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Embedding a comprehensive ethical dimension to organoïd-based research and resulting technologies

Project description

Studies for ethical dimension in organoid research

Organoids are miniaturised and simplified versions of organs produced in vitro – derived from cells. This technology has been developed to study diseases and treatments in a laboratory. But organoids brought disruption to the dualistic normative framework related to health and life science research. Since it is not clear whether it should be categorised as a subject or an object, three uncertainties must be overcome: conceptual (ontological), epistemological/ methodological, and regulatory. The EU-funded HYBRIDA project will study these uncertainties in organoid research with the goal to develop a conceptual and regulatory framework that will allow to overcome dualism. The aim is to build a comprehensive ethical dimension for organoid-based research and resulting technologies.

Objective

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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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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CSA - Coordination and support action

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Call for proposal

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(opens in new window) H2020-SwafS-2018-2020

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Coordinator

UNIVERSITETET I OSLO
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 857 741,66
Address
PROBLEMVEIEN 5-7
0313 Oslo
Norway

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 857 741,66

Participants (7)

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