Volunteer human subjects’ understandings of their participation in a biomedical research experiment
Introduction
The practice of allowing participants in experiments a voice in the conduct of research has received growing attention in recent years (Epstein, 1996; Goodare & Lockwood, 1999; Williamson, 2001). This trend, largely focused on the clinical trial, is to allow patients or their representatives a voice at the planning and management level. Significant inputs have been to research priorities, trial design, choice of outcome measures, and cooperating in recruitment (Entwistle, Renfrew, Yearley, Forrester, & Lamont, 1998; Hanley, Truesdale, King, Elbourne, & Chalmers, 2001).
A different perspective on the participant's voice is to focus on how volunteer human subjects1 understand their own participation in research. Much of the 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 probe research subjects’ understandings, with a particular emphasis on their construal of concepts central to the design of the randomised controlled trial (RCT) and the implications for informed consent and trial management (Edwards, Lilford, & Hewison, 1998; Snowdon, Garcia, & Elbourne, 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. The tests can offer no health benefit to any of the volunteer research subjects. Furthermore, the tests are undertaken in a university research laboratory, not a hospital and conducted by non-clinical scientists, not physicians. 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 randomisation or equipoise) and enabling us to focus primarily on the experience of being a human research subject. How do volunteers view their own role, their relationship with the researchers, and the experimental setting? In particular, we are interested in the way in which volunteers articulate their understanding of the researcher–subject relationship.
In pursuing these questions we do of course acknowledge that volunteers are a heterogeneous population and the research situations in which they may find themselves are equally diverse, with different demands, constraints and benefits. The spectrum of experimental clinical studies ranges from Phase 111 clinical trials offering desperately ill patients the chance of access to a potentially life-saving drug to studies of normal human physiology with no therapeutic aim. Likewise, there is a significant difference between volunteering for an experiment that takes an hour and one that involves months as a subject. All these will affect volunteers’ attitudes and reactions. The broader social setting will also have an influence: our work took place in the UK where a comprehensive National Health Service (NHS) provides access for all to free medical care, and was sponsored by non-commercial interests (charity and research council funds). The experience of the subjects and the researcher–subject relationship will inevitably be shaped by this context.
Section snippets
The research experience and the researcher–subject relationship in the literature
The science laboratory has become a familiar site for ethnographic investigation by sociologists and anthropologists interested in the social process involved in knowledge production (Knorr-Cetina, 1995; Latour & Woolgar, 1979; Lynch, 1985), yet we found that the experiences of human volunteers in the research process have remained curiously invisible in the social studies of science literature. Similarly, while an extensive academic literature exists on the doctor–patient relationship (
Research setting
The setting for this study is the early clinical testing of a new method for diagnosis of breast cancer, using radiation at optical wavelengths (i.e. lightwaves, rather than X-rays or ultrasound radiation) to generate an image of what is inside the breast and thus locate and identify any abnormal growths. This method has potential advantages, in terms of image discrimination and patient safety, over existing methods of investigation. A team of medical physicists at a leading UK university has
Results
In this section, we initially set the scene by describing, from the perspective of the participant–observer, the typical sequence of events when a woman arrives for a scan. We then discuss volunteers’ accounts of their own role, developing a categorisation of the multiple identities volunteers call on in the course of the research encounter, and relating these to the social anxieties that surfaced quite frequently in the course of volunteers’ accounts.
Discussion
Any discussion of our findings must start with reiterating the point made earlier about the diversity of research settings in which volunteers take part in research, and the significance of local context in shaping volunteers’ experience and the relationship between researcher and researched. The setting for our fieldwork plunged volunteers into a situation of intimacy with strangers where the familiar doctor–patient relationship was ruled out as a pattern for conduct and they had to shape
Conclusions
Analysis of existing writings relevant to the researcher–subject relationship and our empirical research on volunteers’ experience lead us to conclude that the interaction cannot be characterised 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, donor, collaborator, employee. Even within the accounts of a single encounter volunteers may describe their own understanding of
Acknowledgements
We would like to thank the editor and two anonymous referees for their helpful comments and suggestions. We also gratefully acknowledge the helpful and insightful comments made by Petra Boynton, Kevin Burchell, Oonagh Corrigan, Alice Farrands, Adam Hedgecoe, and Fiona Stevenson on the draft paper. We warmly thank all the volunteers who agreed to take part, and our research collaborators who generously gave their time to be interviewed. The work was funded by the Economic and Social Research
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