Since Roman law, all entities have been categorized and regulated either as persons or as things (subjects or objects). However, this conceptual, epistemological and regulatory dualism is currently being challenged by disruptive research and innovation, among which organoid research is a prominent example. The dualistic normative framework pertaining to health and life science research are disrupted by three different kinds of uncertainty. First, conceptual uncertainty (ontological uncertainty): how should one conceive of entities that cannot be categorized as either persons or things? What are they? Second, epistemological and methodological uncertainty: How do we know the characteristics of these entities called organoids? How do we address forms of uncertainty that cannot be evaluated through the use of statistical methods, i.e. risk? Epistemological uncertainty comes in two kinds, which can be categorized as qualitative, or strict, uncertainty and ignorance or non-knowledge. In order to develop ethically and socially robust ways of assessing the effects of organoid research and related technologies, there is a need to include these additional forms of uncertainty in the Health Technology Assessment (HTA). Third, regulatory uncertainty: this uncertainty emerges because parts of regulatory frameworks concerning the rights and duties of persons have been merged with elements of regulation dealing with the stewardship of objects or things. These forms of uncertainty are of particular importance. This project aims to address how these uncertainties arise in organoid research and develop a conceptual and regulatory framework able to overcome this dualism. From this follows also the need to communicate the potential and possible pitfalls of organoid research in ways that convey realistic- instead of hyped scenarios.
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