ARE YOU SITTING COMFORTABLY? PERSPECTIVES ... - CiteSeerX

Accountability in Research, 13:111–133, 2006 Copyright © Taylor & Francis Group, LLC ISSN: 0898-9621 print / 1545-5815 online DOI: 10.1080/08989620600654019

ARE YOU SITTING COMFORTABLY? PERSPECTIVES OF THE RESEARCHERS AND THE RESEARCHED ON “BEING COMFORTABLE”

1545-5815 0898-9621 GACR Accountability in Research: Research Policies and Quality Assurance, Vol. 13, No. 02, March 2006: pp. 0–0

AreMorris N. You Sitting and B.Comfortably? Balmer

NORMA MORRIS

Department of Science and Technology Studies, University College London, London, United Kingdom BRIAN BALMER Department of Science and Technology Studies, University College London, London, United Kingdom

In a study of volunteers in medical research we found contrasting readings of “being comfortable” by the volunteer research subjects and the researchers. Although the experimental process (testing a new kind of diagnostic technology) involved some physical discomfort—and the researchers focused on this—the volunteers’ concerns centred on feeling socially comfortable and managing feelings of embarrassment or isolation, and they generally made light of the physical aspects. The bias of volunteer concerns, which is understandable in terms of the different situations of researchers and volunteers and the different tensions they create, has potential implications for the engagement of researchers with their research subjects and prevailing standards for the ethical and accountable conduct of research. Keywords: volunteers, human experimentation, clinical research, research participants, bioethics, optical imaging

This article forms part of a growing body of literature on how volunteer human subjects understand their own participation in research. Much of the previous work here has been primarily geared to address concerns of trial managers about recruitment and retention of subjects for clinical trials (Ross et al, 1999). More recently, there has been increasing use of qualitative methods to

Both authors contributed to all aspects of preparing this article. The work was approved by the Joint UCH/UCL Research Ethics Committee. Address correspondence to Dr. Norma Morris, Department of Science & Technology Studies, University College London, Gower Street, London WC1E 6BT, UK. E-mail: [email protected]

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probe research subjects’ understandings, with particular emphasis on their construal of concepts central to the design of the randomized controlled trial (RCT) and the implications for informed consent and trial management (Edwards et al, 1998; Snowdon et al, 1997). In our study, by contrast, we have chosen a research setting (the early-stage clinical testing of a prototype diagnostic instrument by a UK university-based group) which, while recruiting human subjects to participate in research with a practical clinical aim, is significantly distant from the more familiar comparative, interventionist clinical trial. This setting has the merit, for our purposes, of avoiding or mitigating some of the complicating factors of more typical clinical trials (such as understanding of randomization or equipoise) and enabling us to focus primarily on the experience of being a human research subject. In this article, we concentrate on the volunteers’ and researchers’ different construal of “being comfortable” in the course of the experiment. Our study of volunteers taking part in laboratory testing of a new technology shows that researchers and the researched enter an experiment with different perspectives of what are the anxieties or issues for the volunteer human subjects.1 We have found that volunteers conform with the researchers’ approach (primarily focused on physical comfort) during the experimental session, but a subtext of broader concerns becomes apparent in subsequent one-to-one interviews, when volunteers are asked to talk about their experience and reactions. We argue that ethical codes and guidelines, aimed at assuring the welfare of those taking part in research, need to take cognisance of the full range of the research subjects’ needs and interests, which go beyond the physical, but are inadequately reflected in much current guidance. Likewise, researchers’ accountability to their research subjects (and the subjects’ accountability to the researchers) will be enhanced by increased mutual understanding by both main parties of what is going on when a volunteer takes part in a research intervention. For a theoretical understanding of the researcher-subject relationship and the dynamics of the research encounter, we have 1

We use the older terminology of “research subject” rather than the more acceptable current usage of “participant,” on the grounds that the status of the volunteer—whether subject, object, or participant—is one of the matters at issue during the research encounter, which the use of “participant” might seem to pre-judge.

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taken account of a number of disparate literatures, including concepts of bioethics (Vanderpool, 1996; National Commission, 1978), the doctor-patient relationship (see for example Stevenson et al 2004), the gift relationship (Titmuss, 1971; Tutton and Corrigan, 2004), and both older (Mead, 1968; Parsons, 1968) and more recent (BMJ, 1999) advocacy of a more collaborative or partnership relationship. As argued in an earlier paper (Morris and Balmer, 2006), we found limitations or problems with all of these models, and have concluded that the interaction between researcher and researched cannot be characterized by any single model. Research subjects do not conform solely to one or other of the models of researcher-subject relationship suggested in the literature, such as patient, altruistic donor, collaborator, or quasiemployee. Volunteers during interviews invoke some, all, or none of these various relationships when accounting for their role. On the basis of our empirical data, we therefore suggested that it is more productive to consider the interaction as a social situation, which has to be negotiated in real time in the course of each research encounter. A successful outcome to this negotiation—in terms of a mutually settled relationship—is important both to the volunteers and the researchers, and for the successful conduct of the research. This is the standpoint which informs this article. The Setting for the Study The setting for our fieldwork is the early clinical testing of a new method for diagnosis of breast cancer, using radiation at optical wavelengths: that is, using light to generate an image of what is inside the breast. This method has potential advantages, in terms of image discrimination and patient safety, over existing methods of investigation. We are collaborating with a team of medical physicists at a leading UK university who have developed a prototype optical imaging system, now being tested on human volunteers. As part of the collaboration we feed back information on volunteers’ views to the physicists to help them in the further development of the technology. Instrument development is still at the stage of establishing “proof of principle,” i.e., that images can be obtained that are consistent and that correspond with known features (by which we mean features identified by established modalities, such as ultrasound or mammography). The

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unknowns to be resolved by the human testing programme included: •

•

the capability of the technology regarding consistency and discrimination when presented with real bodies rather than a simulation; whether human volunteers could remain still for the duration of the test scans to allow sufficient quality data to be collected.

The choice of setting provided us with a number of features helpful for a study exploring the nature of the research experience for volunteers. An important corollary of the early stage of development of the technology was that volunteers could expect no personal health benefit from participating in the experimental scan process, and were so informed. This emphasized the research character of the procedure, and distinguished the situation of these volunteers from that of those taking part in a comparative clinical trial, who may enter with an expectation of benefit (Snowdon et al, 1997; Appelbaum et al, 1987; Edwards et al, 1998) and whose concerns may be more directed to structural features of the trial, such as randomization, than the immediate research experience. By contrast, our testing programme was very simple. The experimental nature of the work was further emphasized by the tests taking place in a university research laboratory rather than a hospital, and being conducted by the nonclinical medical physics team who developed the instrument, rather than by medical personnel. All this helped to keep the focus on biomedical research, rather than health care, and will of course also influence and in some ways limit the range and scope of the volunteers’ concerns. Data Collection and Analysis Data were obtained through participant-observation during laboratory test sessions, and qualitative semistructured interviews with the women who volunteered to take part in the experiments. The test sessions lasted up to 40 minutes and audio-taped interviews took between 30 minutes and an hour and thirty minutes, most lasting about one hour. Volunteers were aged between 20 and 75, though predominantly in the younger age groups, in a range of


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occupations from manual to professional. The healthy volunteers were recruited through personal contacts. The patient-volunteers— all with prediagnosed breast conditions, mostly nonmalignant— were recruited by two collaborating consultants at the university teaching hospital: they are asked if they would like to take part in the research, which offers no direct benefit. A small honorarium (£40) was paid to volunteers. All three healthy volunteers and 15 of 18 patient-volunteers were interviewed about their experience by the first author, Norma Morris, normally immediately after their scan, over the period 2001–2004. Thirteen scan sessions were observed by Norma Morris, audio-taped where feasible, and unstructured notes taken as a supplement to the interview material. Further semistructured, qualitative interviews were conducted by the second author, Brian Balmer, with the medical physicists to provide an insight into researchers’ expectations and assumptions regarding the researcher-subject relationship. Analysis followed standard qualitative methods. The interviews were all transcribed and the transcripts were read through in order to provide an overall impression of the information, and then to develop a coding frame based on themes emerging from the interviews, using N-Vivo computer software to facilitate ordering, searching and retrieving the data. Methodologically, the formulation of categories for the coding frame was influenced by approaches within discourse analysis (Gill, 2000), acknowledging that the volunteers’ accounts actively construct, rather than simply describe, their identities as volunteers (Burman and Parker, 1993; Potter, 1996). The transcripts were then coded. The Meaning of “Feeling Comfortable”—Empirical Findings A pronounced difference emerged in the data between the researchers’ and volunteers’ approaches to whether or not the experimental situation was comfortable. The scientists construed comfort largely, though not exclusively, in terms of physical comfort; the volunteers spoke about their comfort in broader terms. Where volunteers were using “comfort” in the sense of mental or emotional comfort, two clear themes emerged: rapport with the research team, and personal embarrassment, which will be discussed below.

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The researchers were concerned about the physical demands the tests would make on volunteers on account of (i) the relatively long duration of each complete scan of the breast (7–10 minutes) during which time the patient-volunteer needed to remain quite still; and (ii) the design of the patient interface, which required the volunteer to lean forward over a lightly padded sloping console with the breast fitted into one of two apertures of different sizes. All-round contact needed to be maintained between the breast and the machine for the whole duration of the test to generate acceptable data. These researcher concerns about physical comfort were reflected in the interactions between the research team and the volunteers during the test sessions. From their arrival in the laboratory, volunteers were invited to make themselves as comfortable as possible and minor adjustments were made to chair and console to improve their position. At the start of the test they would be asked: “Are you comfortable?” Conversations might be initiated during or after running a test as to what was comfortable or uncomfortable. This theme of physical comfort also formed part of our checklist for the semi-structured interviews. Volunteers responded cooperatively to presentation of this theme both during test sessions and in subsequent interview and offered detailed comments on comfort aspects and many practical suggestions for improvement. But their discourse at interview frequently gave prominence to other matters – including in particular other understandings of “feeling comfortable,” and often presented physical aspects of undergoing the test scan as a relatively minor component of their experience and concerns. We explore first the researcher and then the volunteer perspectives in more detail below, where we refer to scientists and volunteers by pseudonyms and with the suffix h-v (healthy volunteer) or p-v (patient-volunteer). Scientists’ Perspectives on Comfort 1. THE FOCUS ON PHYSICAL COMFORT: OBSERVATION AT TEST SESSIONS The researchers’ perspective on what would be the important elements of the volunteers’ experience emerges from researchers’ questions and comments to volunteers during the test sessions and from comments made in interviews with individual team members.


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The dialogue between researchers and volunteers during test sessions focused strongly on physical comfort. At the outset there was a need to adjust the volunteer’s seating position so that she could lean over and into the aperture (the ring) in which the breast needed to be placed in such a way that there was good contact all round. It soon became apparent at test sessions that this was not always easy to achieve. As the researcher—whose role was to guide the volunteers into position—observed at interview: “ … [I]t’s very difficult sometimes, sometimes people are fine, particularly the younger women, they can just bounce into position and just jump around. But [for] some of the older ladies, it’s been very difficult to get [the chair] at the right height in a comfortable position for them to sit still, get a good image from them.” [Annabel]

Observation at test sessions showed that difficulty in getting into position was not confined to older volunteers, and sometimes was resolved only by the volunteers’ taking up slightly awkward positions. The researchers’ concerns were reflected in routine exchanges such as the following: “Are you comfortable enough to do a full scan? OK, we’ll start now. This will last 5–10 minutes’.” [some minutes later] “We’re about two-thirds of the way through. Are you alright? How’s your chin?” [Mark: test session 2]

Volunteers usually replied to these questions about their comfort with a mild affirmative (“It’s alright … that’s not bad”; or “I think so”), or, while the test was running, a murmured “Yes, yes.” Getting into a position that gave good contact between breast and ring, normally required the volunteer to drape herself over the console, and this gave rise to minor problems, such as being unable to rest the forehead on the padded top of the frame or finding somewhere for the arms. At the test session volunteers generally made the best of this, each in her own style; for example, Aurelia, a patient-volunteer in her forties: “Right, give us the [safety] goggles… So where am I supposed to put this arm?”

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Or the more typical, hesitant approach exemplified by Edwina, an older patient-volunteer: R[esearcher]: E[dwina]: R: E: R: E:

Are you comfortable, please? … Yes. Yes? That’s a bit hard on my arms, but I don’t suppose you can … . Would it help to have it on the very top? … does that help, or is it too high? No, that’s better. It was just something like a hard edge digging in.

2. INTERVIEWS AND DISCUSSIONS WITH SCIENTISTS Comments made at interview and in discussion showed that researchers’ focus on volunteers’ physical comfort was motivated not solely by benevolence but also by the need to ensure that volunteers could remain still long enough for a full scan to be performed. As scientists, they had a responsibility to assure as far as possible the successful outcome of their research. Volunteers’ performance thus needed to fit the demands of the larger experimental setup and their comfort was just one aspect of running a successful experiment: “It’s not impossible for a scan to go through where I barely speak to the volunteer … I will concentrate entirely on the instrumentation and then if there’s chance to speak to the patient or if there are any problems in getting the patient positioned or anything interesting going on then I can look over.” [Martin, researcher] “We have other jobs to do and although we obviously are aware there’s a patient there and doing our best to accommodate them and make sure they’re happy, at the same time, obviously a hundred per cent of our concentration is not devoted to the patient.” [Mark, researcher]

Volunteer comfort, construed as physical comfort, was, in this respect, seen primarily as an operational need, but the standard of comfort need not necessarily be high. This was expressed most forcefully in one scientists’ comment that any discomfort felt by the volunteers was insignificant when compared with mammography: “I think that’s the way that I’ve perceived the design of the instrument from the patient’s point of view, my feeling is that it doesn’t have to be perfectly comfortable for the patient, it just has to be a lot better than mammography and that’s not difficult.” [Martin]


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This focus on the success of the experiments—though a perfectly proper concern for researchers to have—may also have deflected their attention from possible non-physical aspects of comfort. Interestingly though, another team members’ language shaded into more ambiguous terms such as “relaxed” or “at ease” which might suggest mental as well as physical comfort: “If the patient was to fidget, if the breast was to move in the ring then we wouldn’t get very good data, so obviously having the patient at ease helps.” [Mark]

The same scientist made a similarly general expression about volunteer comfort, this time in relation to his own anxieties: “I’m just thinking about my own attitudes, I’d never done anything like this before. I suppose I was fairly apprehensive the first time we did a scan, I was apprehensive about such things as their security, how they react to the laboratory.” [Mark]

In this scientist’s view, the researchers’ anxieties encompassed not only their need to get good data, but also their professional responsibilities (as “temporary ambassadors” for science as he put it) to create a good impression, which implicitly brings in wider considerations of comfort. Nor were the scientists oblivious of embarrassment as a possible issue, even prior to their being alerted to this by feedback from the sociologists. They had from the start—though without articulating the reasons— followed a division of labor whereby the female physicist team member positioned the patient-volunteers while the one of the male physicists tended the machines. As the female physicist explained: “I don’t know if it’s actually been completely discussed but I was the one doing the job and it started off [with] that being my job and I think that it was partly because of the modesty factor.”

Thus, while the conversational exchanges about comfort during the test sessions were all about physical comfort, there was, to differing degrees, a private awareness on both sides, which found expression in the interviews, that alternative types of comfort were also potentially important.

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Volunteer Perspectives on “Feeling Comfortable” 1. PHYSICAL COMFORT Discussion of physical comfort also featured in the interviews with volunteers. In general they were franker at interview (where the scientists were not present) in their comments about the (mild) discomfort involved than in the test sessions. For instance, one volunteer who had not shown any discomfort during the test scan, commented: “It’s slightly uncomfortable—only very slightly—but I think that was because of the position of my particular lump. Being on the side. It was on the wrong side of the equipment. Yes ……. I wouldn’t say I was particularly comfortable at this point, with the equipment set up the way it was.” [Yasmin, p-v]

Another volunteer who described the experience (with a little laugh) as “very uncomfortable”, speculated about how other people, less “strong and healthy” than herself would cope: “I think the machine, the way it is being, is not user-friendly … .. . I am quite—I have quite strong stamina, but if I imagine somebody older than me, it would be certainly very, very uncomfortable.” [Ida, p-v]

This device of minimizing one’s own reaction by making the point by reference to how others might react was used also by other volunteers, and in the context of feelings of embarrassment (see below) as well as physical comfort. This indicates, to some extent, a consciousness among those taking part of the representative role of the volunteer – hence the need to consider how others might react. But it is also a rhetorical device serving a social function. It asserts their personal strength: they are not victims. It links to their wish to be cooperative—to be a ‘good’ volunteer, by providing a means of distancing themselves from any appearance of weakness or of complaining,2 particularly since they claimed not to regard the discomfort as serious. Most of the volunteers 2

Werner et al., (2004) show how references to oneself as strong, in narratives about their illness by women with chronic pain (who often meet with scepticism about their condition) serve as part of a justifying argument, appealing to an audience that includes health professionals and the interviewer.


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admitted at interview to feeling some degree of physical discomfort, but most seem to have concurred with the summary given by one of the younger volunteers: “You can feel it pressing places, and you are leaning forward [so] it gets a bit uncomfy after a while—but it’s nothing.” [Estelle, p-v]

This relatively low level of physical discomfort may help explain the greater emphasis on other aspects of comfort. 2. OTHER SENSES OF “COMFORT” In addition to these comments on physical comfort, the volunteers introduced the ideas of mental or social comfort. Three of the volunteers made the distinction quite explicit, challenging the interviewer: “Do we mean physically comfortable or mentally?” [Aileen, p-v] thus giving these two aspects of comfort equal status. Some expressed this idea less directly using the ambiguous term “relaxed.” At times the context makes it clear that reference is to being able physically to relax muscles, for example: “. . . [T]he way I was sitting … I was like doing the left-hand one [ring], and sort of like I was hanging in. It wasn’t completely relaxed.” [Alice, p-v]

But more often it reflects an amalgam of mental and physical components. One of the older volunteers, who subsequently went on to say that, “You possibly could make the procedure a little bit more comfortable,” gave her initial reaction as: “Well, I can only say that I was perfectly relaxed. I had nothing to concern myself about. It was perfectly relaxing, and comfortable, and not at all unpleasant at all.” [Norah, p-v]

While Alice (quoted above) later observed: “I liked the way—you know—the environment. It made you feel quite relaxed. They did make sure that you were comfortable. They put some tunes on. The staff were really good.” [Alice, p-v]

In such comments, the physical and social environments are seamlessly interrelated.

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Rapport and Personal Embarrassment as Determinants of “Feeling comfortable” Two themes dominated volunteers comments on mental or emotional comfort: rapport with the research team (as opposed to feeling isolated), and personal embarrassment. Neither had been explicitly provided for in the interview schedule; they were topics initiated spontaneously by the volunteers. 1. RAPPORT The first clear theme was the importance of the people present and establishing friendly relationships. This theme related to quelling anxiety and fear of isolation, not being made to feel like a guinea pig, and generating positive feelings of involvement. The importance of interpersonal relationships came through in remarks such as: “I liked feeling comfortable, you know, with the people. I think that would be important for a lot of people.” [Edith, h-v]

Or from one of the older patient-volunteers, in response to a question as to whether this kind of diagnostic test might be characterized as “impersonal”: “No, I think you all made us feel very comfortable.” [Edwina, p-v]

Rapport helped to dispel any apprehension about the test procedure: “You know you can talk to part of the team, because, you know, that would put anybody at ease. Then you have got nothing to fear.” [Isobel, h-v]

and enabled a relaxed frame of mind: “The people … and the company were really helpful. And, I don’t know, I was relaxed. Very relaxed.” [Alana, p-v]

It helped volunteers to feel that they were respected as a person, not being treated as an experimental object. One of the younger, and enthusiastic, volunteers commented on the:


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“. . . [O]pportunities to ask whatever I wanted. I didn’t feel like I was shoved away in a box or anything. I felt very involved.” [Aileen, p-v]

Similar sentiments lay behind the request from one of the healthy volunteers that the console where volunteers sat should be turned round to face the research team’s workstation to prevent feelings of isolation. Likewise, occasional mildly critical references to short periods when interactions with the research team seemed to have slackened off unduly may be understood as concerns about feeling less included or weakening of respect. The sense of personal rapport and involvement was thus an important part of negotiating the social situation and balancing the tensions of serving as a research object yet maintaining respect. It acted also as a source of considerable satisfaction to the volunteers. Edith, one of the healthy volunteers, after offering to return for any more tests that might be required, summed up her feelings as: “I felt part of the team”. Similarly, Estelle, one of the youngest patient-volunteers, awaiting surgery for a benign breast lump, commented: “. . . [I]t is just nice to be able to see what they are doing, and have a chat with them, and feel that energy.”

2. EMBARRASSMENT The second theme was anxiety about coping with feelings of embarrassment caused by the need to bare the breasts. Eleven out 18 interviewees spontaneously referred to this, sometimes naming it as their chief anxiety in relation to participating in the tests. For example, two young patient-volunteers, in response to a very general query as to how they felt about doing the test said: “Maybe a little bit nervous—just because of exposing myself [laughs].” [Yasmin, p-v] “I suppose I was slightly worried that it might be a bit embarrassing. But I didn’t worry too much.” [Abigail, p-v]

We have questioned how far this embarrassment might be peculiar to our chosen research setting. This was unusual in that the experiments were laboratory rather than hospital-based and conducted by non-clinical medical physicists (two male, one female).

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Furthermore, this was clearly billed as research—not a part of normal health care. Volunteers’ accounts however attributed relatively little significance to these factors, but rather related their feelings of embarrassment to what they routinely experienced as a patient. The patient-volunteers all found that the design of the experimental instrument required far less exposure than they were used to in hospitals, and this perhaps made them the readier to talk about their fears of embarrassment and less inclined to feel awkward about the presence of a male physicist at the test. One volunteer, who did show consciousness of the unusual set-up expressed herself as “mentally comfortable” and elaborated on this as follows: “I suppose that you are aware that [Mark] isn’t necessarily the same type of doctor as the one you normally see. But things like that—it didn’t bother me. You know, it was quite easy with the gown and everything to be discreet.” [Aileen, p-v]

Another patient-volunteer made a direct comparison to routine breast examinations: “I’m not that shy about my body, but certainly with things like ultrasound and minor examinations, it’s like, “Take your top off ” and that’s it.” [Estelle, p-v]

and contrasted this with the test scan: “Whereas something like that … nobody else sort of really has to see the boobs, because they can just stand out of the way, you know, and you get to wear that gown, and doing one at a time and stuff.”

The “they” referred to here is not the “boobs” but the male physicists who were attending to the computer screens and were largely screened from view of the patient by the bulk of the apparatus. Other volunteers made similar points about the embarrassments inherent in routine care for breast patients or associated with nudity more generally—as one said: “… [A]nything where you have to go in somewhere and take your top off. Or if you are a fellow, your bottom. And … it’s the naked thing, isn’t it?” [Aurelia, p-v]


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Some volunteers (including Estelle, quoted above) claimed that they themselves were hardened to or relatively unaffected by this kind of embarrassment, but nevertheless welcomed the relative privacy afforded by the design of the experimental instrumentation. As Amanda (in her twenties) explained: A:

I thought you know everyone would kind of be on display, but you are not. In the dark as well, so you’re very—very comfortable. Interviewer: How did you feel about the thought that you might be, as you say, on display? A: I was a bit nervous, but I’m not … Because of everything, because of the … [pause] I would have been if it were the first time, but— I’m kind of used to it at the moment… I may have been a few months ago a bit more [trails off] but I’m not.

The tension generated by fear of, or actual, embarrassment is clearly not peculiar to the research situation, and is accepted as part of the life of a breast patient. But it is a sufficient cause of discomfiture that, in summarizing their opinions of the good points and the potential advantages and disadvantages of this method of diagnosis over others, interviewees often included the relative privacy it offered as a significant plus point, alongside safety, powers of discrimination and freedom from pain: “[The advantages are] not having radiation, not being exposed during the test—quite a good one I think, actually, thinking about it, because that is quite stressful sometimes. And if it can look at other things, you know, like the blood supply system, that’s all to the good.” [Yasmin, p-v]

It was predominantly the younger volunteers who commented on the personal embarrassment factor and most expressed it as no more than “feeling shy” (in the terminology used by two of them). But a connection between this and resistance to the dehumanising aspects of being a research subject may underlie the volunteers’ frequent emphasis on how they themselves had learned to cope with this, but treating it as a likely problem for others. Abigail, for example, quoted earlier as worrying whether she might find the test embarrassing, commented at the end of her interview that she had over the years had so many doctors check her breast she herself was beyond caring about that sort of thing, but thought it could be embarrassing for someone without that

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experience. One of the healthy volunteers drew an analogy with the life class which brought into focus the potential tension about being treated as an object and how nudity removes some of one’s social armor: “I’m in a situation where I work with a model, and I’m very conscious that when students are asking something that there should always be a kind of regard for the model in the middle of the room. It’s a similar thing. Because she is vulnerable; or because people are life-drawing her; because she is naked and they’ve got their clothes on.” [Madeleine, h-v]

Nudity here is used as a symbol of potential for being exploited and vulnerable to loss of dignity and loss of respect. Volunteers’ comments on “being comfortable” indicate that they are conscious of this potential and are actively monitoring it. While carrying through their commitment to cooperating in the research, they are positioning themselves actively to counter any such threat, by, for example, emphasizing and fostering friendly relations, and presenting themselves as coping and “strong,” while pointing to the possibilities for others to feel discomfited. Thus the interviews generated discussion of a much wider range of factors that went into the question of feeling comfortable with the process than was apparent from volunteerresearcher interactions during the test sessions. All of these factors and the way they interact could have implications for the future development of the technology, for the cooperation and satisfaction of future volunteers, and for our perceptions of the parameters of accountability for this kind of research with volunteers. Discussion We have claimed that significant differences exist between the way that researchers and volunteers account for the notion of “comfort” in the course of the experimental scan. The team of scientists tended to articulate notions of comfort largely, though not exclusively, in terms of physical comfort, whereas the volunteers invoked a wider sense of the term “comfort,” taking in their mental composure and the immediate social setting.


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Volunteer-Researcher Interactions Undergoing a test scan involved the volunteers in a novel, and potentially unsettling, social situation where there are few analogies to draw with their previous experiences. We described earlier how the volunteers’ interaction with the researchers involved tensions between, on the one hand, co-operation to help the scan succeed, and on the other, physical and emotional comfort. With respect to physical comfort, prior to the scan the volunteers were briefed to expect no pain, and our interview data suggests that the scan presented no serious painful physical challenge. On the other hand, the challenge from potential embarrassment featured frequently and spontaneously in the accounts from the volunteers. Together with their other comments that broadened the term “comfort,” this suggests that performing as a volunteer entailed their striking a more self-conscious balance between helping the scan succeed and maintaining dignity. In this respect, our heuristic polarization between “physical” and “emotional and social” comfort—drawn to highlight the different senses of comfort articulated by scientists and volunteers—is breached, as embarrassment about nudity encompasses both the physical and the emotional. The preoccupation of the volunteers, balancing co-operation with various types of comfort, contrasts with the preoccupations of the scientists. The researchers’ interaction with the volunteers is mediated by their focus on the entire experimental situation and not just on the volunteers. Their primary goal is to obtain “good data,” and to this end the comfort of the volunteers is a significant but not solitary element. This is certainly not to say that the scientists neglected the volunteers—as clearly evidenced in our observations and interviews, the scientists were mindful of the volunteers’ well-being—but this focus on the whole experiment does help account for their concern with more immediate (physical) comfort in relation to positioning of volunteers being one component of the test scan. Additionally, despite their own anxieties, the laboratory remains a more familiar environment to the scientists than to the volunteers. On a more reflexive note (though further discussion is outside the scope of this article), it is worth pointing out that periodic feedback of our results to the team may be having the effect

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of broadening the sense of “being comfortable,” with one researcher noting: “We’ve spoken about the volunteers amongst ourselves, and I think we’ve probably thought more about patient comfort than we would have done otherwise. Whether that’s actually made a difference or not, I’m not sure, but it’s certainly brought it higher in our minds.” [Martin]

Volunteer–Social Science Researcher Interactions In addition to the researcher-volunteer distinctions just discussed, differences exist between the expression of “comfort” by (a) volunteers in interaction with the medical physicists and experimental technology and (b) the interaction with a social science interviewer armed with a tape recorder and interview protocol. The differences in volunteers’ comments on their experience during the course of the test and at interview reflect, at least in part, a choice of topics and style of talk appropriate to the social situation (Goffman, 1971). The test session is a more “public” occasion; the interview more private. The test session takes place in a spartan and darkened laboratory, with three researchers present (two medical physicists and one social scientist), whereas the interview is one-to-one, in a small seminar room. Moreover, the experience of taking part in an experiment is new to most volunteers, so the social rules for the encounter are being negotiated as they go along. Physical comfort is clearly relevant to performance of the volunteering role (since she has to remain still for up to 10 minutes while the scan takes place) and is accepted in test sessions as a safe and appropriate subject for comment. Moreover, this was a topic offered for comment by the researchers leading the experiment. The women all appeared keen to perform well as volunteers, i.e., to give a “good” scan; this is consistent with a tendency to underplay the discomfort involved during the scan session. While the subsequent interview is also a research encounter, it is likely to be a more familiar social situation, and takes place after the range of anxieties and challenges generated by the test session have been borne. The need to give a good performance was still present, as evidenced by the occasional comment “have I said enough?” or “is that what you want?” and this may perhaps have encouraged the volunteers to offer an insight into more private feelings of unease,


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apprehension, and embarrassment as a gift to the interviewer (Small, 1998). The one-to-one situation and the interviewer being female may have made it easier to allude to embarrassment, although we lack firm evidence on this. However it comes about, we find that volunteers consistently present a rather different set of concerns in the interviews from those apparent during test sessions. Limitations Our findings on volunteer experiences are drawn from data collected in a single research setting from all-female volunteers, and influenced to varying degrees by the particular features of that setting, such as laboratory environment, technological orientation, sensitivity of breast disease, nonpainful procedure, and no promise of health benefits for participants. Our analysis of the empirical data includes discussion of how this context may affect volunteers’ experience. One important limitation to note here is that the mental and social stresses that dominate our volunteers’ accounts may be less significant where the subject expects, or hopes for, a direct health benefit,3 and something closer to a doctor-patient relationship may operate. This more familiar situation should generate less social unease than the novelty of a purely research encounter. Another kind of direct personal benefit is financial reward, which for “professional volunteers” (Weinstein, 2001) may result in something akin to an employer-employee relationship, where again there are known social rules to draw upon. This still leaves a range of research settings, including laboratory experiments, testing programmes and some controlled clinical trials, where volunteer research subjects are likely to be facing, and trying to manage, concerns similar to those of the sample we studied. Conclusions The concerns of researchers and ethical review committees with the physical safety, comfort, and welfare of volunteers in clinical 3 Ie access (or chance of access) to an experimental treatment for an otherwise untreatable condition by entering a clinical trial; or access to free health care in societies where this is not universally available.

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research constitute a welcome safeguard for those who participate in research as “human subjects,” but may divert attention from mental and social stresses that for some volunteers, in many types of experiment, loom larger than the physical challenges. Wherever research involves a face-to-face encounter between subject and researcher (whether experimentalist or interviewer), establishing the social ground rules for an acceptable working relationship is key to making the volunteer feel comfortable and respected (Morris and Balmer, 2006). Such a relationship can mitigate the dehumanising aspects of being a research subject (or “research material”), including particularly feeling isolated and invasion of privacy (“the naked thing”). Hence a friendly and collaborative relationship4—to be genuinely a participant not a subject—was what volunteers most strived for. The planning of research, drawing up of protocols, and design of equipment necessarily incorporate assumptions about what volunteers and future patients will find acceptable or problematic in process, ambience, and instrument design. Researchers’ accountability to their research subjects and to future users of their technology demands that these assumptions should be based on as broad and sound an understanding as possible of volunteers’ and users’ priorities, preoccupations, preferences, and concerns. The limited feedback that is available to researchers from their own observation of volunteers’ reactions and comments during test sessions seems to be inadequate for the discharge of these fiduciary and professional responsibilities. We use the term fiduciary to refer to the researcher’s role, as a professional, to serve his/her clients’ (“the volunteer human subjects”) interests to assure safety, transparency, and freedom from avoidable stress. Existing codes of ethics are rather less than helpful here. Their problem lies in the overweening conception of the research subject as a passive entity, characterized above all by vulnerability, and thus requiring that all action devolve upon the researcher (who is often assumed to be a doctor). The Declaration of Helsinki (WMA, 2002) exemplifies this approach. While research situations no doubt exist that conform to this pattern, our own findings demonstrate volunteers’ reasonably firm rejection of this passive role and a focus on social and—one might 4

As Mead claimed to be the norm in anthropology (Mead, 1969)


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even say—collegial interactions as a way of asserting their active participation and comfort. Recognition of this need—to be treated as a responsible person, i. e., a human being, not a guinea pig—is we suggest at the heart of implementing the concept of “respect for persons” that is one of the underlying tenets of bioethics. The growing trend towards replacement of the term “research subject” by “research participant” (see for example BPS, 2000) may signify a move to constructing research subjects as “empowered citizens” (Corrigan, 2004), though much ambiguity surrounds both the meaning of the term “participant” and its use to legitimize new biomedical research activities such as genetic databases (Tutton, To appear). More immediately, there are messages for researchers about the day to day conduct of research: It behoves them to take cognisance of the social stresses of the volunteer-researcher relationship and consider their practices on briefing, processes, ambience, and feedback (Zlotnik Shaul et al, 2005) so as to make volunteers feel “comfortable” in the widest sense. Our data is relevant to debate on empowering volunteers and updating ethical codes to allow for a more active, responsible, and participative volunteer. This trend to empowerment and a partnership relation is already evident in medical care (see for example BMJ, 1999; Charles et al, 1999) and policy on research governance (e.g., DoH, 2001) in regard to patients and carers. We suggest that researchers’ accountability to their subjects requires they be aware of the full range of their concerns and incorporate forms of engagement with the volunteer human subjects in their practice of clinical research. Benefits from such a course, apart from as a matter of research ethics, would include greater satisfaction for volunteers, the possibility of improved research outcomes through tapping the experience and insights of volunteers, and better performance of experiments with committed, cooperative, and humanized partners. Acknowledgments We are grateful to our medical physicist collaborators for their support and in particular to Professor J. C. Hebden for valuable comments and advice on our drafts. We acknowledge with thanks the support of the UK Economic and Social Research Council, who funded the work (Grant No: RES-000–22–0093).

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