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Keywords:

  • clinical research;
  • volunteers;
  • human subjects;
  • breast cancer;
  • health technology

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

Drawing on a research collaboration between a group of medical physicists and social scientists, this paper aims to explore female volunteers’ experiences of participating in a project for developing a new breast disease diagnostic technology using an optical imaging system. In order to understand how these women make sense of being a volunteer, we examine the complexities of their experiences in this type of research setting through an empirically-based study involving participant observation and semi-structured interviews with the volunteers. Traditionally, volunteers are constructed as passive research material. In contrast, the women in our study are by no means docile bodies — but are active in deploying strategies that create opportunities to exert a level of control over perceived threats within the research encounter. We examine how volunteers translate these threats into ‘boundaries’ about what is and is not acceptable or permissible within this environment, paying particular attention to boundary setting around participation, and invasions of the body (such as pain, touch and exposure, and physical safety), and exploring the strategies volunteers draw on to counter perceived threats to their bodies.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

This paper reports on a project run in collaboration with a group of medical physicists, which looks at the experience of volunteer human subjects taking part in the development of a new breast cancer diagnostic technology (using a non-invasive optical imaging system) in a laboratory setting. It forms part of a growing body of literature which explores how volunteer human subjects1 understand their own participation in research. Our focus is on the active participant. While the practice of allowing subjects in experiments a voice in the conduct of research has received some attention (Epstein 1996, Williamson 2001), activist efforts and research studies have largely concentrated on patient involvement at the planning and development stage of clinical trials (Entwistle et al. 1998, Goodare and Lockwood 1999, Hanley et al. 2001). More recently, there has been increasing use of qualitative methods to probe research subjects’ understandings, with a particular emphasis on their construal of concepts central to the design of the randomised controlled trial and the implications for informed consent and trial management (Cox 1999, Corrigan 2003, Lowton 2005).

We discuss how female patients (with either benign or cancerous breast conditions) and healthy volunteers account for their experience of participating in medical research, and seek to manage the threats to bodies and self-esteem associated with this unfamiliar situation. In this context, we construe threats as encompassing both physical and emotional challenges to the volunteer’s sense of wellbeing, and explore how volunteers translate threats into boundaries about what is and is not acceptable or permissible within the research environment affording them an element of control over the research encounter. As other studies have illustrated, boundaries around participation in clinical trials include concerns about perceived risks (Lowton 2005), embarrassment or fear of pain (Shuhatovich et al. 2005), and emotional distress experienced by very ill patients (Cox 1999). In this paper we discuss boundary setting in relation to four particular aspects of the research experience: risk and safety; pain; touch and being ‘on show’; and the gendering of the research setting.

Our research setting is not the conventional randomised controlled trial (RCT). Nor does the research offer any possibility of direct medical benefit to the participants. Moreover, our sample is limited only to women who agreed to take part in the research, consistent with our aim of exploring how women experience and manage the threats of participation. Thus, this study does not address the general question of why women do or do not participate in breast cancer research, and clinical trials in particular, but rather examines the different kinds of boundaries that may be set, and their negotiability. These include boundaries to participation (in the type of non-therapeutic research we studied) and other boundaries that may not necessarily prevent women from participating but are significant as a source of stress within the research encounter. We find that where and how boundaries are set is sensitive to context, both in terms of the perceived risks and benefits of the research and the participant’s personal history and construction of self.

Breast cancer and the female body

Recent studies have highlighted the androcentric nature of much biomedical research (Corrigan 2002, Epstein 2004, Shildrick and Mykitiuk 2005,Wilkinson 2000) where the male body is taken as the biological norm. Breast cancer research is however a significant exception. Breast cancer is overwhelmingly a disease of women (for example, according to Cancer UK, of the 46,000 people diagnosed with breast cancer in the UK each year, only around 300 are men). This is reflected both in the extensive literature on the topic (examples are Klawiter 2008, Potts 2000, Stacey 1997) and in the female-centric patient information and support services, often of little use or relevance to male breast cancer patients (Iredale et al. 2006, Perkins and Middleton 2003, Williams et al. 2003). Our study, set in the context of research on developing a diagnostic for the detection of breast disease in women, likewise highlights the specificity of the female body. Our focus, however, is not on the experience of breast cancer as a disease, but on what the experience of taking part in research in this highly sensitive area means to women – a topic on which there is comparatively little research.

Breast cancer as such is a particularly feared disease among women, as much for its assumed high incidence as for the iconic significance of the female breast. Saywell et al. (2000: 38) state that ‘breast cancer is framed by cultural understandings and conceptions of illness, traditionally marked by anxiety’. This is because cancer challenges our understanding of the body in terms of its vulnerability, its integrity and its potential for violation. Cancer is treated as an evil, invincible predator, the metaphoric ‘war on cancer’ invoking visions of the body being invaded by an unstoppable force (Sontag 1978/1990).

Our focus on the body should not be taken to imply that we in any way subscribe to the reductionist view idealising femininity as passive and bodily centred (Saywell, With Beattie, and Henderson 2000). Our position is that the body is our vehicle for being in the world (Merleau-Ponty 1962), but that ‘bodies are not fixed, inert, purely genetically or biologically programmed entities that function in their particular ways’, but show differences ‘not only at the level of experience and subjectivity but also at the level of practical and physical capabilities’ (Grosz 1994: 190). Consequently, taking the body as the locus of experience is not a return to the ‘dilemma of biology’ (Williams 2002); it recognises women’s corporeal specificity whilst allowing for difference and diversity between women and their experiences.

Stacey (1997: 75) suggests that because ‘the body has been understood to be constituted within and through a system of boundaries’, cancer violates the certainty of such boundaries between normal/abnormal and inside/outside. We draw on this notion of bodily boundaries extending it to include a wider range of potential threats to the body. These can be experienced as invasions (actual and potential) both to the body and to the volunteer’s ability to maintain a sense of emotional wellbeing within the research setting. The accounts of the volunteers in our study suggest that interference with the body (by disease or by some of the more invasive breast cancer diagnostic procedures) diminishes the whole person, breaching the integrity of the body, and breaching integrity in a metaphorical sense too.

Research setting and methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

The optical imaging system we have referred to (known by the acronym MONSTIR)2 uses light-waves to generate an image of what is inside the breast, hence it has potential for diagnosis and monitoring of breast cancer, without use of x-radiation. We are collaborating with a team of medical physicists who have developed a prototype optical imaging system now undergoing clinical testing. The unknowns to be resolved by the initial human testing programme from which our data are drawn include whether the system can detect features corresponding to those seen in other breast diagnostic technologies such as ultrasound and mammograms, and whether they are able to distinguish between different types of lesion i.e. benign or cancerous.

During the test, the volunteer lies on a ‘bed’ which consists of a padded table which supports a hemispherical cup filled with a harmless milk-like liquid, into which she lowers her breast. Optical fibres are fitted around the outside of the cup, light travels through these, then through the coupling liquid to the breast. The lights in the room are turned off, and the volunteer is asked to remain still during the test lasting up to 10 minutes for each breast scanned (see Figure 1).

image

Figure 1. Diagram of bed interface

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The test sessions usually last around 30 to 40 minutes and include the consent procedure and a technical briefing on the test protocol given to the volunteer before the test is carried out. Prior to arriving at the laboratory, the volunteers had already been informed of the aims of the research and received a written information sheet from their consultant. The information sheet emphasised that there were no known or foreseeable hazards associated with the use of light for imaging and explained that volunteers should not expect any direct medical benefit to themselves though there could be benefits to future patients if the device proved successful. A separate information sheet referred to the related study running alongside which involved interviewing volunteers to elicit their views on their experience and soliciting suggestions for improvements.

Data for the study of volunteer experience were obtained through participant observation at test sessions (including consent procedures and technical briefing) using audio recordings and/or field notes, and semi-structured interviews with volunteers. Participant observation consisted mainly of observation of researcher-volunteer interactions, though sometimes involving assistance with routine tasks. The interviews lasted between 30 minutes and an hour and were recorded and transcribed verbatim. The aim of the interview was to allow the volunteers to reflect directly on their experience of participating in the test scan, and interviews therefore took place immediately after the test. Interviews were loosely structured to encourage narrative, but explored a range of topics including how the test scan compared to other types of breast diagnostics, the disadvantages and advantages from a patient’s perspective and ‘how they felt’ about the test and the experience of participating in the research.

The sample

During the period of our study 52 volunteers were scanned, of whom 47 were also interviewed. (Of the five who were not interviewed, two had insufficient time, being due to go into surgery or another clinic appointment; one had a sick child with her; and two were newly diagnosed cancer patients who did not feel up to talking.) The sample comprised nine healthy volunteers and 43 patient volunteers of whom 16 had benign conditions and 27 a diagnosis of cancer. Volunteers were aged between 19 and 69, with a slight preponderance of older women (30 over 45 and 22 under 45). They came from different educational backgrounds, and their occupations ranged from manual to professional. In terms of ethnic group they were largely White British or European. Black and Asian groups were only lightly represented.

In the text which follows we use code numbers to identify volunteers to preserve anonymity. The code distinguishes healthy and patient-volunteers, designated by HV or PV respectively, followed by a numeral designating the individual. The prefix II which appears in all codes is a project identifier.

The method of sample recruitment was a constraint on our research design. Recruitment was organised by our collaborators, not the social scientists, and was on the basis of the needs of the medical physicists to assess the effectiveness of optical tomography for the detection and specification of breast disease. Healthy volunteers were recruited through personal contacts, the patient-volunteers by referral from collaborating clinicians at the Breast Clinic, who used their discretion as to which patients to invite to participate and did not record refusals. We were thus working with a convenience sample, without powers to sample systematically for particular variables. This, combined with relatively small numbers overall, severely limited the possibilities for sub-group analysis. For example, scans from healthy volunteers were used as comparators for the scanning project - hence the small numbers involved in the study; and representation of minority ethnic groups was insufficient for us to consider ethnic variation as a variable in our analysis.

Analysis

Analysis followed standard qualitative methods. Interview transcripts and notes from observation of test sessions were read through in order to provide an overall impression of the information, and then coded by the two researchers undertaking the interviewing and observation, working to a general framework developed in the first phase of the project (Morris and Balmer 2006). 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). Thus, we pay particular attention to the ‘work’ performed by interviewees’ narratives and responses in helping them to construct themselves and their position vis-a-vis the researchers, whether in the course of the interview or in conversational exchanges between researchers and volunteers during test sessions. Each researcher coded independently and the coding was reviewed by the other. Codes were then reconciled and refined in discussion and flexibly grouped into broader analytical themes. We used Atlas-ti software to facilitate ordering, searching and retrieving the data.

Strengths and limitations of study design

The research setting is atypical of the great majority of clinical research involving human subjects (such as randomised controlled trials of new treatments) in that participation in the research offers neither the possibility of direct medical benefit to the participant nor substantial financial reward. In contrast to the situation experienced by patients taking part in a comparative clinical trial (Appelbaum et al. 1987, Snowdon, Garcia, and Elbourne 1997, Edwards, Lilford and Hewison 1998), participants were clear that they could expect no personal medical benefit from this study. The experimental nature of the work was not only emphasised in the patient information but also made apparent through the tests being conducted by the non-clinical medical physics team who developed the instrument, rather than by medical personnel, and taking place in a university research laboratory rather than a hospital. The volunteers demonstrated their awareness that this was a test still needing further validation by often qualifying their comments with ‘if it works’, and recognising the laboratory setting as the ‘research stage, obviously, it is wires and things coming out’. The research is moreover low-risk, non-invasive and pain-free. Our findings on volunteer (and researcher) experience must be read in this context. While certain concerns, such as the need to feel socially comfortable, may be constant across all kinds of face-to-face research encounters, many other considerations and different power relationships are likely to prevail for patients in therapeutic trials and for ‘professional guinea pigs’ (Weinstein 2001). On the other hand, our choice of setting is well suited to exploring the dynamics of research relations, with minimal influence from doctor-patient or employer-employee relationships.

We have already referred to the restrictions on recruitment which, combined with our choice of an in-depth, qualitative approach, restricted the range and number of volunteers available for interview and observation, and constrained the capacity for sub-group analysis. Where it was feasible to attempt such analysis, however, for example between patients with benign and cancerous disease, or younger and older women, no clear differences emerged. On the whole the accounts that volunteers (including healthy volunteers) give of themselves are more striking for their similarities than for differences. This has also been the case in a parallel study we have conducted comparing the UK cohort to a group of volunteers outside the UK, participating in a programme of testing broadly similar technology, which again shows strong similarities in the women’s accounts of their experience and concerns (Morris and Schneider, in press).

We have been mindful that interviewees not only construct themselves at interview: they also construct the researcher. Our position was ambiguous: we were both inside and outside the physics research team, in something of an intermediary role. We have drawn on observation at scan sessions3 and intra-interview comparisons to try to allow for such influences on volunteers’ accounts of themselves in our interpretations of their comments.

Findings

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

Risk and safety

Our findings illustrate how volunteers make a distinction between health care and research with regard to the boundaries they set around what are considered to be acceptable levels of risk. Six of the nine healthy volunteers and most of the patient volunteers had experience of x-ray mammography: when asked to comment on what they perceived as the advantages and disadvantages of the test scan for patients, volunteers often drew on these experiences to illustrate the distinction they were making between no-risk, no-benefit research, and the use of mammograms as part of their medical care as a potential, but possibly necessary risk.

The use of light waves within our study was seen as an advantage for the development of breast diagnostic technology more generally but it also played a specific role in allowing participation where factors around safety and absence of risk were paramount:

I felt perfectly safe in there. Yes. Safer than the mammogram which is obviously radiation…(IIHV2, Healthy).

PV: I find it okay, especially the idea that it is without radio, without x-ray.

R:  Do x-rays worry you at all?

PV: Yes. I don’t like them. And they are not good for your health, you know that? […] The x-ray is bad so you can’t, that’s what they told me at the breast clinic. They won’t start too early because it’s bad for breast (IIPV20, Cancer).

If this technology proves to work then, you know, you could cut down a lot on x-rays, and I know they are pretty… they have their own side effects (IIPV3, Benign).

We noted that volunteers often sought further reassurance that no x-rays were being used; this was a feature of several exchanges between the medical physicist and the volunteers upon first entering the laboratory, as the following example from IIPV15 (Benign) illustrates. Although the information sheet made explicit reference to the fact that there would be no x-ray exposure and that the test would be carried out ‘without using harmful radiation’, during the medical physicist’s explanation of the test protocol to the volunteer, when in the laboratory prior to signing the consent form, IIPV15 repeatedly asked ‘No x-ray? Not harmful?’ Only after repeated reassurance did she assent saying ‘Okay, as long as it’s not harmful, it’s okay’.

In contrast, within a healthcare setting, despite concerns about the risks of exposure to x-ray mammography, many of these same women (including IIPV15) took an active decision to submit themselves to screening because they considered that the health benefits outweighed the potential risks. However, women will reset the limits on entering what they perceive to be risky situations when no direct health benefits are forthcoming:

My knowledge of infra red is that it’s safe but I think when you’ve a few x-rays, mammogram uses x-ray technology, you start to think how safe is this? And I probably wouldn’t put myself in a research situation if I thought there was… like I wouldn’t – for the sake of research – go and have a mammogram. I’d only have the mammogram if I need one so, as long as it’s a safe test I’m happy to do it but I’m not gonna become Madame Curie (IIPV23, Benign).

This example of boundary setting around risks and safety demonstrates the context-dependency of research volunteers’ risk assessment, and the inter-relationship with perceived health benefits, resulting in narrower limits to what is acceptable in no-benefit research. Thus, women willingly submit themselves to diagnostic mammograms but rate them as seriously risky if met in a research context so that they would refuse to expose themselves to similar risks for research purposes.

Pain as a boundary

Anxieties over perceived threats to the body strongly frame the boundaries of what women find permissible within the research environment. Volunteers’ accounts of prior painful and unpleasant experiences of mammography and biopsy as part of their healthcare act as comparators to the test scan, and illustrate the stresses of managing boundaries in the medical context and by implication the anxieties they may carry over into the research setting:

Because, I mean, even though I have had this done for three years or more, when that’s put in the vice, and that’s wound down, it hurts, and I say to the girl, it hurts, she says, well it will do (IIPV34, Cancer).

What has emerged very strongly is how much medical procedures are discursively constructed as brutal when women look back at them. Threats from medical procedures elicited language such as ‘brutal’, ‘attacked me’, being ‘lunged at’, ‘invasive’, ‘traumatic’, and not preparing the patient but ‘just puncturing you’. While medical procedures pushed at the boundaries of pain and invasiveness they were nevertheless tolerated as a necessary part of their treatment, although, for some women, handling pain was difficult.

The experience of pain during mammography has been identified as a crucial factor in women’s long-term participation in breast-screening programmes (Miller, Livingstone and Herbison 2008), with women frequently drawing on their prior experiences predicting that future procedures would be equally painful (Bruyninckx et al. 1999). Although this may cause some women to opt out of breast screening altogether, others may feel compelled to continue attending because the potential health benefits outweigh the pain and discomfort. In contrast, boundaries around what will be tolerated in a research context are more tightly enforced:

So that’s what I was thinking. I was a bit, um, apprehensive, because I didn’t know. It’s the unknown, isn’t it, so I didn’t know what to expect, but I was prepared to go through it. I was told it wasn’t going to hurt, so I thought I could handle that [laugh] (IIPV5, Cancer).

Because he’s [the consultant] obviously got a dry sense of humour […] I was about to say ‘Forget it matey!’ [laughter]. Forget it! Don’t want to know. And then he said, ‘Well, you know, with this, whatever’ he just said, ‘you know, there’s this tomography, you can go for this, whatever’. I can’t remember what he said […] and I looked and thought, oh, what’s this all about, and he said, he might have told me it’s not painful. Oh well, I’ll listen now! (IIPV22, Benign)

These comments illustrate that, when applied to a research environment, only the assurance of a pain-free test would induce some women to volunteer, while for the first patient-volunteer quoted, the assurance that it would not hurt outweighed her apprehension about one of the risks particular to research – the element of ‘the unknown’.

Touch and being ‘on show’

Volunteers also expressed anxieties related to being touched and being ‘on show’ in both the healthcare and research setting. Current breast screening and diagnostic techniques all require some degree of physical touching and exposure of women’s breasts to another person, and it has been suggested that this presents a serious barrier to the uptake of screening within some cultural groups (Miles 1991, Borrayo and Jenkins 2001). Consequently, women may resist participating in breast cancer screening to avoid feeling ‘indecent’ when these cultural boundaries are disrupted. In our sample, the relative privacy of the optical scan procedure was favourably contrasted with other diagnostic tests:

Nobody’s touching you so the whole process, you know, pushing you into the right position or, you know, just, yeah, it’s cool. It’s much better isn’t it when you think about it? (IIHV4, Healthy)

Being physically manipulated in this way was described as embarrassing and humiliating. In contrast, our test scan removes this potentially difficult aspect of breast diagnostics:

Because when you go for an ultrasound, the room’s quite cold because your top’s off and the gel that they put on you as well, so, um, it’s quite uncomfortable because you’re with another person that’s actually [she gestures with her hands moving over her breasts and makes a face]… do you see what I mean? So the fact, the fact that there’s no-one there and you’re alone, I mean, you know, I think that’s much more comfortable (IIPV17, Benign).

Reporting on our previous work (Morris and Balmer 2006) we suggested that exposure was a major but often overlooked anxiety for both volunteers and patient-volunteers in this research setting. Bodily boundaries associated with not wishing to be touched extend to the anxiety of being exposed, and being ‘on show’, invoking feelings of humiliation. Our test is carried out in the dark which also appeared to help women deal with the potential problem of being on show:

PV: …the fact that the light is dark [sic] during the test is really, that’s really quite nice for your patient. You know, to feel more comfortable.

R:  Why is that?

PV: Um, I don’t know. Because if the lights if, well because your body is exposed and like if the light is, um, it’s not dim, to me it’s quite uncomfortable because, I don’t know, you just have the feeling that like people are seeing you and if the light is dim you feel a lot more comfortable, adjusting the position of your body and stuff (IIPV26, Benign).

To manage this difficult situation, women adopted a range of ‘distancing’ strategies. These included speculating how ‘other women’ might feel in this situation. For example,

PV: ... because I’ve had to get undressed so many times because of my treatment, and everything, it’s like having a baby, isn’t it? You just sort of get used to it.

R:  Yeah.

PV: But perhaps for someone who hasn’t, who is not used to doing that…

R:  Yeah…

PV: …they might not feel so happy with it, perhaps.

R:  OK.

PV: They might want a bit more privacy (IIPV38, Cancer).

During her interview IIPV4 (Benign) also introduced the theme of exposure suggesting that having a light blanket over you during the test would make you feel less exposed when other people were in the room. However, she was loath to attribute possible feelings of exposure to herself, stating that while she did not have a problem with it: ‘I can understand why someone else might feel a bit exposed’. This approach could be combined with another frequent distancing strategy, which was to adopt the position of being an ‘old hand’ who was used to the medical process so that the significance of physical exposure was downplayed. IIPV38, quoted above, used this combination in her comment about having ‘had to get undressed so many times’. The women would often eschew the separate changing area provided, undressing in front of the female researchers making comments such as ‘we are all girls here’, or ‘you’ve all seen enough. I really don’t think it matters’. Others simply referred to their own embarrassment as being a thing of the distant past:

You’re just lying there and no-one need even see your breasts, you know. Not that that particularly worries me now. Of course it did the first time I had a breast exam (IIPV23, Benign).

After you go [to the] breast clinic a few times you kind of get used to it, so it’s not really a problem at all any more (IIPV26, Benign).

Anxieties about being touched or on show were expressed both by those with prior experience of diagnostic tests and those with little or no prior experience. The strategies we observed appeared to allow them to reconcile possible tensions between being physically and mentally comfortable by positioning themselves as strong rather than vulnerable.

Gendering of the research setting

We have some evidence that a further factor contributing to women’s ability to manage anxieties around bodily invasions is a gendered shift in research personnel resulting in an all-female research environment. Some women indicated a sense of relief at not having to cope with boundary infringements of being partially naked when a male researcher is present. Initially, scans were conducted by a male and female member of the medical physics team – the female attending the volunteer, the male attending the instrumentation and partly screened by it. As the technology has become more stable and the interface simplified, the female physicist is able to perform both operations. Also in attendance are one female social scientist (as before) and, occasionally, a female clinical collaborator. Some women commented on feeling particularly comfortable in this environment:

PV: I thought there would be more people to be honest.

R: Oh right. Okay.

PV: So I’m quite glad it was just the two of you. Yeah, I was a bit nervous that it might be more than one person or there might be men here (IIPV17, Benign).

…and I think it’s quite nice having only women in there as well. I think that makes people feel even more comfortable (IIPV10, Benign).

As volunteers are physically exposed during the test, having men in the laboratory may exacerbate feelings of vulnerability associated with being naked in this setting:

…but to come as a volunteer for a test to help, and then there’s a man… No, I would have, I wouldn’t have said anything and I would have been a brave bunny and done it, but I would have thought, ooh, why do you have a man there? […] I don’t know, perhaps I’m wrong, but for me, I was comfortable it was all ladies, and I never once considered there would be a man there (IIPV39, Cancer).

I’m probably one of those people who’s quite positive, relatively positive, about their body and about their breasts, so I don’t really mind it, but at the same time you’d don’t want any, at the same time you’d kind of, you’d rather do that, I’d rather do that in front of women than men generally […]. I didn’t say at the time, but I wasn’t expecting Professor X [member of medical physics team] to stay in the room so I, I, yeah, that, um, I could see, of course I could see why he has to, but again it’s the same thing to do with, with whether it’s, it’s women sort of or men when you’re sort of feeling more vulnerable (IIPV8, Benign).

These statements also demonstrate that women will put on a brave face rather than appear unable to cope with the situation, but this does not lessen their feelings of mental discomfort. Consequently, despite IIPV8’s assertion that she had a positive body image, the confidence she professes is disrupted by the unexpected and unwelcome presence of the male member of the team. This interrelation between physical and mental comfort was addressed explicitly by another volunteer who, when asked if she had felt uncomfortable during the test, said ‘I think there’s two ways of interpreting comfortable, uncomfortable, right?’ She went on to say that lying on the table during the scan was physically comfortable but she felt mentally uncomfortable because of ‘being in the environment with, you know, in a lab if you like, and having a man there who was not a medical person’. For her, having either a male or female doctor in ‘a medical type situation’ was fine, but the gender of those involved in a research setting appeared somewhat problematic:

I’m fine whether it’s a man or a woman. However, when I realised that this is like an engineering place, um, I think I would’ve felt a bit uncomfortable if, if it was you know… I presume he [member of medical physics team] is not a medical Professor? (IIPV3, Benign).

In comparison with the other boundary infringements we have discussed, this appears not be to be considered as much of an infringement, and is managed chiefly by tolerating incursions. However, although no-one has ever refused to continue with the test upon entering the laboratory and finding a man in the room, as some of the above comments illustrate, this stoical attitude may belie feelings of anxiety. The volunteers’ comments suggest that an all-female environment may help to reduce embarrassment around physical exposure, which we have identified as a major source of anxiety, enabling women to feel more secure in managing the strangeness of this hitherto unknown research environment.

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

Our empirical exploration of how volunteers manage threats to bodies and self-esteem associated with the research setting, highlights four kinds of boundary-setting and the contextual factors shaping those boundaries. As the majority of our volunteers were patient-volunteers, they had had considerable experience of breast cancer diagnostics within a medical setting, and these prior experiences are the filter through which the research experience is approached. Therefore, illness and medical procedures act as comparators – aids to characterising the research experience – and our findings suggest these are significant and influential contextual features framing and shaping volunteers’ reactions. The x-ray mammogram is a significant player in this, being part of the experience or hearsay knowledge of the healthy volunteers (two-thirds of whom underwent regular screening mammograms) as well as the patients. It sets a benchmark for pain and risk, and may inculcate that attitude of stoicism still visible in research subjects’ handling of issues of exposure and embarrassment.

While the painful experience of x-ray mammography where breasts were ‘squeezed’, ‘squished’, or ‘squashed’ and the risk of x-radiation were tolerated in the desire to safeguard health, suffering pain and putting oneself at risk for research were off-limits. X-ray mammography continues to be the primary method for detecting breast abnormalities particularly amongst older women (Hafslund 2000, Willis 2004). Analyses of how and why women make the decision to participate in screening throw some light on the complex web of influences required to make women voluntarily submit themselves to pain and x-rays. Amongst groups of women who considered themselves as having low or no risk of breast cancer, Willis (2004:128) found that many considered it was still important to take advantage of breast screening services because participation was seen as an important way of ‘exercising control’ over their health. It has been argued that screening becomes implicated in the social imperative to take responsibility for one’s health as ‘a central aspect of the expression of social membership and good citizenry’ and in their own best interests (Howson 1999:406). Potts (2000: 6) makes a similar point by invoking the notion of ‘technological surveillance’ whereby women take on a scientific discourse of breast cancer persuading them that screening is necessary in the name of their health and autonomy. Consequently, women may feel compelled to undergo screening despite concerns about pain and discomfort, which has been shown to be an important reason why women are often reluctant to attend further x-ray mammography screening (Andrews 2001, Doyle and Stanton 2002). In our setting, free from personal health implications and appealing only to the looser civic duty of ‘helping others’, these kinds of compulsions did not apply; hence the contrasting ‘research’ boundaries set by volunteers. These boundaries were broadly similar across our cohort of volunteers, and were quite tightly enforced with very little room for negotiation.

Throughout our discussion we have observed how the notion of physical comfort is closely linked to emotional wellbeing. This interrelationship underpins volunteers’ ability to manage their situation, and volunteers’ comments on their healthcare experiences demonstrate how easily this sense of wellbeing can be disrupted when physical incursions occur. Embarrassment at the thought of exposing their breasts is a problem for women attending screening (Fallowfield, Rodway and Baum 1990), and similar anxieties were expressed by our volunteers with respect to the research setting. However, the setting of bodily boundaries around the ‘embarrassment’ cluster of touch, exposure and gender which we have identified, is expressed less vociferously than those around pain and risk. There appears to be a higher degree of tolerance around the issue of embarrassment which may reflect a pragmatic approach to the test protocol which requires some degree of exposure, without which the test cannot go ahead. Consequently, when asked to appraise the test in relation to other diagnostics they have experienced, volunteers recognise the necessity of being naked from the waist up but this is tempered by the fact that there is no physical touching or manipulation, and exposure is only required briefly at the beginning and end of scans.

This apparent tolerance may however co-exist with anxieties about physical exposure. To manage these anxieties women use distancing strategies as mentioned above, in the same way as they move through various identities to manage other social stresses arising from the strange and unfamiliar social situation this kind of research participation presents (Morris and Balmer 2006). The need to undress and submit themselves to some level of physical exposure to research personnel – who are not only unfamiliar to the volunteer but may also be male and from a non-medical background – may cause unnecessary discomfort to some women. As we demonstrated, in situations where women felt this way, volunteers felt they had to put a ‘brave face’ on the situation, and stoically continued with the test. This underlines the need for researchers designing studies in similar non-medical sites, to control wherever possible the gender constituency of those involved in the tests.

Volunteers make judgements about what they are prepared to put themselves through with regard to research. This suggests that in no-benefit research (as distinct from clinical trials) participation needs to be ‘easy’ and stress free, causing as little anxiety as possible for the participant. We have highlighted how perceived threats to their physical and emotional wellbeing are translated into boundaries, identified in this discussion as relating to pain, touch and exposure, physical safety, and the gender of research personnel. To counteract these perceived threats to the body volunteers take an active role in setting boundaries within the research context, both by setting prior conditions regarding participation (and subsequently reiterating these to the researchers) and deciding if and when infringements to these boundaries are permissible. We find that the ways in which boundaries are constructed and enforced are fluid and context-dependent, and are not the same for all volunteers. Nevertheless, in this situation of a strong research focus on the body, and on the breast in particular, the setting of boundaries was a live issue for all, as was a greater or lesser degree of anxiety about threats of invasion.

The clear distinctions that volunteers made between what they would do ‘for research’ and what they would do in relation to their healthcare, indicates the flexibility of boundaries in the sense that they will be drawn, and more or less vigilantly monitored, in accordance with each volunteer’s assessment of threats and potential rewards. The no-benefit research we studied left out of the equation the highly significant rewards that may be offered by the more usual controlled clinical trial – be that substantial financial reward to healthy volunteers, or a chance of cure for a very sick patient. Such a context will have a powerful effect on judgements made and boundaries set. Our data, and conclusions, are limited to research settings where volunteers can expect no personal medical benefit. This context gives particular visibility to some of the social and emotional challenges of research participation, and the need to handle them so as to maintain a sense of wellbeing and self-respect. It would be of interest to investigate how volunteers locate potentially therapeutic trials with respect to the research/care borderline, what this implies for the work of boundary-setting, and whether or not the issues and strategies we have discussed are still present, overtly or hidden beneath other concerns. At a practical level, and in the context of the no-benefit research we have studied, we would re-emphasise the social and emotional challenges latent in even apparently non-threatening research. Researchers can help volunteers in the process of managing these threats by careful attention to the detail of their research protocols and instrument design and by developing their awareness of such underlying tensions to inform their professional management of the research encounter.

Footnotes
  • 1

     The British Psychological Society (2000) has changed its terminology from ‘subjects’ to ‘participants’. Official guidance on research governance has however defined ‘participants’ more widely, to include all stakeholders (DoH, 2001:20). To avoid ambiguity we have therefore retained the old terminology, in conjunction with ‘volunteer’ or ‘patient-volunteer’

  • 2

    Multi-channel Opto-electronic Near-infrared System for Time resolved Image Reconstruction.

  • 3

     Checking for differences in style and content of self-presentation in the two different situations.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References

We should like to thank all the volunteers and researchers who contributed to this study and gratefully acknowledge the financial support of ESRC (RES-000-22-0093 and RES-000-23-1160). Special thanks also to our colleagues in the STS Department, Dr Brian Balmer and Megan Clinch for invaluable comments and advice at various stages of the drafting.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Research setting and methods
  5. Findings
  6. Discussion
  7. Acknowledgements
  8. References
  • Appelbaum, P.S., Roth, L.H., Lidz, C.W., Benson, P. and Winslade, W. (1987) False hopes and best data — consent to research and the therapeutic misconception, Hastings Center Report, 17, 2, 204.
  • Andrews, F.J. (2001) Pain during mammography: implications for breast screening programmes, Australasian Radiology, 45, 1137.
  • Borrayo, E.A. and Jenkins, S.R. (2001) Feeling indecent: breast cancer screening resistance of Mexican-descent women, Journal of Health Psychology, 6, 5, 53749.
  • British Psychological Society (2000). Code of Conduct, Ethical Principles and Guidelines. Leicester: British Psychological Society.
  • Burman, E. and Parker, I. (1993) Introduction—discourse analysis: The turn to text. In Burman, E. and Parker, I. (eds) Discourse Analytic Research: Repertoires and Readings of Texts in Action. London: Routledge.
  • Bruyninckx, E., Mortelmans, D., Van Goethem, M. and Van Hove, E. (1999) Risk factors of pain in mammographic screening, Social Science and Medicine, 49, 93341.
  • Corrigan, O. (2002) First in man: the politics and ethics of women in clinical drug trials, Feminist Review, 72, 4052.
  • Corrigan, O. (2003) Empty ethics: the problem with informed consent, Sociology of Health and Illness, 25, 3, 76892.
  • Cox, K. (1999) Researching research: patients’ experiences of participation in phase I and II anti-cancer drug trials, European Journal of Oncology Nursing, 3, 3, 14352.
  • DoH/Department of Health (2001) Research Governance Framework for Health and Social Care. London: Department of Health.
  • Doyle, C.A. and Stanton, M.T. (2002) Significant factors in patient satisfaction ratings of screening mammography, Radiography, 8, 15972.
  • Edwards, S.J.L., Lilford, R.J. and Hewison, J. (1998) The ethics of randomised controlled trials from the perspectives of patients, the public and healthcare professionals, British Medical Journal, 317, 7167, 120912.
  • Entwistle, V.A., Renfrew, M.J., Yearley, S., Forrester, J. and Lamont, T. (1998) Lay perspectives: advantages for health research, British Medical Journal, 316, 7129, 4636.
  • Epstein, S. (1996) Impure Science: AIDS, Activism and the Politics of Knowledge. Berkeley: University of California Press.
  • Epstein, S. (2004) Bodily differences and collective identities: the politics of gender and race in biomedical research in the United States, Body and Society, 10, 203, 183203.
  • Fallowfield, L.J., Rodway, A. and Baum, M. (1990) What are the psychological factors influencing attendance, non-attendance and re-attendance at a breast screening centre? Journal of the Royal Society of Medicine, 83, 54751.
  • Gill, R. (2000) Discourse analysis. In Bauer, M. and Gaskell, G. (eds) Qualitative Researching with Text, Image and Sound. London: Sage.
  • Goodare, H. and Lockwood, S. (1999) Involving patients in clinical research, British Medical Journal, 319, 7245.
  • Grosz, E. (1994) Volatile Bodies: Towards a Corporeal Feminism. Bloomington: Indiana University Press.
  • Hafslund, B. (2000) Mammography and the experience of pain and anxiety, Radiography, 6, 26972.
  • Hanley, B., Truesdale, A., King, A., Elbourne, D. and Chalmers, I. (2001) Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey, British Medical Journal, 322, 7285, 51923.
  • Howson, A. (1999) Cervical screening, compliance and moral obligation, Sociology of Health and Illness, 21, 4, 40125.
  • Iredale, R., Brain, K., Williams, B., France, E. and Gray, J. (2006) The experience of men with breast cancer in the United Kingdom, European Journal of Cancer, 42, 3, 33441.
  • Klawiter, M. (2008) The Biopolitics of Breast Cancer: Changing Cultures of Disease and Activism. Minneapolis and London: University of Minnesota Press.
  • Lowton, K. (2005) Trials and Tribulations: understanding motivations for clinical research participants amongst adults with cystic fibrosis, Social Science and Medicine, 61, 185465.
  • Merleau-Ponty, M. (1962) Phenomenology of Perception. London: Routledge and Kegan-Paul.
  • Miles, A. (1991) Women, health, and medicine. Buckingham: Open University Press.
  • Miller, D., Livingstone, V. and Herbison, P. (2008) Interventions for relieving the pain and discomfort of screening mammography (Review), Cochrane Database of Systematic Reviews, Issue 1, Article no: CD002942.
  • Morris, N. and Balmer, B. (2006) Volunteer human subjects’ understanding of their participation in a biomedical research experiment, Social Science and Medicine, 62, 4, 9981008.
  • Morris, N. and Schneider, M. (in press) Volunteer research subjects’ experience of participation in research on a novel diagnostic technology for breast cancer, Qualitative Health Research.
  • Perkins, G.H. and Middleton, L.P. (2003) Breast cancer in men, British Medical Journal, 327, 7409, 23940.
  • Potts, L.K. (2000) Ideology of Breast Cancer: Feminist Perspectives. London: Macmillan Press Ltd.
  • Potter, J. (1996) Representing Reality: Discourse, Rhetoric and Social Construction. London: Sage.
  • Saywell, C., With Beattie, L. and Henderson, L. (2000) Sexualised illness: the newsworthy body in media representations of breast cancer. In Potts, L.K. (ed.) Ideologies of Breast Cancer: Feminist Perspectives. London: Macmillan Press Ltd.
  • Shildrick, M. and Mykitiuk, R. (2005) Ethics of the Body: Postconventional Challenges. Cambridge, MA: MIT Press.
  • Shuhatovich, O.M., Sharman, M.P., Mirabal, Y.N., Earle, N.R., Follen, M. and Basen-Engquist, K. (2005) Participant recruitment and motivation for participation in optical technology for cervical cancer screening research trials, Gynecologic Oncology, 99, S226S231.
  • Snowdon, C., Garcia, J. and Elbourne, D. (1997) Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial, Social Science and Medicine, 45, 9, 133755.
  • Sontag, S. (19781990) Illness as Metaphor and AIDS and its Metaphors. New York: Doubleday.
  • Stacey, J. (1997) Teratologies: a Cultural Study of Cancer. London and New York: Routledge.
  • Weinstein, M. (2001) A public culture for guinea pigs: US human research subjects after the Tuskegee study, Science as Culture, 10, 2, 195223.
  • Wilkinson, S. (2000) Feminist research traditions in health psychology: breast cancer research, Journal of Health Psychology, 5, 3, 35972.
  • Williams, S. (2002) Corporeal reflections on the biological: reductionism, constructionism and beyond. In Bendelow, G., Carpenter, M., Vautier, C. and Williams, S. (eds) Gender, Health and Healing: The Public/Private Divide. London and New York: Routledge.
  • Williams, B.G., Iredale, R., Brain, K., France, E., Barrett-Lee, P. and Gray, J. (2003) Experiences of men with breast cancer: an exploratory focus group study, British Journal of Cancer, 89, 10, 18346.
  • Williamson, C. (2001) What does involving consumers in research mean? QJM, 94, 12, 6614.
  • Willis, K. (2004) Personal choice/social responsibility: women aged 40–49 years and mammography screening, Journal of Sociology, 40, 2, 12136.