Constructing, framing and categorising risk

One conceptual notion of risk departs from the politics of risk definition, based on the assumption that ‘whoever controls the definition of risk controls the rational solution to the problem at hand ’(Slovic 1999: 689). In tissue

engineering there is no such thing as ‘the definition of risk’ though, as broad variability exists between different professional groups on how to frame risk issues, highlighting ‘the contested nature of who is defining what as risk and how’ (Adam et al. 2000: 4).

My study discusses different interpretations of risk as frames as a means of

‘shaping, focusing and organising the world around us’ (Lewicki et al. 2003:

11). Framing, then, is the activity and process of creating and representing frames; of interpreting and making sense of what is going on. These frames are no static entities and not permanent, but are fed by new experiences and

information which can lead to ‘reframing’. I prefer to label this process in terms of ‘reconstructing’ frames and boundaries, to denote my interpretation of frames as social constructions as a meaningful way of discussing different interpretations of risk (see also later). Furthermore, and typically, frames are used to 1) define issues as problematic or not, 2) shape what actions should be taken and by whom, 3) protect oneself by recourse to legal or other rights, 4) justify a stance taken on an issue, and 5) mobilise people to take or refrain from action on issues (Lewicki et al. 2003: 15-19). Risk frames in this case stem from differences in how various stakeholders view the type and level of risk associated with a particular phenomenon.

As such, frames become most explicit in situations of conflict and controversy.

Risk controversies have been described extensively in the literature, where Vaughan & Seifert (1992) take the stance that disagreements about risk can be

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traced back to substantial variation in underlying belief and value systems. The authors present three themes that dominate debates about public health and environmental risks, which are of particular relevance to tissue engineering: the definition of risk (and related concepts), the weight or value attached to

different dimensions of risk, and the issue of framing or structuring the decision or policy problem (Vaughan and Seifert 1992: 120-121).

The first one relates to the issue of how to define risk. For example, the concept of risk tends to embrace broader dimensions for lay populations than for experts. However, this study demonstrates how the debate on risk also reveals broad variability in perception and assessment of risk within and between different professional groups involved in R&D in this technological domain. In my research I use a typology of risk assessment over three distinct but interrelated dimensions, based on scientific risk (safety), clinical risk

(efficacy) and commercial risk (marketability). A model depicting this classification is described later on in this section.

Furthermore, interested parties disagree about the factors that determine the (un)acceptability of risk, most notably regarding the value of health

considerations relative to economic benefits or technological advances, but also in how to weight the amount of uncertainty in scientific risk estimates or the importance of immediate versus long-term consequences. I argue how risk debates in tissue engineering are driven by a broad range of considerations, extending the health versus economic nexus and also including more

differentiated concerns. In my research I demonstrate how a hierarchy of risk is constructed based on two dimensions: first in terms of risk domains (safety, efficacy, marketability), but across sections based on the particular engineering route and cell source used in tissue engineered applications (autologous

versus allogeneic).

Finally ongoing debate exists over how to conceptualise or frame risk issues.

One important question addressed under this heading is whether the

management of (public health) risks is about fairness regarding the distribution of risk and benefit in society, or belongs to scientific and economic domains.

Another question is about the population affected, and if risk estimates should

be targeted at particular vulnerable groups (such as children) or expressed in terms of average risk to the entire population. Finally the levels of aggregation and the time-scale involved are critical. In my research I use the concept of

‘balance of risk’ to demonstrate different perceptions of (levels of) acceptable risk in a given context at one point in time and for particular groups affected.

Thus the balance of risk determines the level (e.g. in terms of individual versus collective) of risk management approaches, but also takes into account

acceptability overtime (‘inter-generational risk’).

These different frameworks of risk are important because they dictate which

‘solutions’ are constructed in the policy process, e.g. which risk management strategies are considered valuable and feasible, and what information is needed and useful in reaching a decision. It also has implications for the legitimacy of different viewpoints in the policy process. By analysing the key dimensions of the construction of risk in tissue engineering, and the different dimensions and values attached to variations in risk, risk framing is linked to policy implications. The construction of risk discourses is tied in with the expression of a technological, political or social acceptable solution. Thus the definition of risk is at the same time the definition of a solution.

A main concern for the conceptual use of the term ‘risk’ in my study relates to the understanding of risk perception as a socially constructed concept,16 but it also includes an interest in the policy implications of (differing) conceptual approaches to risk. By adopting a social constructivist perspective on risk, I move away from the view that scientific knowledge is composed of objective facts that can be explained, predicted and controlled, and as such provide the basis for decision-making.17 A technical approach of risk does not take into

16 As advocated by am ongst others Tom Horlick-Jones (1998). Also other authors have pointed out how risks are necessarily socially constructed, with ‘risk construction as a practice of manufacturing particular uncertainties that m ay have harmful consequences to ‘life’ in the broadest sense of the term ’ (Adam et al. 2000: 2).

17 At the sam e tim e the limitations of this approach should be noted here. Social constructivists deny the existence of an objective m aterial world and as such problem atise the notion of objective truth. Instead they em phasise the contingent basis of social reality, w here social facts are contested and subject to diversity of interpretation. The strength of this approach is its focus on broader social processes and the im portance of the social, political and economic context.

O n e criticism though is that social constructivism still involves objectivism because it assum es that the processes through which social problems are constructed are them selves objective facts which can be studied as such. Also social constructivism has been criticised for its

account the complex and socio-political nature of phenomena, including political dimensions (such as conflict or discrepancy over definition of what risks are and how they should be managed) or ethical concerns (including values in judgement of risk). By focusing on underlying values in risk

assessment and risk decisions, the starting point of analysis is a concern with the perceiver of risk, rather than with risk as a phenomenon in itself (which, in technical terms, is usually expressed as probability in one way or another).

Perceptions of risk, as has been argued, differ over place and time and per social setting, depending on the frame of reference or the social and cultural context is which risk is assessed and managed. While acknowledging that the notion of objective facts versus more subjective concepts of risk are in practice often blurred, and as such represent extremes in the ideal-typical spectrum, by understanding risks as value-based entities that cannot be separated from the policy-related science context, the door is open to analysing diverse belief systems that underpin different notions of risk. This provides a context for the shaping of a risk regulation regime, which is the focus of later chapters.

Against this conceptual background of framing of risk, the purpose of chapters 4 till 7 is to analyse the socially constructed or framed nature of risk in tissue engineering, including the various plural rationalities involved (compare Gabe 1995). As such, my study is not concerned with determining the accuracy of risk assessments or the success of communicating risk to the public, but rather with analysing how concepts of risk are constructed and agreed on in a broader arena. Risks are defined in particular ways that reflect the social and political setting or order, and with particular consequences for the public. Thus this research also aims to take into account the ways in which the constructions of risk shape the political debate in particular ways.

To this effect, my research analyses the wide-ranging accounts provided by professional groups involved in the front-end of tissue engineering research and development, namely scientists, clinicians and manufacturers. My focus is on how and to which extent risks are articulated in the different domains of tissue engineering R&D and in which ways they are framed and differentiated.

selective skepticism, w here W oolgar and Pawluch speak of 'ontological gerrym andering’

(19 85 ). With thanks here to Tom Horlick-Jones for pointing out these limitations.

To conceptually approach these different perceptions of risk, I adopt the

demarcation approach as described in chapter 1. I analyse these perceptions in terms of boundary drawing around particular risk domains and identify the boundary objects that move within and between the different risk domains (and beyond, which is of concern for regulation as discussed subsequently). The next section provides a classification model to engage with the three dominant social worlds of risk perceptions.

3.1.2 Perceptions o f risk in tissue engineering R&D: a classification