The project is coordinated by Jan Helge Solbakk at UiO with 7 other partners (the University of Insubria, Italy; the French National Institute for Health and Medical Research (INSERM); Leiden University Medical Centre (LUMC), the Netherlands; Århus University, Denmark; Université Catholique de Louvain (UCL), Belgium; University of Manchester (MAN), UK; The National Technical University (NTUA), Athens
Project abstract:
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.