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In document De rege et regendi ratione libri tres (página 65-113)

Another challenging standard was ‘Conflict of Interest’ (COI). During my visit to the Philippines in April 2010, I attended two FERCAP surveys and several trainings. On the opening day of one survey, Cecilia a chair of various national boards, explained to the surveyors and trainees some of the challenges of conducting ethical review in her country. Classing conflict of interests as an

‘obstacle’ to quality ethical review, she lamented that in the Philippines:

[w]e do not understand or easily recognize conflicts of interest. One time, we had a member in the National Ethics Committee, a very respected researcher who was also a head of a

health institution. He said, ‘I think our health institution should be exempted from ethics review because we’ve been doing research for so long.’ I said ‘OK byee!’ So its not very clear yet what this is all about. Since we do not recognise conflicts of interest, we do not manage [them].

In not permitting experience to stand over submission to ethics, Cecilia illustrated how both researchers and institutions had to adapt to the changes brought about by GCP and research ethics: neither experience nor seniority provided exemption from external evaluation. As the amount of internationally sponsored research increased in the Philippines, so did attendance at trainings on international standards. I joined a lecture in theatre 222 of the College of Medicine, where some forty or fifty course attendees had gathered for a presentation on Conflict of Interest by Dr Rodriguez, Professor of Legal Medicine and Ethics at the School of Law. His lecture echoed the concern that it was something ‘difficult to see’. The potential in Conflict of Interest which makes people anxious. It can — as Emory University found out — put you on the front page of the New York Times.32 In the same way as ‘confidentiality’ flipped from being a concept committees sought to ensure for participants in the trials that they reviewed to being something the committee itself must demonstrate, conflict of interest is a topic committees examine in the protocols review, and one which affects them directly. Although committees are tasked to consider the former concern, Canadian commentator Lemmens (2006:32) points out that COI has a vast reach. The assessment would include the clinical trial agreement between researchers and sponsors, the budgets of trials (particularly the incentives for the recruitment of subjects and any payments to them) publication agreements, the scientific validity of the trial, access to data and the publications that result. ‘Should RECs be expected to do all of this work’, Lemmens asks,

‘indeed, are they capable?’ (2006:32). In his view, they ‘cannot take sole responsibility for unraveling the complex relationship between scientists and the companies that sponsor them33’ (ibid). The knowledge that brought committee members to their ‘expert’ role on the IRB was also the knowledge that made the exercise of this role problematic: if they knew the field of cancer, say, it was also likely that they knew who worked on cancer in their institute. Even

32 Despite 20 different COI policies in the University. (U.S. Department of Energy 2011).

33 The relationship can be even more complex, when, writing about India, Gulhati considers hospitals owned by drug companies, and their institutional ethics committees, since there is ‘no legal requirement for investigators or members of the Ethics Committee to declare a conflict of interest [in India]’ (Chatterjee 2008: 577).

anonymized protocols, reviewers would probably be able to deduce whose protocol was under review34. Rodriguez described this social proximity as ‘bias’:

There is always this tendency of bias, when you talk about a committee who are all barkadas35 of the one conducting the research. You know our culture, Philippinos. Our barkadas, as medical students we are a close group, close friends there who went through thick and thin all throughout. ‘Hey, this is a proposal from Dr so and so. And I’m the one reviewing it?’ So there is always this potential.

Rodriguez reminded his trainees that they will often know the applicants: ‘[w]e are faculty, same institute. It is a problem as much as you like them, as if you dislike them. You still feel something towards them.’ He also reminded investigators who sat on committees that they may know how to do clinical trials,

but when you sit in the EC you wear a different hat because you are supposed to institute that check and balance. You’re supposed to present an alternative perspective, not the perspective of an investigator.

Those with experience of the clinical research environment were often considered useful people to have on ethics committees, so the appointment did not prevent them from conducting research.

However, Rodriguez pointed out that ‘practically everything you do now you see a sponsor, a multinational corporation funding the researchers.’ He warned committee members to be careful:

In the US, all members make a declaration about their investment. They think anything over $10,000, in WIRB36, if they do Pfeizer protocols. Those with stocks in Pfeizer have to leave the room. That’s how they look at COI [...]. In the US, it was said that the $10,000 is a minuscule, a negligible amount. But here in the Philippines $10,000 US dollars is really something.

Translating from dollars to Philippine pesos was an attempt to evaluate the amount of money that would cause an ‘undue influence’. Things got more complicated however, as money, he told us, was the ‘only tangible thing in the array of secondary interests. It’s always easy to address it because money is there, you see it.’ Other things were less visible, and required different forms and degrees of self awareness.

34 I should point out that I am not arguing that this problem of finding relations in a committee is exclusive to the countries where FERCAP works. A recent anonymous posting to IRB Forum, an ethics discussion group, made public a recommendation by Penn’s legal department to dissolve its internal IRB and use an external commercial IRB due to concerns about internal conflicts of interest (Corman 2009: 10). However, the existence of companies conducting ethical review in the USA does mean that the landscape is less personal: one could send a protocol away to another more ‘independent’ committee.

35 Filipino slang for a group of friends or peers. With thanks to Atoy Navarro for translation assistance.

36 Western IRB, based in Olympia WA has had significant interaction with FERCAP and ethics committees in the Asian region through its WHO funded developing countries training program. See Introduction.

Secondary Interests

‘We think of COI in terms of your perception’ counselled Rodriguez:

You are an ethical individual and therefore you can not do anything wrong. But that’s not the definition of COI. COI means that you are ethical [and] at the same time you recognise you have a different role and a different interest.

Recognising these different roles and interests meant being aware of ‘secondary’ interests — and with this, we entered the realm of the intangible. ‘We cannot come up with a researcher without conflict of interest,’ Rodriguez told us, ‘Life desires to have fame. How do we measure that desire?’

Secondary interests applied as much to ethics review committee members as to those who conducted research, but as I observed above, often these persons were one and the same. While those who sat on ethics committees tended to have an interest in research, interests were something different:

Problems occur when secondary interests dominate, unduly influence, distort, or corrupt the integrity of a physician’s judgement in relation to patient health (Thompson 1993) Fortune, fame, and family threaten the integrity of the professional judgement.37

So how are these ‘interests’ to coincide, to come into ‘conflict’? The extension of ‘interest’ reveals for anthropologists the starting assumptions on which COI disclosures are based. Anthropologist Chris Gregory, in revisiting anthropological readings of economist Adam Smith, finds them selective, focusing only on greed and rational self interest: the Theory of Moral Sentiment, he argues, is more subtle (Gregory 2011). Smith scholars such as Griswold (2006) and Bhanu Mehta (2006) would agree. Consider the passages of Smith selected by Griswold, writing on the imagination and its relation to self interest:

The “natural misrepresentations of self-love can be corrected only by the eye of this impartial spectator” (III.3.4 cf III5.5) Moral self-consciousness requires that I “divide myself, as it were, in two persons” (III.I.6). The idealized judge is still a spectator - the stand-in for “the public” (Griswold 2006:38).

Based on these excerpts, Griswold argues that ‘the theatrical relation is thus internalized; we become our own public,’ concluding that ‘[o]ur understanding and moral assessment not just of others, but of ourselves as well, depend on an exercise of the imagination’ (2006:38). Through contrast with other ways of thinking about persons that we can see the contrivance of imagination at work in the concept of Conflict of Interest. As Strathern remarks,

37 See Thompson (1993) for the counter argument that conflicts are usually not illegitimate, indeed they are frequently necessary and desirable.

[t]he center is where the twentieth century Western imagination puts the self, the personality, the ego. For the ‘person’ in this latter day Western view is an agent, a subject, the author of thought and action, and thus ‘at the center’ of relationships (1988:269).

Strathern is reflecting on a diagram (Figure 24) drawn by Maurice Leenhardt (1979 [1947]) which depicted his understanding of New Caledonian ‘personage.’

While this diagram works well for the way Conflict of Interest is imagined — locating a person by means of her relationships — for Strathern it revealed in visual form a limitation in Leenhardt’s depiction of Caledonian sociality. In her critique, Strathern observes that even in attention to the way in which peoples relationships make them up, the individual subject is foregrounded. She remarks that ‘Leenhardt’s star shaped configuration carries the one and same presumption: living within, guided by, driving, functioning as, or knowing through these structures of relationships must be the individual subject’ (1988:269-270). What COI makes explicit is the tension inherent in this model of the individual subject. While COI models do not re-imagine dividuality, they exist because of the recognition that people belong ‘to a matrix of radiating relations’ (2004 [1991]: 68). The attention to relationships provoked by Conflict of Interest suddenly appears as a way of seeing people that looks a lot like certain proposals for theorising ‘social reality’:

If we are to produce adequate theories of social reality, then the first step is to apprehend persons as simultaneously containing the potential for relationships and always embedded in a matrix of relations with others (Strathern 1990a: 10).

What is the difference between seeing people as always embedded in a matrix of relations and seeing these as ‘interests,’ contained within?

Figure 24: Replication of the diagram produced in Gender of the Gift (1988) in which Strathern’s critique appears.

Discipline

Rodriguez continued: A conflict exists whether or not decisions are affected. Conflict implies only the potential for bias or wrong doing. And the basic step that you must consider is failure to disclose is wrong.’ Participants in the training were encouraged to ‘think about’ what conflicts of interest they might have, with the lecturer assuring them that ‘half the problem is solved if the presence [of interests and their possible conflicts] is recognised’. Having listed various potential conflicts of interest — with conflict itself understood as ‘potential for bias or wrongdoing’ — disclosure was introduced as the next step. ‘Disclosure is the cornerstone of the Conflict of Interest guidelines and regulations,’ Rodriguez announced

You can keep it to yourself, but you will be taking a risk because once its discovered or if a third party disclose it, then you are in deep trouble. In the US it is a very big thing because I think the regulation carries a penal clause, meaning they can give a penalty. It’s not only a concept of ‘Hey, what you did was wrong.’ [...] It’s imperative that all clinical researchers would have this openness when it comes to Conflict of Interest. You simply cannot hide one or two and disclose the rest because eventually it will be discovered. That is a requirement that you alone can perform [...] So you might as well start by disclosing it.

According to Rodriguez, the revelation of conflicts of interest required ‘discipline’, as there was

‘no other way for others to know’ if one was harbouring a conflict of interest around the table at the committee meeting. It would also, he implied, be difficult for those who knew to point to someone. ‘It’s a cultural thing, if we say “You have a conflict of interest, get out”, there will be hurt feelings.’ This sort of discipline, the revelation of internally held knowledge of relationships external to the committee, meant committee members were told they could not ‘be silent’, but had to ‘manage’ their conflicts ‘preemptively.’ We see here legacies of Durkheimian thought, with its public and private dimensions, both visible and invisible, external and internal (Durkheim 1992, Ezrahi 1990). The ‘perceived relationship between inner and outer worlds’ (Strathern 1992a:184) provides a model of human thought and action lends itself well to a consideration of

‘interest’ in the phrase ‘conflict of interest’. Interests are not visible attributes, they must be declared, moved from internal to external. The focus for conflict of interest has moved, replacing an examination of relationships between committee members with an examination of one’s relationship to oneself (thought of as containing or composed of relations), by finding a position from which this can be viewed. I return to the work of Griswold (2006) above, as he traces Smith’s comparison, or conflation, of moral and visual judgement:

Smith [...] compares the process by which we learn to exercise balanced moral judgment to that by which we learn to make correct visual judgments. He has Berkeley’s New Theory of Vision in mind, a book of which he thought very highly. The basic idea is that just as I cannot gauge the correct proportions of objects of different sizes and at varying distances, except by “transporting myself, at least in fancy, to a different station, from whence I can survey both at nearly equal distances,” so too I cannot accurately evaluate the magnitude of my passions in comparison with another’s except by viewing them “neither from our own place nor yet from his, neither with our own eyes nor yet with his, but from the place and with the eyes of a third person, who has no particular connexion with either and who judges with impartiality between us” (Griswold 2006: 38)

On this point I wish to pause: there is more potential in the study of this point of Conflict of Interest than I can draw out here. The material resonates with the creation of objectivity in the Survey through the ‘distance’ of foreign surveyors, it parallels the moralisation of objectivity in the work of Daston and Galison (1992: 81) and draws ‘truth’ and representation together under the banner of moral obligation. For now, what I wish to draw attention to is how members are problematising concealment and revelation, for the duration of the meeting, as a moral act that only the individual member is capable of performing. For a committee, this requires thinking of people as already related: as individual committee members or researchers they have their relationships, and thus their potential conflicts, ‘built in.’

In the Philippine ethnography above, COI may not only jeopardize the ‘objectivity’ of a researcher, but also cast doubt upon the research enterprise itself. Members’ relationships outside the committee come to be constitutive of the trustworthiness of the committee as a unit. When a person discloses a COI, s/he will usually stand and leave the room. The recognition and management of COI can be evidenced by minuting that bodily action. Cecilia and Dr Rodriguez both indicate that for conflict of interest has the potential to inhere in any of the relations of which a person is made up. It can reside in their internal attributes (their ambition) and their relationships (through kin or money) which, during the committee meeting, are seen to be carried in the body of the (in)dividual committee member.38 As Rodriguez says, it is not that some of the people to whom one might be connected might be bad. Rather, it is that the connections themselves, unrevealed might cause difficulties. The distinction, as drawn by the lecturer, was that it is not a crime to have conflicts of interest, but to not declare them. Thus it becomes the responsibility of each member to scan their relations. This is the nature of their ‘disciplining.’

38 I suggest they are thought of perhaps more as ‘dividual’ (Marriot 1976; Strathern 1988) at these moments than individual, since their ‘internal composition depends on external relations’ (Fowler 2004:26), an observation which perhaps, given my revisitation of Smith (re)complicates the individuality of the models from which notions of COI are drawn (see also Hess 2006).

Munro observes that ‘[w]here the consciousness of individuals is regarded as primary, [...] the tendency is always to re-locate relations inside these ‘wholes‘ — to the domain Kant called the

‘universe within’ (2005: 256, references omitted). The ‘interests’ of which Rodriguez speaks are thought of to be both ‘out there’ in society and ‘in’ the individual. They are seen to be forces that move without people: financial interests, company interests, pharmaceutical interests. But it is also easy to imagine these interests ‘into’ persons, in their financial motivations, their ambition.

Furthermore, if those interests are ‘in’ persons, then those persons can then come to stand for those things. ‘Conflict of Interest,’ I suggest requires a ‘holistic model of society in which specific interests would be located in relation to one another’ (Strathern 1988a:26), one where Ethics Committees are called to to ‘play a role mediating the interest of particular groups’ (Tupara 2011:369). In Chapter 2, I showed how during the survey it is the company of others that makes objectivity possible. The views of Surveyors are de-personalised in their combination, making the Survey’s recommendations seem objective. Here, the possibility of concealed interior relations prevents objectivity. Relations — configured as interest — constitute rather than dilute bias.39

Concluding remarks

I initially paid attention to space in this chapter because I wanted to highlight the way the ethics committee — in its physical, enacted form — constitutes a knowledge space. Drawing on David Turnbull (2002), we could think of the requirements of the space, oft repeated in surveys - a computer with a database, a fax machine, a printer, a photocopier — as ‘templates’ for the cathedrals of ethics, assembling standardizing, transmitting and utilizing knowledge. The closing reports of Survey project images of these pieces of technology as achievements of the space, the space the achievement of the will of the committee. The organisation has been convinced.40

39 Or, in Haraway’s terms, ‘embedded relationality is the prophylaxis for both relativism and transcendence’ (Haraway 1996:440).

40 I am not suggesting that the ‘achievement’ of space is unique to Asian contexts, rather that as we saw above, hospitals and universities may need convincing. A parallel of the significance of ‘taking’ space for Ethics is found in the language of Auerbach’s report on an Amherst alumnus, Ezekiel Emmanuel, a bioethicist who took up a role at the US National Institutes of Health:

Emanuel [...] took one look at the government-issue green-hued rooms where NIH scientists did their work and [said] “That’s not the right environment for bioethicists.” Emanuel created a central common space.

Emanuel [...] took one look at the government-issue green-hued rooms where NIH scientists did their work and [said] “That’s not the right environment for bioethicists.” Emanuel created a central common space.

In document De rege et regendi ratione libri tres (página 65-113)

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