their own research regulations require them to obtain informed consent from participants, in order to talk with them about why informed consent may not be suitable.
(individual) from another (society) in order to recombine anew and this fails the committee, what then of ‘reflect’?
In an interview with Carl nine months after the consultation in Shanghai, he clarified that the draft at the time (September 2010) read ‘reflects,’69 for ‘practical’ reasons:
Will you be able to find people who truly represent? ‘Having knowledge of’ might mean anyone who has read a book. The reflect is more in-between. ‘Represent’ - you’d need to find someone who could speak on behalf of the entire group. ‘Reflect’, you could be a part of the group, or it means you’re somehow part of it, it’s not necessary for you to stand for everyone, you’re not necessarily typical. But ‘reflect’ also goes some way to preventing a total stranger... So we had to try and find a word... Everyone will interpret [it] in a different way, not everyone will read it this way for people who wanted the word represent it helps them, and so in a way it serves both sides. It doesn’t say that they do... [it] comes on a little weaker.
Carl’s later analysis reveals assessments about the adequacy and type of ‘knowledge’ desired from persons on an ethics committee. It also makes a careful distinction between types of learning.
Book learning seems too little — the person could be a ‘total stranger’. Representing seems too much of a demand, indeed, perhaps impossible. Sometimes, for Euro-Americans, ‘simply
‘knowing’ about other perspectives may [...] be regarded as a respectable end in itself’ writes Strathern (1999:252). But the discussion around the revisions of the Silver Book suggests that this is not one of those cases. In discovering the inadequacy of “having knowledge”, we are led to ask for what purpose it is inadequate, and what is instead required. What is desired is no longer the characteristic of knowing something, but of being something: being ‘of’ or ‘from’ that community, being a patient with a disease that is under discussion. The ‘ideal’ standards describe not only a broad range of persons in whom scientific expertise resides, but also types of people. Though the standard was ultimately published using the term ‘reflect’ (WHO 2011), the first ‘guidance’ point for Standard Two states that:
Members include individuals with scientific expertise [...] and lay people whose primary role is to share their insights about the communities from which participants are likely to be drawn (WHO 2011:8).
69 It has since been published with that phrasing (WHO 2011).
Laypersons
In ethics, the process by which a decision is made is as important as the outcome. For a decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. (WHO REC Basic Concepts 2009: 22)
An ethically legitimate decision, the Basic Concepts guide implies, might be a difficult thing to achieve. What is it, and how can it arise? The guide demands ‘openness’ and ‘inclusiveness’;
focusing on the decision as process. Here, building on Colin and Wedika’s comments (p.168), I explore further the kinds of things that laypersons are supposed to do and be. The layperson is a well-established figure in Euro-American discourses of public engagement with science. Maranta et al. argue that this figure is
not a sociologically comprehensive representation of lay persons but rather an action in the knowledge production which ascribes epistemic and functional competences to lay persons (2003:154).
Recognisable renditions of laypersons are distinguished by their medical ignorance, and in standing in contrast to the medical members of the committee, they assist in creating the latter as experts (Strathern 2004b, Michael 1996). In the sections below, I explore both the theory and lived experiences of laypersons.
i) In Theory
‘Doctors are all trained the same, so they think the same’, said Wedika, the Sri Lankan ethics committee member who argued above how a (particular) variety of perspectives would improve a committee. In interviews, I often found laypersons were deemed a necessary check on the ‘single’
view of medicine. In the publication resulting from the consultation above, further guidance accompanying Standard Two reads ‘Committees are large enough to ensure that multiple perspectives are brought into the discussion’ (WHO 2011:8) and elsewhere, WHO publications assert that a diversity of backgrounds on a committee ‘can help ensure that [...] judgements are not inappropriately dominated by a single perspective’ (WHO 2009:13).
One of the ways documents attempt to ensure a multiplicity of perspectives on committees is to make decisions made in the absence of a layperson invalid. This is achieved through specifying quorum, the minimum number and type of persons required to be present for a decision (WHO 2000). But laypersons cannot just be present. We know from FERCAP’s Survey’s expectations (Chapter 2) that they need to speak. In addition, according to an American Research Ethics
Training Curriculum, ‘[t]he nonscientific and community representative members must be given the same level of respect as their scientific counterparts’ (River and Borasky 2009:50; emphasis added). But how can this ‘same level of respect’ be ensured? That it needs to be specified already implies that it may not always be given. At a training in the Thailand, Cristina reported a conversation she’d overheard in Taiwan, between a layperson and a doctor, both of whom sat on an ethics committee. ‘How can a housewife debate with a philosopher?’ asked one trainer:
She was just a housewife, and someone asked her, ‘Why are you bothering yourself to come? There’s not much money in it.’ She said, ‘When I’m at home, nobody listens to me.
Here, what I say makes a difference.’ That’s the nature of the people. Once they get that pleasure, it’s hard to explain what it is.
The difference between a housewife and a philosopher was, to the trainer, obvious. But these definitions (and sense of hierarchy, it seems) need to shift. Juntra tells me that in FERCAP trainings:
We always tell the layperson, ‘You’re equal.’ Yes. In Thailand it was really strict before. Now
We always tell the layperson, ‘You’re equal.’ Yes. In Thailand it was really strict before. Now