Background: Organoids and organoid research
Organoid research comes with ambitious promises of revolutionizing biomedical research in the future and with it our view of the human organism and life itself. An organoid is an organized cluster of cells generated in vitro from different kinds of stem cells (either pluripotent or derived from some types of adult tissue) through the use of 3D tissue culturing methods. By using organ-specific cell types, such entities might serve as “three-dimensional culture models” mimicking the structural and functional properties of different organs, both human and non-human such as the retina, heart, brain, intestine, kidney, pancreas, liver, inner ear and skin.
Challenges: Neither a person nor a thing
Since Roman law, all entities have been categorized and regulated either as persons or as things (subjects or objects). Organoids, however, are entities, and organoid research and organoid-related technologies are examples of disruptive research and innovation that challenge this conceptual, epistemological and regulatory dualism. It involves three different kinds of uncertainty:
Objectives: Create new regulatory framework
HYBRIDA will address how these three kinds of uncertainties arise in organoid research and will develop a conceptual and regulatory framework consisting of: (a) Operational guidelines for the field, (b) a code of conduct (CoC) for researchers in academia and industry, (c) a set of contributions to existing ethics and normative frameworks and, if needed, (d) a supplement to the European Code of Conduct for Research Integrity (ECoC).
CFA in HYBRIDA: Co-creation and validation
CFA will be leading a central work package in HYBRIDA, which will encompass a three-stage co-creation and validation process:
Project info: Horizon 2020 project with 8 partners
HYBRIDA is a Horizon 2020 project that runs from 2021 until 2024. It involves eight partners: University of Oslo (coordinator), National Technical University of Athens, University of Manchester, Université Catholique de Louvain, Aarhus University (CFA), Leiden University Medical Center, French National Institute for Health and Medical Research, and Insubria University in Italy. The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101006012.