Milena D. Bister Ulrike Felt Michael Strassnig Ursula Wagner
Refusing the Information Paradigm: Informed Consent, Medical Research, and Patient Participation October 2009
reprint
Department of Social Studies of Science University of Vienna
STS 2009
Copyright You are allowed to download this paper for personal use only. This paper must not be published elsewhere without the author’s explicit permission. The paper must not be used for commercial purposes. Please cite this paper in the following way: Ulrike Felt, Milena D. Bister, Michael Strassnig, and Ursula Wagner (2009). Refusing the information paradigm: Informed consent, medical research, and patient participation. health: An Interdisciplinary Journal for the Social Study of Health, Illness and Medicine 13(1): 87-106. Address for correspondence: Ulrike Felt Department of Social Studies of Science University of Vienna Sensengasse 8/10 A-1090 Vienna, Austria T: ++43 1 4277 49611 E-Mail:
[email protected] http://sciencestudies.univie.ac.at
Refusing the Information Paradigm: Informed Consent, Medical Research, and Patient Participation1 Ulrike Felt, Milena D. Bister, Michael Strassnig, and Ursula Wagner This article challenges the assumption that patient autonomy can best be assured by providing proper information through formalized procedures such as informed consent. We suggest that to understand and consider laypeople’s ways of knowing and decision making, one has to move beyond the information paradigm and take into account a much broader context. Concretely, we investigate informed consent in connection with donating skin tissue remaining from medically indicated surgery. We use interviews with patients and observation protocols to analyse patients’ perceptions and ways of making sense of informed consent beyond its bioethical ideal. Patients situate themselves in a larger system of solidarity, enrol in an overall positive image of science as a linear process of innovation oriented towards output, and simultaneously take a pragmatic stance towards hospital routines as a necessary passage point towards receiving good treatment. Because informed consent is one of the central articulations between the biomedical system and society, we conclude by reflecting on the consequences of our findings on a socio-political level.
Introduction Soliciting informed consent has become an everyday routine in health care and research on human subjects. The practice has likewise been much debated in contemporary bioethics. Against a backdrop of the atrocities of the Second World War, a growing patients’ rights movement, and a greater awareness of possible risks caused by medical research, informed consent has become a standard prerequisite to research involving human subjects (Faden and Beauchamp, 1986). Informed consent has been further consolidated through the proliferation of genetic information, which has reshaped the predominant perceptions of risk and dangers (Chadwick and Berg, 2001). As a consequence, numerous institutions recommend informed consent for patient– biomedicine encounters for ethical reasons. In the Convention on human rights and biomedicine (Council of Europe, 1997: VII, Art. 22), for example, it is declared that ‘any part of a human body’ may only be used ‘if this is done in conformity with appropriate information and consent procedures’. In a revised version of the Declaration of Hel-
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The authors thank the Austrian Federal Ministry of Science and Research (TRAFO Programme) for funding; Nikolaus Wick and Daniela Haluza for their transdisciplinary collaboration; and the patients and experts we interviewed for having shared their views with us. Also, we thank Oonagh Corrigan, Klaus Hoeyer, and Stefan Timmermans for valuable comments on earlier presentations of the arguments made in the article, and the two anonymous reviewers for their careful reading and constructive criticism.
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sinki, put forward by the World Medical Association (2004), it is state that any research on human substances needs to be regulated through informed consent. Furthermore, many journals publishing biomedical research demand formal ethical clearance, which is often linked to informed consent procedures. Hence, one of the main concerns – expressed in institutional recommendations as well as by ethics committees – lies in assuring proper information for patients through formalized procedures. While informed consent is intended to facilitate the ethical ideal of a patient as an autonomous agent, critical social science research points to the limits of informed consent as an ‘ethical panacea’ (Corrigan, 2003). Empirical studies on informed consent, literature on relational autonomy, and science and technology studies (STS) on biomedicalization, challenge the functioning of individual patient autonomy as a guiding principle. Moreover, in a much broader sense, critical Public Understanding of Science problematizes the rather naïve ‘information paradigm’ – also inherent in informed consent – which presumes that ‘rational’ decision making can be grounded on a specific type of information provided. In this article we scrutinize the dominant concept of information provision and its practice in informed consent, and we propose that laypeople’s ways of knowing and decision making take place in a much broader context than anticipated. Concretely, we investigate informed consent in connection with patients donating skin tissue ‘left over’ from elective plastic surgery. Based on our data from interviews with patients and observation protocols, we analyse patients’ perceptions of informed consent and how they describe different resources – knowledge, information, experience, personal relations and so on – that were relevant in their decision making. We start by positioning our analysis in current debates on the limitations of informed consent and in literature from STS focusing on laypeople’s ways of dealing with decision making in complex science-related contexts. After a short description of the methodology and data, we analyse our material in two steps. First, we look at the way informed consent is practised in the Austrian hospital context and how those involved in putting informed consent in place understand and shape it. Second, we investigate the ways in which patients make sense of and manage their decisions concerning their participation in medical research. Finally, because informed consent is a central articulation between biomedicine and society, we reflect our observations and their significance on a socio-political level.
Challenging autonomy in informed consent With the rise of bioethics, ‘autonomy’ has become a leading principle in the field of medicine (Wolpe, 1998). Many bioethicists see informed consent as a means for assuring the autonomy of patients and research subjects (Faden and Beauchamp, 1986). In the majority of the literature on informed consent – which is produced in the fields of bioethics, medicine, and law (Sugarman et al., 1999) – the bioethicists’ argument remains largely unchallenged. Recent qualitative studies, however, have shed a different light on informed consent in diverse contexts. Hoeyer and Lynöe (2006), for example, criticize the ‘notion of intentional autonomy’ persistent in bioethics. In their analysis of people’s motivation to donate blood to a biobank, they show that the ‘decision to donate must be viewed as something other than an information-based, intentional Dep ar t m ent of Soc ial St ud ies of Sc ienc e | Univer sit y of Vienna 2009
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act’ (2006: 16). The donation of bodily substances can be understood only within the larger context of how people perceive the State and its health system and their roles and duties within it. Corrigan (2003), too, calls for considering the context in which informed consent is enacted. Power relationships between biomedical practitioners and patients lead to unequal encounters wherein personal autonomy cannot be realized in the way it is imagined by the dominant bioethical ideal. Dixon-Woods et al. (2006) even depict autonomy as an ‘illusory goal’. In their research on women consenting to surgery, women who initially declined surgery finally consented, thus showing how difficult it was for them to turn down doctors’ ‘offers’. The authors conclude that ‘the ideal of informed consent as the outcome of rational choices exercised by autonomous agents was far from being achieved’ (2006: 2750). Within ethics, critics of putative autonomy challenge the concept’s focus on the individual as a solitary, rational subject that is able to exercise autonomy through informed consent (Berg et al., 2001). In a relational approach to autonomy, however, much more emphasis is placed on the individual’s social contexts. Patients’ choice during informed consent is understood as a process of considering one’s specific social location rather than as an exclusive act of rational reasoning. ‘Autonomy of the subject’, therefore, can neither be seen as intrinsic to human nature, nor can it be considered as the starting point for ethical reasoning. Rather, informed consent is one of the instruments through which ‘autonomy’ is performed and a particular version of it imposed. The framing of autonomy as informed choice that presents a narrow set of ready-made options for patients is seen as insufficient for describing and taking into account the complexities of social and historical contexts that contribute to patients’ ways of dealing with medical encounters (Mackenzie and Stoljar, 2000; Ehrich et al., 2007). Thus, a linear correlation between the provision of factual information and subjects acting autonomously appears untenable. Hence, empirical evidence and critique from within ethics show that concepts of individual autonomy that took root in informed consent need thorough scrutiny.
Public ways of knowing Literature investigating the limits of informed consent frequently emphasize the problem of whether patients properly understand the offered information. One particular assessment derives from empirical quantitative research that focuses on the ‘correctness’ of patients’ answers, and thereby defines comprehension as the ability of accurate repetition (e.g. Wirshing et al., 1998). The provision-side of the problem – how, and how much information should be given – is of central importance in the discussion (e.g. Appelbaum et al., 1987; Katz, 1998; O’Neill, 2003; Sreenivasan, 2003; Dawson, 2005). For example, ethical principles, such as those issued in the Declaration of Helsinki (World Medical Association, 2004) stress the aspects of information and comprehension to ensure that research participants understand the information offered (Vallotton and Truniger, 2001). However, the assumption that patients make rational decisions based on neutral and comprehensive information – what can be called the ‘information paradigm’ – remains largely unquestioned as an intrinsic feature of western knowledge society narrative. Reflection and critique of the information paradigm can further be drawn from ‘critical public understanding of science’. Science-society interactions all too often Dep ar t m ent of Soc ial St ud ies of Sc ienc e | Univer sit y of Vienna 2009
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implicitly embed a ‘deficit model’ that suggests that people lack ‘adequate’ information to make reasoned decisions, which leaves the definition of what comprises adequate information to the experts. Consequently, laypeople’s lack of knowledge is used to explain their refusal of or mistrust in science. Yet qualitative research in STS has elaborated on the observations that public reactions to science are grounded in the variety of experiences people have had with scientific institutions and their actors (Wynne, 1995; Irwin and Wynne, 1996; Michael, 1996). So, instead of constructing ‘ignorance’ as a deficit to be remedied, one might consider that sometimes laypeople deliberately choose to remain ignorant of certain information. That is, if laypeople were to acknowledge the information offered by professionals, then they would be impelled to subscribe to the logic inherent in the offered scientific knowledge. ‘Discourses of ignorance’, as Michael (1996) labels laypeople’s ways of arguing what they do not know about science, hint at the role people attribute to science in their lives. For example, ignorance towards science might be understood as the irrelevance of science in a person’s concern or as people’s mistrust of the exclusivity and self-defining character of science (Michael, 1996). Laypeople remain ignorant for other reasons: they may fear that by questioning the offered information, they may disrupt a relationship on which they feel dependent; they intuitively understand that to question scientific knowledge means to challenge the institution from which it came (Wynne, 1995); or, as Michael (1996: 120) explains, ‘intentional “ignorance” [can be] mobilized to challenge or attack the relevance of a given body of expert knowledge to the “real” issue at stake as perceived by the speaker’. Still, much of contemporary deficit discourse is grounded on a model of the public in which people have a quasi-natural and unconditional desire for knowledge and information, while simultaneously, science becomes increasingly complex and often inaccessible to the public. However, this knowledge-gap rhetoric and the underlying ideals are best understood as historical constructs with different faces at different times. In the 20 th century, for example, a well-established construct pitched the more or less ‘ignorant masses’ in opposition to scientists, who were seen as holders of universally valid knowledge (Bensaude-Vincent, 2001). So in situations involving informed consent, patients’ ignorance does not necessarily signify their lacking information, but rather their ignorance presents a means for obtaining insights into the interrelations between the medical system and society from a patient’s position. In other words, patients’ ignoring of scientific information may be a conscious choice when encountering science, or, as in our case, when dealing with the medico-scientific complex. Moreover, Jasanoff’s (2005) concept of ‘civic epistemologies’ offers further insight into how laypeople deal with science by focusing less on ‘individual knowledge and ignorance of facts’ and more on ‘how political communities know things in common’ (2005: 250). Civic epistemology refers to institutionalized practices by which members of a given society test and deploy knowledge claims used as a basis for collective choices. … [M]odern technoscientific cultures have developed tacit knowledge-ways through which they assess the rationality and robustness of claims that seek to order their lives. (2005: 255) Public ways of knowledge can be analysed along different dimensions, such as styles of knowledge-making, public accountability, the construction of ‘objectivity’, and the role of experts and expertise in a given society. Dep ar t m ent of Soc ial St ud ies of Sc ienc e | Univer sit y of Vienna 2009
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With regard to informed consent procedures, ‘civic epistemologies’ are of central importance. However, ways of knowing remain largely implicit and unrecognized. In our case, where consent to basic medical research is the issue, ways of knowing structure how patients perceive the broader context of the biomedical system and how they make sense of informed consent in that context: What kind of knowledge is generated within this system? What kind of expertise is considered relevant? Who should benefit from knowledge in the end? What is the role of the individual patients’ contributions in creating this knowledge? Whom do the patients trust or distrust? What is the role of the legal and administrative features of the informed consent process? What is the image of science and research in general? In the following, then, we try to understand the informed consent procedure from perspectives that move beyond the debate of ‘adequate information’.
Field of study and methods We obtained the data from a two-year research project on informed consent to basic medical research.2 The project was initiated when a pathologist from a large university hospital in Austria addressed us with the request that we find out more about patients’ perceptions of the research in which they consented to participate by donating excess tissue. The pathologist and a medical student under his supervision conducted basic medical research on skin tissue obtained mainly from patients who underwent abdominoplasty, or breast size reduction or breast reconfiguration after cancer treatments. Their research project analysed the molecular mechanisms of diabetic microangiopathy; that is, they studied the variations in gene activity that might be responsible for damaging small blood vessels due to high blood sugar levels associated with diabetes. In accordance with recent, local ethical guidelines (Mannhalter et al., 2001), medical personnel must ask patients to give their consent to making a tissue donation. To obtain patients’ consent, medical personnel must use an informed consent form that has been approved by the hospital’s ethics committee, and provide patients with a verbal explanation to allow for patients to ask questions. Over a period of 10 months we conducted participant observations of the informed consent conversation between the medical student and the patient, and, subsequently, we interviewed3 the patients, usually on the day before surgery after the patient had been admitted to the hospital. The interviews were semi-structured with rather open questions on different aspects of the informed consent situation. We addressed areas such as patients’ relations with the doctors and the hospital, their perceptions of the medical student and her research, the consent form, their reasoning on whether or not to give their consent, and their relationship with the excised skin. Out of the 24 informed consent procedures we observed, we conducted interviews with 19 patients. Only one of our interviewed patients was male due to the indi-
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‘Informed consent as space of negotiation between biomedicine and society’, funded by the Austrian Federal Ministry of Science and Research within the TRAFO (Transdisciplinary Research) programme. It is important to note that we ourselves had to obtain informed consent from the patients for our social science interviews. Prior to that, our questionnaire had to be approved by the ethics committee of the hospital. We therefore actually found ourselves in the same situation, which we investigated for the pathologists.
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cations for the surgeries. The interviews took place mostly in a separate room, sometimes in the patient’s room, and were often interrupted by medical staff for examinations or for other informed consent procedures. The interviews lasted 20 to 30 minutes on average, were tape-recorded and transcribed. After the interviews, we wrote observation notes. For data analysis, the interviews were coded in the following different categories: (1) meanings of informed consent; (2) descriptions of relevant actors and the hospital context; (3) the role of information, knowledge, and ignorance; (4) narratives about regulation; (5) images of science and research; and (6) body images. These categories had already informed the design of our patient interview questionnaire, but we refined and broadened them in the light of the patient’s responses after gathering first data. We also conducted interviews with experts in medical professions – members of the hospital’s ethics committee, researchers, and experts in medical law – and organized three focus group discussions with diverse actors involved in medicalrelated fields and one with patients to obtain feedback on our findings and collect further contextual information. In the next sections we reflect first on the views of professional stakeholders in the Austrian context regarding informed consent. Then, we offer an analysis of lay conceptions of informed consent that runs across the above mentioned subject groups, by focusing on those elements relevant to the research question addressed in this article.
Informed consent between abstract principles and hospital reality In Austria, as in other European countries, ethics committees have been legally established since the 1990s to regulate medical practices (Baumgartner, 2005). Those committees are meant to serve as a link between patients and medical professionals and to safeguard the rights of patients and research subjects, and facilitate research by creating legally safe grounds. The Panel of Austrian Ethics Committees4 has developed a specific informed consent form to cover participation in biomedical research other than clinical trials. The main issues raised in the form are the purpose of the study, research methods, personal risks and benefits, and data protection. Patients have to affirm with their signature on each page of the form that they have read all the information and have been told in detail about possible risks as well as about the nature, relevance, and extent of the study. However, the formalization of information in the consent procedure does not necessarily lead to an ideal situation. Rather, the practice of informed consent is caught in a previously described tension between ever-growing demands in medicine to standardize routines and everyday practice that needs flexibility in dealing with the requirements of the clinical workflow (Timmermans and Berg, 2003). Hence, in the making of informed consent – by translating ethical recommendations and standards into practice – several demands and routines reshape the ideal of providing proper information to patients. For instance, ethics committees need to manage high numbers of applications while balancing legal requirements, comprehensibility for pa-
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This panel is an umbrella organization of all Austrian ethics committees in hospitals. See http://www.ethikkommissionen.at/ (accessed 22 February 2007).
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tients, and facilitation of research. Or, medical practitioners need to ‘squeeze’ the ideally extensive informed consent interaction into tight hospital routines. In our interviews with three members of the local ethics committee (two medical professionals, one ethicist), the issue of assuring the patients’ freedom of choice with regard to participation in medical research through consent procedures appeared to be of secondary importance. In their narratives, informed consent rather served to secure research legally. In fact, the experts did not address the bioethical ideal of providing neutral and comprehensive information for decision making as a problem. Rather, their accounts pointed to medicine in practice and its interconnections with the law. For example, one respondent stated: ‘The ethical question, I don’t say that it is irrelevant in this whole procedure, but to a great extent it is entangled with legal aspects’ (E1).5 In that light, ethics ‘is not the driving force, but an appendix to the development of the increasing juridification of the doctor–patient relationship’ (E1). Another view was that a researcher, above all, wants the patient’s consent, and that desire influences the information provision. One member of the ethics committee elucidated this problem: ‘You want to actively recruit people for a study, which means that you make things attractive. You don’t stand there and tell them that it might be dangerous for them. Then, maybe, you wouldn’t find anybody’ (E2). These experts thus expressed their feeling of being trapped between ideal and actual practice: while they did not dominantly portray themselves as representatives of the ‘bioethical ideal’, they still performed this ideal as members of the ethics committee by setting up informed consent guidelines and materializing them in forms to be signed by patients. However, they were well aware that in practice these ideals and imaginations are not met for many reasons: The expectations we have from an idealistic side, or for our work on the ethics committee, or for the informed consent conversation from the doctor’s side to participate in studies or to recruit patients differs totally from the motives raised by the patient. (E2) Furthermore, patients were not expected to be willing to receive the amount of information provided in the forms: ‘Often ... it [the information] challenges patients very much intellectually. Why should they be interested in something that doesn’t really interest them ... 10, 15 pages, no patient wants to read that, definitely not.’ (E3) Also, for the two medical researchers directly involved in our study, the gap between the bioethical ideal and clinical practice was obvious. Concerning freedom of choice, the medical student who obtained the patients’ consent argued that it would be difficult for patients to object to participation in general because ‘you won’t refuse a request from somebody who is helping you’ (see also Stokes et al., 2006). At the same time, she did not doubt that in the case of her consent procedure to medical research, people felt free to agree or disagree. She, as well as her supervising pathologist, believed that consent for their specific research project would in fact not even be necessary because their research was ‘ethically unquestionable’, and it would be easy to ‘take their [the patients’] fear of any misuse’ simply ‘because misuse of our research is virtually impossible’ (pathologist). In other words, the pathologist and student thought
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All quotations from interviews are translated by the authors. P indicates an interviewed patient. E indicates an interviewed member of the ethics committee.
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that in the case of their research, patients’ fear of misuse of their tissue was unfounded. Furthermore, because, as the pathologist stated, ‘doctors have the duty to do good’, he and the medical student assumed that this duty put their practice above ethical scrutiny. Their comments, then, mirrored a degree of avoidance to reflect on ethical issues (see Wolpe, 2006). For the pathologist, informed consent was mainly an administrative formality and a legal safeguard for the institution. He viewed giving information to patients only as an extra service. This discrepancy between the bioethical ideal as materialized in the informed consent form, and the complexities and heterogeneous demands of the medical system had tangible consequences for performing informed consent at the bedside. In our case, patients asked to participate in the research study saw no obvious reason and received no explanation for why they were selected for the study. Consequently, the medical student’s request for a patient’s consent came first and foremost as a surprise. Suddenly, the skin tissue excised during surgery was transformed from ‘surgical waste’ – something the patient intended to get rid of – into something valuable for research. Additionally, patients were asked for consent at a moment when all attention was directed towards the surgical intervention. As a result, instead of assessing the donation request based on the fairly complex written information in the consent form, most of the patients preferred to listen to the medical student who ‘translated’ the content of the form into a language that she assumed was suitable for laypeople; that is, the medical student created parallel narratives to the written form. As a consequence, patients hardly read the form; they only browsed through the document because they were requested to sign every page. The patients asked virtually no questions, and, in the end, every patient agreed to donate skin tissue to research.
Making sense of donation The apparent ease with which patients complied in signing consent to research forms raises questions about their ways of dealing with the situation and lack of readiness to engage with the information offered in the form. Indeed, in the interviews, patients managed to make sense of the way they handled the situation and made their decision by mobilizing personal experiences and perspectives, more general cultural images derived from a whole range of sources, and ‘common sense’. The first and most important information appeared to be the distinction between oneself or one’s own body and the removed body part. Patients grasped seemingly instantly that the research will be performed on skin tissue after it is excised during the surgery for which they came to the clinic. Hence, patients assessed that their consenting to medical research neither interfered with the treatment they sought, nor implied additional interventions and pain. Most of the patients did not formulate any enduring or positive relationship with the soon-to-be-removed tissue. They clearly wanted to get rid of the tissue, in that they described it as ‘dead matter’ or ‘cut off and gone’. By accepting the medical student’s account of the consent form information, wherein she often referred to her study on the excised skin as ‘making use of leftovers’, some patients explicitly conceptualized the removed skin as waste’.6 This perception was also rooted
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In their research on embryo donation Nordahl-Svendsen and Koch (2006) found similar perceptions of ‘spare embryos’ as waste. This happens although the parents undergoing IVF treatment have been longing for the creation of those embryos for a considerable amount of time.
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in the patients’ personal histories that reflected often long processes of emotionally distancing themselves from a certain body part that finally resulted in the medical intervention. For most of the interviewed patients, concerns about data protection remained marginal because, first, patients did not regard anymore the excised skin tissue as connected to them ‘personally’, and, second, they perceived the public university hospital as a trustworthy institution. However, patients’ lack of concern about data protection was contrary to the very logic and intent of the informed consent procedure, which was introduced precisely because of the tissue’s value in research (and beyond), and because of its link to possibly sensitive genetic information that reconnects the excised tissue with the patient. Patients, however, had distinct explanations for consenting. In the following we describe three main narrative strands of how patients made sense of tissue donation to medical research.
‘Because we all benefit from it’:7 contributing to a functioning system The first dominant narrative that patients regularly deployed in explaining their readiness to donate skin was linked to their vision of the medical system. While recognizing that their direct personal benefit from the research project was marginal to hypothetical – as explicitly stated in the form as well as by the medical student – patients positioned themselves and the donation act in a larger socio-technical context. They evoked certain notions of a ‘give and take’ relationship that echoed the institutional framing of the health insurance system in Austria: it is publicly funded8 and provides individuals with primary medical care with retention payments that conceal the real costs of care from the patients. Therefore, the patients often perceived their interactions with the medical system as a form of a non-monetary exchange relationship in which donating tissue was a way to support, contribute personally to, and, thus, participate in it. This institutional framing strongly influenced the way patients interpreted being asked to donate their skin tissue: the skin tissue was understood as a gift towards the welfare state that, in turn, provides proper treatment (see also Hoeyer and Lynöe, 2006). Yet patients performed different models of contributing. Some framed the donation in an abstract sense whereby the tissue as research material feeds into a largescale and anonymous biomedical processing system. Others imagined more direct relationships between themselves and other patients, both in the present and future: ‘Maybe in 30 years … because I have psoriasis … I[’ll] need a piece [of skin] myself. And then somebody else [will] help me’ (P6). Against the background of such a relational model based on voluntariness, most patients clearly rejected the idea of receiving financial compensation for a tissue donation, an observation that has also been made elsewhere (Gold, 1996; Bovenberg, 2005; Waldby and Mitchell, 2006): ‘Because we all benefit from it [the donated tissue] if, for example, a drug against skin cancer will be found; everybody profits! And why – just because I have consented [to donate tissue] – should I cash in now?’ (P12). Patients also went beyond the notion of being passive
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Quotation of patient P12 Two-thirds of the Austrian health care system is funded by the contributions to social insurances and by state subventions (see Hofmarcher and Rack, 2001).
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ing passive suppliers of tissue and receivers of health services, and saw themselves as active contributors to the system. In some cases, the patients’ sense of personal responsibility to support the system through donation was further reinforced by an assumption that other patients might not allow research on their tissue. Those assumedly uncooperative others were portrayed as possibly being uninterested in science, ignorant of the long-ranging benefits of research, or too emotionally stressed on the day before surgery. The patients’ recurrent reference to organ donation as a system based on solidarity seemed to express an implicitly assumed, self-evident necessity to fulfil one’s duties as responsible ‘citizen donors’ (Tallacchini, 2006). This assumption of civic responsibility underlined not only the patients’ strong perception of Austria as a ‘caring state’ and their corresponding duties as citizens, but the assumption also denoted a non-monetary character to the donation that avoided possible negative side-effects such as organ trade. For many patients, organ transplantation was the touchstone for legitimizing the donation and possibility of misconduct by the medical system. Out of these narratives, patients imagined themselves, as benevolent citizens who contributed their share to a solidarity-based society (see also Felt et al., 2008).
‘Whatever is needed for good research’9: images of medical science and research The second narrative of the patients for framing their donation revolved around an overall positive image of medical science and research. In our interviews, this narrative was marginally blurred by a concern about cloning, which was the only explicitly stated negative example of scientific research outcomes. Instead of pursuing detailed information about the research conducted on their tissue or even about the processes in the laboratory, patients imagined research agendas and processes based on experiences from their own illness or, for example, from scenarios presented by the media. In their accounts, two specific features of science were stressed: science and research as (1) a linear flow of progressing innovation (see Godin, 2006) focused on the (2) produced output of research. Nearly all patients portrayed science and research as a continuous, linear process that gradually produces innovations that, in the end, benefit humankind and contribute in creating better futures. The portrayal also expressed an expectation that at some point in time – sooner or later – research will lead to cures for diverse diseases. Thus, patients expressed the need for promoting science and research: If it is not done, then there is no research because … it stagnates; then nothing goes on. And generally, if it wasn’t done in the past … we wouldn’t be here now ... with all the technologies and the possibilities … If you look today at what kinds of operations are done ... you didn’t even dream of them years ago. (P23) That some research projects do not yield results was not seen as a fundamental problem. If researchers failed to achieve the expected results then, according to the patients, researchers need to go back and start in a different direction: ‘If you take a road and you see that you cannot go on, well, I just go back three steps and take the next one, don’t I?’ (P2) Furthermore, patients viewed education as a significant factor
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Quotation of patient P9.
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in advancing science. Many alluded to their donation as helping students and doctors learn new skills. In fact, the education of researchers, in patients’ views appeared to be central to the progress of medical science: ‘Maybe on can learn from it [the donated tissue] in research and science, and a good student can become a rather good doctor, maybe’ (P3). Some patients emphasized the relevance of research based on their own or their friends’ and relatives’ experience with certain diseases or their encounters with the medical system. Their narratives were especially vivid and stressed why they knew that science was indispensable for everyone: future generations, their children and grandchildren would benefit from the outcomes of research. Wynne’s (1995) argument that people’s experiences with science in its institutional and social forms are central to their own positioning towards science was clearly visible in these patients’ accounts. Although the pathological research in this study was presented by the medical student to patients as ‘basic’ research, the patients’ focal interest was on medical applications. When patients emphasized the need for scientific advances, they always related to concrete outcomes such as new drugs and treatments. They thought that diseases such as skin cancer o diabetes should be cured and insights into the origin of diseases should be generated: ‘You can develop more and more for diseases like ski cancer and the like. And I think research will get better and better, on will find more and more possibilities to ease and cure’ (P16). In their eyes science must and does benefit humankind. To this end, some patient welcomed collaborations with the pharmaceutical industry since it, too was perceived as contributing to advancements in medicine. Obviously the distinction between basic science and economically driven research I industrial contexts was not clearly made. The patients foregrounded the output of research and not the processes leading to output because either the processes were hard to imagine or they were irrelevant to them in the context of their tissue donation.
‘Because consent is needed for everything’:10 knowing the ropes of the system In parallel with the narratives of actively contributing to scientific progress patients also rationalized their actions by describing themselves as bound to the limitations imposed by medical practice. The clinical context was perceived as a set of sociotechnical rules that serve the system and preserve its stability. Patients, then, took a pragmatic stance towards hospital routines and tried to see them as necessary passage points and as stabilizing elements for receiving proper treatment. In that sense, they ascribed the consent procedure and their consent to donate their tissue to a hospital’s routine, or just to ‘how the system works’. In the context of a hospital routine, patients interpreted informed consent as a way to stabilize and protect the position of medical doctors or the hospital as institution. They thought that informed consent created more contractual, formal relationship that thereby protected the system against patients who might endanger its smooth functioning. As one patient stressed, if there were no informed co sent, then, ‘I
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Quotation of patient P21. Dep ar t m ent of Soc ial St ud ies of Sc ienc e | Univer sit y of Vienna 2009
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could change my mind tomorrow and say: “Sorry, but I want to take it [my skin] home”’ (P10). Hence, patients perceived the formalization of the consent process as one element that assures the proper functioning of the system averting potential litigation. Yet, from the patients’ perspective, informed consent as a formal procedure also meant that public control of the medical system increased by giving voice to individual patients: Not everyone accepts that one [researchers] can simply do research with all [excess] materials but that they [medical staff] are taking care of what areas this goes on in, yes. That means [having] precise controls … and seeing the patient as a patient and not as a number. (P5) Here, informed consent was conceptualized as an instrument that possibly made medical professionals reflect upon their research practices and at the same time made the system more transparent. Consequently, the patients’ perception of informed consent as a forma procedure was ambivalent as were their accounts on the reality of doctor patient relationships. These relationships were also understood as being rather strictly bound to hospital routines. The time the doctor has t interact with patients was regarded as a scarce resource. As a result, patient frequently assumed that asking questions would delay the smooth running of the system, and so they aligned their actions to what they thought would be the behaviour best for supporting the system. On one hand, patients felt ‘taken by surprise’ (P4) when asked for their consent to donate skin; o the other, they did not see any good reasons for declining the request. Hence, consent was given so as not to endanger their relationship with the doctors or the medical student (see also Stokes et al., 2006). Moreover, to some extent they deliberately maintained their role of patient by leaving expert knowledge to medical professionals: ‘If I questioned everything then I [would] never reach the goal. Therefore, I do it [questioning] by no means’ (P2). Patients clearly assigned a priority to their surgery by transferring responsibility to the doctors. Hence, they tried to make their way through the hospital as smoothly as possible. To resolve their ambivalences about hospital routines would demand too much further interaction and possibly cause conflicts with medical professionals, an outcome patients viewed as counterproductive to their immediate medical needs.
Discussion We showed that the ideal behind informed consent – namely, that a ‘qualified’ decision has to be built on predefined information – is countervailed by the patients’ practice with informed consent. Patients redefine the meaning of being informed by disregarding offered formal information in their decision making and drawing on different resources instead. Simultaneously, they implicitly impose their own vision of what it means to participate in medical research. While the consent form explicitly states that the contribution of the patient ends when the skin tissue is excised and that there is no benefit at all for them, patients construct the donation as a beneficent act towards the biomedical system in a more extended sense, that is, towards imagined future patients.
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We further saw that patients enact a certain image of medical research that facilitates the idea of donation. Research is seen as an efficient linear process leading to new, publicly financed and available remedies. In this narrative, the very workings of the system, the practical entanglements, and complexities of research are irrelevant. What counts is the overall result of biomedical research, which is implicitly assumed to be a ‘public good’. This may explain why patients do not allude to potential problems of research being influenced by economic interests. Furthermore, patients deploy rather pragmatic narratives. The process of informed consent is seen as one of the many routinized hospital procedures that first and foremost serves the needs of the institution. Patients perceive informed consent partly as protection for the system from those patients who do not share their rather positive and supportive view of the medical system. Jasanoff’s (2005) notion of ‘civic epistemology’ allows us to understand the patient’s act of giving consent as a way of making sense of the specific technoscientific system at stake. Civic epistemologies may vary across cultures and comprise certain understandings of the roles of experts and institutions, knowledge-making procedures, trust relations, the relevance of public accountability, and so on, and, thus, they are essential for stabilizing a socio-biomedical system. In our case, the trustworthiness of institutions (a university hospital), a well-entrenched subordination to expert authority, and the patients’ rather positive progress-oriented image of the biomedical research built on solidarity are the cornerstones for their understanding of the medical system. This civic epistemology is strongly bound to the Austrian context with its still rather generous health care system, and to the way authority is performed in doctor– patient relations, the idea of a paternalistic state with a subordinated citizenry, as well as to a widely shared culture of non-conflict. Hence, it is not the specific place, doctor, or procedure that is central for the appraisal of informed consent, but rather people’s much broader understanding of how society and its subsystems function. Another facet of the consent process becomes visible when informed consent is understood as a ‘technology of community’ (Rose, 1999), where patients imagine themselves (and are imagined by others) to be a certain collective that should contribute to the advancement of science through their ‘donation’. Thus, through the process of being asked to participate, patients start to perceive themselves as members of a ‘donor collective’. This perception of a collective became visible as many patients expressed their fear that others may not behave in the ‘responsible’ way that they did. We argue, therefore, that patients integrate the act of consenting with previous experiences, and they build on divergent sources of knowledge that enable them to ignore technical information provided in the consent form and to keep the focus on what counts as relevant to them at that specific moment. Patients opt out of the ‘information paradigm’ and, instead, make use of different sets of experiences and imaginations. How patients respond to consent forms, then, raises the question of what is relevant (information) to them in such a process. Even actors representing the medical system are well aware of the gap between bioethical ideals and clinical realities. Hence, informed consent appears to be a ritual that serves to maintain a system, as its very presence in the clinical routine silences ethical reflection. Assuming that there is this gap between an ideal and the actual practice of informed consent, and given that patients do not make a decision based primarily on the Dep ar t m ent of Soc ial St ud ies of Sc ienc e | Univer sit y of Vienna 2009
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factual information provided but rather take other resources into consideration, does it matter? Because patients have apparently found their own ways of handling the situation, the question remains as to why bother them with informed consent since it is evident that they do not want to be ‘educated’ through medical information before they make a decision. If we agree that there is a fundamental discrepancy between the ideal and the practice of informed consent, then our first reaction might be to suggest changes to the current procedures of informed consent. We could follow the patients’ comments regarding potential changes to the form’s text. We might propose that the medical student stays a bit longer at the bedside and tries to reduce hierarchies inherent in such conversations. All these things would be a welcomed change, certainly. However, the question still remains ‘What would it change?’ Indeed, based on our observations we want to question whether the issue is simply one of providing information more efficiently. While one could argue that challenging informed consent may not matter in our concrete setting because patients feel fine about donating their tissue, that the formal rules have been followed and the research continues, we think that there are more socio-political challenges to be addressed, especially if we situate our observations in the context of debates around knowledge society and its diverse manifestations. The ‘scientific citizens’ (Irwin, 2001) – as we met them in the form of our patients – do not only obtain more rights in terms of making their own decisions, they also must often assume unsolicited responsibilities. Hence, it is not sufficient to focus on understanding information-centred ways of knowing, but rather we need to better grasp the collective (and more individual) ‘epistemologies’ at work. The possibility of medical professionals engaging with patients through informed consent is undermined by increasing routinization and formalization processes. The materialization of bioethical ideals in consent forms represents a one-sizefits-all solution without taking into consideration that the selected information might be devoid of meaning to patients. The formalization of ethical reflection further explains why it is possible that an ethical assessment of research, as well as of informed consent, have become partly commercial services offering standardized forms and ‘Ethical Review Red Teaming’11 to ensure that research projects are formulated in a way that passes ethical reviews. Such developments imply that ethics gets caught in formalisms and dressed up as merely legal concerns, or they are ‘managed’,12 and thereby lose their potential as a way of reflection of practices. We further argue that through the current practice of informed consent to medical research an important opportunity is missed: it is, indeed, one of the few occasions where the biomedical system could engage with patients ‘upstream’, that is, very early in the innovation process. If the knowledge society aims to raise citizens’ awareness concerning science and research, its possibilities and limits, then an exchange early on would be an ideal moment for creating a more robust relationship. Other-
11
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In order to ensure that projects pass the ethical review procedures under EU Framework Programme 7, enterprises offer consulting for research proposals See http://ec.europa.eu/research/sciencesocity/index.cfm?fuseaction=public.topic&id=368&lang=22&CFID=6513329&CFTOKEN= 60b6803837a5ed47-B526326D-9FB1–5AF4–8DA480F0C493DBA0 (accessed 28 August 2007).
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wise, the question becomes one of how long and under which circumstances the public stays compliant in the current fragile settings when actors rely mainly on the trust of patients and the trustworthiness of biomedical institutions. One might ask now, who would be the addressees of our observations? Indeed, based on our own approach, we would stress that neither is there one specific addressee nor is there one particular moment in which a more reflexive handling of the interaction between the worlds of patients and the worlds of biomedicine should take place. Rather, it is an awareness of the complexities and challenges biomedical research poses to contemporary societies that needs to be cultivated across many different places, from the ethics committees to the bedside – maybe in terms of what Wynne (1993) aptly labelled ‘institutional reflexivity’.
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