Concluding remarks

As we have seen within this chapter, the understanding among clinical trials officers is that the patient is of outmost importance. Throughout this chapter, I have unfolded how this patient focus finds expression, and how in practice, the future patient gains priority over the real-time trial subject.

Within clinical trials officers’ aspirations to help patients as well as within the legal frameworks

surrounding their work, I argued, is embedded a weighing of risks for the present ‘trial subject’ that are held up against the possible benefits of the future patient as well as for society, and this is where the concept of ordinary ethics has aided the analysis. By analyzing the taken-for-granted understandings within a vocational community of practice among clinical trials officers, that are also codified into laws and enacted in practical daily work, I moved closer to understanding their ethical orientations. As Lambek (2010a) argues, in order to understand the ethical aspects of human life, anthropologists must study practices and judgments as they unfold in ordinary, everyday situations. It is these kinds of situations that I have described in this chapter to illustrate the ordinary ethical practice of clinica l trials officers.

However, ‘ethics’ does in fact also become explicit in situations when this ordinary flow of practice and agreement is breached (Lambek 2010a:2). For example, as described early in this chapter, I have heard numerous accounts of the medical experiments conducted on concentration camp inmates during the Second World War, and clinical trials officers make a concerted effort to distance themselves from these events in arguments for why legislation and the GCP guidelines are needed. Such situations, I would argue, only underscore Lambek’s argument that the extraordinary is inevitably linked to the

192 ordinary, and that what is consciously defined as un-ethical can be understood only in relation to an ordinary, unnoticed backdrop of the ethical.

Thus, extraordinary moments, where actions are recognized as explicitly ethical or unethical, must be preceded by an ordinary ethics with common-sense criteria that can be breached. Although the ordinary and extraordinary are not easily separated, I have strived to outline the ordinary ethics as expressed in the criteria and judgments that are part of everyday work and which are undertaken as common-sensical actions without active deliberations about the ethical nature of these actions. I distinguish the extraordinary from the ordinary as moments where deliberations take place around issues explicitly stated as ethical dilemmas.

I ended this chapter with one such extraordinary moment, where clinical trial officers explicitly discussed an ethical dilemma and where some of their available choices were rejected precisely because they were assessed as un-ethical. The tipping point for the clinical trial team in this example, which distinguished this case from the ordinary focus on the future patient, was the sudden absence of a future patient that could be helped, as there was no longer a product in sight; the ethical dilemma was tied to the sudden loss of potentiality.

Within this chapter, I have begun to answer the second research question¹¹⁹ by exploring how Ferring’s ethics program is interpreted and enacted as it travels into the vocational community of practice among clinical trials officers. I have shown how clinical trials officers exercise practical, ethical judgments and how they tie the values and understandings of their vocational community to Ferring’s ethics program. I demonstrated that the clinical trials officers’ understandings of the ethics program are informed by the logics that reign within their vocational community and in the legislative frameworks that surround their work.

Returning to the definitions of corporate ethics programs brought out in Chapter 2, most scholars distinguish between compliance-oriented programs that focus more on detection and punishment of legal wrongdoings versus values-oriented programs more oriented towards creating a supportive environment for guiding employees’ behaviour (Martineau et al. 2016; Paine 1994; Weaver and Treviño 1999). As argued in Chapter 4, Ferring’s ethics program is a highly values-oriented program; perhaps even more so due to the Scandinavian national cultural heritage and the Global Ethics Office’s

119 ‘How is Ferring’s ethics program interpreted and enacted as it travels into different vocational communities and across levels in the organizational hierarchy?’

193 educational approach. However, despite previous research highlighting that a values-oriented approach is more likely to foster ethical reflection and conduct (Stansbury and Barry 2007; Weaver and Treviño 1999), I found that the efforts of the ethics program to stimulate ethical reflection among the clinical trials officers were dismissed as sheer ‘common sense’; they considered that ‘ethics’ was taken care of by GCP and the legislative requirements for Independent Ethics Committees (IECs) to approve the clinical trials. They did not perceive themselves as in need of an ethics program, as they were ethical already.

Weaver and Treviño (1999) warn that the threats of punishment in compliance-oriented programs may be counterproductive, as employees will feel distrusted by this approach and may potentially rebel against these programs as a result. However, what I found is that a values-oriented program can also be counterproductive if the values it seeks to disseminate are perceived as superfluous or paternalistic.

Among the clinical trials officers, the ethics program was disregarded; not because it was too compliance-based or too rigid, as Weaver and Treviño found, but because it was perceived to be redundant. The ethics was simply ‘common sense’.

As argued by Stansbury and Barry (2007), ethics programs that rely on control mechanisms and more coercive measures may diminish employees’ ability to tackle ethical questions, as these methods tend to remove employees’ accountability because they separate their reflection on ethical issues from the execution of their daily work.

Similarly, the organizational environment seems to play a significant role for clinical trials officers, as the presence of the GCP guidelines, legislation and particularly the IECs seems to remove the ethical responsibility from clinical trials officers and delegate this responsibility to IECs. This resembles the separation of ethical reflection and daily work that Stansbury and Barry (2007) warned against.

Thus, the values-oriented ethics program is disregarded because of the aforementioned understanding that it is common sense and because there is already a strong compliance-oriented environment surrounding the work of clinical trials officers. Scholars have defined such environments as High Reliability Organizations (HRO), i.e. organizations working in fields where mistakes can have severe consequences and which therefore operate with strict procedures for ensuring compliance with processes and policies (Griffith 2015; Weick and Sutcliffe 2007). Examples of such organizations are nuclear power plants, hospitals or airports.

With their close attention to monitoring, following procedures and regimes for registering data, actions and decisions, the clinical trials officers also work in a high-reliability environment, and this contextual factor seems to contribute to how the ethics program is understood among clinical trials officers.

194 Moreover, their self-understanding of working to help patients is another contextual factor that affects their view of the ethics program.

Based on these insights, I would argue that in order to understand the workings of corporate ethics programs, we need to understand them in wider terms than either compliance-oriented or values-oriented. As outlined in Chapter 2, Martineau et al. (2016) have recently pointed out that ethics programs in organizations rarely bear characteristics of only one of these two ideal types. Martineau et al. have suggested that ethics programs should be defined according to the composition of various ethics practices (e.g. detection practices, training practices and structural practices). While this is an important nuance of the dichotomist conception of compliance-orientation versus values-orientation, the insights from this and the previous chapter indicate that this distinction is not sufficient. Two further nuances are needed to further specify the conceptualization of ethics programs.

First, as demonstrated in Chapter 4, Ferring’s ethics program bore strong traits from Scandinavian national culture, and other scholars have found similar national cultural traits in ethics (and

compliance) practices in previous studies (see e.g. Barmeyer and Davoine 2011; Helin and Sandström 2010; Nakhle and Davoine 2016). Therefore, I would argue that ethics programs should be understood as contextually contingent. Although what I found in the previous chapter was a national culture contingency, I deliberately do not phrase it as (national) culturally contingent, as national culture is not the only contextual parameter that may be relevant for how ethics programs are shaped.

Second, I would argue that the environment in which the ethics program operates needs to be taken into consideration when understanding such programs. In the case of clinical trials officers presented in this chapter, the organizational environment was highly compliance-oriented, which seemed to

influence how the staff perceived the ethics program. Thus, if the scientific purpose of defining an ethics program is also to predict responses to this program, I would argue that such programs should be defined according to their values- or compliance-oriented ethics practices comprising these programs (cf. Martineau et al. 2016) as well as in terms of the characteristics of the organizational environment in which this practices are enacted. Although contextual elements are not strictly part of these practices themselves, and thus not part of the conceptualization of ethics programs, I would argue that the organizational context into which they are introduced needs to be systematically linked to such conceptualizations due to their importance for how programs may be received by those subjected to them. Thus, an ethics program may consist of both values- and compliance-oriented ethics practices, as

195 pointed out by Martineau et al. (2016). Moreover, these practices operate in an environment which most likely will comprise several characteristics but which may bear certain traits more strongly, as was the case among the clinical trials officers introduced in this chapter, where the characteristic of the organizational environment as highly compliance-oriented was particularly present.

Recalling Weaver and Treviño’s definition of ethics programs as control systems, cited in Chapter 2, they write that ethics programs ‘aim to create predictability in employee behaviour and

correspondence between specific employee behaviours and more general organizational goals and expectations’ (Weaver and Treviño 1999:317; for a similar definition, see Kaptein 2009), I suggest that this definition be enhanced by adding a tripartite conceptualization. The three elements of the

definition of ethics programs would thus comprise:

(1) Ethics programs are:

Normative and contextually contingent control systems aimed at creating predictability in employee behaviour and a correspondence between specific employee behaviours and more general

organizational goals and expectations (cf. Weaver and Treviño 1999).

(2) Ethics programs contain:

A combination of ethics practices¹²⁰ which are often characterized as being either predominantly values-oriented or predominantly compliance-oriented

(3) Ethics Programs work:

Differently depending on whether the organizational context into which they are introduced is predominantly compliance-oriented or predominantly values-oriented.

I will return to this definition in Chapter 9 and now turn to another vocational community of practice.

120 As defined by Martineau et al. as ‘any rule, method, procedure, process, management tool, structure, or institution that presents an essential teleological character aiming at increasing consciousness, reflection and ethical behavior in an organization, at the individual, collective and strategic levels’ (Martineau et al. 2016:793).

196

6. The Ordinary Ethics of Pharmaceutical