Making and Managing New Biological Entities: conceptual, ontological, epistemological, and ethical aspects

Abstract

Novel biotechnologies produce new person-related biological entities, such as cell-lines, organoids, and synthetic organisms, that tend to disrupt existing concepts, taxonomies, modes of evidence production, as well as moral norms and values. This urges the question of how we can manage these new person-related biological entities? By identifying and analyzing key conceptual, ontological, epistemological, and ethical aspects of such entities, this article provides a set of suggestions of how to make, manage, and regulate of such entities. In particular: To avoid conceptual vagueness and taxonomic confusion, we need to clarify how person-related biological entities relate to existing concepts, such as person, identity, consciousness etc., and to make new concepts, where necessary. Ontologically, we need to determine the thing-and person-likeness of such entities. Epistemically, we must provide measures to verify the characteristics of person-related biological entities and to provide high-quality knowledge of their implications (outcomes). Ethically, we must clarify the moral status, rights, and responsibility for and of the entities, and how they will change our norms and values. Addressing these generic issues up front may improve our making and managing of personrelated biological entities.