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Paper long abstract:

In the research of innovative drugs, the participatory role of most stakeholders is usually limited to enabling the 'technical' development and testing. Potential users, for instance, do enter 'the lab' but dominantly in their capacity of silent research subjects, whereas health policymakers are mainly implied as research funders or regulators. In fact, the connection between experimental phase and societal usage is typically restricted to positive outcome percentages of randomized clinical trials (RCTs) on which medicine agencies base their approval. As a result, implementation of the innovative drug frequently parallels frustration in users, health professionals, and policymakers. How to avoid this disappointment?

As embedded qualitative researchers in a Dutch RCT for nicotine vaccination to quit smoking, we have designed an empirical ethical study in which human activities, social processes, and norms and values are put center stage. Between 2009 and 2013, we have collected material on what research participants and other important stakeholders in the experimental health strategy expect, experience, and value. Fieldwork at the clinical trial location and more than seventy in-depth interviews have resulted in a thick description of nicotine vaccination from the standpoint of the people involved, while our analysis of the scientific debate in journals and international expert meetings suggests that the normative agenda of nicotine vaccination is incomplete. These findings have nourished an evaluative framework that all stakeholders, including developers, may use to bridge the science-society gap. It is to stimulate a two-way dialogue and offers ethical guidance in research and policy decisions around nicotine vaccination.